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

NCT ID: NCT05858034

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-27

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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HIV Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Persons with HIV age ≥50 years followed in the Atrium Health Wake Forest Baptist Health Infectious Diseases Specialty Clinic (AHWFB IDSC), The study will take place at in the outpatient clinics of Atrium Health Wake Forest Baptist Health IDSC in Winston-Salem, NC, High Point Medical Center in High Point, NC, and Lexington Memorial Hospital (Lexington, NC).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Activity Intervention

Customized selection of exercise and other community and online activity options to improve activity.

Group Type OTHER

Customized activity plan

Intervention Type OTHER

Clients with identified challenges to successful aging (pre-frail or frail on screening) will be invited to develop an individualized activity plan to increase mobility, strength, and stamina. Plans will combine activities to improve strength (resistance training), balance (balance exercises), and stamina, and establish weekly goals. Resistance bands and pedometers will be provided. Progress will be measured by self-reported adherence to the activity plan at week 2, 4, 8, 12 and 24 (assessed by telephone at weeks 2, 4, 8 and in person at week 12 and 24). Depression questionnaire (PHQ-9), fatigue screen, exhaustion questions, and SF-12, a measure of health-related quality of life, will be administered at baseline, week 12 and 24.

Nutrition Intervention

Development of a customized nutrition plan to address nutritional needs.

Group Type OTHER

Customized nutrition plan

Intervention Type OTHER

Participants with nutritional needs will have the option of meeting with a nutritionist to develop a personalized nutritional plan with a goal of improving diet quality and optimizing caloric intake. Progress will be measured as above.

Interventions

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Customized activity plan

Clients with identified challenges to successful aging (pre-frail or frail on screening) will be invited to develop an individualized activity plan to increase mobility, strength, and stamina. Plans will combine activities to improve strength (resistance training), balance (balance exercises), and stamina, and establish weekly goals. Resistance bands and pedometers will be provided. Progress will be measured by self-reported adherence to the activity plan at week 2, 4, 8, 12 and 24 (assessed by telephone at weeks 2, 4, 8 and in person at week 12 and 24). Depression questionnaire (PHQ-9), fatigue screen, exhaustion questions, and SF-12, a measure of health-related quality of life, will be administered at baseline, week 12 and 24.

Intervention Type OTHER

Customized nutrition plan

Participants with nutritional needs will have the option of meeting with a nutritionist to develop a personalized nutritional plan with a goal of improving diet quality and optimizing caloric intake. Progress will be measured as above.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Resources and Services Administration (HRSA)

FED

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caryn G Morse, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yolanda Belin

Role: CONTACT

(336) 716-7079

Rica Abbott

Role: CONTACT

(336) 716-7079

Facility Contacts

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Yoland Belin

Role: primary

336-716-7079

Other Identifiers

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3P30AG021332-20

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6 H97HA46081-01-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00095309

Identifier Type: -

Identifier Source: org_study_id

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