Participant experiences in a combination HIV cure-related trial with extended analytical treatment interruption in San Francisco, United States

Abstract

Background

There is limited systematic information available about the perspectives of participants enrolled in intensive combination HIV cure-related trials inclusive of an extended analytical treatment interruption (ATI).

Objective

To assess and understand experiences of people with HIV involved in a combination HIV cure-related trial with an extended ATI.

Methods

The trial included five interventions and was followed by an ATI lasting up to 52 wk. From 2022 – 2023, we conducted in-depth interviews with study participants following their extended ATIs. Interviews were audio-recorded, transcribed, and analyzed via conventional thematic analysis.

Results

We interviewed seven participants. The majority were male, White, and non-Hispanic, with a median age of 37 years. Trust in the research team, scientific altruism and hope of becoming a post-intervention controller were key motivators for joining the trial. Interviewees reported being satisfied with their decision to participate in the trial and the extended ATI. Most recounted feelings of worry related to viral rebound during the ATI. Participants reported both defeat and relief with ART restart. Four faced challenges with protecting partners from HIV during their ATI, such as trying to find out if their partner(s) were using pre-exposure prophylaxis.

Conclusions

Our findings demonstrate potential improvements for future ATI trial participant experiences, such as more robust resources for psychosocial support and partner protections. Dedicating greater effort to understanding participant ATI experiences can inform the design of future participant-centered HIV cure trial protocols.

Keywords:

• HIV cure research
• analytical treatment interruptions
• participant experiences
• socio-behavioral research
• combination trials
• people with HIV

Acknowledgements

The authors are deeply indebted to all the study participants who took part in the UCSF combination HIV cure trial. We would also like to thank the Delaney AIDS Research Enterprise (DARE) and amfAR Institute for HIV Cure Research community advisory board members who provided guidance on the participant experiences study. We are grateful to the entire SCOPE study team at UCSF, including Meghann Williams, Rebecca Hoh, Michael J. Peluso and Steve G. Deeks from the Division of HIV, Infectious Diseases and Global Medicine, Department of Medicine, at UCSF, and the research staff from Ward 84. We would also like to thank Rowena Johnston, formerly from amfAR – The Foundation for AIDS Research, and the many collaborators and partners who made the UCSF Combination HIV Cure Trial possible.

Authors’ contributions

KD led data analysis and wrote the first draft of this manuscript. SON assisted with data analysis. JAS conducted all participant interviews. All authors reviewed the manuscript for intellectual contents and approved the final version of the manuscript.

Disclosure statement

K.D. provides advisory services to Gilead Sciences, Inc. J.S. is a member of Merck KGaA’s Ethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA’s Ethics Advisory Panel; a member of Aspen Neurosciences Clinical Advisory Panel; he was also a member of a Merck Data Monitoring Committee. None of these activities are related to the content of this manuscript.

Additional information

Funding

K.D., J.A.S. and J.S. received support from R01-MH126768 and from the amfAR Institute for HIV Cure Research.