Functional Decline and QoL in People Aging with HIV in Asia

Completed

• Conditions: HIV/AIDS; Disability Physical; Frailty

• Registration Number: NCT04212884
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a multi-center prospective cross-sectional study to determine the burden of decline in intrinsic capacity and functional ability, and the prevalence of geriatric syndromes, such as frailty, and disability in adult people living with HIV (PLWH) in Asia.

Detailed Description

This research project is expected to have the following clinical impact

1. To understand the impact of impaired functional status in PLWH in Asia would be important to determine the long-term health burden needs in this aging population in this part of the world.

2. The identification of risk factors associated with impaired functional status would be important to guide clinical decisions in patient management, such as the choice of anti-retroviral regimen, and screening of and early intervention for modifiable risk factors. These are of paramount importance in the promotion of healthy aging in this population.

3. This proposed cross-sectional study lays the foundation for the establishment of a longitudinal cohort for long-term follow up of people aging with HIV in Asia, with the objectives of evaluating the long-term impact of aging on clinical outcomes and functional status in PLWH in this region.

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-25
• Study First Posted: 2019-12-30
• Study Start: 2020-05-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• HIV antibody positive
• Age 35 years or above
• Asian ethnicity, including but not limited to Chinese, Malay and Indian

Exclusion Criteria

• Inability or refusal to consent
• Active infections requiring in-hospital treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional disability	24 months	Functional disability is defined as any difficulty in any of the six areas of functioning in daily life as assessed by WHO DAS II questionnaire

Secondary Outcome Measures

Name	Time	Method
Cognitive decline	24 months	Cognitive decline is defined as presence of HIV-associated neurocognitive disorder (HAND) according to "Frascati Criteria". Asymptomatic neurocognitive impairment (ANI) involves impairment of cognitive functioning in at least two ability domains, in the absence of interference in everyday functioning. Mild neurocognitive disorder (MND) also involves impairment in at least two ability domains, with at least mild interference in daily functioning. HIV-associated dementia (HAD) requires marked impairment in cognitive functioning in at least two ability domains, in the presence of marked impairment in day-to-day functioning
Frailty	24 months	Frailty is measured using the frailty index
Composite score for intrinsic capacity	24 months	The score is based on (i) self-reported questions assessing the subjects' eight health domains, including mobility, self-care, cognition, interpersonal activities, vision, pain and discomfort, sleep and energy, and affect, and (ii) measures of grip strength, short physical performance battery and cognitive function
Sarcopenia	24 months	Sarcopenia is defined as height-adjusted skeletal muscle mass \<7.0 kg/m2 in men and 5.7 kg/m2 in women using BIA
Physical performance	24 months	Physical performance is measured by six-metre usual gait speed. Low physical performance is defined as usual gait speed ≤0.8 m/s
Health-related quality of life	24 months	Health-related quality of life will be assessed as measured by WHO HIV BREF QOL.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong