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Completed

NCT Number: NCT05199831

Situational Analysis of HIV-related Disability in the Context of 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Treichville, Abidjan, Côte d’Ivoire

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional capacity

    Time frame: Baseline

    Short Physical Performance battery (SPPB)

Secondary outcomes

  1. Comorbidities: blood pressure

    Time frame: Baseline

    Blood pressure

  2. Comorbidities: diabetes

    Time frame: Baseline

    haemoglobin glycated

  3. Comorbidities: obesity

    Time frame: Baseline

    Body mass index

  4. Neurologic outcomes CNS

    Time frame: Baseline

    Central nervous system abnormality

  5. Neurologic outcomes BNPS

    Time frame: Baseline

    Brief Peripheral Neuropathy Score (BNPS)

  6. Other functional scores: gate speed

    Time frame: Baseline

    6 minutes walk test

  7. Other functional scores: fine motricity

    Time frame: Baseline

    grooved pegboard test

  8. Other functional scores: strength

    Time frame: Baseline

    grip strength

  9. Cognitive tests: color trail

    Time frame: Baseline

    Color trail tests 1 & 2

  10. Cognitive tests: fluency test

    Time frame: Baseline

    Category words fluency test

  11. Cognitive tests: Digit symbol substitution test (DSST)

    Time frame: Baseline

    Digit symbol substitution test

  12. Cognitive tests: memory

    Time frame: Baseline

    Grober & Buschke test

  13. Cognitive tests: digit span test (DST)

    Time frame: Baseline

    Digit span test

  14. Disability: WHO Disability Assessment Schedule 2 (WHODAS)

    Time frame: Baseline

    WHODAS-2

  15. Disability: HIV Disability Questionnaire (HDQ)

    Time frame: Baseline

    HDQ short form (HDQ-SF)

  16. Disability: Instrumental Activities of Daily Life (IADL)

    Time frame: Baseline

    IADL assessed using the Epidemca instrument

  17. Physical activity

    Time frame: Baseline

    Self reported physical activity assessed using the GPAQ instrument

  18. Mental health: depression

    Time frame: Baseline

    PHQ-9

  19. Acceptability and preference for an intervention

    Time frame: Baseline

    Participant preference for a possible intervention based on peer support or physical activity

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Institut de Sante Publique, d'Epidemiologie et de Developpement
  • Institute of Research for Development, France
  • University of Toronto
  • Université de Lille

Registry information

Official study title

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

Acronym: ViRAGE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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