Trial reportPloS one2013
Safety, adherence and acceptability of intermittent tenofovir/emtricitabine as HIV pre-exposure prophylaxis (PrEP) among HIV-uninfected Ugandan volunteers living in HIV-serodiscordant relationships: a randomized, clinical trial.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00931346 (A Pilot Study of Pre-Exposure Prophylaxis), which is not on this map. Cited by 57 papers, 7 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.
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
Who cites it
57 citing papers in PubMed, 7 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials.AIDS and behavior · 2024Pooled it
- Pooled it
- Pooled it
- A systematic review of adherence to oral pre-exposure prophylaxis for HIV - how can we improve uptake and adherence?BMC infectious diseases · 2018Pooled it
- In what circumstances could nondaily preexposure prophylaxis for HIV substantially reduce program costs?AIDS (London, England) · 2018Pooled it
- Effectiveness and safety of oral HIV preexposure prophylaxis for all populations.AIDS (London, England) · 2016Pooled it
- Elevations in Serum Creatinine With Tenofovir-Based HIV Pre-Exposure Prophylaxis: A Meta-Analysis of Randomized Placebo-Controlled Trials.Journal of acquired immune deficiency syndromes (1999) · 2016Pooled it
- HPTN 067/ADAPT: Correlates of Sex-Related Pre-exposure Prophylaxis Adherence, Thai Men Who Have Sex With Men, and Transgender Women, 2012-2013.Journal of acquired immune deficiency syndromes (1999) · 2019Trial
- Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 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
- Uptake of hormonal contraceptives and correlates of uptake in a phase III clinical trial in rural South Western Uganda.Reproductive health · 2017Trial
- Comparing the novel method of assessing PrEP adherence/exposure using hair samples to other pharmacologic and traditional measures.Journal of acquired immune deficiency syndromes (1999) · 2015Trial
- Article
- Review
- Pre‑exposure Prophylaxis Awareness and Endorsement among Adolescents and Young Adults in Tanzania: Insights from the 2022 Demographic and Health Survey.Annals of global health · 2025Article
- Observational
- Hypo-osmolar rectal douche tenofovir formulation prevents simian/human immunodeficiency virus acquisition in macaques.JCI insight · 2022Article
- Low prevalence of hepatitis B virus infection in HIV-uninfected pregnant women in Cape Town, South Africa: implications for oral pre-exposure prophylaxis roll out.BMC infectious diseases · 2022Article
- Women for science and science for women: Gaps, challenges and opportunities towards optimizing pre-exposure prophylaxis for HIV-1 prevention.Frontiers in immunology · 2022Review
- Imperfect adherence in real life: a prevention-effective perspective on adherence to daily and event-driven HIV pre-exposure prophylaxis among men who have sex with men - a prospective cohort study in Taiwan.Journal of the International AIDS Society · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEfficacy of oral pre-exposure prophylaxis (PrEP) in prevention of HIV acquisition has been evaluated using a daily regimen. However, adherence to long term daily medication is rarely perfect. Intermittent regimen may be a feasible alternative. Preclinical studies have demonstrated effectiveness of intermittent PrEP in SHIV prevention among animals. However, little is known about intermittent PrEP regimens.
designSeventy two HIV-uninfected volunteers in HIV serodiscordant couple relationships in Uganda were randomly assigned to receive daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada) or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral TDF/FTC or placebo in a 2:1:2:1 ratio. Volunteers and study staff were blinded to drug assignment, but not to regimen assignment.
methodsVolunteers were followed for 4 months after randomization, with monthly clinical and laboratory safety assessments and comprehensive HIV risk reduction services. Adherence was monitored using medication event monitoring system (MEMS) and self-report. Sexual activity data were collected via daily short text message (SMS) and self-report. HIV-specific immune responses were assessed by IFN-γ ELISPOT.
resultsBoth daily and intermittent oral TDF/FTC regimens were well tolerated. Median MEMS adherence rates were 98% (IQR: 93-100) for daily PrEP regimen, 91% (IQR: 73-97) for fixed intermittent dosing and 45% (IQR: 20-63) for post-coital dosing. SMS response rate was 74%, but increased to 80% after excluding server outages; results may have been affected by the novelty of this measure. The majority of volunteers expressed willingness with no particular preference for either regimen.
conclusionsBoth daily and intermittent oral PrEP dosing regimens were safe. Adherence was high for daily and fixed intermittent dosing; post-coital dosing was associated with poor adherence. Fixed intermittent PrEP regimens may be feasible especially if a minimum effective drug concentration correlating with HIV prevention can be achieved with this dosing. REGISTRATION: Clinicaltrials.gov number NCT00931346.
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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.