A Post-Trial Assessment of Factors Influencing Study Drug Adherence in a Randomized Biomedical HIV-1 Prevention Trial
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High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials.
KeywordsAdherence Biomedical prevention HIV-1 Clinical trials
We thank the HPTN 039 study participants, HPTN 039 site staff, and Scott Rose of Family Health International for their dedication and significant contributions. This study was supported through the US National Institutes of Health through funding to the University of Washington (U01 AI52054 and K24 AI 071113) and by the HIV Prevention Trials Network (HPTN) under Cooperative Agreement U01 AI46749 and U01 AI068619, sponsored by the National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Institute of Drug Abuse, National Institute of Mental Health, and Office of AIDS Research.
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