FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis.

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Corneli, AL; Deese, J; Wang, M; Taylor, D; Ahmed, K; Agot, K; Lombaard, J; Manongi, R; Kapiga, S; Kashuba, A; Van Damme, L; FEM-PrEP Study Group,

Published Date

  • July 1, 2014

Published In

Volume / Issue

  • 66 / 3

Start / End Page

  • 324 - 331

PubMed ID

  • 25157647

Pubmed Central ID

  • PMC4059551

Electronic International Standard Serial Number (EISSN)

  • 1944-7884

Digital Object Identifier (DOI)

  • 10.1097/QAI.0000000000000158


  • eng

Conference Location

  • United States