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The development and validation of a scale to measure Treatment Regimen Fatigue among older adults living with HIV

Award Number: R01AG074695
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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The development and validation of a scale to measure Treatment Regimen Fatigue among older adults living with HIV - ABSTRACT This application is in response to PAR-21-068 Multidisciplinary Studies of HIV/AIDS and Aging, as well as NOSI (NOT-OD-21-100) Improving Patient Adherence to Treatment and Prevention Regimens. By 2030, older (aged 50+ years) people living with HIV (PLWH) will comprise 73% of all PLWH. Despite advances in HIV treatment, older PLWH remain at elevated risk for early morbidity and mortality compared to their peers without HIV due to the cumulative impact of HIV disease, multimorbidity, and biopsychosocial challenges on disease management. Treatment regimen/disease-specific fatigue (TRDF)—distress associated with living with, managing, or coping with a chronic condition, its symptoms and/or treatments—is a key barrier to disease management among people with chronic conditions. Previous studies estimate that TRDF impacts 33-65% of all PLWH. True values, however, are unknown, as there is no comprehensive, reliable, and valid tool to assess it. Much of our TRDF knowledge is derived from 1) studies assessing TRDF with single items; 2) qualitative data from younger, healthier PLWH; 3) tools that do not fully capture TDRF and its defining characteristics, such as imbalance between patient workload and patient capacity; and 4) data from studies conducted prior to the advent of single- tablet regimens. A comprehensive TRDF tool would enable us to identify modifiable drivers of TDRF that could enable epidemiologic surveillance, inform geriatric assessments, and guide intervention development. Guided by our novel conceptual model integrating the Workload Capacity Model and Cumulative Complexity Theory and building on our preliminary work, the goal of this study is to design and validate a comprehensive tool to assess TRDF and identify modifiable factors to facilitate its treatment among older English- and Spanish-speaking TRDF among older PLWH with multimorbidity and to refine our novel conceptual model suggest links between TRDF and poor clinical outcomes, including HIV treatment interruption and unsuppressed viremia. Among those with multimorbidity, evidence of poor self-management of the co-occurring condition(s) was observed (e.g., high A1C and/or elevated blood pressure at most recent visit) among those reporting greater disease workload and lower capacity. Interviews with HIV clinicians suggested that older PLWH may be more susceptible to TRDF than younger PLWH, and clinicians reported a lack of knowledge and resources regarding TRDF. Our findings highlight PLWH with multimorbidity. Preliminary data from our mixed methods study to elicit information about an urgent need to develop a tool to assess TRDF among older PLWH and assist clinicians with identifying person-centered interventions to mitigate its effects on disease management. To do this, we will leverage secondary data from previous work to inform the design of English and Spanish versions of our TRDF instruments (Aim 1A), which we will then pre-test (Aim 1B. We will then conduct a psychometric study to validate both versions using rigorous survey development methods, and test our novel conceptual model (Aim 2).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $600,538 )
2026	2026	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	5	5/26/2026	NON-COMPETING CONTINUATION	$600,538
														Subtotal = $600,538

Issue Date FY: 2025 ( Subtotal = $602,149 )
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	001	4	4/9/2025	NON-COMPETING CONTINUATION	$552,994
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	002	4	6/18/2025	NON-COMPETING CONTINUATION	$49,155
2025	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Aging Research	000	2	2/19/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $602,149

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	002	3	5/9/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	001	3	2/13/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$614,102
2024	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Aging Research	000	2	2/13/2024	NON-COMPETING CONTINUATION	-$614,102
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $672,312 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Aging Research	000	2	5/31/2023	NON-COMPETING CONTINUATION	$672,312
														Subtotal = $672,312

Issue Date FY: 2022 ( Subtotal = $589,613 )
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Aging Research	000	1	8/26/2022	NEW	$589,613
														Subtotal = $589,613

Grand Total All Awards = $2,464,612

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The development and validation of a scale to measure Treatment Regimen Fatigue among older adults living with HIV

Award Number: R01AG074695

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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