HIV InfectionsViRAGENCT05199831
Situational Analysis of HIV-related Disability in the Context of Ivory Coast
An observational study of HIV Infections, run by Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire at 2 sites in Côte d’Ivoire.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 500 participants
- Where
- 2 sitesCôte d’Ivoire
- Study dates
- 5 Feb 2021to 10 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥40 years
- HIV-1 infection (or negative HIV test within the last 12 months if control)
- Ongoing antiretroviral treatment if HIV-infected participant
Who cannot join
- Clinical symptoms suggesting an acute infection
- Any severe condition not allowing participation in the study
Trial locations and contacts
2 sites in 1 country.
Côte d’Ivoire2 sites
Centre National de Transfusion Sanguine
Abidjan
CHU Treichville
Abidjan
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- Aging, Disability, Functional limitations, Physical activity, Sub-Saharan Africa
- Medical subject headings
- HIV Infections, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Short Physical Performance battery (SPPB)
Measured: Baseline
Secondary outcomes (19)
Comorbidities: blood pressure
Blood pressure
Measured: Baseline
Comorbidities: diabetes
haemoglobin glycated
Measured: Baseline
Comorbidities: obesity
Body mass index
Measured: Baseline
Neurologic outcomes CNS
Central nervous system abnormality
Measured: Baseline
Neurologic outcomes BNPS
Brief Peripheral Neuropathy Score (BNPS)
Measured: Baseline
Other functional scores: gate speed
6 minutes walk test
Measured: Baseline
Other functional scores: fine motricity
grooved pegboard test
Measured: Baseline
Other functional scores: strength
grip strength
Measured: Baseline
Cognitive tests: color trail
Color trail tests 1 \& 2
Measured: Baseline
Cognitive tests: fluency test
Category words fluency test
Measured: Baseline
Cognitive tests: Digit symbol substitution test (DSST)
Digit symbol substitution test
Measured: Baseline
Cognitive tests: memory
Grober \& Buschke test
Measured: Baseline
Cognitive tests: digit span test (DST)
Digit span test
Measured: Baseline
Disability: WHO Disability Assessment Schedule 2 (WHODAS)
WHODAS-2
Measured: Baseline
Disability: HIV Disability Questionnaire (HDQ)
HDQ short form (HDQ-SF)
Measured: Baseline
Disability: Instrumental Activities of Daily Life (IADL)
IADL assessed using the Epidemca instrument
Measured: Baseline
Physical activity
Self reported physical activity assessed using the GPAQ instrument
Measured: Baseline
Mental health: depression
PHQ-9
Measured: Baseline
Acceptability and preference for an intervention
Participant preference for a possible intervention based on peer support or physical activity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start5 Feb 2021
- Primary completion10 Jan 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Research for Development, France, Institut de Sante Publique, d'Epidemiologie et de Developpement, University of Toronto, Université de Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199831
- Sponsor's protocol ID
- VIRAGE
- Acronym
- ViRAGE
- Status last verified
- Feb 2023
- First submitted
- 14 Dec 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Debeaudrap P, Etoundi N, Tegbe J, Assoumou N, Dialo Z, Tanon A, Bernard C, Bonnet F, Aka H, Coffie P. The association between HIV infection, disability and lifestyle activity among middle-aged and older adults: an analytical cross-sectional study in Ivory Coast (the VIRAGE study). BMC Public Health. 2024 Jun 8;24(1):1549. doi: 10.1186/s12889-024-19020-9.
PubMed 38851706
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Situational Analysis of a Pilot Rehabilitation Intervention Based on Physical Exercise for People Living With HIV in Ivory Coast
- ClinicalTrials.gov ID
- NCT05199831
- Acronym / sponsor ID
- ViRAGE / VIRAGE
- Conditions
- HIV Infections
- Keywords
- Aging, Disability, Functional limitations, Physical activity, Sub-Saharan Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Programme PAC-CI, Site ANRS-MIE de Côte d'IvoireUniversity, hospital or other
- Collaborators
- Institute of Research for Development, France, Institut de Sante Publique, d'Epidemiologie et de Developpement, University of Toronto, Université de Lille
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥40 years
- HIV-1 infection (or negative HIV test within the last 12 months if control)
- Ongoing antiretroviral treatment if HIV-infected participant
Key exclusion criteria (2 listed)
- Clinical symptoms suggesting an acute infection
- Any severe condition not allowing participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional capacity
Time frame: Baseline
Short Physical Performance battery (SPPB)
19 secondary outcomes
Comorbidities: blood pressure
Time frame: Baseline
Comorbidities: diabetes
Time frame: Baseline
Comorbidities: obesity
Time frame: Baseline
Neurologic outcomes CNS
Time frame: Baseline
Neurologic outcomes BNPS
Time frame: Baseline
Other functional scores: gate speed
Time frame: Baseline
Other functional scores: fine motricity
Time frame: Baseline
Other functional scores: strength
Time frame: Baseline
Cognitive tests: color trail
Time frame: Baseline
Cognitive tests: fluency test
Time frame: Baseline
Cognitive tests: Digit symbol substitution test (DSST)
Time frame: Baseline
Cognitive tests: memory
Time frame: Baseline
Cognitive tests: digit span test (DST)
Time frame: Baseline
Disability: WHO Disability Assessment Schedule 2 (WHODAS)
Time frame: Baseline
Disability: HIV Disability Questionnaire (HDQ)
Time frame: Baseline
Disability: Instrumental Activities of Daily Life (IADL)
Time frame: Baseline
Physical activity
Time frame: Baseline
Mental health: depression
Time frame: Baseline
Acceptability and preference for an intervention
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38851706Debeaudrap P, Etoundi N, Tegbe J, Assoumou N, Dialo Z, Tanon A, Bernard C, Bonnet F, Aka H, Coffie P. The association between HIV infection, disability and lifestyle activity among middle-aged and older adults: an analytical cross-sectional study in Ivory Coast (the VIRAGE study). BMC Public Health. 2024 Jun 8;24(1):1549. doi: 10.1186/s12889-024-19020-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire at 2 sites in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.