Trial reportAmerican journal of epidemiology2015
Estimating efficacy in a randomized trial with product nonadherence: application of multiple methods to a trial of preexposure prophylaxis for HIV prevention.
Trial report in American journal of epidemiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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
16 citing papers in PubMed.
- Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring.The Journal of infectious diseases · 2024Trial
- Use of Machine Learning to Estimate the Per-Protocol Effect of Low-Dose Aspirin on Pregnancy Outcomes: A Secondary Analysis of a Randomized Clinical Trial.JAMA network open · 2022Trial
- Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector.BMC health services research · 2021Trial
- Metabolomic basis for response to high dose vitamin D in critical illness.Clinical nutrition (Edinburgh, Scotland) · 2021Trial
- 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
- Age-Specific Risk Scores Do Not Improve HIV-1 Prediction Among Women in South Africa.Journal of acquired immune deficiency syndromes (1999) · 2020Article
- Effects of a computerized psychological inoculation intervention on condom use tendencies in sub Saharan and Caucasian students: two feasibility trials.Health psychology and behavioral medicine · 2019Article
- Article
- Weighing the Evidence of Efficacy of Oral PrEP for HIV Prevention in Women in Southern Africa.AIDS research and human retroviruses · 2018Review
- Antiretroviral Therapy and Mortality in Rural South Africa: A Comparison of Causal Modeling Approaches.American journal of epidemiology · 2018Article
- Modeling HIV vaccine trials of the future.Current opinion in HIV and AIDS · 2016Review
- Implementation and Operational Research: Evolution of Couples' Voluntary Counseling and Testing for HIV in Rwanda: From Research to Public Health Practice.Journal of acquired immune deficiency syndromes (1999) · 2016Article
- Causal Impact: Epidemiological Approaches for a Public Health of Consequence.American journal of public health · 2016Article
- Murnane, Coley, and Baeten respond to "every good randomization deserves observation".American journal of epidemiology · 2015Article
- Invited commentary: every good randomization deserves observation.American journal of epidemiology · 2015Article
- Recommendations for Increasing Physician Provision of Pre-Exposure Prophylaxis: Implications for Medical Student Training.Inquiry : a journal of medical care organization, provision and financingReview
Corrections and comments
- Commented on by
Authors and funding
9 authors.
Funding
Abstract
Antiretroviral preexposure prophylaxis (PrEP) for persons at high risk of human immunodeficiency virus infection is a promising new prevention strategy. Six randomized trials of oral PrEP were recently conducted and demonstrated efficacy estimates ranging from 75% to no effect, with nonadherence likely resulting in attenuated estimates of the protective effect of PrEP. In 1 of these trials, the Partners PrEP Study (Kenya and Uganda, 2008-2011), participants (4,747 serodiscordant heterosexual couples) were randomized to receipt of tenofovir (TDF), coformulated TDF/emtricitabine (FTC), or placebo. Intention-to-treat analyses found efficacy estimates of 67% for TDF and 75% for TDF/FTC. We applied multiple methods to data from that trial to estimate the efficacy of PrEP with high adherence, including principal stratification and inverse-probability-of-censoring (IPC) weights. Results were further from the null when correcting for nonadherence: 1) among the strata with an estimated 100% probability of high adherence (TDF hazard ratio (HR) = 0.19, 95% confidence interval (CI): 0.07, 0.56; TDF/FTC HR = 0.12, 95% CI: 0.03, 0.52); 2) with IPC weights used to approximate a continuously adherent population (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.15, 95% CI: 0.04, 0.52); and 3) in per-protocol analysis (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.16, 95% CI: 0.05, 0.53). Our results suggest that the efficacy of PrEP with high adherence is over 80%.
Indexed as
Identifiers
What OpenQuestion holds
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.