Recall and Appraisal of the Risks, Benefits, and Objectives of Interrupting HIV Treatment in an HIV Cure-Related Study.

Abstract

The goal of HIV cure research is to either eliminate HIV from the body or durably suppress it in the absence of antiretroviral therapy (ART). This research often requires participants to interrupt ART. However, there are numerous risks associated with ART interruptions and therefore it is critical to understand how people with HIV (PWH) who participate recall the elements of consent, to safeguard their rights and welfare. Participants were recruited from the SCOPE Analytic Treatment Interruption (SCOPE-ATI: NCT04359186) study at the University of California San Francisco. We interviewed 12 SCOPE-ATI participants to assess their recall of informed consent elements and therapeutic misconception, using the Brief Informed Consent Evaluation Protocol (BICEP). Interviewees were primarily older adults, male, White, and non-Hispanic/Latinx. Their responses indicated that they understood the primary purpose of the SCOPE-ATI study to be scientific research. Nearly all participants demonstrated high recall of key elements of consent and no therapeutic misconception. We also found that the role of study staff was a major factor in participants' appraisal of risks and that associated psychosocial risks of pausing ART were of minimal concern (e.g., anxiety off ART, possible forward HIV transmission to sex partners). As HIV cure research expands, it is important to reiterate the duty of the investigative team to clearly communicate with participants about the associated risks and to assess their understanding throughout these studies.