Development of Two Versions of a Patient-Preference Questionnaire for Evaluating Potential HIV Cure-Related and Other HIV Interventions
Author(s)
Karine Dube, DrPH1, Sorana Segal-Maurer, MD2, Martin Duracinsky, PhD, MD3, Martha Gauthier, MA4, Kathy Vong, BA4, Harlow Sharp, BA4, Blaise Cureg, MPH4, Imani Weeks, BA4, Kwanza Price, MPH5, Caroline Burk, PharmD, MS5, James Jarrett, MA, PhD5.
1University of California San Diego, School of Medicine, Division of Infectious Diseases and Global Public Health, San Diego, CA, USA, 2NewYork-Presbyterian Queens, The Dr James J Rahal Jr Division of Infectious Diseases, Flushing, NY, USA, 3Patient-Reported Outcomes Research (PROQOL), Health Economics Clinical Trial Unit (URC-ECO), Hôtel-Dieu Hospital, AP-HP, Paris, France, 4Lumanity, Boston, MA, USA, 5Gilead Sciences Inc., Foster City, CA, USA.
1University of California San Diego, School of Medicine, Division of Infectious Diseases and Global Public Health, San Diego, CA, USA, 2NewYork-Presbyterian Queens, The Dr James J Rahal Jr Division of Infectious Diseases, Flushing, NY, USA, 3Patient-Reported Outcomes Research (PROQOL), Health Economics Clinical Trial Unit (URC-ECO), Hôtel-Dieu Hospital, AP-HP, Paris, France, 4Lumanity, Boston, MA, USA, 5Gilead Sciences Inc., Foster City, CA, USA.
OBJECTIVES: Analytical treatment interruptions (ATI) are crucial for assessing potential HIV cure-related regimens but carry risks like viral rebound and psychosocial impacts, potentially deterring participation in clinical trials. The HIV Intervention Preference Questionnaire (HIV-IPQ), a patient-reported outcome measure (PROM), was developed to capture the preferences of people with HIV (PWH) and their treatment before starting a clinical study and the clinical study intervention or ATI period. A conceptual model was developed and an initial round of qualitative interviews with 13 PWH in the United States taking antiretroviral therapy was conducted to confirm the appropriateness of the HIV-IPQ and evaluate its clarity (Duracinsky et al., Value in Health; 2024;27:S321). Feedback received from PWH from a second round of qualitative cognitive debriefing interviews is reported herein.
METHODS: The research team created two versions of the HIV-IPQ which focus on the intervention (HIV-IPQ-I) and ATI (HIV-IPQ-ATI) phases of clinical trials, separately. Cognitive debriefing interviews are being conducted with an additional 15-20 PWH to ensure comprehensibility, clarity, and relevance, and that the recall period and response options are appropriate. Transcripts from completed interviews will be analyzed for potential issues with the HIV-IPQ’s content, language, and structure/format. This process aligns with FDA Patient-Focused Drug Development guidelines (https://www.fda.gov/media/139088/download).
RESULTS: As of June 2025, 9 PWH fully debriefed the HIV-IPQ-I, 1 PWH partially debriefed the HIV-IPQ-I, and 8 PWH fully debriefed the HIV-IPQ-ATI. Feedback from these second-round interviews was generally consistent with the first round, indicating that PWH interpreted the questionnaires as intended.
CONCLUSIONS: Preliminary qualitative feedback of the HIV-IPQ from PWH showed that it is a clear and relevant PROM to assess patient preferences regarding study interventions and ATI. A psychometric evaluation is planned to ensure the PROM’s robustness and accuracy in capturing PWH preferences with intervention or ATI.
METHODS: The research team created two versions of the HIV-IPQ which focus on the intervention (HIV-IPQ-I) and ATI (HIV-IPQ-ATI) phases of clinical trials, separately. Cognitive debriefing interviews are being conducted with an additional 15-20 PWH to ensure comprehensibility, clarity, and relevance, and that the recall period and response options are appropriate. Transcripts from completed interviews will be analyzed for potential issues with the HIV-IPQ’s content, language, and structure/format. This process aligns with FDA Patient-Focused Drug Development guidelines (https://www.fda.gov/media/139088/download).
RESULTS: As of June 2025, 9 PWH fully debriefed the HIV-IPQ-I, 1 PWH partially debriefed the HIV-IPQ-I, and 8 PWH fully debriefed the HIV-IPQ-ATI. Feedback from these second-round interviews was generally consistent with the first round, indicating that PWH interpreted the questionnaires as intended.
CONCLUSIONS: Preliminary qualitative feedback of the HIV-IPQ from PWH showed that it is a clear and relevant PROM to assess patient preferences regarding study interventions and ATI. A psychometric evaluation is planned to ensure the PROM’s robustness and accuracy in capturing PWH preferences with intervention or ATI.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR63
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Infectious Disease (non-vaccine)