Trial reportThe New England journal of medicine2015
Tenofovir-based preexposure prophylaxis for HIV infection among African women.
Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 831 papers, 8 of them syntheses 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.
Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy
URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women
Who cites it
831 citing papers in PubMed, 8 syntheses or guidelines pooled it, 1,291 citations in OpenAlex.
- Review of Impact of Risk Reduction Sessions on Sexual Behaviors in HIV Prevention Trials: Insights from Africa.Archives of sexual behavior · 2025Pooled it
- A Systematic Review and Narrative Synthesis of Factors Affecting Pre-exposure Prophylaxis Willingness Among Black Women for HIV Prevention.AIDS and behavior · 2025Pooled it
- Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials.AIDS and behavior · 2024Pooled it
- Adherence and HIV Protection Thresholds for Emtricitabine and Tenofovir Disoproxil Fumarate Preexposure Prophylaxis among Cisgender Women: A Systematic Review.Current HIV/AIDS reports · 2024Pooled it
- Low clinical impact of HIV drug resistance mutations in oral pre-exposure prophylaxis: a systematic review and meta-analysis.AIDS research and therapy · 2024Pooled it
- Adolescent and young adult research across the HIV prevention and care continua: an international programme analysis and targeted review.Journal of the International AIDS Society · 2023Pooled it
- Pooled it
- Pooled it
- Acceptability of an Integrated Model of Mental Health and PrEP Service Delivery for South African Adolescent Girls: Qualitative Results from a Pilot Hybrid Effectiveness-Implementation Randomized Trial.AIDS and behavior · 2026Trial
- A Dual Prevention Pill for HIV & Pregnancy Prevention: A Pilot Study Among Adolescent Girls and Young Women in Zimbabwe.AIDS and behavior · 2026Trial
- 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
- Trial
- Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya.AIDS care · 2025Trial
- Vaginal Bacteria and Proinflammatory Host Immune Mediators as Biomarkers of Human Immunodeficiency Virus Acquisition Risk Among African Women.The Journal of infectious diseases · 2024Trial
- Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial.The Lancet. Infectious diseases · 2024Trial
- Efficacy of the Dapivirine Vaginal Ring Accounting for Imperfect Adherence.AIDS and behavior · 2024Trial
- Pharmacologic Drug Detection and Self-Reported Adherence in the HPTN069/ACTG5305 Phase II PrEP Trial.AIDS and behavior · 2024Trial
- Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial.The lancet. HIV · 2024Trial
- Depression Among Pregnant and Breastfeeding Persons Participating in Two Randomized Trials of the Dapivirine Vaginal Ring and Oral Pre-Exposure Prophylaxis (PrEP) in Malawi, South Africa, Uganda, and Zimbabwe.AIDS and behavior · 2024Trial
- Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring.The Journal of infectious diseases · 2024Trial
771 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
27 authors at 15 institutions in 5 countries.
Funding
Abstract
backgroundReproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 (HIV-1) infection.
methodsWe conducted a randomized, placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate (TDF), oral tenofovir-emtricitabine (TDF-FTC), or 1% tenofovir (TFV) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. HIV-1 testing was performed monthly, and plasma TFV levels were assessed quarterly.
resultsOf 12,320 women who were screened, 5029 were enrolled in the study. The rate of retention in the study was 91% during 5509 person-years of follow-up. A total of 312 HIV-1 infections occurred; the incidence of HIV-1 infection was 5.7 per 100 person-years. In the modified intention-to-treat analysis, the effectiveness was -49.0% with TDF (hazard ratio for infection, 1.49; 95% confidence interval [CI], 0.97 to 2.29), -4.4% with TDF-FTC (hazard ratio, 1.04; 95% CI, 0.73 to 1.49), and 14.5% with TFV gel (hazard ratio, 0.85; 95% CI, 0.61 to 1.21). In a random sample, TFV was detected in 30%, 29%, and 25% of available plasma samples from participants randomly assigned to receive TDF, TDF-FTC, and TFV gel, respectively. Independent predictors of TFV detection included being married, being older than 25 years of age, and being multiparous. Detection of TFV in plasma was negatively associated with characteristics predictive of HIV-1 acquisition. Elevations of serum creatinine levels were seen more frequently among participants randomly assigned to receive oral TDF-FTC than among those assigned to receive oral placebo (1.3% vs. 0.2%, P=0.004). We observed no significant differences in the frequencies of other adverse events.
conclusionsNone of the drug regimens we evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis. Adherence to study drugs was low. (Funded by the National Institutes of Health; VOICE ClinicalTrials.gov number, NCT00705679.).
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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.