Balancing Vulnerability and Freedom: Perspectives on HIV Cure-Related Trials With Analytical Treatment Interruption Among People With HIV and Healthcare Practitioners in the United States
Author(s)
Karine Dube, DrPH;
University of California San Diego School of Medicine, La Jolla, CA, USA
University of California San Diego School of Medicine, La Jolla, CA, USA
Presentation Documents
OBJECTIVES: Recruitment in HIV cure-related trials with analytical treatment interruptions (ATIs) remains challenging. Here, we sought to understand perspectives of ATIs from people with HIV (PWH) and healthcare practitioners (HCP).
METHODS: Qualitative virtual interviews with 12 PWH and 5 HCPs were conducted from June 13 to July 8, 2024. Two focus groups with PWH (N=3 and N=5) were held in August 2024 to further explore participants’ perspectives on ATI. Thematic analysis of transcripts was done using qualitative data analysis software.
RESULTS: ATIs were largely perceived to add freedom to participants’ lives; however, participants also felt more vulnerable. Perceived benefits for PWH included not having to remember to take medication, relief from side effects of medication, reduced costs, and reduced feelings of stigma. Most participants preferred a minimum 1-year ATI, ideally 2 years, during a clinical trial. Regardless of ATI duration, PWH and HCPs expressed concerns about maintaining an undetectable viral load (including risk of HIV transmission), long-term safety, and antiretroviral therapy (ART) resistance. PWH and HCPs emphasized the importance of continued clinical monitoring to provide reassurance during ATIs; convenience in monitoring was also important to PWH. HCPs noted that ATIs could be suitable for PWH having difficulty with their current ART, provided the ATI would not disrupt continuity of care.
CONCLUSIONS: Participating in a trial with an ATI could provide more freedom for PWH; for example, freedom from side effects or from anxieties or stigma associated with daily treatments for HIV. Simultaneously, PWH and HCPs expressed concerns about the risk of detectable viral loads, the possibility of HIV transmission, or emergent ART resistance during ATI. These findings highlight the delicate balance between the increased freedom and heightened vulnerability that might be experienced during ATI, underscoring the need for careful consideration of the pros and cons of ATIs in clinical trials.
METHODS: Qualitative virtual interviews with 12 PWH and 5 HCPs were conducted from June 13 to July 8, 2024. Two focus groups with PWH (N=3 and N=5) were held in August 2024 to further explore participants’ perspectives on ATI. Thematic analysis of transcripts was done using qualitative data analysis software.
RESULTS: ATIs were largely perceived to add freedom to participants’ lives; however, participants also felt more vulnerable. Perceived benefits for PWH included not having to remember to take medication, relief from side effects of medication, reduced costs, and reduced feelings of stigma. Most participants preferred a minimum 1-year ATI, ideally 2 years, during a clinical trial. Regardless of ATI duration, PWH and HCPs expressed concerns about maintaining an undetectable viral load (including risk of HIV transmission), long-term safety, and antiretroviral therapy (ART) resistance. PWH and HCPs emphasized the importance of continued clinical monitoring to provide reassurance during ATIs; convenience in monitoring was also important to PWH. HCPs noted that ATIs could be suitable for PWH having difficulty with their current ART, provided the ATI would not disrupt continuity of care.
CONCLUSIONS: Participating in a trial with an ATI could provide more freedom for PWH; for example, freedom from side effects or from anxieties or stigma associated with daily treatments for HIV. Simultaneously, PWH and HCPs expressed concerns about the risk of detectable viral loads, the possibility of HIV transmission, or emergent ART resistance during ATI. These findings highlight the delicate balance between the increased freedom and heightened vulnerability that might be experienced during ATI, underscoring the need for careful consideration of the pros and cons of ATIs in clinical trials.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR126
Topic
Patient-Centered Research
Disease
SDC: Infectious Disease (non-vaccine)