Skip Navigation LinksHome > July 1, 2014 - Volume 66 - Issue 3 > FEM-PrEP: Adherence Patterns and Factors Associated With Ad...
JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0000000000000158
Epidemiology and Prevention

FEM-PrEP: Adherence Patterns and Factors Associated With Adherence to a Daily Oral Study Product for Pre-exposure Prophylaxis

Corneli, Amy L. MPH, PhD*; Deese, Jennifer MPH; Wang, Meng MS; Taylor, Doug PhD; Ahmed, Khatija MBChB, MMed (Micro)§; Agot, Kawango MPH, PhD; Lombaard, Johan MBChB; Manongi, Rachel MD, PhD#; Kapiga, Saidi MD, MPH, ScD#; Kashuba, Angela BScPhm, PharmD**; Van Damme, Lut MD, MS, PhD; for the FEM-PrEP Study Group

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Abstract

Background: Several clinical trials have demonstrated the safety and effectiveness of oral tenofovir disoproxil fumarate (TDF), with or without emtricitabine (FTC), as pre-exposure prophylaxis (PrEP) for reducing the risk of HIV acquisition. Adherence to the study product was insufficient to demonstrate the effectiveness of FTC/TDF in 2 PrEP clinical trials conducted among women (FEM-PrEP and the Vaginal and Oral Interventions to Control the Epidemic study), but further analyses of adherence in these studies may inform PrEP demonstration projects and future HIV prevention clinical trials.

Methods: We randomly selected a subcohort of 150 participants randomized to FTC/TDF in 3 FEM-PrEP sites (Bondo, Kenya; Bloemfontein, South Africa; and Pretoria, South Africa) to examine adherence levels over time and to assess factors associated with adherence, based on plasma tenofovir and intracellular tenofovir diphosphate drug concentrations in specimens collected at 4-week visit intervals.

Results: We observed drug concentrations consistent with good adherence in 28.5% of all visit intervals when drug was available to use, but only 12% of participants achieved good adherence throughout their study participation. In multivariate analysis, the Bloemfontein site [odds ratio (OR): 2.43; 95% confidence interval (CI): 1.32 to 4.48] and liking the pill color (OR: 2.93; 95% CI: 1.18 to 7.27) were positively associated with good adherence, whereas using oral contraceptive pills at enrollment was negatively associated with good adherence (OR: 0.37; 95% CI: 0.18 to 0.74).

Conclusions: Most participants did not regularly adhere to the study product throughout their trial participation, although a small minority did. Few factors associated with good adherence to the study product were identified in FEM-PrEP.

© 2014 by Lippincott Williams & Wilkins

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