Appendix D7: Specimen Transport Log: Bbss Site lab . ...... The social marketing strategy for the BBSS stipulates that p
Appendix 3.6.1: BBSS Operations Manual
Biological and Behavioural Surveillance Survey (BBSS) among MSM [Country]
Operations Manual
PREAMBLE This operations manual is for the official use of the [country] Ministry of Health’s MSM Biological and Behavioural Surveillance Survey (BBSS) and is a confidential document. Reading of or use of this manual is restricted to personnel of: the Ministry of Health of [country] (MoH) BBSS study team and its Steering Committee; the National Alliance of State & Territorial AIDS Directors study team (NASTAD); Centers for Diseases Control and Prevention; and BBSS field staff. This manual stipulates how all activities related to the MSM BBSS should be implemented. It is imperative that these guidelines be followed in order to ensure the smooth operation of the study. The information contained herein is not to be discussed beyond the realm of the aforementioned personnel. It is the sole responsibility of the reader to observe this strict confidentiality clause with respect to the BBSS in general and this manual in specific. A decision to read the remaining material found in this manual will be taken as acceptance to observe strict confidentiality.
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ACKNOWLEDGEMENTS This operations manual has been adapted from two very helpful resources: the operations manual for the [country] Ministry of Health’s BBSS with MSM (2012), and the Centers for Disease Control and Prevention’s National HIV Behavioral Surveillance System survey with Heterosexuals (NHBS–HET2, 2010). The [country] study team would like to extend their sincere thanks to the authors of these two manuals for sharing their study documents to be adapted, and for sharing other expertise related to survey implementation.
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TABLE OF CONTENTS Glossary of Terms ..................................................................................................................................... 1 I. Introduction ............................................................................................................................................ 3 Overview ..................................................................................................................................................... 3 Background and Context ............................................................................................................... 3 Survey Methodology...................................................................................................................... 4 II. Staffing................................................................................................................................................... 9 Overview ..................................................................................................................................................... 9 Research Team ................................................................................................................................ 9 Onsite Study Staff ........................................................................................................................... 9 Human Resource Plan ................................................................................................................. 11 Staff Training ................................................................................................................................. 12 III. Survey Implementation Materials ................................................................................................ 15 Overview ................................................................................................................................................... 15 Survey Logo................................................................................................................................... 15 Coupons ......................................................................................................................................... 15 IV. Field Site Management .................................................................................................................. 20 Overview ................................................................................................................................................... 20 Creating a safe and trusting survey environment ................................................................... 20 Hours of Operation ...................................................................................................................... 20 Prior to first visit ........................................................................................................................... 20 Participant Flow ............................................................................................................................ 22 First Visit Procedures ................................................................................................................... 23 Second Visit Procedures .............................................................................................................. 37 [City] procedures .......................................................................................................................... 41 V. Lab procedures and sample preparation ....................................................................................... 42 Overview ................................................................................................................................................... 42 Testing room set-up at the Survey Site ...................................................................................... 42 Biohazard Waste ........................................................................................................................... 44 On-site storage .............................................................................................................................. 44 Transport of prepared samples .................................................................................................. 44 Processing by Regional laboratories .......................................................................................... 45 Processing by Reference Laboratories ....................................................................................... 45 Results generation ........................................................................................................................ 46 Referral ........................................................................................................................................... 46 Rejection Criteria .......................................................................................................................... 46 VI. General Survey Site Management ............................................................................................... 48
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Overview ................................................................................................................................................... 48 Crowd Control .............................................................................................................................. 48 Field safety..................................................................................................................................... 48 General Guidelines ....................................................................................................................... 48 Difficult situations ........................................................................................................................ 49 Reporting adverse events ............................................................................................................ 51 Data Transfer ................................................................................................................................. 51 VII. Appendices....................................................................................................................................... 52 Appendix A1: MSM Screening Questionnaire..................................................................................... 52 Appendix A2: Security Questions ......................................................................................................... 55 Appendix B1: BBSS Incentive Tracking Form ...................................................................................... 56 Appendix B2: Coupon Distribution Questionnaire ............................................................................ 57 Appendix C1: Informed Consent Form ................................................................................................ 58 Appendix C2: FIRST VISIT Checklist.................................................................................................... 63 Appendix C3: Subsequent Visit Checklist ............................................................................................ 64 Appendix D1: Lab Form ......................................................................................................................... 65 Appendix D2: PHLEBOTOMY CHECKLIST ....................................................................................... 66 Appendix D3 NURSES CHECKLIST .................................................................................................... 68 Appendix D4: Pre and Post HIV Testing Guide .................................................................................. 69 Appendix D5: Specimen Storage Log ................................................................................................... 70 Appendix D6: Batch Log ......................................................................................................................... 71 Appendix D7: Specimen Transport Log: Bbss Site lab ..................... Error! Bookmark not defined. Appendix D8: Specimen Transport Log: lab to [country] .................................................................. 72 Appendix D9: Specimen Transport Log: lab to [NAME OF LAB] .................................................... 73 Appendix D10: Specimen Shipping Log............................................................................................... 74 Appendix D12: Ladymeade Lab Form................................................ Error! Bookmark not defined. Appendix D13: HIV Testing Algorithm................................................................................................ 76 Appendix E1: Recruiter Script ................................................................................................................ 77 Appendix E2: Facility list for treatment and care ................................................................................ 79 Appendix E3: Participant Contact Information ................................................................................... 80 Appendix G1: Field Supervisor Daily Checklist.................................................................................. 81 Appendix G2: Coupon Manager’s Checklist ....................................................................................... 82 Appendix G3: Interviewer Checklist ..................................................................................................... 83 Appendix G5: Field Supervisor Evaluation Form ............................................................................... 86 Appendix G6: Coupon Manager Evaluation ....................................................................................... 88 Appendix G7: Interviewer Assessment Form ...................................................................................... 90 Appendix G8: HIV Counselling & Testing/ Phlebotomist Evaluation Form ................................. 92
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Table of Tables
Table 1: Research Team - MSM BBSS ............................................................................................................ 7 Table 2: All Staff Training ........................................................................................................................................ 12 Table 3: Selected Staff Training ............................................................................................................................... 13 Table 4: Performance Evaluation Schedule ........................................................................................................... 13 Table 5: Coupon ID numbers for seeds and three survey sites .......................................................................... 15 Table 6: Forms for BBSS ........................................................................................................................................... 19 Table 7: Laboratory test results and processing ................................................................................................... 30
Table of Figures Figure 1: RDS Recruitment Waves ...........................................................................................................................5 Figure 2: Survey Logo .............................................................................................................................................. 15 Figure 3: Front side of Coupon ............................................................................................................................... 16 Figure 4: Back Side of Coupon ................................................................................................................................ 17 Figure 5: Participant Flow - Second Visit .............................................................................................................. 39 Figure 6: Participant Flow - Second Visit .................................................................................................... 23
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GLOSSARY OF TERMS Acquired Immune Deficiency Syndrome (AIDS): The syndrome caused by the human immunodeficiency virus that presents with opportunistic infections, immunosuppression and other symptoms. Biological and Behavioural Surveillance Survey (BBSS):Data collection consisting of two elements: 1) a survey of behaviours and knowledge related to risk of acquiring the disease(s) of interest, and 2) biological testing to determine the participant’s disease status with respect to each disease. Bridge: An individual engaging in high-risk behaviours who is also connected with the general population, thus increasing the risk of HIV transmission to a larger, lower-risk group. CDC: United States Centers for Disease Control and Prevention. United States Government agency providing technical assistance and funding to the [country] Ministry of Health and NASTAD to support the implementation of Key Populations Surveillance in [country]. Focus group discussion: A qualitative data collection method where one or two moderators pose interview questions to the group that are discussed between participants. Formative assessment: A study conducted prior to the implementation of a larger research project. Its primary objective is to answer questions in order to facilitate the implementation of the main survey. Human immunodeficiency virus (HIV): A virus transmitted by the transfer of bodily fluids that targets human immune cells, leading to immunodeficiency and AIDS. In-depth interview: A guided interview with an individual who self-identifies as a member of the population of interest. Incentive: An object or non-tangible gift offered to individuals recruited for the formative assessment to compensate them for their time and effort during their participation. An incentive may be of monetary value or it may be a health screening test, which has value only to the participant receiving it. Informed consent: A participant’s informed decision to participate in an interview or discussion after having received information about the purpose, procedures, risks and benefits, and that participation is voluntary. Men who have sex with men (MSM): The term is applied irrespective of the individual’s sexuality or self-identification, and is used to identify men who engage in anal or oral sex with other men.
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Key Populations: One of various sub-groups that is at elevated risk of HIV infection or transmission because they engage in specific, known high-risk behaviours and/or are stigmatized by the general population. Key Populations Steering Committee: Multi-sectorial Advisory Committee to MoH consisting of individuals with local content expertise in service provision and policy formulation for Key Populations. Ministry of Health: The Ministry of Health is the national authority charged with oversight of the entire health system in [country]. The Ministry plays a central role in the protection of the population’s health and in ensuring that all organisations and institutions that produce health goods and services conform to standards of safety. National Alliance of State and Territorial AIDS Directors (NASTAD): Technical assistance partner supporting the Ministry of Health in the implementation of Key Populations surveillance in [country]. Recruitment: In respondent-driven sampling, the process of providing coupons to participants and following up on coupons distributed, with the ultimate goal of identifying enough eligible survey participants to reach the stated sample size. Respondent-driven sampling (RDS): Chain-referral sampling that starts with a limited number of “seeds” who refer their peers. RDS is based on the theory that bias in recruitment is overcome after recruitment proceeds through a sufficiently large number of waves. Statistical adjustment is accomplished through the use of RDSAT based on respondents’ network size. Respondent-Driven Sampling Analysis Tool (RDSAT): A statistical software that is used to adjust RDS survey and to display participant recruitment patterns. Respondent-Driven Sampling Coupon Manager (RDSCM): A software package that tracks the distribution of incentives, survey recruitment and identified physical markers to facilitate survey participants’ identity verification on subsequent visits to the survey office. Seed: An individual who is well-connected within the networks of the surveyed community. Each seed will recruit individuals within his network to start the waves of sampling in RDS.
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I. INTRODUCTION Overview A biological and behavioural surveillance survey integrates biological testing for key diseases like HIV with a behavioural survey to provide comprehensive information on disease prevalence and behavioural risk profiles among a given population. Men who have sex with men (MSM) have been identified as one of the Key Populations for HIV infection in [country]. Key Populations are characteristically ‘hard-to-reach-populations’ and as a result there are often significant gaps in behavioural and epidemiological knowledge about these groups, including their risk behaviours and HIV prevalence. Gaining information about MSM is one of the surveillance priorities in [country], especially in light of the behaviour of unprotected anal sex which is known to be one of the high risk mechanisms for HIV transmission. Background and Context There is a dearth of information on HIV infection among Key Populations, including MSM, in [country] and few targeted prevention initiatives for MSM currently exist. To date, there have been no national biological and behavioral surveillance surveys (BBSS) conducted amongst MSM in [country]. The current surveillance activity will be carried out by the [country] Ministry of Health with technical assistance from the National Alliance of State and Territorial AIDS Directors (NASTAD) and technical support and funding from the United States Centers for Disease Control and Prevention (CDC). Estimated HIV prevalence among adults in [country] is x.x% nationwide. According to the Surveillance Unit at the MoH of [country], by the end of 2009, approximately xx,xxx persons were living with HIV in the country. Trends in surveillance data show that men have historically outnumbered women in testing positive for HIV. There have been several attempts to estimate point prevalence among MSM in [country], with results ranging from xx to xx percent prevalence, however these estimates are not generalizable to the larger population due to the use of non-random sampling and low sample sizes. In addition to the available research data, UNAIDS reported in 2005 that same-sex transmission among males accounted for approximately x.x% of HIV prevalence in [country]. The overall objective of this study is to collect representative behavioural and biological information about MSM in [country]. This study aims to identify and recruit MSM, determine the prevalence of HIV and selected STIs and chronic diseases, identify and describe HIV risk factors, inform on how to reach and serve MSM health needs and inform planning and implementation of care, treatment, support and prevention interventions among MSM. Specific study objectives: - To estimate the size of the MSM population in [country] 3
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To identify gaps in prevention services and methods to provide successful outreach and health services to MSM To determine the prevalence of risk factors and their associations with HIV and STI prevalence among MSM To determine the prevalence of HIV and other STIs among MSM in [country] To assess HIV and STI testing behaviours among MSM To contribute to available literature on HIV among MSM in [country] and inform planning and implementation of future activities targeting MSM
Survey Methodology As in other research studies, this project will use a specific sampling methodology that determines how to select study participants how data about them is gathered. It is important that this methodology is well-understood and followed by all persons involved in managing and implementing the research study in order to reduce bias, and assure the quality of the information produced. Respondent-Driven Sampling (RDS) is the methodology that will be used in this research study. In RDS, participants recruit their peers to participate, who in turn recruit their peers, thus forming chains of referrals. RDS is similar to the sampling method known as snowball sampling, but RDS accounts for and controls the biases that are inherent to chain referral sampling, and is therefore considered a more robust and scientifically rigorous sampling method. Formative assessment and survey promotion activities A formative assessment to learn more about the MSM population in [country] was conducted in 2011. This assessment yielded key information about the appropriateness of RDS methodology for this population. The formative assessment process and subsequent outreach to community members to inform them of the survey and gain their support for it were also intended to raise awareness of the survey so that MSM would be willing to participate if they were recruited. RDS Theory and Assumptions According to Heckathorn1, there are six assumptions about the chain-referral sampling process that must be met for RDS to generate accurate data and population estimates: 1) Respondents know each other as members of the target population, so ties must be reciprocal. 2) Participants recruit peers with whom they have a reciprocal relationship (i.e. the participant knows the recruit and the recruit knows the participant). 3) Respondents are linked by a network composed of a single component. Social networks have to be sufficiently connected for the chain-referral process to work. 1
Heckathorn, Douglas D. 2007."Extensions of Respondent-Driven Sampling: Analyzing Continuous Variables and Controlling for Differential Recruitment." Sociological Methodology. 4
4) Sampling occurs with replacement. The sampling fraction (ratio of the sample size to the population size) is small enough that it is unlikely the same participant will be sampled more than once. 5) Respondents can accurately report their personal network size (i.e. number of relatives, friends, and acquaintances who fall within the target population). Accurate personal network size is needed for data weighting. 6) Peer recruitment is a random selection from the recruiter’s network. Recruitment is not preferential with respect to key variables, such as race and age. Recruitment RDS begins with the non-random selection of a small number of initial recruiters or “seeds” by the study team. These seeds recruit peers who in turn recruit their peers. In this manner, participants become recruiters after successfully completing the survey. Recruiters are limited in the number of persons they can recruit by the number of recruitment coupons they are given. In this study, participants who are eligible to recruit their peers will be given three coupons which they can give to other persons to invite them to participate in the study. Recruiters are linked to their recruits by the unique number associated with each recruitment coupon. A key aspect of RDS is that participants receive dual incentives: a “primary” incentive for participating in the study and a “secondary” incentive for each eligible recruit who participates. Figure 1: RDS Recruitment Waves2
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Behavioral Surveillance Introduction to Respondent-Driven Sampling Participant Manual, CDC Global AIDS Program, September 2007 5
Figure one illustrates how the chain referral process can proceed from one seed. Each round of recruits following the initial seed is referred to as a wave. In general, the more waves there are in an RDS study, the more generalizable the results will be to the population being researched.
It is important to note that other than choosing the initial seeds, study staff do not recruit participants into the study in any way.
Instead of direct recruitment by study staff, there are several mechanisms to keep participant recruitment going on its own: Selecting Seeds The initial recruiters known as seeds are selected non-randomly by the study staff based on two important criteria: 1. Their affiliation with, representation of, or ability to recruit important subgroups in the MSM population. The formative assessment identified several subgroups of MSM such as: bisexual, closeted, out, transgendered, and young men. The seeds will be chosen to represent these key populations. 2. The seeds’ ability and willingness to be active in recruiting their peers into the study and helping their referral chains to grow by passive support of the survey project among their peers.
Training participants to recruit their peers At the end of a participant’s first visit to the study site, they will be trained on how to recruit their peers into the study. They are coached on what to say, who to recruit (i.e. should not recruit strangers) and the importance of reaching out to members of their network. Staff at the survey site will be crossed trained to perform multiple functions. The staff performing the Coupon Manager function is the primary staff person responsible for training the recruiters. Field Supervisors will provide back-up coverage to all staff positions.
Introducing new seeds If some individuals from the initial group of seeds are not able to generate sufficient referrals in their recruitment chain, new seeds can be introduced to reinvigorate recruiting. New seeds will be introduced as necessary during the initial weeks of the survey. If recruitment continues to be slow, additional coupons may also be offered to stimulate peer recruitment or incentive levels may be changed to further motivate recruiters.
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Further promotion of the survey or information gathering among MSM may be conducted by the Study Lead if it is found that recruitment is slow due to lack of knowledge about the survey and its objectives, or if there are obstacles such as survey locations and operating times that are impeding recruits’ participation.
Eligibility As this survey is focused on sampling from the MSM population in [country] to determine the HIV prevalence and risk behaviours among that group, only certain persons will be eligible to participate in this study. To be eligible for this study, participants must: -
Be born male Currently be of the male sex although not required to identify as a man Have had oral and/or anal sex with another male in last 12 months Be aged 18 or older Have been a resident of [country] for the past 6 months
All recruits will be screened for eligibility prior to being enrolled in the study by answering questions on a computer, with the assistance of an interviewer. If any recruit does not match all of the above criteria, they will be respectfully informed that they will not be able to participate. Persons who come to survey sites with a valid recruitment coupon but are not eligible to participate will be given a [currency amount] non-cash voucher to compensate for their time. If recruit appears to be drunk, high, drowsy or disorderly as he is being assessed for eligibility, he will not be enrolled in the study. To ensure the highest ethical standards and the gathering of quality data, it is important that all participants are alert and functional throughout the course of their participation. Study staff will be responsible for assessing recruits’ alertness during the eligibility screening, and will identify those they think might not be able to participate for the above mentioned reasons. If it is determined prior to the eligibility screening questions that the potential participant is incapacitated for any of the above indicated reasons, the recruit will be given the opportunity to reschedule this appointment. If the recruit is assessed as incapacitated after determined eligible to participate, the participant will be given a [currency amount] noncash voucher to compensate for their time but will not be allowed to reschedule. It is important that recruits are not made aware of all of the study’s eligibility criteria. Interviewers assessing eligibility can provide explanations for why someone isn’t eligible such as:
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“Our computer system has determined that you are ineligible for this survey based on your answers. A number of factors go into determining eligibility, and I am not sure which factors are involved in your case.”
Sample Size The co-investigators have decided on a sample size of xx men for this study. That means that this study needs xx men who are eligible and agree to participate after being informed about the study through the consent form.
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II. STAFFING Overview A variety of staff are necessary for implementation of the BBSS and good communication and teamwork are critical to the success of the survey. All staff are responsible for implementing study activities as described in the study protocol and this Operations Manual. In this section, the various roles and responsibilities of the study team and the BBSS field staff are presented. Research Team Principal Investigator and Co-Investigators The Principal Investigator (PI) and Co-Investigators are responsible for leading and implementing the BBSS as described in the study protocol approved by ethical review boards prior to the start of the study. They are also responsible for scientific oversight of the research process, and assuring the appropriate follow-up on any ethics violations or adverse events during the course of the study. The PI and other Co-Investigators also conduct much of the outreach to other agencies to raise awareness of and support for the research project. As such, the PI and Co-Investigators are the primary representatives of the study to other parties in [country]. Study Lead (Surveillance Study Coordinator) The Study Lead, also known as the Surveillance Study Coordinator, leads the implementation of the study and supervises field staff. She is responsible for training and coordinating with study staff to facilitate study progress on a day to day basis. The Study Lead oversees activities at each field site through the Field Supervisors, and reports on study progress or adverse events to the PI and the Co-Investigators.
Onsite Study Staff Field Supervisor The Field Supervisor has primary responsibility for day-to-day survey activities at their assigned site. The Field Supervisor is expected to manage the field site and the staff team; ensure data integrity; coordinate survey activities with the Study Lead; prepare, manage and reconcile incentives on a daily basis as well as ensure safety and security of field staff, participants and confidential data. Field Supervisors are also responsible for ensuring that survey protocols are implemented consistently from site to site in order to assure the quality of the research process.
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Data Manager The Data Manager is responsible for managing, entering (or overseeing data entry) and securing electronic and paper-based survey data at the Ministry of Health’s administrative base. The Data Manager works closely with study data and is responsible for data integrity for the survey. The Data Manager is responsible for confirming the proper transfer of information from the survey sites every day that the sites are operational. The Data Manager is responsible for data quality and the revision of data based on the data corrections log. The Data Manager also prepares datasets by compiling data from the different data sources, and produces regular reports for the PI and Co-Investigators to assess study progress. Coupon Manager The Coupon Manager is responsible for managing and tracking recruitment coupons, survey IDs and other participant data using the Coupon Manager electronic database. The Coupon Manager is also responsible for scheduling appointments, training study participants on recruitment of their peers, and coordinating check in/out activities with other members of the study team. Interviewer The Interviewer is the main point of contact for study participants at the field site. As such, the Interviewer is responsible for greeting participants upon arrival at the survey site, assessing their eligibility, and assuring their successful progression through the survey process. The interviewer may be called on to help administer the behavioural interview using Computer Assisted Personal Interview (CAPI) if the participant does not self-administer. Selfadministered surveys utilize the Audio Computer Assisted Survey Interview (ACASI) software.3 Phlebotomist/ HIV Tester The Phlebotomist obtains blood samples from study participants for diagnostic purposes. The Phlebotomist also performs an HIV rapid test; other tests are done by outside laboratories. The Phlebotomist is responsible for appropriately preparing specimens to laboratories for the conduct of testing outside of the survey site. The phlebotomists are also trained HIV testers and are therefore responsible for HIV pre and post-test counselling. Security Personnel The [city] and [city] sites will have security personnel posted at the reception desk. The security officer is responsible for assuring the safe and orderly conduct of personnel and visitors to the survey site. The officer is the first point of contact for all visitors to the site and is also 3
ACASI and CAPI facilitate administration of the behavioural interviews in an identical manner; the former includes audio recordings of the interview questions whereas the latter does not include an audio component. 10
responsible for granting access to the site and alerting the relevant staff members to the presence of participants at the survey site.
Table 1: Research Team - MSM BBSS Organisation
Ministry of Health
NASTAD
CDC
Name
Role
[provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual] [provide name of individual]
Principal Investigator Co-Investigator Co-Investigator Co-Investigator Study Lead Co-Investigator Technical Advisor Technical Advisor Technical Advisor Co-Investigator Co-Investigator Co-Investigator
Human Resource Plan For each day the site is opened, it is estimated that up to nine participants can be seen at each operating survey site, assuming that the site is running at full capacity. Survey sites might not run at full capacity for one of two reasons: 1. The survey needs time to start up and allow seeds to recruit their peers 2. There are fewer than nine recruits making appointments or walking into the survey site each day. Based on previous RDS studies, it is estimated that about three to four weeks is required for sites to start operating at full capacity. Considering that participants with valid coupons may be deemed non-eligible, it is estimated that the staff will need to receive more than 576 men at the survey sites to meet the target sample size. It is estimated that about 650 recruits will be processed across all survey sites to meet the target sample size. In order to assure a sufficient pool of appropriately trained staff for the survey, staff will be hired to enable each staff member work approximately 75% of full-time. It is anticipated that this approach will reduce staff fatigue. In order to staff the two full-time and one part-time sites, we estimate the need for the following numbers of persons for each staff position. a. Field supervisor: (x 3)
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b. c. d. e.
Coupon manager: (x 2) Data manager: (x 1) Interviewer: (x 5) Phlebotomist/ HIV Tester/Nurse: (x 3)
The Field Supervisor and interviewers would work approximately 75% FTE while the data manager and coupon managers will work approximately 40 hour weeks. The MoH’s peer-support programme will provide any follow-up psychosocial support needed by any participants. The peer support programme is staffed by personnel certified by the HIV/AIDS Coordinating Unit (HCU) to provide HIV-related psychosocial support. These personnel will be available on an on-call basis as their services are deemed necessary. Staff Training Thorough staff training is of utmost importance for the success of the survey. Some of the varied reasons for comprehensive staff training are listed here: The study is intended to produce national data on HIV among MSM for the first time in [country]. The information gained will be used for many purposes, including a baseline from which to assess progress over time. It is therefore essential that data must be of high quality. It is therefore vital that the RDS methodology is thoroughly understood and adhered to by the staff. The target population of this survey is a highly marginalized and stigmatized group. The sexual behaviours of this population are taboo and deemed unacceptable by many citizens. It is therefore imperative that the staff is well trained to interact with participants in a courteous and non-discriminatory manner. As a national, multi-site survey, there are many logistical elements that are important for study staff to understand and perform accurately in order to assure the success of the project. Staff training will focus on ensuring staff competency in the skills mentioned below in Table 2. The following training modules will be covered in staff training: Table 2: All Staff Training
Cultural competency with MSM Introduction to BBSS & study team Review of formative assessment process Research ethics BBSS survey promotion methods used Introduction to RDS method
Procedures for testing Incentives Aggressive behavior management Site Safety CPR training Recruiter training
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Introduction to activities and participant flow at survey site Recruitment process Consent process Coupon Management Essential interviewer skills
Confidentiality training o Confidentiality in the study process Confidentiality agreement with MoH Procedures for post-exposure prophylaxis/report of adverse events ACASI process and methods Team Building HIV & Related Health Systems Training
Table 3: Selected Staff Training
Data management RDSAT Laboratory procedures
Recruitment monitoring RDSCM Preparation of specimens for transport
Initial staff training to cover these topics will be conducted with new field staff in an interactive workshop-style setting. In addition, hands-on practice of field procedures learned in the initial training will follow at the [city] and [city] survey sites. These sessions will focus on assuring familiarity with procedures and tasks, with staff alternately role-playing as ‘staff’ and ‘participants’. All aspects of the study process will be practiced, including greeting, screening, entering participants into RDSCM interviewing, mock health screens, check-out, recruiter training and data transfer. Staff Performance Review All staff will undergo performance reviews on a regular basis. With prior consent of participants, staff will be periodically observed in key aspects of survey administration, such as eligibility screening, test counselling and administration of the survey questionnaire. A written form will be filed for each evaluation session. The following schedule (Table 4) will be used to conduct performance reviews:
Table 4: Performance Evaluation Schedule
Survey staff Field Supervisors
Evaluated by Study Lead, Principal/Co Investigator
Coupon Manager
Field Supervisor,
Frequency For first 3 weeks, once per week, then once per month thereafter For first 3 weeks, once per
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Study Lead Interviewers
Field Supervisor
Phlebotomists
Study Lead & [name of medical supervisor]
Data Manager
Study Lead, Principal/Co Investigator
week, and then once per month For first 3 interviews, and then every 10th ACASI/CAPI interview. At least 3 practice ACASI/CAPI interviews should be conducted and evaluated prior to the start of data collection For first 3 weeks, once per week, and then once per month For first 3 weeks, once per week, and then once per month
In addition, informal performance reviews will be conducted daily by the field supervisor, and periodically by the Study Lead. Based on these informal reviews, feedback will be provided to study staff.
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III. SURVEY IMPLEMENTATION MATERIALS Overview This section describes social marketing and communication materials to be used for the Survey. The procurement of survey supplies as well as educational and prevention materials are thoroughly reviewed herein. Survey Logo Figure two illustrates the logo of the BBSS which will be marketed as the ‘Men’s Health Survey’. The development of this logo was informed by the formative assessment. The purpose of branding the study with a logo is to promote survey recognition among the MSM population. The social marketing strategy for the BBSS stipulates that promotional materials are used in a limited manner with a focus within the MSM community. Since RDS relies on peer recruitment, it is crucial that the survey is known and trusted among community members to encourage participation. Therefore social marketing of the survey will be targeted and information about the survey will be shared only with entities and individuals approved by the research team. Gatekeepers within the community can be strategically involved in survey promotion. The survey will not be advertised among the general population. Figure 2: Survey Logo
[insert logo here] Coupons The recruitment coupons are a crucial aspect of preparing for the survey because they are used to identify and recruit individuals into the survey. An official study coupon linked to a previous participant will be required for participation; it identifies a participant as validly recruited and will be used to keep track of referral chains. These chains provide information about the size and strength of social networks, what types of people know and recruit each other, and the estimated size of the MSM population. Each coupon is preprinted with numbers that are unique and sequential. These numbers are three or four digits long and will reflect the type of coupon and the survey site where the recruiter was enrolled (i.e. [city], [city] or [city]). Table 5: Coupon ID numbers for seeds and three survey sites
Type of coupon Seeds [city] [city] [city]
Coupon ID 10-50 1000 - 1400 2000 - 2400 3000 - 3200
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For coupons other than the seed referral cards, the four digit numbers are linked to the recruiter’s survey ID number. Coupons include an expiration date, but participants will not be turned away for having an expired coupon until the study is in its final stages. While participants receive coupons, the seeds – the participants who begin the RDS chain – will be given referral cards. These cards will be printed with two digit ID numbers to alert the survey staff to the participant being a seed. Upon arrival at the survey site with a valid coupon or referral card, the two or four digit ID on the coupon (See Figures 3, 4 and 5) will become the survey identifier for the participant. This number will be used to label the participant’s behavioural survey and biological samples. Upon completing either the biological and behavioural components of the survey or the behavioural component alone, each participant will be offered up to three (3) coupons with which to recruit his peers. Participants may receive less than three coupons towards the end of the survey, when fewer or no coupons are issued in order to terminate recruitment into the study. Alternatively, a participant may opt to receive less than three (3) coupons if he indicates an inability to recruit three (3) peers to participate in the study. The research team may change the number of coupons distributed depending on the rate of recruitment. If recruitment is slow, the team may decide to increase the numbers of coupons given to each participant. Conversely, if recruitment exceeds the staff or site capacity to enroll participants, the numbers of coupons distributed may be decreased. Figures 3 and 4 illustrate the front and back of a coupon for ‘The Men’s Health Survey’. The following information is included on the front side of the coupon: 1. Coupon number ranging from 1000 to 3200 2. Name of the survey 3. Phone numbers to call for survey information and to schedule an appointment 4. Days and hours of operations 5. Cities where survey sites are located 6. Survey logo Figure 3: Front side of Coupon
[insert coupon] Figure 4 illustrates the back side of the coupon. The following information is included: 1. The name of the Survey
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2. Space for Survey Staff to record operations and tracking information 3. Space for participant to record date/time of appointment 4. An activation and expiration date
Figure 4: Back Side of Coupon
[insert coupon] Coupons are tracked and managed using the computer software Respondent-Driven Sampling Coupon Manager (RDSCM). The Coupon Manager will have primary responsibility for managing coupons in RDSCM. In addition to entering coupon information in RDSCM, a backup paper Coupon Distribution Log is maintained at each site to track the numbers of the coupons and their distribution. Returned coupons are also tracked and filed. These coupons will be labeled to reflect the manner in which they were used e.g. “Used” or “Void”. Labeling all survey documents with survey IDs [Location of site] [Location of site] [Location of site] Each paper document will be labeled with the participant’s survey ID number. These numbers are the same as the three or four digit ID numbers recorded on coupons and referral cards and [Contact number] [Contact number] [Contact number] serves as participants’ unique identifying ID that will link all elements of their participation in the survey. Survey Forms To assist with the quality assurance and daily operations of the survey, there is a comprehensive bank of forms that will be used by survey staff in the execution of the survey. Some of the forms are electronic while other forms are paper based. Table 6 below depicts a full list of all paper and electronic forms that will be completed by staff as part of this study. Prevention Supplies At the end of their first visit, participants will “check out” with the Coupon Manager and will be offered a range of prevention materials inclusive of condoms and lubricants, gifts with prevention messages as well as literature on disease prevention. Acceptance of these materials is not compulsory. Prevention literature/materials will also be available in the waiting area with appropriate signage inviting participants to avail themselves if so inclined. Restocking survey materials Some survey supplies will be prepared and available at the survey site before the start of the survey. Additional materials will need to be ordered on an as needed basis. Pre-printed items will be stored at the survey sites, and additional materials will be kept at the HCU Office and should be ordered by the Field Supervisor alerting the Study Lead when there are shortages or
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supplies are running low. The Field Supervisor should place orders with the Study Lead at least two to three weeks in advance of when supplies will be needed at the survey site.
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Table 6: Forms for BBSS
Focal Area Check-in
A1
Form MSM Screening Questionnaire
A2
Security Questions
Coupon Management
B1 B2
BBSS Incentive Tracking Form Coupon Distribution Questionnaire
Interviewing
C1 C2 C3 D1 D2 D3 D4 D5 D6 D7
Paper Paper Paper Paper Paper Paper Paper Paper Paper Paper
Explains all conditions, rights and responsibilities to inform participant prior to enrolling Tracks participant’s activities at the survey site during first visit to the survey site Tracks participant’s activities at the survey site during subsequent visits to survey site Records the results of all tests undertaken in the biological survey Tracking form for phlebotomist to ensure all procedures are followed in the medical room Tracking form for nurses to ensure all procedures are followed in the medical room Records HIV pre and post testing (reference guide) Records information about biological sample storage for quality assurance purposes Records samples for transport to labs for testing by batch numbers Records information about biological sample transport for tracking and quality assurance
Paper
Records information about biological sample transport for tracking and quality assurance
Paper Paper
Records information about biological samples shipping for quality assurance and tracking Form for processing of samples at the [NAME OF LAB]
Paper
Information about recruiting peers to participants completing biological and behavioural
E2
Informed Consent Form First Visit Checklist Subsequent Visit Checklist Lab Form Phlebotomy Checklist Nurses’ Checklist Pre & Post HIV Testing Guide Specimen Storage Log Batch Log Specimen Transport Log BBSS to [NAME OF LAB] Specimen Transport Log BBSS to [NAME OF LAB] Specimen Shipping Log [NAME OF LAB] Lab Form HIV Testing Algorithm Recruiter Training Script and Talking Points Facility list for referrals
Paper
Referral information for follow up treatment or testing
E4
Participant Information Sheet
Paper
Contact information for research team should participants desire to follow up on any information.
G1 G2 G3 G4 G5 G6 G7 G8
Field Supervisor Checklist Coupon Manager Checklist Interviewer Checklist Field Incident Report Field Supervisor Evaluation Form Coupon Manager Evaluation Form Interviewer Assessment Form HIV Counselling and Testing Evaluation Form
Paper Paper Paper Paper Paper
Reporting of onsite incidents Checklist should be used to document evaluations of the Field Supervisor. Checklist should be used to document evaluations of the Coupon Manager. Checklist should be used to document observations of interviews 19 Checklist should be used to document evaluations of HIV tester/ phlebotomist and nursing staff
Biological Survey Forms
D8
Check-out
Staff Monitoring
D09 D10 D12 E1
Format Electroni c Electroni c Paper Paper
Purpose Initial check that participant meets eligibility criteria for participation Seven security questions to confirm identity on subsequent visits Backup log that records coupons distributed to each participant Collects information about recruits selected by the participant
IV.
FIELD SITE MANAGEMENT Overview The survey will operate three field sites: [city], [city] and [city]. These are fixed locations (except for [city], which will be mobile) where all aspects of survey administration, both behavioural and biological, will be conducted. This section of the operations manual outlines protocols to govern the administration of the survey as well as procedures to guide the survey staff. In addition to reading and understanding this section, all field staff should be well-acquainted with the full survey protocol.
Creating a safe and trusting survey environment The creation of an appropriate ambiance which encourages participants to complete all aspects of the survey is crucial to its success. The physical environment as well as verbal and non-verbal cues given by staff members is instrumental to building a safe, comfortable atmosphere at the site. Staff will be asked to ensure that participants feel welcomed and at ease while at the survey site in order to foster a positive atmosphere for the participants and thus encourage recruitment and referrals. Hours of Operation There are three survey sites located in [city], [city] and [city]. The [city] and [city] sites will operate from Tuesday to Saturday from 10am to 6pm. These days and/or hours may change if feedback from participants indicates that they are not able to participate during stated times. The [city] site is a mobile site which will periodically change locations and operates on an average of 2 days per week Prior to first visit Making initial appointments Initial appointments will be made via telephone. All participants inclusive of seeds can call the field site and indicate that they are in possession of a referral card or coupon and request an appointment. Under no circumstance will survey staff initiate an individual’s participation by calling or otherwise recruiting them for the survey.
The Coupon Manager is responsible for scheduling appointments, since the validity of the potential participant’s coupon must be confirmed. If the Coupon Manager is not available, the field supervisor can make the appointment. The Coupon Manager will ask the potential participant for the number on his coupon and check this against the RDSCM, then schedule his appointment if the number is valid. Checking the number in RDSCM will help ensure the
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There are several points of information that the Coupon Manager should share with the potential participant when they are making an appointment: 1) There will be an initial conversation (i.e. eligibility screening) before starting the survey process. 2) The participant must bring his coupon with him in order to be seen 3) The participant cannot be accompanied by anyone else to the survey site. Any individual(s) accompanying the participant, will be asked to return when the participant has completed the survey 4) The approximately length of time of the visit will be 90 – 120 minutes. These points will be printed at the coupon manager’s system as reminders to staff scheduling appointments. participant has a valid coupon and does not come to the site unnecessarily. The appointment date will be recorded in the appointment system which is kept electronically. The computers assigned to the field supervisor, coupon manager and the reception desk will all have access to the electronic calendar. Only the coupon manager (or the field supervisor in the coupon manager’s absence) will be able to make changes to the appointment system. The referral and appointment cards indicate designated numbers for the three survey locations. The potential participant will be required to call the phone number designated to the preferred site location at which he wishes undertake the survey. The Coupon Manager will endeavour to issue an appointment within one to two weeks of the date of the call. If an appointment cannot be issued within one to two weeks, or the potential participant wishes to be seen on an earlier date, the participant will be given the option of coming to the survey site as a standby appointment for the [city] and [city] locations. The [city] site will not facilitate same day or standby appointments; all appointments must be made a minimum of 5 working days in advance. The availability of standby appointments at the [city] sites will be dependent on cancellations and can only be assessed on the given day at the survey site. . No more than 3 standby appointments will be given per day and these are determined and approved by the field supervisor. Appointments for these potential participants should also be made, in case they cannot be seen on the given day they are placed on standby. Staff should ask participants to write their appointment time on their coupon when the appointment is made.
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Participant Flow There is a strict protocol which governs how participants should proceed through the survey site. The following procedures must be followed sequentially without deviation. Adherence to this protocol is essential to ensure successful completion of the survey. The Field Supervisor is responsible for ensuring that staff follow the intended survey flow, as well as the general functioning of the site. Figure 5 illustrates the participant flow at the survey site.
Figure 5: Participant Flow First Visit
Reception-Coupon validation (Interviewer and Coupon Manager)
Visual validation of coupon RDSCM validation of coupon (Coupon Manager)
No
Yes
Valid Coupon Create Record in RDSCM
Eligibility Screening (Interviewer)
Invalid Coupon Edit RDSCM & Void Coupon
Exit - No Incentive/ No coupons
No Not Eligible Edit RDSCM & Void Coupon
Eligible for Participation
*Biologically Male * 18 Years *Resident >6 months *Sex within 12 months
No
Yes
No Incomplete Questionnaire/ Refuse to Continue
Behavioural Survey Orientation (Interviewer)
Yes
No Refuse Testing
Behavioural Survey (Interviewer Assisted upon request)
Yes
No Incomplete Testing
General Health Screening & HIV TC (Nurse / Phlebotomist)
Exit – [$] noncash voucher/ No coupons
Exit – [$] noncash voucher/ No coupons
Exit (Partial Incentive – Coupons
Check Out (Coupon Manager)
No consent Edit RDSCM & Void Coupon
Consent (Interviewer)
Yes
Exit - [$] noncash voucher/ No coupons
Exit Partial Incentive – Coupons
Yes No Recruiter Training (Coupon Manager)
Unable/ Refuse to Recruit
Exit Full Incentive Coupons
Check Out (Coupon Manager)
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First Visit Procedures There are distinct procedures which will apply to the first visit. The second and subsequent visits will also follow stipulated procedures indicated in the subsequent section. The following activities will occur in sequence during the first visit: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
Check-in the potential participant Validate the coupon presented Gauge factors that may affect eligibility Verify the coupon presented Create the participant folder Conduct the Eligibility Screening Conduct the Informed Consent process Conduct the Behavioural Survey Conduct the Health Screening Offer rapid test results Offer the participant the opportunity to recruit; train them to recruit Update the RDSCM record Pay the Primary Incentives Schedule a second visit Distribute prevention materials (If biological survey completed medical team distributes materials; Coupon Manager distributes material for participants who refused biological survey.
Check-in the potential participant There is an intercom system set up at the front door of the survey site. Once the potential participant has indicated that they are at the site to participate in the survey, the security personnel will open the door and invite the participant to sit in the reception area. The security personnel will then indicate to the field supervisor via walkie talkie that there is a potential participant at the survey site. The field supervisor will greet and welcome the potential participant to the site. After welcoming the potential participant, the Field Supervisor will introduce the interviewer assigned to the potential participant. Should the Field Supervisor be unable to greet the participant, the coupon manager will perform this function.
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Prior to the presentation of the referral card or coupon, staff must inquire about the reason the person is at the survey site. It is imperative that the study staff does not reveal any information about the survey before the coupon or referral card is presented. If a coupon or referral card is not presented, the study staff must redirect the individual. At no time must the study staff reveal any information about the site. Any person who rings the buzzer at the site must indicate that they are here for the survey. The door will not be opened for any other individual.
The first survey activity is completed in the reception area and entails confirming the participant’s appointment time and validating the coupon or referral card which should be presented by the participant. Participants are only allowed to pass the reception area if they present with a valid coupon or referral card. If a participant presents at the site self-referring as a participant, the interviewer can use the following response: “I am not at liberty to answer your questions. I am sorry that I cannot offer you any further information.” After inquiring about their reason for coming to the site, the Interviewer greeting the participant should take the following steps before proceeding to check-in the participant: Validate the coupon presented Visually inspect the coupon and confirm that it is an official study coupon or referral card. Note the ID number, the study logo, the type of paper, etc. All these elements should match official coupons. If the coupon is not visibly valid, the Interviewer should thank the individual for coming and indicate that he is not eligible to participate. The coupon or referral card must not be returned to the participant. The Interviewer should take the coupon or referral card to the Coupon Manager for filing. If the coupon is valid, proceed to the next step. If the individual indicates that he does not have his coupon with him for any given reason the following must be stated: “I’m sorry but we cannot proceed if you do not have a coupon with you now. Let’s make an appointment for another time. Please remember to bring your coupon at that time. Ascertain if an appointment was scheduled It must first be confirmed that the participant’s appointment is in the electronic appointment system. If the participant’s appointment is at a different time or he doesn’t have an
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appointment, consult the Field Supervisor about whether this person can participate on a standby basis. If the potential participant cannot be accommodated, inform him that he doesn’t have an appointment at that time and get the Coupon Manager to schedule one for him.
Gauge factors that may affect eligibility While confirming the coupon and appointment, the Interviewer should gauge other factors that could affect the potential participant’s eligibility. Based on the interviewer’s observations of the following situations, the interviewer may determine that the potential participant is not eligible to participate in the study: - The person appears impaired and their ability to give informed consent is questionable - The person is recognized as a previous participant - The participant appears less than 18 years old
Impairment If the person appears impaired (drunk, high or incoherent) and the interviewer questions their ability to give informed consent or to complete the interview, the appointment should be rescheduled. In this case, the coupon is returned to the person. The Interviewer should handle this situation carefully and indicate: “I’m sorry we won’t be able to see you today. Can we re-schedule your appointment for another day?”
Previous participant If the person is recognized as a previous participant (even if he has a valid coupon), the Interviewer should not check in the person. Participants are not allowed to enroll in this study more than once. All staff should be alert to repeat participants, referred to as ‘duplicates’. Study procedures are in place to identify potential duplicates.
If the interviewer suspects that the individual has participated in the survey before, then the coupon manager should be alerted immediately. The individual should be interviewed by the Coupon Manager to determine whether their security questions or physical characteristics match another participant that is already in the RDSCM programme. If these match, the coupon manager must alert the field supervisor. Field Supervisors are responsible for final verification that a participant is a duplicate. If the Field Supervisor confirms the individual as a duplicate, the coupon will be voided and he will not be eligible for any incentive. The coupon manager keeps the voided coupon and files them for the study site’s records. 25
The field supervisor should respectfully inform the person of their ineligibility and issue a reminder that an individual is only allowed to participate in the study on one occasion.
Individual under age 18 If the individual appears to be less than 18 years old, the Interviewer should proceed with check-in and note suspicions of ineligibility. If the potential participant does not self-report being less than 18, the interviewer should alert the Field Supervisor. The interviewer should present the reasons why it is believed that the participant is younger than age 18 to the field supervisor. The field supervisor will assess the individual. If both the field supervisor and the interviewer concur that the potential participant is younger than 18, the individual should be deemed ineligible. The field supervisor will inform the individual of their ineligibility to participate in the survey. Verify the coupon presented Once the coupon is validated, the potential participant is asked to be seated in the waiting area and the coupon is taken to the Coupon Manager. The Coupon Manager will then create an RDSCM record. RDSCM is a software programme that is used during check-in and checkout processes and it has three main functions. These functions are as follows: - Link participants with the individual they recruited to be part of the study by coupon number – RDS data analysis necessitates linking recruiter data to the data of his recruits. This enables analysis on network patterns. - Keep track of incentives – The software facilitates monitoring of the incentives due to participants by keeping track of the individuals to whom they gave coupons to and have completed the survey successfully. - Collect data related to recruiting: Non-response bias is measured by asking specific questions about individuals who refuse to take a coupon from the recruiter. RDSCM is installed on the computer assigned to the coupon manager. The RDSCM programme is used during check-in and check-out of participants. While operating RDSCM, the following security measures should apply: -
The computer screen should never be visible to participants. RDSCM should never be left open and unattended. A limited number of survey staff should have access to and operate RDSCM.
The first action undertaken by the Coupon Manager in the software programme is the creation of an RDSCM record. The Coupon Manager should enter in the following information:
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-
-
Coupon (or referral card) number: The potential participant’s coupon (or referral card) number will be needed to start a record. Survey ID: The two or four digit survey ID will be the same as the participant’s coupon (or referral card) number. RDSCM will prompt the user to use the coupon number as the survey ID. Interviewer ID: The Coupon Manager should enter in the two digit ID of the assigned interviewer. The Coupon Manager should also write the Interviewer ID on the participant’s coupon (or referral card).
Create the participant folder Once this record is completed, the Coupon Manager prepares a participant folder. This folder will contain the following blank forms: - First Visit Check list - Participant tracking form - 2 Consent forms - Lab form The Coupon Manager labels the participant’s survey ID on each of the blank forms in the folder with the exception of one of the consent forms. The coupon which the participant presented is stapled onto the inside cover of the folder. The assigned interviewer is given the potential participant’s folder. If the potential participant is known to the interviewer, the interviewer should ask the individual if they would prefer another interviewer work with them. If the potential participant indicates a preference for another interviewer, the Field Supervisor should be informed and another interviewer would be assign to the potential participant. Conduct the Eligibility Screening To commence the interview process, the Interviewer escorts the potential participant to an available interview room to commence screening for the eligibility criteria. The screening is completed using the MSM Screening Questionnaire which is available electronically. The Interviewer should follow several steps to administer the screening questionnaire: 1) Log on to the computer and open a new survey record 2) Enter the potential participant’s survey ID on the screening form 3) State the questions out loud for the participant and record their answers in the electronic form. 4) Silently fill in the answers to the questions intended for the Interviewer alone 5) If an individual is deemed not eligible, inform him: “The computer has not selected you to participate in the health survey. Thank you for your time.” In this scenario, the interviewer should inform the Coupon Manager that the person is ineligible and this should be noted on the first visit checklist. The coupon is returned to the Coupon
27
Manager. The Coupon Manager should void the coupon in RDSCM, mark the coupon “VOID” and give the participant folder to the field supervisor. The Coupon Manager will issue a [currency amount] non-cash voucher to the person in acknowledgment of the time taken to come to the survey site. If an individual is deemed eligible, the Interviewer notes this on the participant tracking form, writes ‘USED’ on the coupon stapled to the participant folder and should proceed to provide him informed consent. From this point onwards the individual is considered a survey participant.
Conduct the informed Consent Process The second step in the interview process is obtaining informed consent from the participant and responding to any questions the participant may have. The interviewer will read the informed consent form verbatim and seek to obtain consent for both the interview and the health screening. The interviewer provides a copy of the informed consent form to the participant to follow as it is being read and to retain a copy, if he so desires. Participants who decline biological testing during informed consent will have another opportunity to provide consent upon completion of the questionnaire. If the person chooses NOT to participate in the survey or is unable to complete the consent process, the interviewer should indicate this on the consent form. The interviewer should end the interview session, and inform the Coupon Manager that the person did not consent and return the participant folder and all its contents to the Coupon Manager. Participants are allowed to participate in the behavioural survey and not the health screening, but they must participate in the behavioural survey to proceed to the health screening. The interviewer should remind the participant that names are not used under any circumstances in this survey. If the participant consents to participate in the survey, the interviewer signs the consent form labeled with the participant’s survey ID to document the participant’s agreement. The participant can choose not to accept the second copy of the consent form which they used to follow along with the interviewer. If so, the interviewer can accept the blank consent form. Conduct the Behavioural Survey
28
Once consent is received the behavioural survey will be administered. The participant has the option to complete the interview on the computer without the assistance of the interviewer using the ACASI programme or to be administered the interview on the computer with the assistance of the interviewer with the use of the CAPI programme. As indicated in a previous section, there are two versions of the computer based administration software for the survey: ACASI stands for Audio Computer Assisted Self-Interview and CAPI stands for Computer Assisted Personal Interview. With the ACASI option, the interviewer leaves the interview room and the participant completes the questionnaire unaccompanied. The participant will be given a pair of headphones to be able to hear questions and response choices read aloud. The interview will inform that participant that he/she will be located outside of the interview room and can be called upon if any questions or concerns may arise. If the participant consented to biological testing, the interviewer will immediately escort the The Interviewer will orient the participants to the two software options for completing the behavioural survey. The participant will then indicate whether he will like to take the survey on his own or with the assistance of an Interviewer. If the participant self-administers the questionnaire, the Interviewer will remain nearby and monitor his progress and be sure to be available assist with questions or any other difficulties. In this case, the interviewer will direct the participant to participate in a brief computer demonstration which describes how to use the programme and then exit the interview room. participant to the testing room once the behvioural survey has been completed. If the participant did not consent to testing during the informed consent process, confirm their choice by asking: My records reflect that you did not consent to HIV testing when I asked earlier during the interview. Before I close out the survey, I’d like to ask you again about whether or not you would like an HIV test. Did you want the HIV test or STD screening as part of today’s survey? Participants may change their minds after participating in the questionnaire, so it is important to give them another chance to reconsider testing. Avoid even the appearance of trying to influence the participant’s decision. Your tone should convey that you are asking again only because we want to make sure not to make a mistake. Should the participant decline testing, the interviewer contacts the coupon manager via walkie talkie to proceed to the final steps of the survey process which includes being offered the opportunity to recruit and being paid primary incentives. Should the participant agree to testing, administer consent procedures and enter the specific procedures to which he consents:
29
• HIV Counseling and testing • Having other lab tests (if offered) • Storing a blood specimen for future testing Some participants who initially consented to the HIV test could change their minds as well. In that case, complete the remaining procedures other than the HIV test (e.g., recruiter training). If this happens, do not modify the information in the computer. Although undesirable, it is permissible to have consent documented but no HIV test; however, HIV tests results without documented consent are not permitted. Conduct the biological element of the survey Participants consenting to the biological element of the survey are escorted to the testing room after completing the behavioural survey. The [country] MOH guidelines for counselling, testing and referral services will be followed with each participant during the biological part of the survey. HIV rapid test results will be available during the first visit and all other results will require laboratory testing off-site, and will be available at the second visit. The chronic disease screening, which includes hypertension and diabetes testing, will be offered to the participant on either the first or second visit to the survey office depending on the availability of nursing staff. Table 7 shows how the tests will be processed and when they’ll be available. Table 7: Laboratory test results and processing
Test HIV - rapid HIV - delayed Syphilis Chlamydia Gonorrhea Herpes Simplex Virus 2 Hepatitis B Hypertension Screen Diabetes
When available 1st visit 2 weeks after 1st visit 2 weeks after 1st visit 2 weeks after 1st visit 2 weeks after 1st visit 2 weeks after 1st visit 2 weeks after 1st visit 1st visit or 2nd visit 1st visit or 2nd visit
Where processed At survey site [NAME OF LAB] [NAME OF LAB] [NAME OF LAB] [NAME OF LAB] [NAME OF LAB] [NAME OF LAB] At the survey site At the survey site
Pre-test counselling will include an explanation of disease transmission in the case of infectious diseases, as well as, include the meaning of test results, available resources for treatment and care, risks associated with sexual behaviour, risk reduction strategies, as well as means to prevent HIV and STI infection. During the informed consent process, participants should be informed that they can select either a rapid or a delayed HIV test. Those selecting rapid tests will be offered their results before they leave the survey site. Those opting for delayed testing will be offered their HIV test results along with their other lab results during their second and subsequent visits. Participants 30
who have declined to receive their test results once they are available should be reoffered their results at each subsequent visit to the survey site. Phlebotomist orients participant Upon entering the testing room, the phlebotomist will orient participants to the testing procedures. The Phlebotomist welcomes the participant and collects the participant’s folder from the interviewer. The participant is reminded that the survey is confidential and anonymous hence names are not required. The Phlebotomist checks the consent form in the participant’s folder to confirm that consent was given for participation in the biological survey. If consent was given previously, the phlebotomist will reiterate that during the informed consent process, the participant consented to participate in the biological element of the survey by agreeing to receive a number of tests. The Phlebotomist will indicate: During your interview, you gave consent to have 4 small tubes of blood taken from your arm to test for Herpes (HSV), Hepatitis B, Syphilis, HIV Rapid Test including a delayed test and to give a urine sample for Chlamydia and Gonorrhea. You will get the results HIV Rapid Tests today; the others will be ready 2 weeks from today. Those are tested off site. If the phlebotomist reviews the participant’s file and notes that the participant did not agree to testing on the informed consent form, the interviewer is contacted immediately via walkie talkie and the folder is returned to the interviewer. The interviewer will then address the error made by confirming whether the participant agreed to testing, adjusting the participant’s folder to accurately reflect if consent was given and proceeding to the next step of the survey process for the given participant. The testing process commences Once the phlebotomist confirms consent, it will then be explained to the participant that before the blood collection, a “mid-stream urine” sample for Chlamydia and Gonorrhea testing will be taken. Instructions for the urine sample will be as follows: First you pass a small amount of urine into the toilet, then stop or hold it, pass some into the bottle and finish in the toilet. So, it’s toilet, bottle and toilet. Do not touch the inside of the container, this is to avoid contamination of the sample. When finished, please bring it back to me. The urine container will be labeled in front of the participant and the participant will be directed to the washroom. When the participant returns with the urine, the participant will be instructed to place the urine on the counter by the sink in the testing room and asked to return to their seat. The Phlebotomist will explain that blood will now be taken for the remaining tests from veniputure. With the use of four vacutainers the Phlebotomists will draw all the required blood for testing. Fifteen milliliters of blood will be drawn for each participant to perform all blood31
based tests. In order to conduct rapid HIV testing, the phlebotomist will aliquot blood from the last vile of blood drawn. The sample will be placed onto the two rapid tests which will run in parallel, according to the MoH algorithm. All positive HIV results will be confirmed by ELISA at [NAME OF LAB], and one in every 10 negative rapid test results will also be sent to the [NAME OF LAB] for quality control processing. Under two conditions, an additional 5 ml of blood will be drawn from the participants. This occurs if (1) the HIV rapid is positive and (2) for each 10th negative rapid test for confirmation. Test results & Referrals Post-test counselling messages should be tailored to participants’ results and risk profiles, following [country] MoH guidelines for Provider-initiated-counselling and testing procedures. Post-test counselling includes goals, means, and strategies for behavioral risk reduction, maintenance of risk reduction, and explanation of risk reduction methods (e.g. condom use). Counselling of HIV-infected participants should include an assessment of psychosocial needs, a discussion of living with HIV-infection, treatment and care, and issues related to discrimination. HIV transmission to partners also needs to be discussed and strategies for behavioral change addressed. Information about health facilities near participants will be shared as part of the post-test counselling process, and everyone should be strongly encouraged to seek care in order to protect themselves and others. Although this study does not provide any care directly to participants, linkages to care are an important part of the study. With the exception of the HIV rapid test results which are same-day tests, all test results will be sent to each study site, as they become available, by the Data Manager over a secure internet connection. The Field Supervisor and Data Manager are responsible for maintaining a comprehensive test result database for each site. The Field Supervisor is responsible for sending test results performed at the study site to the Data Manager daily for collation at the central office while the Data Manager is responsible for updating the database with results from the offsite labs. When a negative test result is received electronically over secure internet connection, the field supervisor will update the result on the Lab Form in the participant’s folder. This folder will be viewed by Phlebotomist when delivering results during the participant’s second visit. When a positive test is received, the field supervisor will update the result on the Lab Form in the participant’s folder, however the folder will not be issued to the phlebotomist until the paper referral is received by the field supervisor from the Study Lead. Participants will return to the study site for a second visit at least two weeks after their first visit, at which time their delayed test results will be available. Participants should be
32
encouraged at the end of their first visit to call prior to their return to assure their results are ready. The second visit will be scheduled on an appointment card at the end of their first visit. After the participant has completed the testing procedures, the phlebotomist will contact the Interviewer via walkie talkie to return to the testing room for the participant. The phlebotomist will update the First Visit Checklist reflecting the study progress up to that point and give the participant folder to the Interviewer. The Interviewer will escort the participant to an interview room and offer some key points about the participant’s eligibility to recruit. The Coupon Manager will offer the participant an opportunity to recruit others into the study as well as pay the primary incentives to the participant. Offer the participant the opportunity to recruit The Coupon Manager will be able to assess if the participant is eligible to recruits based on the information in the participant’s first visit checklist. The Coupon Manager should thereafter communicate some key points about what being a recruiter involves.
A participant is eligible to receive recruitment coupons if he has completed the questionnaire. If the participant chooses NOT to be a recruiter, the participant will skip recruiter training and will proceed directly to distribution of safe sex and educational materials, and incentives.
If the participant agrees to recruit, the Coupon Manager will conduct recruiter training. The Coupon Manager will distribute the coupons, necessary incentives and update the RDSCM record. A model script for training participants in peer recruitment can be found in Appendix E3. Some key points of this training include: -
-
-
Recruiting is completely voluntary. Participants do not have to recruit if they do not want to, and they will still receive a stipend for completing the survey if they choose not to recruit. Recruitment is important to the project. The success of the project relies on people recruiting others, to get a large sample across the country that represents the population. There is an opportunity to earn a [currency amount] non-cash vouchers per person recruited. It is not guaranteed that they will earn the [currency amount]
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per person recruited, but if they follow the instructions for recruiting, it is likely they will. If the participant opts to be a recruiter, training must be given to enable him to understand the benefits of recruiting, what needs to be communicated to the recruits and the process of receiving incentives once recruits have successfully completed the survey. The training script to use is in Appendix E3. The Coupon Manager or Interviewer should provide the recruiter training to the participant. However, if the Coupon Manager or Interviewer is engaged with another participant, the Field Supervisor should provide the training. The final check-out procedures include editing the RDSCM record, distributing coupons (if eligible and willing to recruit), distributing incentives (if applicable), and providing prevention materials and referrals. Update the RDSCM record The Coupon Manager begins by reviewing the participant’s folder and verifying the following: √ Participant was eligible for the survey √ Willing or unwilling to recruit others for the survey - If not willing to recruit others the Coupon Manager should indicate thus on the checklist. The Coupon Manager should NOT do anything else in RDSCM. - If participant is willing to recruit others the Coupon Manager should indicate thus on the checklist. The participant is now a recruiter and the following occurs: - The recruiter’s information is added into his RDSCM record - Recruiter training is conducted - Coupons are distributed - Recruiter information is reinforced Establishing a unique code in RDSCM Following this update, the Coupon Manager should ask the participant the Security Questions (appendix A2) so that they can create a unique code in RDSCM and confirm the participant’s identity when they return for their second visit. To explain the process for creating the code, the Coupon Manager can say something like: “Now I’ll be asking you a series of questions so we can confirm your identity when you come back for your second visit. Asking you these questions will help us make sure that your test results and any incentives due to you will be given to you alone, and not to anyone else.” To administer the security questions, the Coupon Manager should open RDSCM and go to the participant’s file, searching by their Coupon ID/Survey ID. Once there, administer the seven security questions to the participant, entering the code in the ‘Recruiter ID’ field. Be sure to remind the participant that they will need to exactly match the unique code on their second 34
visit, without exception. This rule is in place to protect their privacy. They are not required to give real information when asked for parts of their name or birthdate, but they will need to give information that they can remember and duplicate on subsequent visits. At this point in time, the Coupon Manager should also fill out the section in the participant’s RDSCM record called ‘Physical Marks’. In order to fill out this information, the Coupon Manager looks for visible marks such as scars, tattoos, missing teeth, large moles or skin discoloration or other identifiable features. Start at the tip of the participant’s left hand and look up his arm, over his face and neck, then down his right arm to the tip of his hand, and record marks you find. The Coupon Manager should also include general identifiers such as approximate age, height and build. This information will be used to help identify duplicate participants, and to help confirm identity when the participant returns for his second visit.
Pay the Primary Incentives Based on what activities the participant has completed in their first visit, they will be due certain incentives. Participants completing only the behavioural survey are due non-cash incentives in the value of [currency amount]. Participants who complete both the survey and any biological testing are due non-cash incentives in the value of [currency amount]. Once the participant has been paid their incentive, note their payment in RDSCM and save the record. Fill out a record for payment in the incentive tracking form, and have the participant initial that it was received.
Schedule a second visit As part of the checkout process, the Coupon Manager should schedule an appointment for the second visit, when the participant receives his test results and any incentives due to him from participants he has recruited. It is important that the participant is clear about his appointment date and time, because he cannot be contacted by study staff again, and reminder calls are not available. -
-
-
Step 1– Make an appointment for the second visit. Enter the time and date of the appointment on the card for the participant to keep. Step 2– Enter the appointment into the site’s appointment system. The participant should come back to the same survey site for their second appointment. Step 3– Remind the participant that he can call to change or reschedule his appointment as needed. Ask the participant to return with his appointment card on the second visit, in order to accelerate the check-in process. Step 4 – Encourage the participant to call the site before his second visit so he can ensure their test results are ready and not make a trip unnecessarily.
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Distribute prevention materials All participants who complete at least part of the survey should be provided with prevention materials by either the Coupon Manager or the medical staff. The Coupon Manager is responsible for the distribution of prevention materials to all participants who refuse to participate in the biological survey. If the participant has completed the biological survey, the medical staff is responsible for distributing prevention materials. These materials may include: - Informational pamphlets on HIV, STD,HIV prevention and chronic diseases - Condoms, lubricants and other supplies - Those in need of health care or social services should also receive referrals to the appropriate service providers.
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Second Visit Procedures The first step of the second visit is to determine the reason the participant is returning to the survey site. Making this determination will guide the staff how to procedure through the second visit procedures. Successive visits to the survey site will be for one or more of the following reasons: -
The participant was determined to be unable to complete the survey on their previous visit. (drunk, high, incoherent etc.) The participant is returning to receive delayed testing results and information about care and treatment, if necessary The participant is returning to receive payment for successful completion of the survey by individuals he recruited
Figure 5: Participant Flow - Second Visit, illustrates the participant flow through the site on a participant’s second visit. For the second visit, the participant arrives at the survey site and will be greeted by the Field Supervisor. The participant’s appointment card and appointment time should be confirmed by the Interviewer before they proceed to the Coupon Manager. This process is similar to confirmation for first visit participants, with a visual check of the card, and examining the electronic appointment system to confirm the participant has an appointment or is able to be seen at that time. During the check in the Interviewer will verify with the field supervisor that the participant’s test results have been received. If the participant’s test results have been received, the phlebotomist will be alerted that the participant is at the survey site. If the test results have not be received, this will be made known to the participant. After validation of the coupon and verification of test results availability, the participant is escorted to the Coupon Manager. . Process of administering Recruiter Incentives Verifying recruiter identity In order to protect confidentiality, the first step undertaken when the participant returns to the survey site is to confirm their identity. Participants may or may not come to their appointment with the appointment card that was issued to them at the end of their first visit. In either case, their identity should be verified by helping them to match the unique code generated in RDSCM on their first visit. The code is generated by RDSCM through the security questions answered on their first visit. After the participant is checked in by the Interviewer, the Coupon Manager will ask the participant the same seven questions to regenerate their unique code. Participants must generate the exact code that was used on their first visit. This process can sometimes be a challenge for participants, so the Coupon Manager should be prepared to work
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with the participant to help them regenerate the code without providing them information from the code itself. Administering Recruiter Questions One of the activities that should be performed at a participant’s second and subsequent visits is asking about their attempts to recruit others into the study. After verifying the participant’s identity by matching the unique code in RDSCM, the Coupon Manager will ask the participant whether they have tried to recruit anyone for the survey. If they have, the coupon manager will ask the participant to answer some questions about who they have recruited. The coupon distribution questionnaire is in Appendix B2. The Coupon Manager will ask how many potential recruits the participant approached, and how many coupons he handed out. The recruiter questionnaire should be completed for each person the participant tried to recruit into the study. Paying Recruiter Incentives The Coupon Manager is responsible for assessing and paying incentives.
Participants are eligible for secondary incentives at subsequent visits if they have recruited one or more participants who were eligible for the survey AND agreed to participate.
For each participating recruit who enrolls in the study, his recruiter is due a non-cash incentive of [currency amount]. Coupon Managers should proceed through the following steps to provide and document incentives: -
Step 1– Login to RDSCM and open the participant’s file Step 2– Inform participant that he may receive incentives as a top-up or gift card Step 3 – Update in RDSCM that participant received his incentive Step 4 – Document incentive in the incentive tracking form and ask him to initial using any initials to show that he received them.
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Figure 5: Participant Flow - Second Visit
Arrival at Survey Site – (Interviewer / FS)
Yes
Valid Appointment Card CM check RDSCM to determine if incentive ready
Visual validation Results Appointment Card / Checks the Appointment System or Survey ID for retrieval of Incentives
No Card
Not Valid
No Appointment Card Code confirmed by CM – Participant identified
Invalid Appointment Card
Exit: condoms, lubricants and prevention literature
Retrieval of the participant folder and checklist from his individual file Participant did not perform delayed HIV testing Reimbursement is not ready or warranted Participant performed delayed HIV testing
Exit: condoms, lubricants and prevention literature
CM escorts participant to counselor for results
The Counselor greets the participant, invites him to sit and conducts the counselling. If the Participant accepts to receive the results, the Counsellor provides the results as per national guidelines. Post counselling Assessment for further follow-up
Exit: condoms, lubricants and prevention literature
Incentive warranted Participant performed delayed HIV testing The CM gives the appropriate reimbursement to the client and documents it in the Participant Compensation form, Cash Reimbursement Log, and RDSCM
Incentive warranted: The CM gives the appropriate reimbursement to the client and documents it in the Participant Compensation form, Cash Reimbursement Log, and RDSCM.
CM escorts participant to counselor for results
Results given Post counselling Assessment for further follow-up
Referral to social worker made if necessary
Exit: condoms, lubricants and prevention literature
Exit: condoms, lubricants and prevention literature
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Process of receiving test results at the second visit Participant test results will be accessed online from a secure location by the Field Supervisor’s computer. Test results will be organised by survey ID on an excel database. Once a participant has verified their identity and received any incentives that are due to them, the coupon manager should verify if the participants test results are ready. The Field Supervisor should look up their test results by their survey ID number and write the results on the lab form. If the Field Supervisor receives a positive result, they should ask a second person such as the Coupon Manager or an Interviewer to visually check the result in the database to confirm that it was read correctly.
Delayed HIV results from the first visit Participants who elected not to receive rapid HIV results at the first visit will be offered their results at the second visit. Post-test counselling messages will be tailored to recruits’ results and risk profiles. [country] MoH guidelines for counselling must be followed. Post-test counselling will include goals, means, and strategies for behavioral risk reduction, maintenance of risk reduction, and explanation of risk reduction methods (e.g. condom use). Counselling of HIV-infected participants will include an assessment of psychosocial needs, a discussion of living with HIVinfection, treatment and care, and issues related to discrimination. HIV transmission to partners will also be discussed and strategies for behavioral change will be addressed.
Other delayed test results The delayed tests are: Herpes, Gonorrhea, Chlamydia and Syphilis. As with HIV tests, post-test counselling messages will be tailored to recruits’ results and risk profiles, and counselling will follow MoH guidelines.
Referrals for participants Participants who are diagnosed with HIV, STIs or chronic diseases through testing conducted as part of this study will be offered general information about care and treatment options. Formal referrals will not be made, in order to protect participant privacy. Participants will receive a MoH brochure listing care and treatment facilities. Verbal counselling on follow-up steps will be offered, as it is important for clients to protect their own health and that of their partners.
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[city] procedures Survey activities in [city] will operate in various venues for the duration of the survey. It is anticipated that the [city] sites will operate on Monday and Tuesday of each week, and sites will relocate to different locations in [city] to protect participant privacy. [city] sites will operate on an appointment basis and will not have walk-in options in order to protect privacy. An appointment only system means that participants in [city] will not encounter each other while at the survey site. Depending on demand, other days of the week may be used for appointments, and if there are no appointments scheduled for a particular week, study staff will not travel to [city]. Staffing in [city] Fewer study personnel will be used in [city] sites because only one participant will be at the survey site at a time. The complement of staff working at sites in [city] will be three persons: a Field Supervisor, an Interviewer and a Tester / Phlebotomist. In this scenario, the Field Supervisor will serve in the function of Coupon Manager in addition to their supervisory role. Site operations in [city] The survey sites in [city] are smaller than those in [city], and have less infrastructure, as all equipment will be carried to [city] each week, and the [city] site will not remain in the same place throughout the duration of the study. As a result, operations at the survey sites will run differently in [city]. For example, some survey sites in [city] may not have a reception area, so participants may be greeted and checked in differently. There is also likely to be fewer private rooms in which to conduct eligibility screening, ACASI interviews and testing and counselling, so staff will need to be proactive and flexible in order to assure privacy for those sensitive conversations. The participant flow charts for the first and second visit as seen above in Figures 5 and 6 will be followed for both the [city] and the [city] survey sites. However, given the staffing differences in [city] and the smaller and less confidential layout of some of the spaces that will be used, staff will need to adjust the way the procedures are carried out in order to assure the same confidentiality and privacy that the participant would receive at the [city] sites.
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V. LAB PROCEDURES AND SAMPLE PREPARATION Overview This section details procedures and logistics related to HIV rapid testing as well as for other offsite laboratory tests for VDRL (syphilis), Hepatitis B, HSV (herpes), Chlamydia and Gonorrhea sample collection. It also addresses disposal of biohazard waste at the survey sites, on site storage, transport to off-site laboratories, processing by laboratories locally and preparation for shipment overseas. Testing procedures by laboratories on samples received, generation and transmission of results to survey sites, on site data management of results, and referrals for follow up treatment and support will also be addressed Some laboratory testing will occur at the survey site, and some will occur off site. Off-site laboratories that will be used in this study are located in [country] and [country]. Results from offsite laboratories will be received by the PI, located at HCU, MoH by courier services (local tests) and secure email (testing conducted in [country]). The PI will then forward results to the Data Manager through the Study Lead. Testing room set-up at the Survey Site The survey site should have a complete inventory of all equipment and consumables (See Appendix D6) and requisition forms to reorder when the stock level is low if the need arises. All infection control, biohazard waste disposal and occupational safety and health procedures must be adhered to and all sites need to have a copy of the following: -
Ministry of Health Infection Prevention and Control manual Ministry of Health Post Exposure Prophylaxis Guidelines Ministry of Health Post exposure Prophylaxis Policy Ministry of Health National HIV Rapid testing Algorithm.
Biological Procedures Sample Collection There are several samples to be collected. In total this involves - A total of 15 -20 mls of blood for 3-4 red top vacutainers for HIV confirmation/quality control where applicable, VDRL, Hepatitis B and HSV - A mid-stream urine sample for performance of overseas STI tests. The patient should not have urinated for one hour prior to sample collection - 10 -15ml of urine will be collected in sealed containers and labeled appropriately
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HIV Rapid Test This is expected to be done on site by a trained HIV Rapid Tester and be preceded by HIV pretest counselling by a trained counselor. The test itself will be done in accordance with the National Testing Algorithm. In this algorithm, the result generated is the result parallel testing with a tie breaker in the event of a discordant result in the parallel phase. If the result of algorithm yields a negative outcome, the participant receives post-test counselling on the meaning of the result. If the algorithm is a positive outcome the client is also counseled. Sample collection will be done from aliquoting from the last vacutainer of blood collected into the two rapid tests run in parallel. A blood sample will be drawn by the phlebotomist on site who will venipuncture a suitable vein in the forearm (usually antecubital fossa) or hand to obtain blood. Please note for all the tests it is recommended that 15mls of blood be drawn at this time. An additional 5mls of blood will be taken under two conditions; (1) the participant opts for a delayed HIV test or (2) additional blood is taken for a confirmatory testing following a rapid HIV test. Samples need to be placed in red top vacutainers and suitably labeled. The [name of lab] requisition form needs to be used and filled completely in quadruplicate but ensuring no names are put but a survey ID used (See Appendix D8). It must be ensured that no address of the site is given but that the ‘Men’s Health Survey’ is indicated where a location is requested. Using this same methodology, one in every 10 negative HIV rapid test results will require a blood sample sent to the [name of lab] as a quality control for the batch of HIV Rapid test kits.
Guidelines for handling Blood for HIV/Virology/Serology - For HIV/Serology, send clotted samples, (5 ml) whole blood in red top vacutainers or 3ml serum. - ALL samples for HIV serology must be coded (Do not use Name of Patient) - Refrigerate samples if not transported immediately, or remove serum from clot if sample is held more than forty-eight (48) hours. - Samples must be transported on ice. - Completed request forms must accompany each sample. - Do not place request forms in bags with samples. - Do not wrap sample in request forms - Request forms must have: o Survey Identification Code; o Contact Numbers for [name of PI] at HCU; o Date/ Time of Collection/ Onset; o Test Required.
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VDRL, Hepatitis B, Herpes Simplex Virus. If the participant opts for an HIV rapid test, following a simple verbal confirmation of consent, a blood sample should be drawn totaling 15 mls. Five mls of blood should be placed in each of three red top vacutainers and each vial appropriately labeled. - For the VDRL test: o The [NAME OF LAB] requisition form should be used but only indicating the survey ID number, and the address should be ‘Men’s Health Survey’. - For the Hepatitis B test: o The [NAME OF LAB] requisition form should be used as per what was referred to for the HIV confirmation/quality control test. It should be noted that if a participant requires both an HIV and Hepatitis B test to be done, one [NAME OF LAB] form can be filled with multiple requisition tests done on it. - For the Herpes Simplex Virus: o The form from the Ladymeade Reference Lab should be used and as per other forms should have no recorded names, and for address of requisitioning site, only the survey name ‘Men’s Health Survey [country]’ should be labeled Chlamydia/Gonorrhea test This is to be done by the client being given the necessary instructions by the nursing or other suitably trained personnel to collect a sterile mid-stream urine using a sterile urine container. The Ladymeade Reference Lab form will accompany this sample from the survey site to [NAME OF LAB] for shipment to [country]. This form is included in Appendix D12 Biohazard Waste All contaminated consumables need to be disposed of in the available biohazard bags or sharps container where appropriate. It will be disposed of periodically from the site to [NAME OF LAB] where it will be stockpiled with other biohazard waste and disposed. On-site storage Specimens should be stored at 2-30 degrees Celsius (needs stabilization within 24 hours) and serological samples 2-8 degrees Celsius. Daily temperature checks should be performed and recorded for the refrigerator storing samples to assure its proper functioning and appropriate temperature. Transport of prepared samples Transport Procedures All samples for transport between sites nationally and regionally should be managed in accordance with WHO regulations for transport of infectious substances 2011 – 2012 (See Appendix D7) All samples collected need to be transported using ice packs and labeled appropriately. The Phlebotomist must ensure that there is a suitable and completed requisition form to accompany
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the labeled specimens. It is recommended that all blood samples be placed in a sample rack and together with the urine specimens be placed in a sealed biohazard labeled container. There should be three containers for every site: - One for samples to be sent to [NAME OF LAB] ( HIV, Hepatitis B ) - One for samples to be sent to [NAME OF LAB] ( VDRL ) - One for samples to be sent to the Regional Laboratory to be processed for stabilization , transfer to [NAME OF LAB] for storage and preparation for eventual shipping overseas (HSV, CT, NG) - Each container should have a mini-rack to hold blood vacutainers Proper labeling of samples, filling of forms and packaging into the specimen transport containers is the sole responsibility of the phlebotomist. A log of all samples packed in the container needs to be signed on a daily basis by phlebotomist and this list given to the field supervisor for further data management. It is the responsibility of the phlebotomist to ensure transport of samples in the containers to the assigned Regional lab. They are for the following sites - [Capital City] site: All samples go to the [city] General Hospital - [city] site: All samples go to the [city] General Hospital - [city] sites: All samples go to the [city] Regional Hospital A log book will be available at the laboratory and personnel to receive all samples being dropped off by the biological staff labeled Men’s Health Survey. It is recommended that personnel transport once daily so as to reach the lab around 12pm to 1pm daily. The samples to be taken should be the samples taken after 1pm the day before and which should have been refrigerated as well as the samples taken on the day of transport. Processing by Regional laboratories When the samples are received by the Regional Laboratories, assistance will be given with the following a. Courier of VDRL samples and forms to [NAME OF LAB] b. Courier of HIV, Hepatitis B samples and forms to [NAME OF LAB] within 48 hours from blood draw for serological samples as per [NAME OF LAB] Users guide c. Within 24 hours forward urine in the Cobas stabilization tubes to [NAME OF LAB] (CT, NG) d. Spin and aliquot serum on sample for HSV.
Processing by Reference Laboratories [name of Laboratory] They will be asked to receive the samples separately and record on a separate log book for survey accountability and tracking purposes. [Name of lab] will assist in HIV confirmation and Hepatitis B testing.
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They will also assist in ensuring courier of the processed urine and serum samples for HSV overseas to Ladymeade Reference Lab. The overseas courier system is being requested to occur every two weeks. Queens Park Counselling Centre and Clinic [NAME OF LAB] will be asked to receive the samples separately and record on a separate log book for survey accountability and tracking purposes. Queens Park Counselling Centre and Clinic will assist in VDRL result generation. Ladymeade Reference Laboratory Ladymeade will receive samples shipped overseas by the courier and to process samples for Chlamydia and Gonorrhea via their Standard Operating Procedures for the urine specimens
Results generation [Name of Lab(s)] This laboratory will generate results per participant for HIV, syphilis and Hepatitis B tests. This report will be picked up periodically by staff at the HIV and AIDS Coordinating Unit to send to the [name of city] Office site and directed to the PI, the Study Lead and the Data Manager.
Ladymeade Reference Lab This laboratory will generate results and send the results via email to the PI.
Referral With the results obtained, the participant will need to be given the results at the next visit. Information will be provided to the participant per protocols in sections above to link participants to care and treatment.
Rejection Criteria Please note sample rejection criteria from laboratories taken from [NAME OF LAB] user’s manual:
No Sample Received Unlabeled Sample Inappropriate sample HIV samples labeled with Patients name Grossly haemolyzed sample Insufficient sample Inappropriate sample container
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Leaking sample Mismatched sample & form Incomplete request form No requesting institution stated on Request form No requesting physician stated on Request form No Date of onset stated on Request form No test request stated on Request form Delayed transport Transported at the incorrect temperature Test not offered
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VI.
GENERAL SURVEY SITE MANAGEMENT
Overview
Crowd Control To protect the credibility of the survey site and the privacy of survey participants it is imperative that there are procedures to manage heavy traffic of individuals at the site for any given reason. There are a number of possible circumstances which may lead to the presence of large numbers of individuals at the site. For example, as successive individuals complete the survey, it is reasonable to assume that awareness of the survey will heighten among the MSM community and possibly among the general population. This may result in individuals attending the site without appointments; they may accompany someone with an appointment or attend the site self- identifying as a potential participant and requesting inclusion. There is also the possibility that individuals may attend the site requesting information about the survey. Finally, there is also the expected situation where persons who have completed the survey may return for subsequent visits unexpectedly. Field safety It is important for project staff to prevent problems by using practical measures and advance planning as much as possible. Project staff must be alert to their own safety and to that of their co-workers at all times. A basic awareness of one’s surroundings is critical when working at the field site. Generally, the Field Supervisor is responsible for crowd control and overall safety. Each of the project staff must also be responsible for maintaining a safe working environment. Staff should consider the following steps for field safety: o o o o
Call 999 without hesitation if danger is present. Always carry your BBSS staff identification card. Plan ahead, be alert. Always have at least 3 project staff members at each field site during the hours of operation.
General Guidelines - Plan ahead • Have an emergency action plan. • Know what you are going to do ahead of time in case things go wrong. Know who to contact in case of emergency. - Always know the location of all exits from any point in the field site(s).
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•
During interviews, always position yourself closest to the door; you do not want an unruly participant between you and the exit.
-
Be alert • Be aware of your surroundings. • If a threatening situation arises, remove yourself from the situation immediately. Leave quickly, but do so carefully and with a "cool head." • Use all of your senses to assess a situation. If your sixth sense tells you that the situation is not safe, then seek immediate assistance from a fellow staff member or security staff (if applicable). • Approach every potential participant as though he is welcoming, but be cautious if you have concerns about an individual.
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Be Practical • Limit the amount of cash you carry. • Avoid wearing or carrying articles that look valuable. Jewelry, purses, expensive watches, and cameras invite theft. • Do not carry weapons. • Never leave the keys in your car or the doors unlocked. • Do not be under the influence of illegal drugs or alcohol while you are working. • Do not make change or give donations to those asking for money while at the field site(s). • Do not buy or receive merchandise from participants. • Do not accept gifts from anyone. • Do not offer rides to or accept rides from participants. • Do not socialize or have sex with participants outside of the study.
Difficult situations
End the interview at any point if you feel threatened by the participant.
Aggressive or threatening individuals If directly confronted by an individual, employ verbal de-escalation techniques: position yourself at an angle and allow extra space between you and the other person; do not smile; let them vent; listen to and acknowledge their concerns; avoid becoming defensive; lower your voice, tone, and tempo; and respond to valid complaints.
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Sexual harassment If a participant is making sexual advances or sexually harassing you, you have the right to terminate the interview. If you feel the participant is behaving inappropriately, you should first remind them that you are only there to interview them and that you are not interested in any sexual offers. If the participant continues, tell them that you are going to stop the interview if they cannot stay focused on the questions. If this does not work, terminate the interview.
Drunk, high, or drowsy participants A participant may not be able to complete the interview or give accurate data for a variety of reasons. He may be unable to give coherent answers to the questions, nod off or appear to be very drowsy during an interview if he has had little sleep or has recently used alcohol or drugs. If you are screening someone for eligibility and they cannot give coherent answers, answer the final Eligibility Screener question “Is this person alert and able to complete the health survey?” as “No”. Explain to the participant that he can opt to return at another time to complete the survey. If the participant selects this option, return coupon to him and reschedule the participant. If you have begun the interview (after screening) and the participant is no longer giving coherent answers, stop the interview, thank the participant for his time, and enter a description of what happened in the interviewer comments. You may reschedule the interview if the participant is willing.
Calling for back-up It is important for staff to be alert and recognize times when they need assistance. One way to call for back-up is by use of a code word to call for assistance. You might use something like the phrase “bring the red folder.” For example, if you are not comfortable interviewing a participant alone or need help with an uncooperative participant, ask a co-worker to bring the “red folder” to indicate that assistance is needed. The Field Supervisor should be made aware of challenges or incidents as they arise at the field site, and is responsible for handling them as soon as possible. The Field Supervisor should call the Study Lead for further guidance if they are not able to handle the situation themself. Social workers are on-call to handle participants who are upset or angry, and they can be engaged by the Field Supervisor as needed.
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Reporting adverse events An adverse event is any event that occurs which could adversely affect the survey or the staff involved in it. Adverse events can range from aggressive behaviour from a participant to a breach of confidential information to the nature of the survey being announced to the general public. In the event that an adverse event or field incident occurs, notify the Field Supervisor immediately. The Field Supervisor will then notify the Study Lead who will complete a “Field Incident Report” (Appendix E1). The Study Lead and co-investigators will then determine what actions to take, and whether the incident qualifies as an adverse event. Data Transfer Each day that field sites are open and enrolling participants, staff will collect electronic and paper data, both of which need to be securely stored at the end of the work day. Electronic data will be encrypted as it is entered into the computer, and will be stored locally on each computer. This electronic data needs to be transferred to the central server at the end of each day for its security. The Field Supervisor, or in their absence, the Coupon Manager, is responsible for performing the data transfer on a daily basis. The Field Supervisor should send list of Survey IDs to the Data Manager when uploading QDS files so they can cross-check that all are received. The data transfer process is detailed in the data management manual.
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VII. APPENDICES Appendix A1: MSM Screening Questionnaire INSTRUCTIONS: The Interviewer will complete this entire screening questionnaire for every candidate that comes for visit #1. “Hello. My name is ____. I would like to first thank you for taking the time to participate in the study. This study is about HIV-related risk behaviours of men in [country] and it also includes testing for HIV, sexually transmitted infections and chronic diseases. Before we start the study, I need to first find out if you are eligible. If you are eligible to participate, then I will explain the study in more detail. Let me also say that everything you tell us will be completely confidential. No one will be able to link your responses to you. Are you ready?” 1. [Interviewer ID] |____|____| 2. [Is this person a seed?]
1. Yes Enter 2-digit ID: |____| ____|
2. No Enter |___|___|___|___| 1 Yes 3. [Skip if seed] [Does the 2 No Ineligible candidate have a valid coupon?] 4. Have you participated in this 1 Yes Ineligible study before? 2 No 5. How old are you now?
4-digit
Coupon
#:
AGE IN COMPLETED YEARS: ___ ___ IF zero, complete coupon rejecter questionnaire) 3. Has anyone refused the coupons? Yes_________ No __________ 4. How many people refused to accept coupons? _______ 5. What is the race or ethnic background of those who refused coupons? a. How many were Caucasian? ______________ b. How many were Syrian/Lebanese? _______________ c. How many were East Indian? __________________ d. How many were African? ___________________ e. How many were Chinese? _________________ f. How many were mixed? ____________________ g. How many were another race/ethnicity? _______________ 6. Which of the following are reasons that people who refused gave you about why they did not take a coupon? [Read each one. Check all that apply.]
□ They didn’t have time □ They don’t live in [country] □ They didn’t trust you (recruiter) □ They already had a coupon □ They already participated □ They didn’t want to be identified as MSM □ Incentive too small □ Some other reason: ____________________________________ □ Don’t Know □ Refused
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Appendix C1: Informed Consent Form Title of the Study: [country] Men’s Health Survey The Ministry of Health invites you to take part in a study on Men’s Health. There are some behaviours that put some persons at higher risk for contracting HIV and other Sexually Transmitted Diseases. This Study will collect information on risk factors and the information we learn can help to identify, plan and implement successful outreach and health services for men. This document is a consent form and you will be offered a copy to keep. Please take your time to review it. You are free to ask questions at any time. Please ask any member of the study team to explain any words or information that is not clear to you. Taking part in this study is completely voluntary. Purpose of the Study The purpose of the study is to gather health and behavioural information on Men who may be at higher risk of HIV and sexually transmitted infections in [country]. The information will be used to design and refine health programmes. Procedure This Survey consists of an interview, health screening and a follow-up component. If you agree to participate in this study, you will be asked to: 1. 2. 3. 4.
Take part in an interview about your behaviours and knowledge about HIV Have a chronic disease screen for diabetes and hypertension Provide a urine sample for some STI tests Have approximately 15 ml (about 3 teaspoons) of blood drawn from a vein in your arm for HIV and STI testing with results due in two weeks. You may also choose to learn your HIV test results before you leave here today if you wish. 5. Recruit some of your friends to participate in the study 6. Make a return visit in 2 weeks to learn your test results and provide basic information on individuals you attempted to recruit into the study. Let me explain some of these things I just mentioned in more detail. The Interview: b. This is an anonymous survey. You will complete the interview in a private room, you will read the questions and record your answers on the computer, or if you prefer, an interviewer will read the questions and record your answers. The survey has questions about your knowledge, attitudes and practices related to sexual health. It will take about 45 minutes to complete this interview. c. Your answers are completely confidential. You will not be linked to the answers that you provide because your name will not appear anywhere on the questionnaire or on ANY survey documents.
58
d. The survey has some questions that are personal. They may be hard to talk about. If you choose to participate you have a right to refuse to answer any questions that you feel uncomfortable with. e. If you change your mind about participating during the course of the interview you have the right to withdraw at any time. If you refuse to answer a question or want to end the interview, you will not be penalized, nor will it affect you or your future care whatsoever. f.
In order to receive HIV, STI or chronic disease screening, you will need to take the questionnaire.
g. At the end of the survey, you will be offered a chance to recruit between 1 and 3 other people for this study. The Health Screening: a. If you agree to the survey, we will offer you a free HIV test. If you already know that you are HIV positive, we would still like to offer you an HIV test today so that we can pair today's HIV test result with your survey results. b. If you agree to the HIV test, you will have a 10- to 15-minute HIV prevention counselling session with a trained staff member. The session will cover the meaning of results from the HIV test. After the counselling, we will take a sample of blood for testing. c. A test is done through drawing about 1 teaspoon of blood from your arm. With this sample, a rapid or a delayed HIV test will be run. If you choose, your HIV test results will be available before you leave. d. You may still take the survey and HIV test even if you already know your HIV status. We will offer you information about available services, if needed. If the rapid test result is reactive, or if you know you are already HIV-infected, we will draw about 5 ml of blood for a second test to confirm your rapid test result. The result of the confirmatory test will be ready within two weeks. We will set up a day and time for you to get your results. e. Your test results will be paired with your survey. We will match your test results using the same ID assigned to the survey. No one besides you will be told your test results, and neither the survey nor the test will be placed in any medical record. f. In addition to the HIV test, we will also offer you free STI testing and chronic disease screening. g. The blood and urine samples that we collect will be used to test for sexually transmitted infections (Syphilis, Herpes Simplex Virus-2, Hepatitis B, Chlamydia and Gonorrhoea). Test results should be available within two weeks. We will also offer you chronic disease screening for hypertension and diabetes. You will be referred to the health centre of your choice or advised to check your attending physician (public or private) if follow-up medical care and/or treatment is necessary. If you have symptoms today that you think might be from an STI, you can receive information about options for treatment. h. If you agree to the chronic disease screening for diabetes (finger stick with results available almost immediately) and blood pressure, you will have an additional 10- to 15-minute counselling session with a trained staff member. i. If you agree to testing, we will keep left-over blood samples at the Testing Laboratory for up to five years. We will not put your name on the specimen. There will be no way to connect it to you.
59
The Follow up: a. If we ask for your help in asking people to join this study, we will give you up to 3 recruitment coupons to recruit other men into the study. b. If they enroll in the study, you will receive a voucher valued at [currency amount] for each person who completes the survey. We ask you to come back after 2 weeks to check if the people you recruited enrolled in the study. We will give you a full explanation of these procedures at the end of your visit today. c. We will ask you to make a return visit two weeks after your first visit, to inform you of your test results and provide basic information on individuals you attempted to recruit into the study. Things to consider There are risks involved in being in this study: 1. Some of the questions in the survey are about sex, alcohol and drugs and may make you feel uncomfortable, embarrassed, or stressed. All answers you give will be kept private. 2.
Drawing blood may cause some pain, bleeding, swelling, bruising and rarely infection where the needle entered the skin. Sometimes drawing blood causes people to feel dizzy or even faint. 3. You may feel uncomfortable or distressed if you find out you have been infected with HIV or another STI, or that you have a chronic disease. You can talk about your concerns with the trained staff member who tells you your results, if you wish. Benefits Benefits you may get from being in this study include: 1.
You will receive condoms, lubricant and information on HIV/AIDS, sexually transmitted infections and chronic diseases. 2. You will, if you wish, receive free information about other local programs, medical programs, support groups, and health projects, as needed. 3. If your HIV test or STI test results are positive, you will be counseled about ways to prevent the spread of infection. You will also be offered information about available medical care for any infections or if screening shows you have a chronic disease. 4. If your test results are negative, you will receive counseling on how to prevent future infections. Also, information gained from this study will help the Ministry of Health to know more about HIV, STIs and how they are spread. This information will be used to improve health programs and to develop new ways of helping others prevent disease and promote good health. Alternatives If you choose not to take part in the study but would like to take an HIV test, we will inform you of agencies or clinics that provide testing. Compensation
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We appreciate the time and effort you will spend in order to participate. You will be paid for the time you spend taking part in the study today in the form of gift cards or phone cards. You will not receive cash. For completion of the survey, you will get a voucher valued at [currency amount]. If you take part in the all the health screens, you will get an additional voucher worth [currency amount]. You may also get a voucher valued at [currency amount] each for up to 3 people whom you send to us who complete the study. Persons to Contact This study is led by: [include names of Principal Investigators (PI)] at the Ministry of Health. [Names of PIs} may both be reached at: (xxx)xxx-xxxx. [name of study coordinator], the Study Coordinator, oversees the daily operations of the study. Her phone number is (xxx)xxx-xxxx. You may call them with any questions about being in the study, or if you feel that you have been harmed through your participation in the study. If you feel that you have been injured through participation in this study, you are entitled to free care at any public hospital or clinic. Please speak with [name of PI] before incurring any medical expenses due to injury from your participation. Confidentiality Statement What you tell us is confidential. Your responses will be labeled with a study number only. No one except the study staff will have access to the survey, except as otherwise required by law. Your responses will be grouped with survey answers from other persons. Survey forms and computers will be locked in a file cabinet at the study office. Computers with study data will be physically secured and protected by coded passwords. Only specific study staff will have access to the locked file cabinet or the computers. Your name will not be attached to any answers you give to the study questions or to your blood, or urine samples. Your samples will be identified only by a code, so it will not be possible for the people studying your samples to know who you are. If you know me, you may ask for another staff member to assist you so that your answers will be fully private. Costs You will not have to pay for your participation in the study. Right to Refuse or Withdraw This study is completely VOLUNTARY. You are not giving up any legal claims or rights for being a part of this study. If you agree to participate, you are free to quit at any time. You can choose to only do the survey and not to have an HIV test or other STI testing and chronic disease screening. You can also choose not to recruit others. Agreement Statement of Study Staff Obtaining Consent
61
I have explained the study to the participant. I am available to answer questions now or in the future about the survey and participating in the survey. The participant has answered the following questions as indicated: Age and Consent 1) Do you have any more questions about what I have just said? Yes (Answer questions) No, I do not have questions (Go to 2) 2) Are you 18 years of age or older? Yes (Go to 3) No (Not Eligible) 3) Do you consent to participate in the overall study, including survey interview? Yes No (Not eligible to continue) 4) Do you agree to give a blood sample for HIV testing? Yes No If No, ask participant “would you mind telling us why you have chosen not to provide a blood sample for HIV testing?”
5) Do you agree to allow your blood sample to be used for STI testing? Yes No 6) Do you agree to give a urine sample for STI testing? Yes No 7) Do you agree to allow chronic disease screening for diabetes, and hypertension? Yes No 8) Do you agree to allow your samples to be stored up to five years for confirmatory testing related to this study only? Yes No Consent Statement You have read or have had read to you the explanation of this study, you have been given a copy of this form, the opportunity to discuss any questions that you might have and the right to refuse participation. I am going to ask for your consent to participate in this study. Date: ____________ Initials of Interviewer: ________ if positive verbal consent I have fully explained to the participant the nature and purpose of the procedures described above and the risks involved in its performance. I have asked if any questions have arisen regarding the procedures and have answered these questions to the best of my ability.
Date: ____________ Signature of Interviewer:_________________________
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Appendix C2: FIRST VISIT Checklist Interviewer ID: Coupon ID: ITEM Ensure person is at right place Visually validate coupon
Coupon Manager ID: Recruit ID: RESULT (Y) (N) (Y) (N)
Check appointment book Validate and enter coupon/referral card on RDSCM Participant folder created with labels & coupon Client eligible Computer number Informed consent for survey received HIV rapid test consent HSV-2 consent Syphilis consent Chlamydia test consent Gonorrhea test consent Hypertension test consent Diabetes test consent Blood stored for up to 5 years Interview completed Blood stored at 2-8 degrees C Urine stored at 2-8 degrees C HIV pre and post test counseling HIV and STI tests conducted Chronic disease screen conducted Client agreed to recruit Create unique Recruiter ID Number of coupons given RDSCM fully updated Complete coupon log form Appropriate incentives given Travel comp. given (if ineligible) Complete incentive tracking form Follow up visit date & time Coupon filed and stamped accordingly
(N) (N/A) (N) (N/A)
(Y)
(N) (N/A)
Coupon Manager
(Y)
(N) (N/A)
Interviewer Interviewer Interviewer Interviewer Interviewer Interviewer Interviewer Interviewer Interviewer Interviewer Interviewer Interviewer Medical staff Medical staff Medical staff Medical staff Nurse Coupon manager Coupon manager Coupon manager Coupon manager Coupon manager Coupon manager
(Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (Y) (N) (on 2nd visit) (N/A) (Y) (N) (N/A) (Y) (N) (N/A) (0) (1) (2) (3) (Y) (N) (N/A) (Y) (N) (N/A) Behavioural (Y) (N) (N/A) Biological (Y) (N) (N/A) (Y) (N) (N/A)
Coupon manager
(Y) (N) (N/A) Coupon manager (Y) DD-MM-YY; Time: ------Coupon manager (N) none Participated: (Y) (N) (N/A) Ineligible: (Y) (N) (N/A) Not visually valid: (Y) (N) (N/A) (Y) (N) Coupon manager
Package given to client (brochures, condoms etc) Checklist approved by Field Supervisor before client exit I agree that all steps on this form have been completed: ________________________ Date (DD-MM-YY)
(Y) (Y)
Date: DD-MM-YY INITIALED Interviewer/Security Interviewer/Coupon manager Coupon manager Coupon manager
(Y)
(N)
Field Supervisor
_____________________________ Staff signature
63
Appendix C3: Subsequent Visit Checklist Date: Interviewer ID: Coupon ID: ITEM RDSCM Unique Code Recruiter questionnaire completed No. coupons retrieved Secondary incentive paid HIV test Confirmatory result communicated Syphilis test result communicated HSV-2 test result communicated Gonorrhea test result communicated Chlamydia test result communicated Hep B test result communicated Hypertension test completed Diabetes test completed
Coupon Manager ID: Recruit ID:
Date: DD-MM-YY RESULT
(Correct) (Incorrect) (Y) (N) (0) (1) (2) (3) (Y) (N) (N/A) Voucher#: (Y) (N) (N/A) Date Received: (Y) (N) (N/A) Date Received: (Y) (N) (N/A) Date Received: (Y) (N) (N/A) Date Received: (Y) (N) (N/A) Date Received: (Y) (N) (N/A) Date Received: (Y) (N) (on 1st visit) (N/A) Date Received: (Y) (N) (on 1st visit) (N/A) Date Received:
(Y) Referral information Provided (Y) Package given to participant (condoms, lube, brochures, etc.) I agree that all steps on this form have been completed:
________________________ Date (DD-MM-YY)
(N) (N)
INITIALED Coupon manager Coupon manager Coupon manager Coupon manager Medical staff Medical staff Medical staff Medical staff Medical staff Medical staff Nurse Nurse Medical staff Coupon Manager
_____________________________ Staff signature
64
Appendix D1: Lab Form Survey ID: ______________ Chronic Disease Screening Sample/Test
Date
Systolic
Diastolic
Initials
Date
Value
Initials
Job title
Job title
Hypertension Screening
Glucose Screening
HIV Testing Rapid Test
Indicate with tick (√)
Date
Result (Negative/ Positive)
Pre- Test
Is the result positive? (Circle appropriate)
Post – Test
Done by (Initials)
Y
Job title
N
If yes, sample taken for confirmatory testing (Circle appropriate) Y
N
HIV Confirmatory Date result received
Result
Date Result received by participant
Referral to Care and Treatment Site (Y/N)
Name of Site
STI Screening Date Taken
Date result Rec’vd
Result
Result entered by
Date Participant informed
Referral to Care and Treatment Site
Hep B VDRL HSV Chlamydia Gonorrhea
65
Appendix D2: PHLEBOTOMY CHECKLIST Date: ____________________________ TASKS
Site: [city] □
[city] □
[CITY] □
DY 1
DY 2
DY 3
DY 4
DY 5
initials
initials
initials
initials
initials
Check & Record Room & Fridge Temperature and enter on Log.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Count Tests Kits Inventory (i.e. Determine, Uni-Gold, Stat-Pak and Chase Buffer) and Log.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Perform Negative Quality Controls (QC) using Dried Tube Specimen (DTS) with Determine, Uni-Gold & StatPak.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Perform Positive Quality Controls (QC) using Dried Tube Specimen (DTS) with Determine, Uni-Gold & StatPak.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Enter Quality Controls results in the Quality Controls Sample Log.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Set up work station/area.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Log results after each client is seen.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Pipette urine from sterile container into testing vial for Chlamydia and Gonorrhea as outlined.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Prepare necessary paper work, package with samples for transport.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Refrigerate & record overnight samples.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Log sample pick up time and
Yes □
Yes □
Yes □
Yes □
Yes □
COMMENTS
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courier’s initials.
No □
No □
No □
No □
No □
Prepare DTS controls overnight. (Follow procedure on the corkboard).
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Disinfect /Sanitize work area at the end of the day.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Prepare station for next day.
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Yes □
Yes □
Yes □
Yes □
Yes □
No □
No □
No □
No □
No □
Check & Log inventory.
Check & Log room / fridge temperatures on leaving.
Comments: __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ ________________________________________
Medical Supervisor (M.S.) __________________________________________
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Appendix D3 NURSES CHECKLIST Site: [city] □ [city] □ [CITY] □ Name: ____________________________ TASKS CHECKED Check & Record Stock, Enter on log. Prepare work station and check BP & Glucose machines and supplies. Prepare STI results. Receive client – Introduction and verification of verbal and written consent. Explain Chronic Disease Testing (Blood Pressure (BP) and Diabetes) and procedure. Perform Chronic disease testing (BP & Finger Stick for Diabetes) and discuss results and provide referral if necessary. Provide and Counsel on the STI results Prepare and complete necessary paper work, secure results that were not collected. Disinfect /Sanitize work area at the end of the day and prepare station for next day. Check & Log inventory.
DATE
TIME IN
TIME OUT
INITIALS
Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □
Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □
Comments: __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __
Medical Supervisor (M.S.) __________________________________________
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Appendix D4: Pre and Post HIV Testing Guide Receive client – Introduction and verification of verbal and written consent of all tests. Invite client to have a seat and reassure that the session will be confidential. Explain to client which tests are to be done, with brief discussion on HIV, Herpes, Syphilis, Hepatitis B, Chlamydia and Gonorrhoea. Explain to client which test results are same visit and which will be ready within 2 weeks and requires an appointment. Explain the venipuncture procedure and perform. (Universal Precaution) Take 4 vials of blood. Explain Midstream Urine (MSU) collection procedure, label container with Survey ID # and request MSC sample for Chlamydia and Gonorrhoea, direct client to washroom. Ask client to place urine sample on sink countertop. Pre Test Counsel / Discussion - HIV transmission, Window Period, prevention (safe sex), sources of support, partner disclosure and referral, explain meaning of each results (negative & positive). Open kits for HIV Rapid Test (as per Algorithm Determine and Uni-Gold) Perform HIV Rapid Test on 4th vial. (Allow 15 mins.) Post Test Counsel / Discussion – HIV results are ready, tell and show results to client, ensure that client understands their results, Explain Window Period as it relates to their most recent risk, discuss sources of support, partner disclosure and referral, address remaining risk behaviours and the need for retesting if necessary. Give client gift bag, referral information and a reminder to make an appointment to collect results in 2 weeks. Client has completed the medical session. Complete Survey Checklist Radio Interviewer to escort client to the Coupon Manager.
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Appendix D5: Specimen Storage Log
1
SPECIMEN (Tick if specimen packed/received)
Chlamydia
HSV-2
Syphilis
HIV
#
SURVEY ID of Specimen
Gonorrhea
Biological Tests Indicated
Blood Volume
Quality
Urine
Collection Date and time Date
Time
Volume
(ML)
(ML)
(ML)
(ML) Quality
2
3
4
70
INITIALS
Appendix D6: Batch Log
Batch #
List of Samples in Batch by Survey ID
YY-MM-DY-Site Code
71
Appendix D7: Specimen Transport Log: BBSS to [NAME OF LAB] Date
Batch #
BBSS Site
Departure Time from BBSS SITE
Date
Deposit Time
Transit Time
Handover From MoH Driver Staff Block letters
To [NAME OF LAB] Staff
72
Appendix D8: Specimen Transport Log: BBSS to [NAME OF LAB] Date
Batch #
BBSS Site
Departure Time from BBSS Site
Date
Deposit Time
Transit Time
Handover From MoH Driver Block letters
To [NAME OF LAB] Staff
73
Appendix D9: Specimen Shipping Log Survey ID
Date Sent to [NAME OF LAB] Lab
Date Specimen Shipped from [NAME OF LAB]
Specimen Type Urine or Blood
74
Appendix D10: [NAME OF LAB] Lab Form
[Name of laboratory
Address and contact number]
75
Appendix D12: HIV Testing Algorithm [insert national algorithm]
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Appendix E1: Recruiter Script Who to recruit We are going to give you 3 coupons to give to someone you know, such as a friend, relative. It is important that you do not give this coupon to a stranger. Be sure to give the coupon to someone who has not participated already. You can give the coupons to anyone who is biologically male, over 18 years old, and has lived in [country] or [other island of country if applicable] for at least 6 months. Coupons Coupons are like tickets that allow someone to participate in the study, so everyone must have a ticket to get into the survey door. It is very important that you tell anyone you give coupons to that they need to have the coupon on them when they call to make an appointment and come to the survey site. The first thing that happens when they get here is that we check the coupon to make sure that it is valid. The persons you recruit will have to bring their coupons to the office and answer questions like you did today, to determine if they are eligible to participate in the study. You will not get replacement coupons if your coupons are lost or the person recruited turns out to be ineligible. Each coupon has an expiration date and we encourage you to ask persons to use the coupon by this date.. It is therefore important that you tell people that you give the coupon to that they need to call and make an appointment before the date written on the coupon. Process The whole survey process for the study takes about 11/2 hours Tell the person you recruit to make an appointment at a time when they can complete the whole survey. Everyone who completes an interview will get a non cash voucher valued at [currency amount]. Everyone who also takes an HIV test will get a non cash voucher valued at [currency amount]. Vouchers are either in the form of pre-paid mobile phone cards or grocery vouchers. Rewards You will receive a voucher valued at [currency amount] for each person who you successfully recruit to participate in the study. Note that this voucher valued at [currency amount] is not guaranteed just because you give someone a coupon – the person must actually take part in the survey. You can call the office on the number indicated on your reminder card to find out if you are due a reward. We will only be able to give you the reward—please don’t send someone else in to get the reward. Recruiter questions To make sure that we give the reward to the right person, we are going to ask questions so that we can identify you again when you come to the survey office. We connect the number of the coupons we give you to the coupon you brought in, so we know who to pay When you come in for your reward, we will ask you these same questions so that we will be able to know who you are and how many rewards you are due. .You can call our office to see if anyone you gave coupons to was eligible and completed the survey. We can’t tell you who came in with a coupon from you, but we can tell you whether or not we have a reward voucher for you.
77
Do you have any questions? Remember give the coupon to someone you know. Thanks for helping us.
78
Appendix E2: Facility list for treatment and care [insert list for city or country]
79
Appendix E3: Participant Contact Information There are several persons that you may contact if you have any questions or concerns about your participation in this study. This study is led by: [Name of individuals] at the Ministry of Health. Both [name of principal investigators] can be contacted at (xxx)xxx-xxxx. [Name of individual] is the Study Coordinator and oversees the daily operations of the study and her phone number is (xxx)xxx-xxxx. You may call them with any questions or concerns about being in the study. You may call any of these three persons with questions about being in the study, or if you feel that you have been harmed through your participation in the study. If you feel that you have been injured through participation in this study, you are entitled to free care at any public hospital or clinic. Please speak with [name of principal investigator] before incurring any medical expenses due to injury from your participation. This study has been approved by the Ethics Committee of the [country] Ministry of Health.
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Appendix G1: Field Supervisor Daily Checklist Field Supervisor: 1.
Date:
Yes
N/A
Check white board for notifications, status updates, and reminders
□
from previous day and/or shift.
□
□
a. Check Appointment Book for confirmed appointments
□
□
b. Check Standby list and schedule standbys if feasible
□
□
□
□
□
□
2.
Prepare for daily staff meeting:
3.
Host daily meeting with all staff a.
Update and briefing with Interviewers
b.
Update and briefing with Coupon Manager
c.
Update and briefing with Medical staff
□
□
d.
Update and briefing with Security Personnel
□
□
□
□
□
4.
Ensure/verify site is ready for receiving clients
□
□
5.
Disburse incentives to Coupon Manager (signature required)
□
□
6.
Download & review Data documents
□
□
7.
Review & act on Data Correction logs
□
□
8.
Update Results Ready log
□
□
9.
Officially open site for client visits
□
□
10.
Welcome clients and hand over to Interviewer
□
□
11.
Provide oversight to the administrative processes: a.
Monitor Interviewers’ performance
□
□
b.
Monitor Coupon Managers’ performance
□
□
12.
Make appointments when Coupon Manager is engaged with clients
13.
Ensure Check List activities have been completed and sign off before clients leave the site
□
□
□
□ □
14.
Respond to site incidents as required
15.
Ensure that client folders & coupons are correctly filed
□
□
16.
Reconcile incentives with Coupon Manager (end of day)
□
□
17.
Ensure that specimens stored and labeled for MOH hand over
□
□
18.
Upload ACASI for encryption and retrieval by Data Manager
19.
Upload other relevant data for retrieval by Data Manager
□ □
□
□
□
81
20.
Check and reconcile site inventory i.e. stock and supplies (weekly)
□
□
Appendix G2: Coupon Manager’s Checklist
Preparation before Interview Check Appointment Book Check All Devices Used for Site –( Laptops/Desktops/Walkie Talkies/Appointment Phone/Printer/ Headsets) Check All Survey Programs (RDSCM) Check and put together client folder – (Labels/ Two Consent Forms/ Overall Site Checklist / Recruiter Script/Pens ) Gather Coupons and Incentives from Supervisor Log Coupons and Incentive value in Coupon Log Check for Refreshments (coffee, snacks, tea, snacks) Process after interview Save Clients RDSCM record on desktop/laptop Record Coupons in Coupons Log Check Appointment Book for time of next interview or second visits that one may need to be aware for Clean and Clear up after appointment (in cases of second visit) Remove all wares and garbage left behind after appointment (in case of second visit) Wash wares that client may have used Check Garbage roster ( at the end of day )
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Appendix G3: Interviewer Checklist Preparation before first Interview Check Appointment Book Check All Devices Used for Site –( Laptops/Desktops/Walkie Talkies/Appointment Phone/Printer/ Headsets) Check All Survey Programs (ACASI) Check and put together client folder – (Labels/ Two Consent Forms/ Overall Site Checklist / Recruiter Script/Pens ) Check for Refreshments (coffee, snacks, tea, snacks)
Process after interview Save Clients Interview on desktop/laptop File Clients Paper Information safely (i.e. consent form/checklist) Clean and Clear up ACASI/CAPI room Remove all wares and garbage left behind in ACASI/CAPI room Wash wares that client may have used Check Appointment Book for time of next interview. Check Garbage roster ( at the end of day )
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Appendix G4: Field Incident Report Form Field Incident Report Date: ___/___/______ Survey Site Location:_____________________________________________ Name of Person Filing Report: _____________________________________ Position held at site (check all that applies): Interviewer Field Supervisor Coupon Manager Phlebotomist / HIV tester Nurse HIV Tester Security Officer Other (Specify): ________________________________________ Location of Incident:_____________________________________________ Type of incident: ___________________________________________ Date of Incident: ______ / ______ / __________ Time of Incident: ______ / ______ / am / pm Description of Incident: __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________ Actions Taken: __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ ______________________________________
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Date forwarded to The MoH: ____/____ / ______ Time: ____/____ / am / pm Additional Comments: __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ _______________________________________________________________________
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Appendix G5: Field Supervisor Evaluation Form General Instructions: This checklist should be used to document evaluations of the Field Supervisor. The Study lead and/or the Principal Investigator(s) should conduct the observations. The Field Supervisors should be evaluated once per week for the first three weeks of data collection, then once per month. Following each evaluation, the evaluator and Field Supervisor should meet to review the completed checklist and discuss areas where the Field Supervisor could improve. Each evaluation should build on previous evaluations to monitor Improvement. Field Supervisor: Rating instructions: Circle the number of the label that corresponds with your evaluation for each criterion. Some criteria may not apply to every observation. If one does not, please check the ‘N/A’ box for that criterion
Evaluation Date: Evaluator: General knowledge and skills 1. Field Supervisor was knowledgeable about the protocol. 2. Field Supervisor was knowledgeable about RDS methods. 3. Field Supervisor knew staff strengths and weaknesses. Before daily field site operations 4. Field Supervisor held a daily staff meeting before opening field site.
1 Not at all 1 Not at all 1 Not at all
2
Rating 3 Some
4
5 Fully
2
3 Some
4
5 Fully
4
5 Fully
2
3 Some
1 No
5 Yes
5. Field Supervisor opened field site according to established hours of operation.
1 No
5 Yes
6. Field Supervisor distributed clean data correction logs to interviewers.
1 No
5 Yes
During field site operation hours 7. Field Supervisor did not leave field site unattended without delegating responsibility to another staff member. 8. Field Supervisor directed team and positioned staff (Coupon Manager, Interviewers, HIV tester/ Phlebotomist, Security person if applicable).
1 Not at all
2 Rarely
3 Sometimes
1 Never
2 Rarely
3 Sometimes
4 Usually
4 Usually
5 Fully
5 Always
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9. Field Supervisor scheduled participant appointments and recorded them
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
10. Field Supervisor monitored the flow of participants at the field site and controlled the flow when necessary.
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
11. Field Supervisor monitored staff interactions with past participants, friends, and the public.
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
Criterion #
Additional Notes
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Appendix G6: Coupon Manager Evaluation General Instructions: This checklist should be used to document evaluations of the Coupon Manager. The Study Lead and or Principal Investigator(s) should conduct the observations. The Coupon Manager should be evaluated once per week for the first three weeks of data collection, then once per month. Following each evaluation, the evaluator and Coupon Manager should meet to review the completed checklist and discuss areas where the Coupon Manager could improve. Each evaluation should build on previous evaluations to monitor improvement. Coupon Manager: Rating instructions: Circle the number of the label that corresponds with your evaluation Evaluation Date: for each criterion. Some criteria may not apply to every observation. If one does not, Evaluator: please check the ‘N/A’ box for that criterion Rating General 1. Coupon Manager was 1 2 3 knowledgeable about the Not at Rarely Sometimes Operations Manual and RDS all methods. 2. Coupon Manager kept station 1 2 3 organized with respect to RDSCM Not at Rarely Sometimes hardcopy, used/voided coupons all and referral cards, information cards, etc. 3. Coupon Manager never left 1 2 3 RDSCM open and unattended and Not at Rarely Sometimes did not let participants view all computer screen. Check-in 4. Coupon Manager greeted 1 2 3 participants appropriately Never Rarely Sometimes 5. Coupon Manager collected the 1 2 3 participant’s coupon & checked for Never Rarely Sometimes activation/expiration dates. N/A 6. Coupon Manager entered 1 2 3 appropriate information to create a Never Rarely Sometimes record in RDSCM for Participants with valid coupons. 7. Coupon Manager affixed coupon 1 2 3 to and included labels with Never Rarely Sometimes Coupon Numbers in Participant folder. 8. Coupon Manager voided & filed 1 2 3 invalid coupons appropriately. Never Rarely Sometimes Recruiter Training (if done by Coupon Manager) 9. Coupon Manager verified that 1 2 3 Participant qualified to recruit Never Rarely Sometimes others.
4 Usually
5 Fully
4 Usually
5 Fully
4 Usually
5 Fully
4 Usually 4 Usually
5 Always 5 Always
4 Usually
5 Always
4 Usually
5 Always
4 Usually
5 Always
4 Usually
5 Always
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10. Coupon Manager presented key instructions for recruiting others. a. To give coupons to friends, relatives and people participant is close to. b. To NOT give coupons to people who have already participated c. To NOT give coupons to strangers
Check-out 11. Interviewer filled out and signed Check list appropriately 12. Coupon Manager marked and filed the coupon appropriately. 13. Coupon Manager created Recruiter ID and collected physical mark information as prescribed in RDSCM (for recruiters). 14. Coupon Manager distributed appropriate number of coupons to recruiters and accurately recorded coupon numbers in RDSCM record. 15. Coupon Manager distributed local HIV prevention materials and referrals when appropriate. Criterion #
1 Never 1 Never
2 Rarely 2 Rarely
3 Sometimes 3 Sometimes
4 Usually 4 Usually
5 Always 5 Always
1 Never 1 Never
Rarely
3 Sometimes 3 Sometimes
4 Usually 4 Usually
5 Always 5 Always
Rarely
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never 1 Never
2 Rarely 2 Rarely
3 Sometimes 3 Sometimes
4 Usually 4 Usually
5 Always 5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
Additional Notes:
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Appendix G7: Interviewer Assessment Form General Instructions: This checklist should be used to document observations of the interviews. Interviewers should successfully complete a minimum of three practice interviews prior to the start of data collection. Once data collection begins, the Field Supervisor must observe and evaluate each Interviewer’s first three interviews with real participants. In addition, all Interviewers must be evaluated approximately once every ten completed interviews until data collection ends. Following each evaluation, the Evaluator and Interviewer should meet to review the completed checklist and discuss areas where the interviewer could improve.
Interviewer:
Valuator:
Rating instructions: Circle the number of the label that corresponds with your evaluation for each criterion. Some criteria may not apply to every interview. If one does not, please check the ‘N/A’ box for that criterion.
Materials 1. Interviewer had all necessary materials (flashcards, consent forms) organized and ready before starting.
1 Not at all
Evaluation Date:
2
Ratings 3 Some
4
5 Fully
Eligibility Screening Start Time:_________End Time: 2. Interviewer followed instructions in 1 2 obtaining information that determines Not at eligibility Criteria. all
3 Some
4
5 Fully
Consent Process Start Time: _____ 4. Interviewer followed all aspects of informed consent per local IRB requirements i.e. read verbatim .
End Time: 1 2 Not at all
3 Some
4
5 Fully
5. Interviewer provided Participant with a copy of the Consent Form to follow along (per local protocol).
1 Not at all
2
3 Some
4
5 Fully
6. Interviewer offered Participant a personal copy of the Consent Form to keep
1 Not at all
2
3 Some
4
5 Fully
1 Not at all
2
3 Some
4
5 Fully
Establishing Rapport 7. Interviewer established a good rapport with Participant at beginning of interview and maintained it throughout interview.
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8. Interviewer made eye contact with participant throughout interview.
1 Not at all
2
3 Some
4
5 Fully
9. Interviewer’s verbal & non-verbal behaviour conveyed a neutral attitude (refrained from giving positive or negative feedback about responses). Criterion # Additional Notes:
1 Not at all
2
3 Some
4
5 Fully
Interviewer Assessment Form Part 2 Questionnaire Start Time: _________ End Time: 10. Interviewer “oriented” the Participant (read introductory statement).
1 Not at all
2
3 Some
4
5 Fully
11. Interviewer read questions exactly as written.
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
12. Interviewer read definitions verbatim (e.g., for partner types, "sharing," etc.).
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
13. When instructed ("READ CHOICES"), interviewer read all response options exactly as written.
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
14. When instructed ("DO NOT read choices."), Interviewer omitted response options.
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
15. Interviewer recognized inconsistent responses, clarified with respondent. 16. The Interviewer’s pace for reading questions was…
1 Never 1 Much too Short 1 Much
2 Rarely 2 Too Short
3 Sometimes 3 Just Right
4 Usually 4 Too Fast
2 Too
3 Just right
4 Too
5 Always 5 Much Too Fast 5 Much
17. The amount of time Interviewers gave for responses was…
Ratings
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18. Interviewer filled out and signed Check list appropriately
Anchoring Time Periods With Examples 20. Interviewer facilitated recall by using time period anchors (e.g. "During the past 12 months means since [interview month] of last year”). N/A _
too Slow 1 Never
Slow 2 Rarely
Long 3 Sometimes
4 Usually
too Long 5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never 1 Never 1 Never Additional Notes:
2 Rarely 2 Rarely 2 Rarely
3 Sometimes 3 Sometimes 3 Sometimes
4 Usually 4 Usually 4 Usually
5 Always 5 Always 5 Always
Probes 21. Interviewer probed incomplete and inappropriate responses. 22. Interviewer used nonleading probes (i.e., probed without leading participant to a response). Recruiter Training ( If done by Interviewer)
Criterion #
Appendix G8: HIV Counselling & Testing/ Phlebotomist Evaluation Form HIV Counselling and Testing Evaluation Form
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General Instructions: This checklist should be used to document evaluations of the HIV test counselor. The Study Lead and Principal Investigator(s) should conduct the observations. The HIV test counselor should be evaluated for the first three tests. In addition, all HIV test counselors must be evaluated approximately once every ten tests performed until data collection ends. Following each evaluation, the evaluator and HIV test counselor should meet to review the completed checklist and discuss areas where the HIV test counselor could improve. Each evaluation should build on previous evaluations to monitor improvement. Permission from the participant must be received for a particular HIV testing session to be evaluated. HIV test Counselor: Rating instructions: Circle the number of the label that corresponds with your evaluation for each criterion. Some criteria may not apply to every observation. If one does not, please check the ‘N/A’ box for that criterion. Evaluation Date: Evaluator: Counselling Process Rating
1. Pre- test counselling was conducted after the survey was completed. 2. Counsellor addressed participants questions and risk raised during interview and pretest counselling session 3. Counsellor provided a scheduled appointment for participant to obtain result.
4. Counsellor returned test result in a manner that preserved the privacy of the participant.
5. Counsellor provided appropriate post-test counselling and referral
1 Never
1 Never
1 Never
1 Never
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
Usually
5 Always
RAPID TESTING 6. Rapid testing was conducted in
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an appropriate environment (with respect to temperature, lighting, adequate work space). 7. Counsellor labelled rapid test devices with survey ID.
8. Finger stick specimen was collected appropriately (finger cleaned with alcohol finger milked stuck in fleshy side used loop provided in kit etc) 9. Rapid test were kept in a location so that they were not viewable by participants. 10. Rapid test result read with the appropriate time frame for the test performed (20-40 mins for the most) 11. Counsellor recorded times at which test was started and result were read.
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usuall y
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
2 Rarely
3 Sometimes
4 Usually
5 Always
PHLEBOTOMY AND SPECIMEN STORAGE 12. Counsellor had supplies ready and arrange before beginning 1 phlebotomy. Never 13. Coounsellor adequately counselled participant on what to 1 expect during phlebotomy. Never 14.Counsellor adhere to OSHA regulation with respect to 1 universal precaution (gloves etc ) Never SPECIMEN COLLECTION AND STORAGE 15. Project site use a separate ID (not the survey ID for processing 1 specimen). Never 16. A paper log (with no personal identifying info.) maintain a link 1 between the survey ID and the lab Never ID 17. Counsellor appropriately labelled specimens for lab testing 1 with survey and lab ID. Never 18. For processing and tracking specimens the site only uses forms 1
2
3
4
5
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that were approved as part of the pre-implemented checklist. 19. Specimens were stored in and transported by coolers that are appropriately labelled according to OSHA regulation (see operation manual for detail) 20. Project site collects all required HIV testing variables. 21. The site tracks whether participants have return for their results.
Never
Rarely
Sometimes
Usually
Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Never
2 Rarely
3 Sometimes
4 Usually
5 Always
1 Rarely
SECURITY AND CONFIDENTIALITY 22. HIV testing forms and logs are kept locked when not in the 1 immediate possession of a staff Never member.
2 Never
2 Rarely
3
4
5
Sometime Usually
Always
3 Sometimes
5 Always
4 Usually
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