Trial reportJournal of acquired immune deficiency syndromes (1999)2014
FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 112 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
112 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Male Circumcision and HIV Risk Compensation Among Men Who Have Sex with Men: A Systematic Review and Meta-Analysis.AIDS and behavior · 2026Pooled it
- Trial
- Engagement of adolescent girls and young women into an early oral PrEP open-label study in Southern Africa: lessons learned from HPTN 082.BMC public health · 2025Trial
- Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women.The New England journal of medicine · 2023Trial
- "It's already in your body and it's preventing": a qualitative study of African female adolescent's acceptability and preferences for proxy HIV prevention methods in Cape Town, South Africa.BMC public health · 2023Trial
- Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial.BMC public health · 2022Trial
- Trial
- Trial
- Chemsex is not a barrier to self-reported daily PrEP adherence among PROUD study participants.The International journal on drug policy · 2019Trial
- Negative rumours about a vaginal ring for HIV-1 prevention in sub-Saharan Africa.Culture, health & sexuality · 2019Trial
- Young Women's Stated Preferences for Biomedical HIV Prevention: Results of a Discrete Choice Experiment in Kenya and South Africa.Journal of acquired immune deficiency syndromes (1999) · 2019Trial
- Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men.AIDS care · 2019Trial
- Trial
- Young Women's Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa.AIDS and behavior · 2018Trial
- Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial.AIDS and behavior · 2018Trial
- Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial.The lancet. HIV · 2018Trial
- Trial
- Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots following Directly Observed Therapy.Antimicrobial agents and chemotherapy · 2018Trial
- Acceptability and use of a dapivirine vaginal ring in a phase III trial.AIDS (London, England) · 2017Trial
- Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use: Findings from the Carraguard Phase 3 Trial.AIDS and behavior · 2016Trial
52 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundSeveral 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.
methodsWe 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.
resultsWe 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).
conclusionsMost 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.