Functional Decline and QoL in People Aging With HIV in Asia

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS; Frailty; Disability Physical

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Rity Wong; Phone Number: +85235053376; Email: ritywong@cuhk.edu.hk
• Study Contact Backup: Name: Catherine Cheung, MPhil; Phone Number: +85222528842; Email: catherinecheung@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Grace Lui; Phone Number: 35051464; Email: gracelui@cuhk.edu.hk
  • Sha Tin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Grace Lui; Phone Number: 35053376; Email: gracelui@cuhk.edu.hk
    • Contact: Rity Wong; Phone Number: 35053376; Email: ritywong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All PLWH followed up at the five participating HIV centers will be screened and invited to participate in this study. Each site will also enroll age and sex-matched HIV-uninfected participants in a 1:2 ratio.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PLWH; PLWH followed up at the five participating HIV centers
HIV-uninfected individuals; Age and sex-matched HIV-uninfected individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional disability	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite score for intrinsic capacity	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	24 months
Physical performance	Physical performance is measured by six-metre usual gait speed. Low physical performance is defined as usual gait speed ≤0.8 m/s	24 months
Cognitive decline	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	24 months
Frailty	Frailty is measured using the frailty index	24 months
Sarcopenia	Sarcopenia is defined as height-adjusted skeletal muscle mass <7.0 kg/m2 in men and 5.7 kg/m2 in women using BIA	24 months
Health-related quality of life	Health-related quality of life will be assessed as measured by WHO HIV BREF QOL.	24 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: University of Malaya; Tan Tock Seng Hospital; National Taiwan University; Chongqing Public Health Medical Center
• Investigators: Principal Investigator: Grace Lui, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: Geri_HIV_protocol_v4_26Nov2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No