Functional Decline and QoL in People Aging with HIV in Asia

NCT04212884 | Completed

• 1 other identifier: Geri_HIV_protocol_v4_26Nov2019
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 2

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.

Conditions

Frailty; Disability Physical; HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Composite score for intrinsic capacity

  24 months

• Physical performance

  24 months

• Cognitive decline

  24 months

• Frailty

  24 months

• Sarcopenia

  24 months

Study Arms (2)

PLWH

PLWH followed up at the five participating HIV centers

HIV-uninfected individuals

Age and sex-matched HIV-uninfected individuals

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• University of Malaya: collaborator
• National Taiwan University: collaborator
• Chongqing Public Health Medical Center: collaborator
• Tan Tock Seng Hospital: collaborator

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be stored for future analysis of biomarkers related to inflammation and ageing.

MeSH Terms

Conditions

Frailty; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Grace LUI

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 30, 2019
• Study Start: May 1, 2020
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

HK (2)