ArticleClinical trials (London, England)2015
Testing the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial.
Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence.Journal of the International AIDS Society · 2018Pooled it
- Oral Preexposure Prophylaxis Uptake and Discontinuation in the HIV Vaccine Trials Network 704/HIV Prevention Trials Network 085 Study: Implications for Biomedical Human Immunodeficiency Virus Prevention Trials.Open forum infectious diseases · 2024Trial
- Brief Report: Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017).Journal of acquired immune deficiency syndromes (1999) · 2019Trial
- Review
- A review of reported stakeholder engagement in early-stage translational research.Journal of clinical and translational science · 2025Article
- Standard of prevention for infectious diseases' prevention clinical trials during pandemics: learning lessons for global policies from biomedical HIV prevention clinical trials and a case study of COVID-19.Frontiers in public health · 2024Article
- Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel.The lancet. HIV · 2022Review
- Article
- Challenges in Translating PrEP Interest Into Uptake in an Observational Study of Young Black MSM.Journal of acquired immune deficiency syndromes (1999) · 2017Observational
- Modeling HIV vaccine trials of the future.Current opinion in HIV and AIDS · 2016Review
- Superior Efficacy of a Human Immunodeficiency Virus Vaccine Combined with Antiretroviral Prevention in Simian-Human Immunodeficiency Virus-Challenged Nonhuman Primates.Journal of virology · 2016Article
- HIV-1 prophylactic vaccines: state of the art.Journal of virus eradication · 2016Review
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
backgroundThe field of HIV prevention research has recently experienced some mixed results in efficacy trials of pre-exposure prophylaxis, vaginal microbicides, and HIV vaccines. While there have been positive trial results in some studies, in the near term, no single method will be sufficient to quell the epidemic. Improved HIV prevention methods, choices among methods, and coverage for all at-risk populations will be needed. The emergence of partially effective prevention methods that are not uniformly available raises complex ethical and scientific questions regarding the design of ongoing prevention trials.
methodsWe present here an ethical analysis regarding inclusion of pre-exposure prophylaxis in an ongoing phase IIb vaccine efficacy trial, HVTN 505. This is the first large vaccine efficacy trial to address the issue of pre-exposure prophylaxis, and the decisions made by the protocol team were informed by extensive stakeholder consultations. The key ethical concerns are analyzed here, and the process of stakeholder engagement and decision-making described. DISCUSSION: This discussion and analysis will be useful as current and future research teams grapple with ethical and scientific study design questions emerging with the rapidly expanding evidence base for HIV prevention.
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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.