Development of New Patient Reported Outcome (PRO) Conceptual Models for Treatment Adherence and Satisfaction in People with HIV
Author(s)
Megan Chen, MSPH1, Soodi Navadeh, MD, PhD1, Gerrit Vandenberg, MPH2, Seojin Park, PharmD, MS1, Michael Bogart, PharmD1, Danielle Altman, MA2, Zahava Rosenberg-Yunger, MA, PhD2, Jessica Baldasaro, BS2, Courtney Chatha, MS2, Kailynn Schmidt, BSc2;
1Gilead Sciences, Inc., Foster City, CA, USA, 2Modus Outcomes, a THREAD company, Cary, NC, USA
1Gilead Sciences, Inc., Foster City, CA, USA, 2Modus Outcomes, a THREAD company, Cary, NC, USA
Presentation Documents
OBJECTIVES: Recent improvements in treatments for people with HIV (PWH) inspired the exploration of concepts related to treatment adherence and satisfaction with the newer treatment options, including the assessment of currently available patient-reported outcome (PRO) measures and the development of two conceptual models.
METHODS: This study consisted of three research streams: clinician consultation, a landscape literature review, and qualitative interviews with PWH. HIV clinicians were consulted about factors influencing HIV treatment adherence, satisfaction, and relevant PROs. A landscape review of qualitative and clinical outcome assessment research in people with HIV (from PubMed and clinicaltrials.gov) identified factors affecting adherence and satisfaction, along with relevant PROs. Conceptual models were developed by grouping of concepts into higher-level domains, and PRO items were mapped to these models to assess coverage. Finally, qualitative interviews with open-ended questions explored PWH’s experiences with HIV treatment and perceptions of barriers and facilitators to treatment adherence and satisfaction.
RESULTS: Findings from the three research streams resulted in the development of two conceptual models: treatment adherence (15 domains, e.g. attitudes and beliefs, communication, access to care) and treatment satisfaction (14 domains, e.g. effectiveness, side effects). These models highlight the role of treatment convenience, socioeconomic factors, and healthcare access in both adherence and satisfaction. PWH frequently noted access to care (e.g., insurance and treatment), side effects, effectiveness, interactions with their healthcare provider interactions, and HIV-related stigma as key factors affecting their adherence and satisfaction with treatment. Existing PROs provided coverage of some concepts; gaps were identified related to contemporary PWH’s experiences.
CONCLUSIONS: Expert clinician interviews and qualitative interviews from people with HIV revealed that existing PROs may not fully capture the real-world patient experience with treatment satisfaction and adherence. In response, two conceptual models were developed to capture these domains. Future research to develop novel PROs assessing concepts important to people with HIV is warranted.
METHODS: This study consisted of three research streams: clinician consultation, a landscape literature review, and qualitative interviews with PWH. HIV clinicians were consulted about factors influencing HIV treatment adherence, satisfaction, and relevant PROs. A landscape review of qualitative and clinical outcome assessment research in people with HIV (from PubMed and clinicaltrials.gov) identified factors affecting adherence and satisfaction, along with relevant PROs. Conceptual models were developed by grouping of concepts into higher-level domains, and PRO items were mapped to these models to assess coverage. Finally, qualitative interviews with open-ended questions explored PWH’s experiences with HIV treatment and perceptions of barriers and facilitators to treatment adherence and satisfaction.
RESULTS: Findings from the three research streams resulted in the development of two conceptual models: treatment adherence (15 domains, e.g. attitudes and beliefs, communication, access to care) and treatment satisfaction (14 domains, e.g. effectiveness, side effects). These models highlight the role of treatment convenience, socioeconomic factors, and healthcare access in both adherence and satisfaction. PWH frequently noted access to care (e.g., insurance and treatment), side effects, effectiveness, interactions with their healthcare provider interactions, and HIV-related stigma as key factors affecting their adherence and satisfaction with treatment. Existing PROs provided coverage of some concepts; gaps were identified related to contemporary PWH’s experiences.
CONCLUSIONS: Expert clinician interviews and qualitative interviews from people with HIV revealed that existing PROs may not fully capture the real-world patient experience with treatment satisfaction and adherence. In response, two conceptual models were developed to capture these domains. Future research to develop novel PROs assessing concepts important to people with HIV is warranted.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR33
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Infectious Disease (non-vaccine)