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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858034
• Other study ID #: IRB00095309
• Secondary ID: 3P30AG021332-206
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Yolanda Belin
• Phone: (336) 716-7079
• Email: ybelin[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Aging
• HIV
• HIV Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Health Resources and Services Administration (HRSA), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	electronic frailty index human immunodeficiency virus (eFI-HIV) scores	categorized as fit (eFI =0.10), pre-frail (0.10 < eFI=0.21), and frail (eFI > 0.21) - the greater the score, the increased frailty	Baseline
Other	Comprehensive geriatric screening (CGS) - Short Physical Performance Battery	Short performance battery score (0-12) - The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three or four classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance)	Week 12
Other	Comprehensive geriatric screening (CGS) - Pepper Assessment Tool for Disability (PAT-D) Scores	self-reported mobility, basic and instrumental activities of daily living - Responses are made on a five-point Likert scale ranging from 1 ("usually did with no difficulty") to 5 ("unable to do") or a box can be checked that reads "usually did not do for other reasons".	Week 12
Other	Comprehensive geriatric screening (CGS) - brief cognitive screen (Mini-Cog) Scores	(Total Possible Score: 0-5) - A total score of 0, 1, or 2 indicates higher likelihood of clinically important cognitive impairment. A total score of 3, 4, or 5 indicates lower likelihood of dementia but does not rule out some degree of cognitive impairment.	Week 12
Other	depression Patient Health Questionnaire (PHQ-9) Scores	Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.	Week 12
Other	anxiety questionnaire - General Anxiety Disorder-7 (GAD-7) Scores	Scoring GAD-7 Anxiety Severity. This is calculated by assigning scores - GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety.	Week 12
Other	fatigue/exhaustion survey scores	The fatigue/exhaustion questions will be administered using a paper survey	Week 12
Primary	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	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
Secondary	Percentage of Adherence with Plan	Reported adherence to activity and nutrition plan	Week 12