OBJECTIVES: Analytical treatment interruptions (ATI) are important in the evaluation of potential regimens for HIV cure. A review of existing clinical outcome assessments identified a gap in measurement tools to capture aspects of such interventions involving an ATI that may be preferable to standard of care. Our objective was to develop a de novo patient preference questionnaire to address this need.

METHODS: A literature search was conducted to identify key aspects of HIV treatment experience that may impact treatment preferences from the perspective of people with HIV (PWH), informing the development of a conceptual model. The conceptual model served as the foundation for the draft HIV Treatment Preference Questionnaire (HIV-TPQ) content. Three clinicians with ATI expertise and a PWH advocate reviewed the draft HIV-TPQ; revisions were made based on their feedback. Qualitative interviews were conducted with 13 PWH representing various demographic backgrounds currently taking antiretroviral therapy to confirm appropriate content of the revised measure and evaluate its clarity. Interview transcripts were analyzed to identify issues regarding the content, language, and structure of the questionnaire.

RESULTS: The treatment experience domain of the conceptual model included subdomains related to positive outcomes (eg, improvements to activities of daily living) and burdens (eg, physical impacts, stigma) associated with treatment which contributed to the development of the 11-item draft HIV-TPQ. Expert feedback informed revisions to clarify the wording of the HIV-TPQ and highlighted aspects for further exploration during cognitive debriefing. Most interview participants interpreted the HIV-TPQ as intended; minor clarity and interpretation issues informed modifications to the instructions and 3 items.

CONCLUSIONS: The HIV-TPQ was developed with reference to FDA Patient-Focused Drug Development guidelines to evaluate preferences of PWH in the context of potential regimens for HIV cure that involve an ATI. Additional work is planned to test the revised HIV-TPQ qualitatively and psychometrically.