Study design approaches for future active-controlled HIV prevention trials.

ABSTRACT:

Objectives

Vigorous discussions are ongoing about future efficacy trial designs of candidate human immunodeficiency virus (HIV) prevention interventions. The study design challenges of HIV prevention interventions are considerable given rapid evolution of the prevention landscape and evidence of multiple modalities of highly effective products; future trials will likely be 'active-controlled', i.e., not include a placebo arm. Thus, novel design approaches are needed to accurately assess new interventions against these highly effective active controls.

Methods

To discuss active control design challenges and identify solutions, an initial virtual workshop series was hosted and supported by the International AIDS Enterprise (October 2020-March 2021). Subsequent symposia discuss

SUBMITTER: Donnell D 

PROVIDER: S-EPMC10798828 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature