Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05858034

Conditions

HIV

Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Customized activity plan

Customized nutrition plan

Study Details

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).

Conditions

HIV

Aging

Study ID

NCT05858034

Start date

Jun 27, 2023

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Activity Intervention

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

other: Nutrition Intervention

Development of a customized nutrition plan to address nutritional needs.

Interventions

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.

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.

Primary outcome measure

  • Physical Performance scores [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Yolanda Belin, MS

(336) 716-7079yolanda.belin@advocatehealth.org

Rica Abbott, MPH

(336) 716-7079rica.abbott@advocatehealth.org

Locations

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Yoland Belin

336-716-7079ybelin@wakehealth.edu

Principal Investigator:

Caryn G Morse, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 27, 2026

Last verified

Mar, 2026

Keywords

  • human immunodeficiency virus
  • frailty
  • biomarkers of aging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-27.