NCT05199831

Brief Summary

The goal of this study is to document the impairment, functional and activity limitation and disability associated with HIV infection in an African urban context. It will combine quantitative and a qualitative methods. The quantitative evaluation will include 300 adults living with HIV of age ≥40 years receiving antiretroviral therapy and followed at the infectious disease department (SMIT), CHU de Treichville, Abidjan, and 200 adults without HIV infection of similar age and sex (control group). This cross-sectional evaluation will combine clinical, functional and cognitive evaluations and questionnaire on disability, depression and physical activity. The qualitative research will be based on semi-directed interviews and will examine disability perception and biographic reconstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

December 14, 2021

Last Update Submit

February 6, 2023

Conditions

HIV Infections

Keywords

AgingDisabilityFunctional limitationsPhysical activitySub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

  • Functional capacity

    Short Physical Performance battery (SPPB)

    Baseline

Secondary Outcomes (19)

  • Comorbidities: blood pressure

    Baseline

  • Comorbidities: diabetes

    Baseline

  • Comorbidities: obesity

    Baseline

  • Neurologic outcomes CNS

    Baseline

  • Neurologic outcomes BNPS

    Baseline

  • +14 more secondary outcomes

Study Arms (2)

Participants living with HIV

Clinical, functional and cognitive evaluations; questionnaires on disability, social participation, mental health and physical activity

Controls not infected with HIV

Clinical, functional and cognitive evaluations; questionnaires on disability, social participation, mental health and physical activity

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants living with HIV are recruited from the Department of tropical and infectious disease at Treichville teaching hospital, Abidjan, Ivory Coast. Participants are randomly selected from the list of patients in care. Controls are recruited from the Blood donor centre nearby Treichville hospital. They are selected in order to match HIV-infected population distribution regarding age and sex.

You may qualify if:

  • Age ≥40 years
  • HIV-1 infection (or negative HIV test within the last 12 months if control)
  • Ongoing antiretroviral treatment if HIV-infected participant

You may not qualify if:

  • Clinical symptoms suggesting an acute infection
  • Any severe condition not allowing participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre National de Transfusion Sanguine

Abidjan, Côte d’Ivoire

Location

CHU Treichville

Abidjan, Côte d’Ivoire

Location

Related Publications (1)

  • Debeaudrap P, Etoundi N, Tegbe J, Assoumou N, Dialo Z, Tanon A, Bernard C, Bonnet F, Aka H, Coffie P. The association between HIV infection, disability and lifestyle activity among middle-aged and older adults: an analytical cross-sectional study in Ivory Coast (the VIRAGE study). BMC Public Health. 2024 Jun 8;24(1):1549. doi: 10.1186/s12889-024-19020-9.

    PMID: 38851706DERIVED

MeSH Terms

Conditions

HIV InfectionsMotor Activity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 20, 2022

Study Start

February 5, 2021

Primary Completion

January 10, 2022

Study Completion

August 10, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

CÔ(2)