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

NCT05858034 | Recruiting

• 3 other identifiers: IRB000953093P30AG021332-206 H97HA46081-01-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

human immunodeficiency virus; frailty; biomarkers of aging

Outcome Measures

Primary Outcomes (1)

• Physical Performance scores

  Change in physical performance battery scores - Minimum score 0 - Maximum score 12 - Higher scores indicate better lower extremity function

  Week 12

Secondary Outcomes (2)

• Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores

  Week 12

• Percentage of Adherence with Plan

  Week 12

Other Outcomes (7)

• electronic frailty index human immunodeficiency virus (eFI-HIV) scores

  Baseline

• Comprehensive geriatric screening (CGS) - Short Physical Performance Battery

  Week 12

• Comprehensive geriatric screening (CGS) - Pepper Assessment Tool for Disability (PAT-D) Scores

  Week 12

Study Arms (2)

Activity Intervention

OTHER

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

Other: Customized activity plan

Nutrition Intervention

OTHER

Development of a customized nutrition plan to address nutritional needs.

Other: Customized nutrition plan

Interventions

Customized activity plan 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.

Activity Intervention

Customized nutrition plan 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.

Nutrition Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Health Resources and Services Administration (HRSA): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Frailty

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Caryn G Morse, MD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolanda Belin, MS

CONTACT

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

Rica Abbott, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 15, 2023
• Study Start: June 27, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after completion of the study.
• Access Criteria: Principal investigator permission and Institutional Review Board (IRB) review required.

Locations

US (1)