Designing HIV Vaccine Efficacy Trials in the Context of Highly Effective Non-vaccine Prevention Modalities.

ABSTRACT: The evolving HIV prevention landscape poses challenges to the statistical design of future trials of candidate HIV vaccines. Study designs must address the anticipated reduction in HIV incidence due to adding new prevention modalities to the standard prevention package provided to trial participants, and must also accommodate individual choices of participants with regard to the use of these modalities. We explore four potential trial designs that address these challenges, with a focus on accommodating the newest addition to the prevention package-antiretroviral-based oral pre-exposure prophylaxis (PrEP). The designs differ with respect to how individuals who take up oral PrEP at screening are handled. An All-Comers Design enrolls and randomizes all eligible individuals, a Decliners Design

SUBMITTER: Janes H 

PROVIDER: S-EPMC10022814 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature