ArticleStatistical communications in infectious diseases2021
Sample size calculation for active-arm trial with counterfactual incidence based on recency assay.
Article in Statistical communications in infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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.
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Who cites it
15 citing papers in PubMed, 16 citations in OpenAlex.
- 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
- Comparing Approaches for Estimating Counterfactual HIV Incidence Among Populations With High Vulnerability to HIV in Lima, Peru: A Multi-Study Comparative Analysis.Journal of the International AIDS Society · 2026Article
- Addressing Population Heterogeneity for HIV Incidence Estimation Based on Recency Test.Statistics in medicine · 2025Article
- 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
- An enhanced cross-sectional HIV incidence estimator that incorporates prior HIV test results.Statistics in medicine · 2024Article
- Fusing trial data for treatment comparisons: Single vs multi-span bridging.Statistics in medicine · 2024Article
- Likelihood-based inferences for active-arm trial with counterfactual incidence based on recency assay.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
- Study design approaches for future active-controlled HIV prevention trials.Statistical communications in infectious diseases · 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
- Testing for treatment effect twice using internal and external controls in clinical trials.Journal of causal inference · 2023Article
- Statistical considerations for cross-sectional HIV incidence estimation based on recency test.Statistics in medicine · 2022Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
Abstract
Objectives: The past decade has seen tremendous progress in the development of biomedical agents that are effective as pre-exposure prophylaxis (PrEP) for HIV prevention. To expand the choice of products and delivery methods, new medications and delivery methods are under development. Future trials of non-inferiority, given the high efficacy of ARV-based PrEP products as they become current or future standard of care, would require a large number of participants and long follow-up time that may not be feasible. This motivates the construction of a counterfactual estimate that approximates incidence for a randomized concurrent control group receiving no PrEP. Methods: We propose an approach that is to enroll a cohort of prospective PrEP users and aug-ment screening for HIV with laboratory markers of duration of HIV infection to indicate recent infections. We discuss the assumptions under which these data would yield an estimate of the counterfactual HIV incidence and develop sample size and power calculations for comparisons to incidence observed on an investigational PrEP agent. Results: We consider two hypothetical trials for men who have sex with men (MSM) and transgender women (TGW) from different regions and young women in sub-Saharan Africa. The calculated sample sizes are reasonable and yield desirable power in simulation studies. Conclusions: Future one-arm trials with counterfactual placebo incidence based on a recency assay can be conducted with reasonable total screening sample sizes and adequate power to determine treatment efficacy.
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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.