Development of Two Versions of a Patient-Reported Outcome Measure to Evaluate Participant Experience and Satisfaction During the Intervention and Analytical Treatment Interruption Periods of Cure-Related and Other HIV Trials
Author(s)
Karine Dube, DrPH1, Sorana Segal-Maurer, MD2, Martin Duracinsky, PhD, MD3, Martha Gauthier, MA4, Kathy Vong, BA4, Harlow Sharp, BA4, 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: Clinical trials incorporating analytical treatment interruptions (ATI) are necessary for assessing potential HIV cure regimens in people with HIV (PWH). A need was identified for a patient-reported outcome measure (PROM) to assess the experience and satisfaction of PWH during the intervention and ATI phases of HIV trials. In response, the Questionnaire to Understand the Experience and Satisfaction in a Trial in HIV (QUEST-HIV) was developed.
METHODS: Following a review of the literature and existing PROMs that assess patient experience/satisfaction among PWH the research team developed the QUEST-HIV. A PWH advocate and 3 disease experts reviewed the original draft of the questionnaire, and it was subsequently refined. Researchers are conducting hybrid concept elicitation and cognitive debriefing interviews with approximately 12 PWH in the United States who are currently on antiretroviral therapy to confirm the content validity, clarity, and appropriateness of the QUEST-HIV.
RESULTS: Two versions of the QUEST-HIV were developed, with one assessing the experience and satisfaction during the study intervention period (QUEST-HIV-I) and the other during the ATI period (QUEST-HIV-ATI). Both PROMs have a 7-day recall period, with each item assessed on a 5-point Likert scale. The QUEST-HIV-I includes questions related to experience/satisfaction with the study intervention (e.g., any concerns with viral load, potential for rebound, transmitting HIV to intimate partners, and side effects; convenience, modality, and pain/discomfort). The QUEST-HIV-ATI includes questions related to experience/satisfaction with being off all HIV medications (e.g., concerns with viral load, rebound, transmitting HIV to intimate partners, and lingering side effects; in addition to not taking daily medication, frequency of viral load monitoring, and convenience of the monitoring process) during an experimental trial period.
CONCLUSIONS: The QUEST-HIV content was validated to assess experience/satisfaction of PWH regarding study interventions and ATI. Both QUEST-HIV versions will be used and psychometrically validated during cure-related trials and other HIV trials.
METHODS: Following a review of the literature and existing PROMs that assess patient experience/satisfaction among PWH the research team developed the QUEST-HIV. A PWH advocate and 3 disease experts reviewed the original draft of the questionnaire, and it was subsequently refined. Researchers are conducting hybrid concept elicitation and cognitive debriefing interviews with approximately 12 PWH in the United States who are currently on antiretroviral therapy to confirm the content validity, clarity, and appropriateness of the QUEST-HIV.
RESULTS: Two versions of the QUEST-HIV were developed, with one assessing the experience and satisfaction during the study intervention period (QUEST-HIV-I) and the other during the ATI period (QUEST-HIV-ATI). Both PROMs have a 7-day recall period, with each item assessed on a 5-point Likert scale. The QUEST-HIV-I includes questions related to experience/satisfaction with the study intervention (e.g., any concerns with viral load, potential for rebound, transmitting HIV to intimate partners, and side effects; convenience, modality, and pain/discomfort). The QUEST-HIV-ATI includes questions related to experience/satisfaction with being off all HIV medications (e.g., concerns with viral load, rebound, transmitting HIV to intimate partners, and lingering side effects; in addition to not taking daily medication, frequency of viral load monitoring, and convenience of the monitoring process) during an experimental trial period.
CONCLUSIONS: The QUEST-HIV content was validated to assess experience/satisfaction of PWH regarding study interventions and ATI. Both QUEST-HIV versions will be used and psychometrically validated during cure-related trials and other HIV trials.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR64
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Infectious Disease (non-vaccine)