The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV-Remission Trials

Stuart Rennie; Gail Henderson; Nittaya Phanuphak; Kristine Kuczynski; Donn Colby; Nuchanart Ormsby; Eugene Kroon; Denise Hsu; Udom Likhitwonnawut; Sandhya Vasan; Carlo Sacdalan; Thidarat Jupimai; Oratai Butterworth; Holly Peay

doi:10.1002/eahr.500172

The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV-Remission Trials

Ethics Hum Res. 2023 Jul-Aug;45(4):2-15. doi: 10.1002/eahr.500172.

Authors

Affiliations

¹ Professor at the Center for Bioethics in the Department of Social Medicine at the University of North Carolina at Chapel Hill.
² Professor in the Department of Social Medicine and the director of the Center for Genomics and Society at the University of North Carolina at Chapel Hill.
³ Executive director of the Institute of HIV Research and Innovation in Bangkok.
⁴ Program manager at the Center for Genomics and Society and PPMH Precision Genomic Screening Program in the School of Medicine at the University of North Carolina at Chapel Hill.
⁵ Senior research physician at the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
⁶ Research assistant and an administrative support associate in the Computational Medicine Program in the School of Medicine at the University of North Carolina at Chapel Hill.
⁷ Senior research physician at the Institute of HIV Research and Innovation in Bangkok.
⁸ Associate director of therapeutics at the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
⁹ Member of the National Community Advisory Board in Thailand.
¹⁰ Vice president of Global Infectious Diseases Research and the director of the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
¹¹ Research physician at the SEARCH Research Foundation in Bangkok.
¹² Clinical research assistant at the Center of Excellence in Pediatric Infectious Diseases and Vaccines Faculty of Medicine at the Chulalongkorn University in Bangkok.
¹³ Clinical project manager at the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
¹⁴ Senior research public health analyst at RTI International.

PMID: 37368521
DOI: 10.1002/eahr.500172

Abstract

Analytic treatment interruption (ATI) is scientifically necessary in HIV-remission ("cure") studies to test the effects of new interventions. However, stopping antiretroviral treatment poses risks to research participants and their sexual partners. Ethical debate about whether and how to conduct such studies has largely centered on designing risk-mitigation strategies and identifying the responsibilities of research stakeholders. In this paper, we argue that because the possibility of HIV transmission from research participants to partners during ATI cannot practicably be eliminated-that is, it is ineliminable-the successful conduct of such trials ultimately depends on relationships of trust and trustworthiness. We describe our experiences with conducting and studying HIV-remission trials with ATI in Thailand to examine the strengths, complexities, and limitations of the risk-mitigation and responsibility approaches and to explore ways in which the building of trust-and trustworthiness-may help enhance the scientific, practical, and ethical dimensions of these trials.

Keywords: HIV cure trials; HIV-remission trials; HIV-transmission risk; analytic treatment interruption; research relationships; trust.

MeSH terms

Anti-Retroviral Agents / therapeutic use
HIV Infections* / drug therapy
Humans
Social Behavior
Trust
Withholding Treatment

Substances

Anti-Retroviral Agents