Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort.
In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks.
These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach.
- research ethics
- behavioural research
- HIV Infection and AIDS
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Contributors Each author has reviewed the current manuscript and made contributions as per the requirements of the journal. All authors were engaged in the planning, conduct and reporting of the work in this paper. EK, JA, GEH, HLP, RJC, SR and JF conceived the project and its design, as well as worked on the development of the manuscript throughout. EK, NP and NC conducted the trial whose participants were interviewed and provided critical expert comments on the themes developed in this manuscript as it was being conceived and written. TJ conducted the interviews, and made significant contributions to the code development and the manuscript. GEH, RJC, AG, HLP and KM developed the codebook and coded the interviews, with input from SR, JF, NQO and TJ. AG, NQO and KM made significant contributions to developing the themes of the paper and its writing. EK, NQO and TJ were involved in the details of translation and interpretation of key themes in the Thai context.
Funding This work was supported by a grant from the National Institute for Allergy and Infectious Disease (1R01AI127024).
Competing interests None declared.
Ethics approval The study was approved by the IRBs at the University of North Carolina at Chapel Hill and the Walter Reed Army Institute of Research (WRAIR), and by the Chulalongkorn University Institutional Review Board, which oversees all SEARCH-related studies.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Due to concerns about maintaining confidentiality of our interviews, and their small numbers, we are not making those interview transcripts available.
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