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

Study Overview
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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.

Official Title
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Identifying Challenges to Healthy Aging in Persons With HIV Age 50 and Older

Conditions
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HIV, Aging

Intervention / Treatment
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* Other: Customized activity plan
* Other: Customized nutrition plan


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Activity Intervention<br>Customized selection of exercise and other community and online activity options to improve activity. | Other: Customized activity plan<br>* 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.<br>|
| Other: Nutrition Intervention<br>Development of a customized nutrition plan to address nutritional needs. | Other: Customized nutrition plan<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores | 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 | Week 12 | 
| Percentage of Adherence with Plan | Reported adherence to activity and nutrition plan | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human immunodeficiency virus, frailty, biomarkers of aging