Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010
Poloko M Kebaabetswe, Michael J Stirratt, Eleanor McLellan-Lemal, Faith L Henderson, Simone C Gray, Charles E Rose, Tiffany Williams, Lynn A Paxton, Poloko M Kebaabetswe, Michael J Stirratt, Eleanor McLellan-Lemal, Faith L Henderson, Simone C Gray, Charles E Rose, Tiffany Williams, Lynn A Paxton
Abstract
This study examined study product adherence and its determinants in the Botswana oral pre-exposure prophylaxis efficacy trial. Among the 1,219 participants, the mean adherence by pill count and 3-day self-report was 94 % for each. In multivariable models, pill count adherence was significantly associated with adverse events (nausea, dizziness, vomiting) (RR 0.98 95 % CI 0.98-1.00; p = 0.03) and side effect concerns (RR 0.98 95 % CI 0.96-0.99; p = 0.01). Self-reported adherence was significantly associated with having an HIV-positive partner (RR 1.02 95 % CI 1.00-1.04; p = 0.02) and Francistown residence (RR 0.98 95 % CI 0.96, 0.99; p = 0.0001). Detectable drug concentrations showed modest associations with self-report and pill count adherence, and drug levels were higher among those self-reporting 100 % adherence than those reporting <100 %. Most common adherence barriers involved refill delays and other logistic challenges; cellphone alarm reminder use was the most common facilitator.
Trial registration: ClinicalTrials.gov NCT00448669.
Conflict of interest statement
Conflict of interest The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the U.S. Centers for Disease Control and Prevention or the National Institute of Mental Health.
Source: PubMed