Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: The PrEPVacc trial.

ABSTRACT: BackgroundThere is increasing recognition that the interpretation of active-controlled HIV prevention trials should consider the counterfactual placebo HIV incidence rate, that is, the rate that would have been observed if the trial had included a placebo control arm. The PrEPVacc HIV vaccine and pre-exposure prophylaxis trial (NCT04066881) incorporated a pre-trial registration cohort partly for this purpose. In this article, we describe our attempts to model the counterfactual placebo HIV incidence rate from the registration cohort.MethodsPrEPVacc was conducted at four study sites in three African countries. During the set up of the trial, potential participants were invited to join a registration cohort, which included HIV testing every 3 months. The trial included a non-inferiority comp

SUBMITTER: Kansiime S 

PROVIDER: S-EPMC12092936 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature