Participant experiences in HIV cure-directed trial with an extended analytical treatment interruption in Philadelphia, United States

Abstract

Background

A feature of HIV cure trials is the need to interrupt treatment to test the efficacy of experimental interventions—a process known as analytical treatment interruptions (ATIs).

Objectives

We report the experiences of participants after they completed an extended ATI.

Methods

From April to November 2022, we conducted post-ATI in-depth interviews with BEAT2 clinical trial (NCT03588715) participants who stopped ART while receiving an immunotherapy regimen. We used conventional content analysis to code the data.

Results

We conducted interviews with 11 Black/African American and three White/Caucasian participants (11 males, two females, and one transgender woman). The mean ATI was 38 weeks. Participants noted several significant experiences surrounding the interventions’ side effects, ATI, and returning to medication. Some participants had positive experiences with their ATI. Other participants were nervous during the ATI. Rising viral loads led some to feel a sense of failure. Although trial experiences were heterogeneous, participants unanimously had positive interactions with the clinical trial staff which facilitated their retention in the trial. Participants shared their experiences with the trial, including changes in expectations, experiences with experimental interventions and procedures, compensation as a measure of respect, effort, transportation, and effects of COVID-19 during the trial. Based on these results, we provide considerations for the conduct of future HIV cure-directed clinical trials involving ATIs.

Conclusions

Managing expectations, focusing on participants’ contributions, and providing support to reduce feelings of having failed the research team and/or the HIV community following viral rebound should be part of HIV cure trial design. Discussing the mental health impact of rebound during consent, distinct from risk, is needed. Continued efforts to understand how people with HIV experience ATIs will improve future designs of HIV cure clinical trials.

Keywords:

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

Acknowledgements

The authors are indebted to all the BEAT2 trial participants. We are also grateful to the BEAT-HIV Collaboratory, the BEAT-HIV Community Engagement Group (CEG), Philadelphia FIGHT Community Health Centers, and the University of Pennsylvania. We would like to thank Rease Maddox, Roy Hayes, Marcus Hill, Christopher Roebuck, and William (Bill) Freshwater from the BEAT-HIV CAB, and Waheedah Shabazz-El who chaired the CAB when the socio-behavioral study was first conceptualized. We would also like to thank Kenneth M. Lynn from the Hospital of the University of Pennsylvania and Linden Lalley-Chareczko from Philadelphia FIGHT Community Health Centers. We are grateful to Jim Riley from the BEAT-HIV CEG, and Amy Onorato who serves as BEAT-HIV Community Engagement Coordinator. We would like to thank Rebecca Neergaard and Caroline O’Brien from the University of Pennsylvania Mixed Methods Research Laboratory.

Author contributions

Conceptualization: F.K.B., K.A.R., D.M., and K.D. Data curation and project administration: A.B. and E.P. Formal analysis and investigation: K.D., F.K.B., K.A.R., and N.J. Funding acquisition and supervision: F.K.B., K.A.R., and L.J.M. Writing—original draft preparation: A.B., E.P., L.J.M., and K.D. All authors reviewed and edited manuscript drafts including the final draft of the manuscript.

Disclosure statement

KD provides advisory services to Gilead Sciences, Inc. All other authors declare that they have no competing interests.

Additional information

Funding

This work was funded by a pilot grant from the Penn Mental Health AIDS Research Center (PMHARC), an NIH-funded program (P30 MH 097488). It was also supported by UM1AI126620 and UM1AI164570 (BEAT-HIV Collaboratory) which is co-supported by the National Institute of Allergies and Infectious Diseases (NIAID), the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Drug Abuse (NIDA), and the Robert I. Jacobs Fund of The Philadelphia Foundation. LJM is also supported by the Herbert Kean, M.D., Family Professorship. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. J.A.S. and K.D. received support from R01-MH126768.