Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older

Not Applicable

Recruiting

• Conditions: HIV; Aging
• Interventions: Other: Customized nutrition plan; Other: Customized activity plan

• Registration Number: NCT05858034
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The primary objective of this study is to identify and characterize frailty and pre-frailty in persons age 50 and older living with human immunodeficiency virus (HIV) followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinics (IDSC).

Detailed Description

The study will implement electronic medical record-based screening for frailty (eFI), further characterize frailty using comprehensive geriatric screening, and offer a customized activity and nutrition plan to a subset of participants. Participation in phlebotomy for research biomarkers of aging is optional. The study also seeks to validate the electronic medical record embedded electronic frailty index (eFI) for the prediction of adverse outcomes in aging persons with HIV, characterize the symptoms of pre-frailty and frailty in persons followed in the IDSC, and assess the acceptability and efficacy of a customized activity and nutrition intervention targeting frailty. The study will also correlate research biomarkers of aging with aging symptoms in a subset of participants.

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-15
• Study Start: 2023-06-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Person living with human immunodeficiency virus (HIV)
• Age ≥50 years
• Followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinic (IDSC)
• Eligible for Ryan White Program
• Able to provide informed consent
• Pre-frail or frail by electronic frailty index (eFI)

Exclusion Criteria

• Age <50 years (study designed to characterize frailty in aging persons with HIV)
• Unable to complete the required assessments or questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutrition Intervention	Customized nutrition plan	Development of a customized nutrition plan to address nutritional needs.
Activity Intervention	Customized activity plan	Customized selection of exercise and other community and online activity options to improve activity.

Primary Outcome Measures

Name	Time	Method
Physical Performance scores	Week 12	Change in physical performance battery scores - Minimum score 0 - Maximum score 12 - Higher scores indicate better lower extremity function

Secondary Outcome Measures

Name	Time	Method
Percentage of Adherence with Plan	Week 12	Reported adherence to activity and nutrition plan
Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores	Week 12	Change in quality of life as measured by SF-12 - Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States