FrailtyNCT04212884
Functional Decline and QoL in People Aging with HIV in Asia
An observational study of Frailty and Disability Physical, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Disability Physical, HIV/AIDS
- How many people
- 1,500 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 May 2020to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- HIV antibody positive
- Age 35 years or above
- Asian ethnicity, including but not limited to Chinese, Malay and Indian
Who cannot join
- Inability or refusal to consent
- Active infections requiring in-hospital treatment
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Prince of Wales Hospital
Shatin
About this study
Official title: 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.
Read the detailed description
This research project is expected to have the following clinical impact
- 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.
- 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.
- 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.
- Conditions
- Frailty, Disability Physical, HIV/AIDS
- Medical subject headings
- Frailty, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PLWH | PLWH followed up at the five participating HIV centers | |
| HIV-uninfected individuals | Age and sex-matched HIV-uninfected individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 24 months
Frailty
Frailty is measured using the frailty index
Measured: 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
Measured: 24 months
Health-related quality of life
Health-related quality of life will be assessed as measured by WHO HIV BREF QOL.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 May 2020
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, National Taiwan University, Chongqing Public Health Medical Center, Tan Tock Seng Hospital
- Responsible party
- Principal investigator, Shui-Shan Lee, MD, Chinese University of Hong Kong
- Investigators
- Grace LUI, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212884
- Sponsor's protocol ID
- Geri_HIV_protocol_v4_26Nov2019
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2019
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Decline and Quality of Life in People Aging with HIV in Asia
- ClinicalTrials.gov ID
- NCT04212884
- Acronym / sponsor ID
- Geri_HIV_protocol_v4_26Nov2019
- Conditions
- Frailty, Disability Physical, HIV/AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- University of Malaya, National Taiwan University, Chongqing Public Health Medical Center, Tan Tock Seng Hospital
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLWH | – | –PLWH followed up at the five participating HIV centers |
| HIV-uninfected individuals | – | –Age and sex-matched HIV-uninfected individuals |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- HIV antibody positive
- Age 35 years or above
- Asian ethnicity, including but not limited to Chinese, Malay and Indian
Key exclusion criteria (2 listed)
- Inability or refusal to consent
- Active infections requiring in-hospital treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional disability
Time frame: 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
6 secondary outcomes
Composite score for intrinsic capacity
Time frame: 24 months
Physical performance
Time frame: 24 months
Cognitive decline
Time frame: 24 months
Frailty
Time frame: 24 months
Sarcopenia
Time frame: 24 months
Health-related quality of life
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace LUI principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Disability Physical, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.