Participant Perspectives in an HIV Treatment Interruption Study in San Francisco, United States
Year: 2025
Type: article
Abstract: HIV cure-related clinical research studies often include analytical treatment interruptions (ATIs), in which participants pause antiretroviral treatment (ART). During ATIs, researchers closely monitor laboratory values and adverse events. We assessed and compared the perspectives of two distinct groups of participants: HIV noncontrollers and controllers in a San Francisco-based ATI study focused on identifying biomarkers predicting HIV viral rebound. Data were collected from 2021 to 2024 over five study time points to assess motivations, understanding of the study, decisional regret, and partner protections. All participants (n = 16) endorsed the goal of helping advance HIV research as a motivator, about half were also driven by interest in their body's response to the ATI, and some indicated monetary compensation as a key motivator. Most participants (6 of 10 noncontrollers and 4 of 6 controllers) did not view personal health benefit as a primary study goal. All understood the option for an extended ATI if they had not met ART restart criteria after 28 days. At the study's onset, all sexually active participants (n = 14) were informed about the risk of transmission to sex partners and the need for partner protections during ATIs. Among noncontrollers, 2 of 5 reported using condoms, being abstinent or partner use of pre-exposure prophylaxis (PrEP) during sexual activity. Among controllers, 3 of 5 reported sexual activity: one with a partner on PrEP, one with a partner on ART, and one using other protection methods. Decisional regret about study participation, measured on a scale of 0-100, was low among both noncontrollers (range 1.67-13.57), and controllers (range 8.33-10) during the ATI, and remained low following it (noncontroller M = 5.07, SD = 4.52; controller M = 10.00, SD = 11.31). Participants generally understood the study, highlighted the need for partner protection support during ATI, and reported low decisional regret.
Authors: Elizabeth Nguyen, Elizabeth Nguyen, Anastasia Korolkova, Anastasia Korolkova, Ali Ahmed, Steven Meanley, Lynda Dee, Maryam Hussain, Fang Wan, Rebecca Hoh, Antonio Rodriguez, Tony Figueroa, Lillian B. Cohn, Steven G. Deeks, Michael J. Peluso, Shadi Eskaf, Jeremy Sugarman, John A. Sauceda, John A. Sauceda, Karine Dubé
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Fred Hutchinson Cancer Center - to discover circulating markers to determine the size of the HIV reservoir in the body, to clinically test interventions that might reduce the size..., G6142041912, G641159528, G6925360402, Investigating Psychosocial Experiences of HIV Cure Trial Participants Undergoing Extended HIV Treatment Interruptions: Implications for Ethical Conduct, Characterizing the virologic and immunologic signatures of HIV exceptional control
OpenAlex ID: W4413971200