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.
