TY - JOUR T1 - Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment JF - Journal of Medical Ethics JO - J Med Ethics SP - 270 LP - 276 DO - 10.1136/medethics-2017-104433 VL - 44 IS - 4 AU - Gail E Henderson AU - Holly L Peay AU - Eugene Kroon AU - Rosemary Jean Cadigan AU - Karen Meagher AU - Thidarat Jupimai AU - Adam Gilbertson AU - Jill Fisher AU - Nuchanart Q Ormsby AU - Nitiya Chomchey AU - Nittaya Phanuphak AU - Jintanat Ananworanich AU - Stuart Rennie Y1 - 2018/04/01 UR - http://jme.bmj.com/content/44/4/270.abstract N2 - 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. ER -