Jan 9, 2007 - adherence among PLHA receiving ART in India. ... Key words Antiretroviral therapy (ART) - adherence - HIV-infected - India - resource limited ...
Indian J Med Res 127, January 2008, pp 28-36
Adherence to antiretroviral therapy & its determinants amongst HIV patients in India A. Sarna, S. Pujari*++, A.K. Sengar**, R. Garg+, I. Gupta+++ & J. van Dam#
Horizons/Population Council, New Delhi, *Ruby Hall Clinic & Grant Medical Foundation, Pune ** Northern Railway Hospital, Delhi, +Employees State Insurance Corporation, Delhi, ++University of South Florida, Tampa, +++Institute of Economic Growth, Delhi, India & Population Council, Washigton DC, USA
Received January 9, 2007 Background & objectives: Very high levels of adherence are required for ART to be effective. There is limited information available from India on adherence to ART and its predictors. We carried out this study to examine adherence levels and to explore the factors associated with adherence among PLHA receiving ART in India. Methods: Using a cross-sectional study design 310 HIV+ patients receiving ART (252 paying out-ofpocket; 58 free via employee-insurance programme) were interviewed from Pune and Delhi health facilities, using a semi-structural questionnaire. Results: The median age for patients was 36 yr. The median time from diagnosis of HIV-infection was 34.5 months, median time on ART was 16 months and median CD4 cell count at start of ART was 110 cells/ml. 98 per cent of the respondents were using a non protease inhibitor (PI) treatment regimen. Mean 4-day adherence was 93 per cent. Adherence was lower over longer periods of recall: 20 per cent reported missed does over the past 7 days; 33 per cent reported ever missing a full day’s medications and 16 per cent had a treatment interruption of more than 7-days at least once. On univariate analysis less than university education, being unemployed, obtaining free treatment, severe depression, baseline CD4 count>200/ml, hospitalization >2 times, having moderate to severe side-effects and taking 4 or more medicines were associated with lower adherence ( 95%) are required for ART to be effective long term and to prevent the emergence of resistant viral strains2. There has been a concern about the capability of patients in resource-limited settings to adhere to ART, especially in the African context3. Although studies from resource-limited settings have documented high levels of adherence amongst these patients4-6, a recent review7 highlights the need for an increased focus on adherence in the face of findings from Cote d’Ivoire, Cameroon and Botswana that have documented lower adherence levels in ART programmes. Although the Indian national ART Programme was launched in April 2004, antiretroviral (ARV) medications have been widely available in the private sector and through some employer supported health insurance programmes in India since 1998 (personal communication) from ESI and Railways. People living with HIV/AIDS (PLHA) who could access these sources have been on ART for several years. There is limited information regarding levels of adherence and predictors of suboptimal adherence to treatment among PLHA receiving ART in India. Two recent studies from India have documented non-adherence in more than a quarter of the patients interviewed8,9. Several factors are associated with adherence. Depression and psychiatric illness, active alcohol or drug use, and lack of social support have been found to be associated with lower adherence2,10. In general, sociodemographic factors do not seem to predict adherence behaviour, although some studies have found that male sex, white ethnicity, older age, higher income and higher education and literacy correlate with better adherence11. A patient’s ability to identify medications and his/her understanding of the relationship between adherence and medication resistance also predict better adherence10. Health literacy and HIV related knowledge are found to be associated with better adherence12,13. Disease characteristics such as prior opportunistic infections implying an increased perceived severity of illness appear to motivate patients to adhere better14. Patient provider relationship and trust in the provider is believed to be a motivating factor for adherence15. A high pill burden and inability to integrate the treatment regime into patient’s daily routine have been reported as barriers to adherence11.
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We undertook this study to investigate levels of adherence to treatment among PLHA receiving ART at selected public and private health facilities in India. The specific objectives of the study were to (i) measure current levels of adherence and (ii) explore the factors associated with adherence among PLHA receiving ART. Material & Methods Study population, recruitment and study design: Using a cross-sectional design, a quantitative survey was undertaken. Three hundred and ten PLHA receiving ART were interviewed as they came in for routine follow up visits at outpatient clinics at one private sector and one public sector health facility in Pune, and two public sector health facilities in Delhi between May and August 2004. Clinics were selected if they were providing ART services, had a pool of HIV-infected patients on ART and were willing to participate in the study. Inclusion criteria for a patient to be included in the study were HIV-positive status, 18 yr of age or older, ability to provide consent and having been on ART for at least 30 days. At the time of the study, the national ARV programme had not yet started, and only a few HIVinfected patients were receiving ART at public health facilities through employer supported health insurance programmes. To access patients receiving free ART Employees State Insurance Corporation (ESIC) and Indian Railways clinics were included. As a small number of PLHA were receiving ART, three public sector health facilities were selected (2 in Delhi viz., Jhilmil ESIC Hospital and Northern Railway Hospital and in Chinchowad ESIC Hospital, Pune) and all patients on ART were invited to participate; 47 patients (82%) of a total of 57 receiving ART at these sites were recruited: 6 did not come the clinic for follow up visits during the study period and 4 refused to be interviewed. In the private sector health facility 273 patients (35%) of a total of 800 patients on ART were recruited to participate in the study. The sample size was based on an estimated population proportion of 50 per cent, a confidence level of 90 per cent and alpha of 0.05 using: z21-a/2P (1 – P)/d2. Patients were recruited consecutively till the sample size was reached. Of these 263 patients (96%) completed the interview at the private facility, 3 patients had to leave before completing the interview and 7 refused to participate. Eleven of the 263 patients accessing services at the private sector facility had complete health coverage through an employer provided government
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INDIAN J MED RES, JANUARY 2008
health insurance scheme (CGHS). In all, 252 patients paying out-of-pocket and 58 patients (47 plus 11) covered by insurance were interviewed. Dedicated adherence counselling was not available at any site; physicians provided adherence related advice as a part of routine clinical care. However, paying patients did receive financial counselling and were assessed for ability to pay before initiating ART. At all sites patients were first approached by the clinic staff who explained the study procedures; patients who agreed to participate were then contacted by the research staff who obtained written informed consent. Patients were paid Rs 100 towards transportation and refreshment costs. Measurement of adherence: A semi-structured questionnaire adapted from the Adult AIDS Clinical Trials Group (AACTG) was used16. The questionnaire was culturally adapted, translated and back translated by independent persons. Trained external research interviewers, who were not employed by the health facilities, conducted face-to-face interviews in Hindi, Marathi and English as per patient preference. Ethical clearance was obtained from the Ethical Review Board of the Population Council and the managements of participating health facilities. All information collected was based on patient selfreport with the exception of CD4 counts at the start of treatment and confirmation of ARV treatment regimen, which were provided by the treating physician from medical records. The primary adherence measure was based on a 4-day recall. Mean 4-day adherence was calculated by dividing the number of pills actually taken by the number of pills needed to be taken for 4 days X 100. Adherence was then dichotomized to define high adherence as >90 per cent and lower adherence as 200 cells 30 (12) Current Depression* Minimal 131 (52) Mild 36 (14) Moderate 45 (18) Severe 39 (16)
Receive Total Free ART n=310 (%) n=58 (%) 42 (72) 16 (28)
261 (84) 49 (16)
13 (22) 31 (53) 14 (24)
51 (16) 204 (66) 55 (18)
21 (36) 30 (52) 7 (12)
30 (10) 165 (53) 115 (37)
43 (74) 15 (26)
255 (82) 55 (18)
53 (91) 1 (2) 4 (7)
263 (85) 21 (7) 26 (8)
26 (45) 16 (28) 12 (21) 4 (7)
88 (28) 70 (23) 81 (26) 77 (23)
13 (22) 13 (22) 32 (55)
55 (18) 73 (24) 182 (59)
22 (38) 15 (26) 21 (36)
128 (41) 85 (27) 97 (31)
9 (17) 16 (30) 29 (54)
133 (44) 114 (37) 59 (20)
16 (28) 11 (19) 9 (15) 22 (38)
147 (48) 47 (15) 54 (17) 61 (20)
Note: Percentages rounded of the nearest whole. *P90%); all these respondents reported perfect adherence of 100 per cent.
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Adherence was relatively lower over longer periods of recall. Twenty per cent of the respondents reported missed doses over the past 7 days. Thirty-three per cent reported ever missing a full day’s medication; 20 per cent reported doing so in the last 3 months. Sixteen per cent respondents reported having stopped medications (treatment interruption) for a period of more than 7 days at least once. More than a quarter of the respondents reported not having followed the medication schedule over the past 4 days. There were no significant differences in reported adherence between male and female respondents on any measure of adherence. Adherence was significantly lower among patients receiving free ARVs on all measures of adherence: mean 4-day adherence, total number of missed pills over last week (7-days), last time a full day’s medication was missed (ever missing a full day’s medication), number of times treatment was interrupted for more than 1 wk since initiating ART and following ARV medication schedule over the past 4-days (Table II). Mean 4-day adherence was lower among patients receiving free Table II. Adherence (Self-reported) to the treatment among patients Per cent Out-of-pocket ART n=252
Free ART n=58
Mean 4-day adherence*
96.4
80.6
Mean 4-day cut-off at 90%** Higher adherence (>90%) Lower adherence (
