A partner protection package for HIV cure-related trials involving analytical treatment interruptions.

ABSTRACT: Analytical treatment interruptions (ATIs) have become a key methodological approach to evaluate the effects of experimental HIV cure-related research interventions. During ATIs, sex partners of trial participants might be at risk of acquiring HIV. This risk raises both ethical and feasibility concerns about ATI trials. We propose a partner protection package (P3) approach to address these concerns. A P3 approach would provide guidance to investigators, sponsors, and those who are designing and implementing context-specific partner protections in HIV cure-related trials involving ATIs. The approach would also help assure institutional review boards, trial participants, and communities that ATI trials with a P3 would provide appropriate partner protections. We offer a prototype P3 framework

SUBMITTER: Dube K 

PROVIDER: S-EPMC10543569 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature