Skip to content

Functional Decline and QoL in People Aging with HIV in Asia

Functional Decline and Quality of Life in People Aging with HIV in Asia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04212884
Enrollment
1500
Registered
2019-12-30
Start date
2020-05-01
Completion date
2025-01-31
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disability Physical, Frailty, HIV/AIDS

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.

Interventions

None listed

Sponsors

University of Malaya
CollaboratorOTHER
National Taiwan University
CollaboratorOTHER
Chongqing Public Health Medical Center
CollaboratorOTHER
Tan Tock Seng Hospital
CollaboratorOTHER
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional disability24 monthsFunctional 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

MeasureTime frameDescription
Physical performance24 monthsPhysical performance is measured by six-metre usual gait speed. Low physical performance is defined as usual gait speed ≤0.8 m/s
Cognitive decline24 monthsCognitive 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
Composite score for intrinsic capacity24 monthsThe 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
Sarcopenia24 monthsSarcopenia is defined as height-adjusted skeletal muscle mass \<7.0 kg/m2 in men and 5.7 kg/m2 in women using BIA
Health-related quality of life24 monthsHealth-related quality of life will be assessed as measured by WHO HIV BREF QOL.
Frailty24 monthsFrailty is measured using the frailty index

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026