Clinical trial NCT05199831: Situational Analysis of HIV-related Disability in the Context of Ivory Coast
Official title: Preliminary Situational Analysis of a Pilot Rehabilitation Intervention Based on Physical Exercise for People Living With HIV in Ivory Coast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Aging
Disability
Functional limitations
Physical activity
Sub-Saharan Africa
Lead sponsor: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Sponsor class: OTHER
Collaborators: name: Institute of Research for Development, France
name: Institut de Sante Publique, d'Epidemiologie et de Developpement
name: University of Toronto
name: Université de Lille
First posted: 2022-01-20
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Functional capacity
timeFrame: Baseline
Secondary outcomes:
measure: Comorbidities: blood pressure
timeFrame: Baseline
measure: Comorbidities: diabetes
timeFrame: Baseline
measure: Comorbidities: obesity
timeFrame: Baseline
measure: Neurologic outcomes CNS
timeFrame: Baseline
measure: Neurologic outcomes BNPS
timeFrame: Baseline
measure: Other functional scores: gate speed
timeFrame: Baseline
measure: Other functional scores: fine motricity
timeFrame: Baseline
measure: Other functional scores: strength
timeFrame: Baseline
measure: Cognitive tests: color trail
timeFrame: Baseline
measure: Cognitive tests: fluency test
timeFrame: Baseline
measure: Cognitive tests: Digit symbol substitution test (DSST)
timeFrame: Baseline
measure: Cognitive tests: memory
timeFrame: Baseline
measure: Cognitive tests: digit span test (DST)
timeFrame: Baseline
measure: Disability: WHO Disability Assessment Schedule 2 (WHODAS)
timeFrame: Baseline
measure: Disability: HIV Disability Questionnaire (HDQ)
timeFrame: Baseline
measure: Disability: Instrumental Activities of Daily Life (IADL)
timeFrame: Baseline
measure: Physical activity
timeFrame: Baseline
measure: Mental health: depression
timeFrame: Baseline
measure: Acceptability and preference for an intervention
timeFrame: Baseline
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: Centre National de Transfusion Sanguine
city: Abidjan
country: Côte D'Ivoire
facility: CHU Treichville
Study officials:
References: