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Completed

NCT Number: NCT04212884

Functional Decline and QoL 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.

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Key information

Conditions

Frailty Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disability Physical Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Composite score for intrinsic capacity

    Time frame: 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

  2. Physical performance

    Time frame: 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

  3. Cognitive decline

    Time frame: 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

  4. Frailty

    Time frame: 24 months

    Frailty is measured using the frailty index

  5. Sarcopenia

    Time frame: 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

  6. Health-related quality of life

    Time frame: 24 months

    Health-related quality of life will be assessed as measured by WHO HIV BREF QOL.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Chongqing Public Health Medical Center
  • National Taiwan University
  • Tan Tock Seng Hospital
  • University of Malaya

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2019
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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