Situational Analysis of HIV-related Disability in the Context of Ivory Coast

NCT ID: NCT05199831

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2022-08-10

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.

Detailed Description

Background With the scale up of antiretroviral therapy (ART), people living with HIV (PLWHIV) life expectancy has increased dramatically over the last decades and HIV has become a chronic disease. However, the long-term infection with HIV is often associated with a number of health related challenges responsible of impairments and functional limitations. To achieve the ambitious objective that most of the PLWHIV receive ART and have a good quality of life, it is therefore necessary to address the HIV-related disability.

Objectives This research aims to provide a comprehensive analysis of the frequency and nature of the impairments and functional limitation occurring in PLWHIV, and of their impact on participants lives. It will also assess the level of physical activity and the acceptability of an intervention based on physical activity.

It will adopt a multidisciplinary approach, which will combine objective and subjective measurements of disability including bio-clinical data, epidemiological data and qualitative data reflecting PLWHIV's perspective. It will also include an evaluation of the a priori acceptability of using physical exercise with PLWHIV.

Three dimensions of disability will be considered in the analysis: 1) impairment and morbidities (neurological, motor and cognitive), 2) activities (or functional) limitations, 3) social participation restrictions. The evaluation of acceptability will cover perceived relevance, adequacy, perceived efficacy and easiness of use of the intervention.

Design and methods The quantitative evaluation will include 300 PLWHIV receiving ART and followed at the infectious disease department (SMIT), CHU de Treichville, Abidjan. A control group of HV uninfected adults will also be included (n = 150). This cross-sectional evaluation will combine clinical, functional and cognitive evaluations and questionnaire on disability (WHODAS, HDQ), depression (PHQ-9) and physical exercise acceptability.

The qualitative component will include around twenty PLWHIV. Participants will be selected to reflect the diversity of the population living with HIV (regarding sex, age, family situation). The qualitative research will be based on semi-directed interviews and will examine disability perception, biographic reconstruction after the onset of impairment and the acceptability of physical exercise.

Quantitative and qualitative researches will be integrated using an explanatory sequential design. The quantitative results will be used to the qualitative research questions sampling and design. In addition, results of the two components regarding the social participation and the perception and attitude toward physical activity will be integrated.

Conditions

HIV Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Participants living with HIV

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

No interventions assigned to this group

Controls not infected with HIV

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Research for Development, France

OTHER_GOV

Sponsor Role: collaborator

Institut de Sante Publique, d'Epidemiologie et de Developpement

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Université de Lille

OTHER

Sponsor Role: collaborator

Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre National de Transfusion Sanguine

Abidjan, , Côte d’Ivoire

CHU Treichville

Abidjan, , Côte d’Ivoire

Countries

Côte d’Ivoire

References

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.

Reference Type: DERIVED

PMID: 38851706 (View on PubMed)

Other Identifiers

VIRAGE

Identifier Type: -

Identifier Source: org_study_id