Trial reportJournal of acquired immune deficiency syndromes (1999)2015
Comparing the novel method of assessing PrEP adherence/exposure using hair samples to other pharmacologic and traditional measures.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 63 papers, 1 of them a synthesis 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.
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Kenya, Africa
URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence
Who cites it
63 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.
- Antiretroviral Concentration in Hair as a Measure for Antiretroviral Medication Adherence: A Systematic Review of Global Literature.AIDS and behavior · 2020Pooled it
- Evaluating adherence in an active-controlled HIV pre-exposure prophylaxis trial (PrEPVacc) to inform the estimation of HIV incidence in a counterfactual placebo arm.HIV research & clinical practice · 2025Trial
- Exploring and Predicting HIV Preexposure Prophylaxis Adherence Patterns Among Men Who Have Sex With Men: Randomized Controlled Longitudinal Study of an mHealth Intervention in Western China.JMIR mHealth and uHealth · 2024Trial
- Pharmacologic Drug Detection and Self-Reported Adherence in the HPTN069/ACTG5305 Phase II PrEP Trial.AIDS and behavior · 2024Trial
- Effect of a Reminder System on Pre-exposure Prophylaxis Adherence in Men Who Have Sex With Men: Prospective Cohort Study Based on WeChat Intervention.Journal of medical Internet research · 2022Trial
- Short Communication: Higher Tenofovir Concentrations in Hair Are Associated with Decreases in Viral Load and Not Self-Reported Adherence in HIV-Infected Adolescents with Second-Line Virological Treatment Failure.AIDS research and human retroviruses · 2021Trial
- 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
- Short- and Long-Term Pharmacologic Measures of HIV Pre-exposure Prophylaxis Use Among High-Risk Men Who Have Sex With Men in HPTN 067/ADAPT.Journal of acquired immune deficiency syndromes (1999) · 2019Trial
- Trial
- Comparing pharmacologic measures of tenofovir exposure in a U.S. pre-exposure prophylaxis randomized trial.PloS one · 2018Trial
- Baseline Data on Viral Suppression, Treatment Adherence and Mental Health in Peripartum Girls and Young Women With HIV in Zimbabwe.Journal of the International AIDS Society · 2026Observational
- Understanding Factors Influencing HIV pre-exposure prophylaxis adherence among men who have sex with men in Western China: a data-driven exploration using bayesian networks.BMC public health · 2025Article
- Sexual Risk Compensation and Retention in PrEP Care in Korea: An HIV PrEP Demonstration Study.Journal of Korean medical science · 2025Article
- Development and feasibility of the peer and nurse-led HIV Self-Testing Education and Promotion (STEP) intervention among social networks of men in Dar es Salaam, Tanzania: application of the ADAPT-ITT model.BMC health services research · 2024Article
- Article
- Acceptance of digital phenotyping linked to a digital pill system to measure PrEP adherence among men who have sex with men with substance use.PLOS digital health · 2024Article
- Feasibility, Acceptability and Appropriateness of MedViewer: A Novel Hair-Based Antiretroviral Real-Time Clinical Monitoring Tool Providing Adherence Feedback to Patients and Their Providers.AIDS and behavior · 2023Article
- Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence: Protocol for a Single-Arm Cross-sectional Study.JMIR research protocols · 2023Article
- Lessons Learned From the Implementation of a Pilot Study on Self-collected Specimen Return by Sexual Minority Men (Project Caboodle!): Qualitative Exploration.JMIR formative research · 2023Article
- Perceptions and Experiences of Returning Self-collected Specimens for HIV, Bacterial STI and Potential PrEP Adherence Testing among Sexual Minority Men in the United States.AIDS and behavior · 2023Article
3 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
13 authors at 10 institutions in 4 countries.
Funding
Abstract
objectiveThe efficacy of pre-exposure prophylaxis (PrEP) in HIV will diminish with poor adherence; pharmacologic measures of drug exposure have proven critical to PrEP trial interpretation. We assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking.
designParticipants were randomized to placebo, daily PrEP, or intermittent PrEP to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine (TFV/FTC) in 2 phase II PrEP clinical trials conducted in Africa. Different measures of drug exposure, including self-report, medication event monitoring system (MEMS)-caps openings, and TFV/FTC levels in hair and other biomatrices were compared.
methodsAt weeks 8 and 16, self-reported pill-taking, MEMS-caps openings, and TFV/FTC levels in hair, plasma, and peripheral blood mononuclear cells (PBMCs) were measured. Regression models evaluated predictors of TFV/FTC concentrations in the 3 biomatrices; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated. Both trials were registered on ClinicalTrials.gov (NCT00931346/NCT00971230).
resultsHair collection was highly feasible and acceptable (100% in week 8; 96% in week 16). In multivariate analysis, strong associations were seen between pharmacologic measures and MEMS-caps openings (all P < 0.001); self-report was only weakly associated with pharmacologic measures. TFV/FTC hair concentrations were significantly correlated with levels in plasma and PBMCs (correlation coefficients, 0.41-0.86, all P < 0.001).
conclusionsMeasuring TFV/FTC exposure in small hair samples in African PrEP trials was feasible and acceptable. Hair levels correlated strongly with PBMC, plasma concentrations, and MEMS-caps openings. As in other PrEP trials, self-report was the weakest measure of exposure. Further study of hair TFV/FTC levels in PrEP trials and demonstration projects to assess adherence/exposure is warranted.
Indexed as
Identifiers
What OpenQuestion holds
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.