Promoting Aging and Thriving With HIV

Not Applicable

Not yet recruiting

• Conditions: HIV - Human Immunodeficiency Virus; HIV (Human Immunodeficiency Virus); HIV; Geriatric; Geriatric Assessment

• Registration Number: NCT07192419
• Lead Sponsor: Indiana University

Brief Summary

The pilot is an intervention of a geriatric assessment and management tool (PATH) in outpatient HIV clinics.

Detailed Description

This will be a Pilot, two-arm, randomized parallel-group, clinical trial with blinded research staff of a Geriatric assessment and management tool vs usual care to evaluate the feasibility, acceptability, and preliminary efficacy of the tool on quality of life for older adults with HIV.

Study Timeline

• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-17
• Study First Posted: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study Start: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 50 or older
• Receive HIV care (at least 1 visit at the same site within the past 12 months) from either Eskenazi Health IDC or LifeCare clinics,
• Able to provide informed consent

Exclusion Criteria

• Patients who are long-term nursing home residents
• Patients who are receiving geriatric care services, however will liberalize this criteria if difficulty with recruitment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: recruitment and retention	Recruitment day one, throughout the study to final assessment six months post baseline of the last participant.	Feasibility will be measured by tracking the number of participants approached, enrolled, retained, observations by study team throughout study.
Feasibility: patient/provider experience	After completing final outcomes at the 6 month assessment (or earlier if difficulty with recruitment/retention) patients and providers will be invited to participate in an optional qualitative interview.	Feasibility will be measured by qualitative Interviews with patients and providers. Interview questions will be used to derive personal anecdotes of the patient/provider experience pertaining to the feasibility of the study.
Acceptability; General attitudes, perception of intervention	After completing final outcomes at the 6 month assessment (or as needed if difficulty with recruitment/retention) patients and providers will be invited to participate in an optional qualitative interview.	Acceptability will be measured by qualitative Interviews with patients and providers. Interview questions will be used to derive personal anecdotes of the patient/provider general attitudes, perception of intervention.

Secondary Outcome Measures

Name	Time	Method
Impact of PATH Outcomes: measured by identification of geriatric conditions	Geriatric Conditions will be measured through chart review at baseline, 3month, and 6 month assessments to determine overall change from baseline.	To evaluate the impact of PATH HIV Outcomes the study will look at change from baseline in patient geriatric conditions. This study hypothesizes that compared to usual care, PATH participants will have more geriatric conditions identified and managed as compared to baseline geriatric conditions.
Impact of PATH Outcomes: measured by addressing unmet needs.	Unmet needs will be measured through survey questions and chart review at baseline, 3month, and 6 month assessments.	Evaluate the impact of PATH HIV on addressing unmet needs of older adults living with HIV. This study hypothesizes that compared to usual care, PATH participants will have more psychosocial needs addressed compared to the number of unmet needs at baseline.
Quality of life as measured by Medical Outcomes 36-Item Short Form Survey (SF-36)	Quality of life will be measures at baseline, 3 months and 6 months post baseline assessments.	Evaluate the preliminary impact of PATH on health-related quality of life for older adults with HIV using the Medical Outcomes 36-Item Short Form Survey (SF-36). This study hypothesizes that compared to usual care, intervention recipients will have improved quality of life as measured by SF-36. The SF-36 includes eight scales measuring domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These scores can be combined into a Mental Component Summary Score and a Physical Component Summary Score. Component summary scores range from 0 (poor) to 100 (excellent) with the higher scores representing higher physical/mental health respectively.

Trial Locations

Locations (2)

Eskenazi Health; 🇺🇸 Indianapolis, Indiana, United States

IU Health LifeCare; 🇺🇸 Indianapolis, Indiana, United States