Clinical trial NCT05858034: Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older
Official title: Identifying Challenges to Healthy Aging in Persons With HIV Age 50 and Older
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Aging
Keywords: human immunodeficiency virus
frailty
biomarkers of aging
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: National Institute on Aging (NIA)
First posted: 2023-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Performance scores
timeFrame: Week 12
Secondary outcomes:
measure: Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores
timeFrame: Week 12
measure: Percentage of Adherence with Plan
timeFrame: Week 12
Other outcomes:
measure: electronic frailty index human immunodeficiency virus (eFI-HIV) scores
timeFrame: Baseline
measure: Comprehensive geriatric screening (CGS) - Short Physical Performance Battery
timeFrame: Week 12
measure: Comprehensive geriatric screening (CGS) - Pepper Assessment Tool for Disability (PAT-D) Scores
timeFrame: Week 12
measure: Comprehensive geriatric screening (CGS) - brief cognitive screen (Mini-Cog) Scores
timeFrame: Week 12
measure: depression Patient Health Questionnaire (PHQ-9) Scores
timeFrame: Week 12
measure: anxiety questionnaire - General Anxiety Disorder-7 (GAD-7) Scores
timeFrame: Week 12
measure: fatigue/exhaustion survey scores
timeFrame: Week 12
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Caryn G Morse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: