1. Pharmacologic Drug Detection and Self-Reported Adherence in the HPTN069/ACTG5305 Phase II PrEP Trial.
- Author
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Cooper, Stanley E., Zhang, Shuaiqi, Haines, Daniel, Mayer, Kenneth H., Amico, K. Rivet, Landovitz, Raphael J., Hendrix, Craig W., Marzinke, Mark A., Chege, Wairimu, McCauley, Marybeth, and Gulick, Roy M.
- Subjects
PATIENT compliance ,SELF-evaluation ,ANTIRETROVIRAL agents ,PATIENT safety ,RESEARCH funding ,STATISTICAL sampling ,BLIND experiment ,TENOFOVIR ,INTERVIEWING ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,DRUG monitoring ,CONTROL groups ,PRE-tests & post-tests ,EMTRICITABINE ,ODDS ratio ,DRUG efficacy ,MARITAL status ,DRUGS ,COMPARATIVE studies ,SOCIODEMOGRAPHIC factors ,CONFIDENCE intervals ,PATIENTS' attitudes ,DRUG tolerance ,MARAVIROC (Drug) ,REGRESSION analysis ,EDUCATIONAL attainment ,EMPLOYMENT - Abstract
Adherence drives efficacy in PrEP clinical trials. We compared drug concentrations and self-reported adherence in HPTN069/ACTG5305, a double-blinded, randomized trial of the safety and tolerability of candidate PrEP regimens that included maraviroc (MVC), tenofovir (TDF), and emtricitabine (FTC). Plasma drug concentrations and self-reported adherence by computer-assisted self-interview (CASI) were assessed at study weeks 24 and 48. Descriptive statistics and a generalized linear model were used to assess the association between selected demographic factors, self-report of daily medication adherence and plasma drug concentrations consistent with daily adherence. Among 718 paired observations from 370 participants, 43% (306/718) reported daily adherence by CASI, 65% (467/718) had drug concentrations consistent with daily adherence and 11% (81/718) had CASI responses that reported daily adherence despite having drug concentrations consistent with less-than-daily adherence. In adjusted analyses, participants who were assigned male at birth (aOR 1.42 [95% CI 1.02, 1.97]), older (5-year increments aOR 1.10 [95% CI 1.09, 1.11]), White (aOR 2.2 [95% CI 1.88, 2.56]), had advanced education (aOR 3.89 [95% CI 2.97, 5.09]), were employed (aOR 1.89 [95% CI 1.50, 2.40]), or partnered/married (aOR 2 [95% CI 1.72, 2.32]) were more likely to have drug concentrations consistent with daily adherence. Participants who were not employed (aOR 2.7 [95% CI 1.31, 5.55]) or who were single/not partnered (aOR 2.33 [CI 95% 1.25, 4.34]) were more likely to have drug concentrations that did not reflect daily adherence despite self-reported PrEP adherence. These findings support the need for ongoing adherence counseling in clinical trials of new PrEP regimens. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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