Trial reportAIDS and behavior2015
Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials.
Trial report in AIDS and behavior, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
56 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Performance of Adherence Measures for Oral, Tenofovir-Based HIV Pre-Exposure Prophylaxis: A Systematic Review.AIDS and behavior · 2025Pooled it
- Cognitive Effects of Heading in Professional Football: A Systematic Review.International journal of sports medicine · 2025Pooled it
- The effectiveness of tenofovir-based pre-exposure prophylaxis for prevention of HIV acquisition among sub-Saharan African women at high risk: a systematic review.The Pan African medical journal · 2021Pooled it
- Characterizing the Role of Neighborhood Disadvantage in a Digital PrEP Intervention for Young Sexual and Gender Minority Men.AIDS and behavior · 2026Trial
- Comparing PrEP adherence via objective and self-reported measures among fishermen working on Lake Victoria, Kenya.AIDS care · 2025Trial
- Prenatal exposure to HIV pre-exposure prophylaxis and birth, growth, and social-emotional developmental outcomes throughout early childhood in Kenya: a prospective cohort study.The Lancet. Global health · 2025Trial
- Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya.AIDS care · 2025Trial
- Studying the Digital Intervention Engagement-Mediated Relationship Between Intrapersonal Measures and Pre-Exposure Prophylaxis Adherence in Sexual and Gender Minority Youth: Secondary Analysis of a Randomized Controlled Trial.Journal of medical Internet research · 2025Trial
- In-utero exposure to tenofovir-containing pre-exposure prophylaxis and bone mineral content in HIV-unexposed infants in South Africa.Journal of the International AIDS Society · 2024Trial
- Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial.Circulation · 2023Trial
- TransPrEP: Results from the Pilot Study of a Social Network-Based Intervention to Support PrEP Adherence Among Transgender Women in Lima, Peru.AIDS and behavior · 2021Trial
- Successful integration of HIV pre-exposure prophylaxis into a community-based HIV prevention program for female sex workers in Kolkata, India.International journal of STD & AIDS · 2021Trial
- Trial
- Comparing pharmacologic measures of tenofovir exposure in a U.S. pre-exposure prophylaxis randomized trial.PloS one · 2018Trial
- Trial
- A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence.Journal of general internal medicine · 2016Trial
- Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.Journal of the International AIDS Society · 2016Trial
- Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066).AIDS research and human retroviruses · 2016Trial
- Trial
- Prevalence and correlates of PrEP use and missed PrEP doses due to alcohol among sexually active adults and sexual minority men in San Francisco.Drug and alcohol dependence · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
Oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has been evaluated as pre-exposure prophylaxis (PrEP). We describe the accuracy of self-reported adherence to FTC/TDF and pill counts when compared to drug concentrations in the FEM-PrEP trial. Using drug concentrations of plasma tenofovir (TFV) and intracellular tenofovir diphosphate (TFVdp) among a random sub-sample of 150 participants assigned to FTC/TDF, we estimated the positive predictive value (PPV) of four adherence measures. We also assessed factors associated with misreporting of adherence using multiple drug-concentration thresholds and explored pill use and misreporting using semi-structured interviews (SSIs). Reporting use of ≥1 pill in the previous 7 days had the highest PPV, while pill-count data consistent with missing ≤1 day had the lowest PPV. However, all four measures demonstrated poor PPV. Reported use of oral contraceptives (OR 2.26; p = 0.014) and weeks of time in the study (OR 1.02; p < 0.001) were significantly associated with misreporting adherence. Although most SSI participants said they did not misreport adherence, participant-dependent adherence measures were clearly unreliable in the FEM-PrEP trial. Pharmacokinetic monitoring remains the measure of choice until more reliable participant-dependent measures are developed.
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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.