Abstract
Recent clinical trials have shown that a daily dose of oral TDF/FTC pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency (HIV) risk. Understanding trial participants’ perspectives about retention and PrEP adherence is critical to inform future PrEP trials and the scale-up and implementation of PrEP programs. We analyzed 53 in-depth interviews conducted in April 2010 with participants in the TDF2 study, a Phase 3, randomized, double-blind, placebo-controlled clinical trial of daily oral TDF/FTC with heterosexual men and women in Francistown and Gaborone, Botswana. We examined participants’ knowledge, attitudes, and experiences of the trial, identified facilitators and barriers to enrollment and retention, and compared participant responses by study site, sex, and study drug adherence. Our findings point to several factors to consider for participant retention and adherence in PrEP trials and programs, including conducting pre-enrollment education and myth reduction counseling, providing accurate estimates of participant obligations and side effect symptoms, ensuring participant understanding of the effects of non-adherence, gauging personal commitment and interest in study outcomes, and developing a strong external social support network for participants.
Highlights
Recent clinical trials have shown that a daily dose of oral TDF/FTC (Truvada®) pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency virus (HIV) infection risk among men who have sex with men (MSM), heterosexual men and women, and injecting drug users [1]-[4]
The TDF2 trial had experienced lower than expected rates of retention, which led to an earlier than planned study closure and questions about participants’ willingness to participate and retention in future PrEP implementation efforts in Botswana [3]
More than 60% had participated in the clinical trial for at least 13 months at the time they were interviewed
Summary
Recent clinical trials have shown that a daily dose of oral TDF/FTC (Truvada®) pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency virus (HIV) infection risk among men who have sex with men (MSM), heterosexual men and women, and injecting drug users [1]-[4]. Two additional clinical trials conducted among African women failed to show efficacy [5] [6]. Results from these trials suggest that there is a strong dose response between PrEP use and HIV protection [7], and that PrEP is an effective method for HIV prevention when adherence is high [8]. Understanding participants’ perspectives about adherence to PrEP and compliance with clinical trial visits is critical, to ensure rigorous scientific method and confidence in clinical trial findings, and to inform the implementation and scale-up of PrEP programs. Efforts to understand the social and environmental contexts of clinical trial participant experiences and perspectives may help to identify barriers and facilitators to correct PrEP use in the “real world”
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