Implementation of an Electronic Fingerprinting Data Collection System ...

incentive for improved health, and thought FI could help some people improve ART adherence. At the same time, many patients felt they and others should be self-motivated to remain adherent and should not have to be incentivized. A few patients felt FI were unnecessary for themselves as they had already achieved VS. SIs were more likely than staff to report positive patient interactions, increased patient adherence to clinic visits and engagement in care. The majority of SIs liked the ability to reward patients, although some felt FI should have been targeted only to low adherers. Several SIs indicated that they had been opposed to FI for VS at the start of the study but were in favor by the end, primarily due to positive patient interactions as SIs were uncertain about the effect on VS. Staff reported implementation challenges and although some reported positive patient interactions, others disliked when patients felt ‘‘entitled’’ to the FI. Conclusions: Although staff reported some challenges, the FI program was generally well received by patients, SIs and staff, despite the fact that some disagreed with the concept of FI for VS.

P23.15 Assessment of the Vaginal Residence Time of Biomarkers of Semen Exposure Andrea R. Thurman1, Terry A. Jacot1, Johan Melendez2, Thomas D. Kimble1, Margaret Christine Snead3, Roxanne Jamshidi2, Angie Wheeless4, David F. Archer1, Jill L. Schwartz1, Gustavo F. Doncel1, Christine Mauck1 1

CONRAD, Eastern Virginia Medical School, Norfolk, VA, United States, 2Johns Hopkins University School of Medicine, Baltimore, MD, United States, 3Centers for Disease Control and Prevention, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Atlanta, GA, United States, 4FHI 360, Research Triangle Park, NC, United States Background: Biomarkers of mucosal semen exposure can be used to objectively verify protocol compliance and exposure to pregnancy, infection or HIV in clinical trials. The primary objective of this study was to determine the residence time in the vagina (up to 15 days post semen exposure) of 3 biomarkers of semen exposure: prostate specific antigen (PSA) using quantitative total PSA assay, testis specific protein Y encoded 4 (TSPY4) and the sex determining region (SRY) of the Y chromosome, using standard PCR multiplexed with TSPY4 and quantitative PCR. Methods: Healthy women were randomized to unprotected intercourse (n = 17) versus vaginal inoculation with their male partner’s semen in the clinic (n = 16), then further randomized to have vaginal swabs obtained at either 7 or 4 time points after semen exposure, up to 15 days post exposure. Post-exposure vaginal swabs were either obtained at home by the participant or in the clinic by the research nurse. Results: When compared to semen inoculation, unprotected intercourse resulted in significantly higher concentrations of semen biomarkers in the first 7 days post exposure. Sampling frequency did not appear to affect biomarker concentrations. Participant sampling at home and nurse sampling in the clinic resulted in similar biomarker concentrations. PSA and SRY, amplified by multiplex PCR, were markers of recent (6 - 72 hours) semen exposure. TSPY4 and SRY, amplified by qPCR, were reliably detectable for up to 7 days post exposure. Conclusions: We identified biomarkers of recent and longer term exposure to semen, which can be used to assess protocol compliance in contraceptive and microbicide studies. In the

latter, semen exposure may be used as a surrogate of HIV exposure. Having swabs obtained at home by study participants is feasible and frequent sampling does not appear to reduce the concentration of these biomarkers.

P23.16 Implementation of an Electronic Fingerprinting Data Collection System in Zambia: Technical Challenges Kristin M. Wall1,2, William Kilembe3, Mubiana Inambao4, Roice Fulton2, Sarah Anderson3, Alex Tran2, David Mark5, Shawn Sarwar6, Trisha Finnegan6, Susan Allen2 1

Emory University, Atlanta, GA, United States, 2Rwanda Zambia HIV Research Group, Atlanta, GA, United States, 3 Rwanda Zambia HIV Research Group, Lusaka, Zambia, 4 Rwanda Zambia HIV Research Group, Ndola, Zambia, 5International AIDS Vaccine Initiative, New York, NY, United States, 6Biometrac, Washington, DC, United States Background: Patient identification ensures data collection accuracy and enhances patient care, including prevention of primary and secondary HIV transmission. However, linking patients within and between health services is an operational challenge in much of sub-Saharan Africa. Anonymous electronic fingerprinting systems are a proposed solution. Methods: The feasibility and acceptability of using an electronic fingerprinting system to follow individuals between HIV prevention services was assessed in four Government of Zambia (GRZ) clinics in Ndola, Zambia. The device consists of a Google Nexus 7 tablet with portable single-finger multi-spectral imaging sensor. Templates of scanned fingerprints are sent to a central server via WiFi or mobile. We also pilot tested device sensitivity and specificity under various conditions with Rwanda Zambia HIV Research Group staff in Lusaka and Ndola. Results: Over 50 GRZ clinic-based system users collected fingerprints from 628 HIV testing, antenatal care, male circumcision, and antiretroviral treatment GRZ clinic clients (refusal rate < 5%). Technical challenges included occasional mobile network interruptions, prepaid airtime overruns, and both false positive and false negative fingerprint matching. The first two issues were resolved by caching data during connection interruptions and switching to postpaid airtime. After initial testing among 125 staff, we found device matching was improved by using both thumb and index fingerprints. The device now has a false fingerprint matching rate of 1/1000 and a false rejection rate of < 1/ 10,000. Security questions are included as an additional method to confirm matches (year of birth, gender, and father’s first name). Conclusions: The anonymous fingerprinting system was acceptable among patients in public health settings. System updates have significantly reduced error rates. We now plan expand the system to other government clinics and to assess acceptability of the device among female sex workers in Ndola and Lusaka.

P23.17 Using Mixed-methods to Understanding Trial Adherence to a Polyurethane Tenofovir Disoproxil Fumarate Intravaginal Ring in Low-risk US Women Dana L. Watnick, Marla J. Keller, Lilia Espinoza, Betsy C. Herold, Laurie J. Bauman Albert Einstein College of Medicine, Bronx, NY, United States

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