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

Preliminary Situational Analysis of a Pilot Rehabilitation Intervention Based on Physical Exercise for People Living With HIV in Ivory Coast

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Côte D'Ivoire
  • Abidjan, Côte D'Ivoire
    • Centre National de Transfusion Sanguine
  • Abidjan, Côte D'Ivoire
    • CHU Treichville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Short Physical Performance battery (SPPB)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidities: blood pressure	Blood pressure	Baseline
Comorbidities: diabetes	haemoglobin glycated	Baseline
Comorbidities: obesity	Body mass index	Baseline
Neurologic outcomes CNS	Central nervous system abnormality	Baseline
Neurologic outcomes BNPS	Brief Peripheral Neuropathy Score (BNPS)	Baseline
Other functional scores: gate speed	6 minutes walk test	Baseline
Other functional scores: fine motricity	grooved pegboard test	Baseline
Other functional scores: strength	grip strength	Baseline
Cognitive tests: color trail	Color trail tests 1 & 2	Baseline
Cognitive tests: fluency test	Category words fluency test	Baseline
Cognitive tests: Digit symbol substitution test (DSST)	Digit symbol substitution test	Baseline
Cognitive tests: memory	Grober & Buschke test	Baseline
Cognitive tests: digit span test (DST)	Digit span test	Baseline
Disability: WHO Disability Assessment Schedule 2 (WHODAS)	WHODAS-2	Baseline
Disability: HIV Disability Questionnaire (HDQ)	HDQ short form (HDQ-SF)	Baseline
Disability: Instrumental Activities of Daily Life (IADL)	IADL assessed using the Epidemca instrument	Baseline
Physical activity	Self reported physical activity assessed using the GPAQ instrument	Baseline
Mental health: depression	PHQ-9	Baseline
Acceptability and preference for an intervention	Participant preference for a possible intervention based on peer support or physical activity	Baseline

Collaborators and Investigators

• Sponsor: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
• Collaborators: University of Toronto; Institut de Sante Publique, d'Epidemiologie et de Developpement; Institute of Research for Development, France; Université de Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2021
• Primary Completion (ACTUAL): January 10, 2022
• Study Completion (ACTUAL): August 10, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (ACTUAL): January 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Aging; Sub-Saharan Africa; Disability; Functional limitations
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: VIRAGE (Other Identifier: Baylor College of Medicine)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No