ViRAGE: Situational Analysis of HIV-related Disability in the Context of Ivory Coast
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Functional capacity [Baseline]
Short Physical Performance battery (SPPB)
Secondary Outcome Measures
- Comorbidities: blood pressure [Baseline]
Blood pressure
- Comorbidities: diabetes [Baseline]
haemoglobin glycated
- Comorbidities: obesity [Baseline]
Body mass index
- Neurologic outcomes CNS [Baseline]
Central nervous system abnormality
- Neurologic outcomes BNPS [Baseline]
Brief Peripheral Neuropathy Score (BNPS)
- Other functional scores: gate speed [Baseline]
6 minutes walk test
- Other functional scores: motricity [Baseline]
grooved pegboard test
- Other functional scores: strength [Baseline]
grip strength
- Cognitive tests: color trail [Baseline]
Color trail tests 1 & 2
- Cognitive tests: fluency test [Baseline]
Category words fluency test
- Cognitive tests: DSST [Baseline]
Digit symbol substitution test
- Cognitive tests: memory [Baseline]
Grober & Buschke test
- Cognitive tests DST [Baseline]
Digit span test
- Disability: WHODAS [Baseline]
WHODAS-2
- Disability: HDQ [Baseline]
HDQ-SF
- Disability: IADL [Baseline]
IADL
- Physical activity [Baseline]
GPAQ
- Mental health [Baseline]
PHQ-9
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre National de Transfusion Sanguine | Abidjan | Côte D'Ivoire | ||
| 2 | CHU Treichville | Abidjan | Côte D'Ivoire |
Sponsors and Collaborators
- Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
- Institute of Research for Development, France
- Institut de Sante Publique, d'Epidemiologie et de Developpement
- University of Toronto
- Université de Lille
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIRAGE