Partner protections in HIV cure-related trials involving analytical treatment interruption: Updated toolkit to mitigate HIV transmission risk.
Karine Dubé, Thomas J Villa, William Freshwater, Brittney Mauk, Annette Rid, Michael J Peluso
Author Information
Karine Dubé: University of California San Diego School of Medicine, Division of Infectious Diseases and Global Public Health, 9500 Gilman Drive, La Jolla, CA, 92093, USA.
Thomas J Villa: HIV Obstruction by Programmed Epigenetics (HOPE) Delaney Collaboratory Community Advisory Board, Gladstone Institutes, 1650 Owens Street, San Francisco, CA, 94158, USA.
William Freshwater: Former Analytical Treatment Interruption (ATI)/HIV Cure Trial Participant, Bethesda, Philadelphia, PA, USA.
Brittney Mauk: DLH, 6720B Rockledge Drive, Suite 777, Bethesda, MA, 20817, USA.
Annette Rid: Department of Bioethics, NIH Clinical Center, 10 Center Drive, Bethesda, MD, 20892, USA.
Michael J Peluso: University of California, San Francisco (UCSF), Division of HIV, Infectious Diseases, and Global Medicine, 1001 Potrero Avenue, San Francisco, CA, 94110, USA.
Analytical treatment interruptions (ATIs) are widely used to evaluate HIV cure-related research interventions. However, sex partners of cure-related trial participants might be at risk of acquiring HIV during ATIs. Addressing this risk is key to ensuring the continued success of trials involving ATIs and offer greater acceptability across multiple trials sites. In 2022, the Advancing Clinical Therapeutics Globally (ACTG) Network convened a Partner Protections Working Group (PPWG) to update the 2020 HIV transmission risk toolkit developed by Peluso and colleagues. In our review of the original toolkit, we identified new challenges and needs at the participant, partner and study levels, as well as new evidence on measures to address these needs and more advanced ethical thinking on partner protections in HIV cure-related trials with ATIs. Based on these findings, we developed an updated toolkit that will provide trial participants and their partners with better support to address new and unfamiliar situations and protect partners from undue harm. We present this toolkit, make it available as a resource for cure-related trials with ATIs and discuss possible future directions.
