Date Published: October 31, 2017
Publisher: Springer US
Author(s): Andrew Abaasa, Craig Hendrix, Monica Gandhi, Peter Anderson, Anatoli Kamali, Freddie Kibengo, Eduard J. Sanders, Gaudensia Mutua, Namandjé N. Bumpus, Frances Priddy, Jessica E. Haberer.
Measuring PrEP adherence remains challenging. In 2009–2010, the International AIDS Vaccine Initiative randomized phase II trial participants to daily tenofovir disoproxil fumarate/emtricitabine or placebo in Uganda and Kenya. Adherence was measured by electronic monitoring (EM), self-report (SR), and drug concentrations in plasma and hair. Each adherence measure was categorised as low, moderate, or high and also considered continuously; the incremental value of combining measures was determined. Forty-five participants were followed over 4 months. Discrimination for EM adherence by area under receiver operating curves (AROC) was poor for SR (0.53) and best for hair (AROC 0.85). When combining hair with plasma or hair with self-report, discrimination was improved (AROC > 0.9). Self-reported adherence was of low utility by itself. Hair level was the single best PK measure to predict EM-assessed adherence; the other measurements had lower discrimination values. Combining short-term (plasma) and long-term (hair) metrics could be useful to assess patterns of drug-taking in the context of PrEP.
According to UNAIDS, an estimated 2 million individuals acquired HIV in 2015 globally, with infection rates being highest in sub-Saharan Africa . There is therefore an urgent need for effective methods to prevent ongoing transmission of HIV. A number of clinical trials examining the efficacy of oral pre-exposure prophylaxis (PrEP) [2–6] with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) have been published in recent years. Results from these studies have been largely positive, indicate that PrEP prevents acquisition of HIV infection when users are adherent [2, 4], and have led to broad recommendations for PrEP use worldwide .
Among participants taking daily PrEP in a clinical trial, we described patterns of adherence to PrEP by combining short and long-term pharmacokinetic measures and aligning them with concurrent electronic data monitoring metrics and self-reported adherence. We found evidence of consistently high adherence over different durations of time as assessed by multiple measures at both sites. In Kenya, the EM measure showed more moderate levels of adherence than in Uganda. Prior qualitative work with this population found that challenges, such as complexities of daily life, may have contributed to lower adherence for MSM .