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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05199831
Acronym
ViRAGE
Enrollment
500
Registered
2022-01-20
Start date
2021-02-05
Completion date
2022-08-10
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Aging, Disability, Functional limitations, Physical activity, Sub-Saharan Africa

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.

Interventions

None listed

Sponsors

Institute of Research for Development, France
CollaboratorOTHER_GOV
Institut de Sante Publique, d'Epidemiologie et de Developpement
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Université de Lille
CollaboratorOTHER
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional capacityBaselineShort Physical Performance battery (SPPB)

Secondary

MeasureTime frameDescription
Comorbidities: diabetesBaselinehaemoglobin glycated
Comorbidities: obesityBaselineBody mass index
Neurologic outcomes CNSBaselineCentral nervous system abnormality
Neurologic outcomes BNPSBaselineBrief Peripheral Neuropathy Score (BNPS)
Other functional scores: gate speedBaseline6 minutes walk test
Other functional scores: fine motricityBaselinegrooved pegboard test
Other functional scores: strengthBaselinegrip strength
Cognitive tests: color trailBaselineColor trail tests 1 & 2
Cognitive tests: fluency testBaselineCategory words fluency test
Comorbidities: blood pressureBaselineBlood pressure
Cognitive tests: memoryBaselineGrober & Buschke test
Cognitive tests: digit span test (DST)BaselineDigit span test
Disability: WHO Disability Assessment Schedule 2 (WHODAS)BaselineWHODAS-2
Disability: HIV Disability Questionnaire (HDQ)BaselineHDQ short form (HDQ-SF)
Disability: Instrumental Activities of Daily Life (IADL)BaselineIADL assessed using the Epidemca instrument
Physical activityBaselineSelf reported physical activity assessed using the GPAQ instrument
Mental health: depressionBaselinePHQ-9
Acceptability and preference for an interventionBaselineParticipant preference for a possible intervention based on peer support or physical activity
Cognitive tests: Digit symbol substitution test (DSST)BaselineDigit symbol substitution test

Countries

Côte d’Ivoire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026