OBJECTIVES: Long-acting oral antiretroviral therapy (LA-OART) is in development for people living with HIV (PLWH). This study aimed to demonstrate content validity of patient reported outcome (PRO) measures for use within LA-OART clinical trials. Previously, a targeted literature review and concept elicitation interviews with clinicians and PLWH were conducted to develop conceptual models (CMs) capturing PLWH experiences of OART, adherence facilitators and barriers, and perspectives on a hypothetical switch to LA-OART. Herein we describe cognitive debriefing (CD) interviews to ensure relevance and understandability of these PRO measures.

METHODS: CMs were discussed, concepts were prioritized during an Item Generation Meeting with PRO and clinical experts, and concepts were drafted into measures in paper and electronic formats, following FDA PRO development guidance. Recruitment followed an inclusive sampling strategy, aiming for adequate representation of the PLWH population. Interviews were completed across 3 waves (10 PLWH per wave; 5 debriefing paper, 5 electronic).

RESULTS: Three measures were drafted: the HIV Patient Perspective of Regimen (HIV-PP-R), which explores perceptions of the trial OART; the HIV Patient Perspective of Regimen Change (HIV-PP-RC), which explores perceptions of the trial OART versus the pre-trial OART; and the HIV Drivers of Adherence Questionnaire (HIV-DAQ), which explores OART-taking behavior and reasons for this behavior during the trial. Thirty PLWH (aged 22-64 years) participated in CD, including 63% men who have sex with men, 7% transgender women, 7% people who inject drugs and 33% heterosexual men or women. Participants perceived all 3 measures as assessing relevant and important concepts. Measures were refined following each wave. Understandability was confirmed in wave 3. The final HIV-PP-R and HIV-PP-RC contained 10 items each. The final HIV-DAQ contained 22 items.

CONCLUSIONS: CD findings support content validity of the 3 measures. With these measures, LA-OART trials may better assess adherence attributes of and considerations in switching to LA-OART among PLWH.