ReviewThe lancet. HIV2020
A Bayesian averted infection framework for PrEP trials with low numbers of HIV infections: application to the results of the DISCOVER trial.
Review in The lancet. HIV, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- 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
- HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo.The Journal of infectious diseases · 2024Trial
- Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial.Journal of the International AIDS Society · 2021Trial
- A Population-Based HIV Vaccine Efficacy Trial Design: Statistical Framework and Design Considerations.Vaccines · 2026Review
- Pharmacological markers of HIV prevention for oral pre-exposure prophylaxis in men who have sex with men.Nature communications · 2026Article
- Sample size estimation for the averted events ratio.Clinical trials (London, England) · 2026Article
- Review
- Bridged treatment comparisons: an illustrative application in HIV treatment.American journal of epidemiology · 2025Article
- Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: The PrEPVacc trial.Clinical trials (London, England) · 2025Article
- Active-Controlled Trial Design for HIV Prevention Trials With a Counterfactual Placebo.Statistics in medicine · 2025Article
- Fusing trial data for treatment comparisons: Single vs multi-span bridging.Statistics in medicine · 2024Article
- Estimating counterfactual placebo HIV incidence in HIV prevention trials without placebo arms based on markers of HIV exposure.Clinical trials (London, England) · 2024Article
- Study design approaches for future active-controlled HIV prevention trials.Statistical communications in infectious diseases · 2024Article
- Generalizing the intention-to-treat effect of an active control from historical placebo-controlled trials: A case study of the efficacy of daily oral TDF/FTC in the HPTN 084 study.Journal of the American Statistical Association · 2024Article
- Efficacy estimates of oral pre-exposure prophylaxis for HIV prevention in cisgender women with partial adherence.Nature medicine · 2023Article
- Interpretation of active-control randomised trials: the case for a new analytical perspective involving averted events.BMC medical research methodology · 2023Review
- Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: example of injectable cabotegravir and oral PrEP in women.Journal of the International AIDS Society · 2023Article
- Estimating HIV Incident Diagnoses Among Men Who Have Sex With Men Eligible for Pre-exposure Prophylaxis but Not Taking It: Protocol and Feasibility Assessment of Data Sources and Methods.JMIR research protocols · 2023Article
- Confidence limits for the averted infections ratio estimated via the counterfactual placebo incidence rate.Statistical communications in infectious diseases · 2021Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
Trials of candidate agents for HIV pre-exposure prophylaxis (PrEP) might randomly assign participants to be given a new PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine. This design presents unique challenges in interpretation. First, with two active arms, HIV incidence might be low. Second, the effectiveness of tenofovir disoproxil fumarate plus emtricitabine varies across populations; thus, similar HIV incidence between groups could be consistent with a wide range of effectiveness for the new PrEP. We propose a two-part approach to trial results. First, we use Bayesian methods to incorporate assumptions about the background incidence of HIV in the trial in the absence of PrEP, possibly augmented by external data. On the basis of the estimated background incidence, we estimate and compare the number of averted (or prevented) HIV infections in each of the two trial groups, calculating the averted infections ratio. We apply these methods to a completed trial of tenofovir alafenamide plus emtricitabine for PrEP. Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.
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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.