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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Enrolling

Conditions

Aging
HIV

Treatments

Other: Customized activity plan
Other: Customized nutrition plan

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT05858034
IRB00095309
6 H97HA46081-01-01 (Other Grant/Funding Number)
3P30AG021332-20 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Activity Intervention
Other group
Description:
Customized selection of exercise and other community and online activity options to improve activity.
Treatment:
Other: Customized activity plan
Nutrition Intervention
Other group
Description:
Development of a customized nutrition plan to address nutritional needs.
Treatment:
Other: Customized nutrition plan

Trial contacts and locations

1

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Central trial contact

Yolanda Belin; Rica Abbott

Data sourced from clinicaltrials.gov

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