HIV InfectionsVIRAGE+NCT06139497
Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
A study testing Physical activity programme and Home-based physical activity in people with HIV Infections and Cardiovascular Diseases, run by ANRS, Emerging Infectious Diseases at 2 sites in Côte d’Ivoire.
Trial summary
The overall objective of this research is to provide evidence on the effectiveness and implementation of two strategies deliver a structured programme of physical activity (PA) people living with HIV older than 50 years from Ivory Coast. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Infections, Cardiovascular Diseases, Insulin Resistance Syndrome X
- What is being tested?
- Physical activity programme and Home-based physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesCôte d’Ivoire
- Study dates
- 31 Oct 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years
- Documented HIV infection.
- Receiving antiretroviral therapy for ≥ 12 months.
- Residing in the Abobo district (Côte d'Ivoire).
- Presence of at least one functional limitation or disability criterion among the following:
- Performance in the 6-minute walk test ≤ 300 m.
Show all 19Show fewer
- Handgrip strength ≤ 35 kg for men or ≤ 24 kg for women.
- WHODAS score ≥ 10.
- SPPB score between 4 and 9.
- Signed informed consent.
- People living with HIV:
- Age ≥40 years
- Documented HIV infection.
- Receiving antiretroviral therapy for ≥ 12 months.
- Controls:
- Age ≥40 years
- Negative HIV test within the last 12 months;
- Living in Abobo area
- Written consent to participate to the study
Who cannot join
- Medical contraindication to physical activity.
- Anticipated unavailability.
- Severe functional limitation (SPPB ≤ 3).
- Another health condition requiring priority care.
- Eligibility criteria for the formative research:
- Participants living with HIV:
Show all 12Show fewer
- HIV infection with HIV-2 type only
- Any clinical symptoms suggesting an acute infection
- Any life-threatening pathology in the short term or any pathology not allowing participation in the study
- Controls:
- Any clinical symptoms suggesting an acute infection
- Any life-threatening pathology in the short term or any pathology not allowing participation in the study
Trial locations and contacts
2 sites in 1 country.
Côte d’Ivoire2 sites
Centre Médical Spécialisé El Rapha
Abidjan
Formation semi urbaine (FSU) d'Abobo Avocatier
Abidjan
About this study
Official title: Feasibility and Effectiveness of a Pilot Program of Physical Activity to Improve Functional Limitations and Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
The overall objective of this research is to provide evidence on the effectiveness and implementation of two strategies deliver a structured programme of physical activity (PA) people living with HIV older than 50 years from Ivory Coast.
The research will starts a baseline formative research including people with and without HIV infection.
Read more
Participants are randomized 1:1:1 to one for the following group: (1) a reference arm receiving a group-based PA program supervised by a coach (n = 60), (2) an exploratory arm receiving a home-based PA program with remote supervision via phone calls and messaging apps (n = 60) and (3) a control arm receiving health education sessions (n = 60). The total follow-up period is 12 months, with an initial 6-month active phase and then a 6-month maintenance.
The primary effectiveness outcome is the improvement at the 6-minute step-up test between baseline and 6 months. Secondary outcomes include changes in performance on other functional tests and improvement of cardio-metabolic risk factors. Implementation outcomes include acceptability, adoption, feasibility and sustainability of the intervention.Implementation outcomes will be assessed using mixed methods during the intervention. Effectiveness outcomes and patient-centered outcomes will be assessed at baseline, 6 and 12 months.
Read the detailed description
This is is a prospective, randomised, pilot trial with two phases: a 6-month active phase to implement the intervention and a 6-month maintenance phase to evaluate the sustainability of the intervention's effects. This study adopts a type II hybrid design assessing both the effectiveness of the intervention and the implementation outcomes to identify factors influencing its adoption by users, as well as its integration into healthcare practices
It starts with a baseline research combining a cross-sectional study and a qualitative formative research. The cross-sectional study comprises clinical evaluations, functional tests, as well as quantitative evaluations by questionnaire of disability (WHODAS, HDQ) and depression (PHQ-9). It includes 300 people living wiht HIV (PLHIV) receiving antiretroviral therapy and followed at the Avocatier health facility (FSU) and the El Rapha medical health centre (CMS), in the Abobo district, Abidjan. A comparison group of adults without HIV infection of similar sex and age distribution is included as a reference group (n = 150).
The qualitative research explores how the practice of physical activity is perceived culturally and socially and to determine the factors that may influence the implementation of this type of activity.
The intervention consists of a 48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times a week for at least 60 minutes. Two delivery approaches for the exercise programme are proposed. In the group-based arm, participants are invited to participate in group sessions directly supervised by a coach. The other sessions are unsupervised. During the first 24 weeks (active phase), the supervised group sessions are scheduled on a weekly basis while they are more spaced out, on a monthly basis, during the second part of the 48 weeks (maintenance phase). In the home-based arm, participants have to perform the same exercise programme at home. Participants are contacted by phone by a study staff every week to review the activities performed, collect information on their adherence to and perception of the programme and to provide positive feedback, help to addess challenges and reinforce their motivation. Participants of the control group are offered monthly health education sessions and a delayed participation to the programme.
- Being tested
- Physical activity programme, Home-based physical activity
- Keywords
- HIV, Disabilities, Aging, Readaptation, Resource-limited countries, Physical activity, non-communicable disease
- Medical subject headings
- HIV Infections, Cardiovascular Diseases, Metabolic Syndrome, Motor Activity, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programmeBehavioural
48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times per week. The sessions are supervised by a coach at least once a week during the first 6 months then monthly. The other session of the PA programme is performed at home and the overall weekly PA is reviewed with the coach at the end of the supervised session.
Home-based physical activityBehavioural
48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times per week. Participants have to perform the exercise programme at home exclusively. They are called every week by a research assistant to review the activities performed, collect information on their adherence and perception on the programme.
| Study group | Role | What they receive |
|---|---|---|
| Groupes-based arm | Experimental | Participants are invited to participate in group sessions directly supervised by a coach. The other sessions are unsupervised. During the first 24 weeks (active phase), the supervised group sessions are scheduled on a weekly basis while they are more spaced out, on a monthly basis, during the second part of the 48 weeks (maintenance phase). Receives: Behavioral: Physical activity programme |
| Home-based arm | Experimental | Participants have to perform the same exercise programme at home. Start with two weeks of direct supervision to learn how to carry out safely the training and how to adapt the intensity of the exercise using the rated perceived exertion (RPE) and the heart rate self-monitored during exercise. Receives: Behavioral: Home-based physical activity |
| Control arm | No intervention | Health education session every months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance at the 6 minute step-up test
Number of ascent-descent cycles counted over 6 minutes
Measured: Baseline, Month 6 and Month 12
Secondary outcomes (13)
Performance at the 6 minute walking test
Distance covered during a 6-minute period of rapid walking on a flat and hard surface
Measured: Baseline and Month 12
Performances at the 6 minute stand up test
Number of stand up - sit movements performed during a 6 minute period
Measured: Baseline, Month 6
Performances at the Y balance Test
Sum of distances reached in each direction (the best is chosen for each direction) divided by 3 x length of lower limb (standardization) and multiplied by 100
Measured: Baseline
Grip strength
Force in kg measured with a dynamometer, twice per limb
Measured: Baseline, Month 6 and Month 12
WHO Disability Assessment Schedule - 2.0 (WHODAS) score
Score ranging between 0 and 100. Higher score indicates higher levels of difficulties for functioning
Measured: Baseline and Month 12
HIV Disability Questionnaire - short form (HDQ-SF) score
The higher the calculated score, the more significant the encountered difficulties
Measured: Day 0
Short Physical Performance Battery (SPPB) score
Score between 0 and 12, with 0 indicating the worst performance and 12 the highest degree of functionality
Measured: Baseline and Month 12
Scores of the Neuroscreen app tests
Scores calculated by the application overall and for different cognitive domains: that higher scores indicated better performance.
Measured: Baseline and Month 12
Fasting blood glucose
Measured on capillary blood
Measured: Baseline and Month 12
IDIR test
Measure of urinary branched chain amino acid (BCCA) to detect insulin resistance
Measured: Baseline, Month 6 and Month 12
WHO-QoL
Quality of life brief questionnaire (WHO). It includes 26 items measured on 5 point scales.
Measured: Baseline, Month 6 and Month 12
PHQ-9
Short questionnaire on depression. Score ranging from 0 to 27. Higher score indicates depressive symptoms
Measured: Baseline, Month 6 and Month 12
Satisfaction and acceptability of physical activity
Questionnaire based on Sekhon's framework. Use 5-point Likert scales
Measured: Week 12, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start31 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionMay 2027 (estimated)
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.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type 2 (dual focus on effectiveness and implementation outcomes)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Institut de Recherche pour le Développement (IRD), Programme PAC-CI, Université Paris Cité
- Responsible party
- Sponsor
- Investigators
- Pierre Debeaudrap, Principal investigator, IRDPatrick Coffie, Principal investigator, PAC-CI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139497
- Sponsor's protocol ID
- ANRS 0396 VIRAGE+
- Acronym
- VIRAGE+
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diadhiou N, Assoumou N, Tegbe J, Boa HE, Bao ML, Amador-Paz S, Vitiello D, Coffie P, Debeaudrap P. Effectiveness and Implementation of Adapted Physical Activity Delivery Strategies for Older Adults Living With HIV in Ivory Coast: Protocol for a Type 2 Hybrid Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 6;15:e84677. doi: 10.2196/84677.
PubMed 41494181
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Pilot Program of Physical Activity to Improve Functional Limitations and Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
- ClinicalTrials.gov ID
- NCT06139497
- Acronym / sponsor ID
- VIRAGE+ / ANRS 0396 VIRAGE+
- Keywords
- HIV, Disabilities, Aging, Readaptation, Resource-limited countries, Physical activity, non-communicable disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut de Recherche pour le Développement (IRD), Programme PAC-CI, Université Paris Cité
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Nov 2023 (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 overall objective of this research is to provide evidence on the effectiveness and implementation of two strategies deliver a structured programme of physical activity (PA) people living with HIV older than 50 years from Ivory Coast.
The research will starts a baseline formative research including people with and without HIV infection.
Participants are randomized 1:1:1 to one for the following group: (1) a reference arm receiving a group-based PA program supervised by a coach (n = 60), (2) an exploratory arm receiving a home-based PA program with remote supervision via phone calls and messaging apps (n = 60) and (3) a control arm receiving health education sessions (n = 60). The total follow-up period is 12 months, with an initial 6-month active phase and then a 6-month maintenance.
The primary effectiveness outcome is the improvement at the 6-minute step-up test between baseline and 6 months. Secondary outcomes include changes in performance on other functional tests and improvement of cardio-metabolic risk factors. Implementation outcomes include acceptability, adoption, feasibility and sustainability of the intervention.Implementation outcomes will be assessed using mixed methods during the intervention. Effectiveness outcomes and patient-centered outcomes will be assessed at baseline, 6 and 12 months.
Detailed description
This is is a prospective, randomised, pilot trial with two phases: a 6-month active phase to implement the intervention and a 6-month maintenance phase to evaluate the sustainability of the intervention's effects. This study adopts a type II hybrid design assessing both the effectiveness of the intervention and the implementation outcomes to identify factors influencing its adoption by users, as well as its integration into healthcare practices
It starts with a baseline research combining a cross-sectional study and a qualitative formative research. The cross-sectional study comprises clinical evaluations, functional tests, as well as quantitative evaluations by questionnaire of disability (WHODAS, HDQ) and depression (PHQ-9). It includes 300 people living wiht HIV (PLHIV) receiving antiretroviral therapy and followed at the Avocatier health facility (FSU) and the El Rapha medical health centre (CMS), in the Abobo district, Abidjan. A comparison group of adults without HIV infection of similar sex and age distribution is included as a reference group (n = 150).
The qualitative research explores how the practice of physical activity is perceived culturally and socially and to determine the factors that may influence the implementation of this type of activity.
The intervention consists of a 48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times a week for at least 60 minutes. Two delivery approaches for the exercise programme are proposed. In the group-based arm, participants are invited to participate in group sessions directly supervised by a coach. The other sessions are unsupervised. During the first 24 weeks (active phase), the supervised group sessions are scheduled on a weekly basis while they are more spaced out, on a monthly basis, during the second part of the 48 weeks (maintenance phase). In the home-based arm, participants have to perform the same exercise programme at home. Participants are contacted by phone by a study staff every week to review the activities performed, collect information on their adherence to and perception of the programme and to provide positive feedback, help to addess challenges and reinforce their motivation. Participants of the control group are offered monthly health education sessions and a delayed participation to the programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Hybrid type 2 (dual focus on effectiveness and implementation outcomes)
| Arm | Type | Receives |
|---|---|---|
| Groupes-based arm | Experimental | Behavioral: Physical activity programmeParticipants are invited to participate in group sessions directly supervised by a coach. The other sessions are unsupervised. During the first 24 weeks (active phase), the supervised group sessions are scheduled on a weekly basis while they are more spaced out, on a monthly basis, during the second part of the 48 weeks (maintenance phase). |
| Home-based arm | Experimental | Behavioral: Home-based physical activityParticipants have to perform the same exercise programme at home. Start with two weeks of direct supervision to learn how to carry out safely the training and how to adapt the intensity of the exercise using the rated perceived exertion (RPE) and the heart rate self-monitored during exercise. |
| Control arm | No intervention | –Health education session every months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥50 years
- Documented HIV infection.
- Receiving antiretroviral therapy for ≥ 12 months.
- Residing in the Abobo district (Côte d'Ivoire).
- Presence of at least one functional limitation or disability criterion among the following:
Key exclusion criteria (12 listed)
- Medical contraindication to physical activity.
- Anticipated unavailability.
- Severe functional limitation (SPPB ≤ 3).
- Another health condition requiring priority care.
- HIV infection with HIV-2 type only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programme48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times per week. The sessions are supervised by a coach at least once a week during the first 6 months then monthly. The other session of the PA programme is performed at home and the overall weekly PA is reviewed with the coach at the end of the supervised session. | Behavioural | Groupes-based arm |
| Home-based physical activity48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times per week. Participants have to perform the exercise programme at home exclusively. They are called every week by a research assistant to review the activities performed, collect information on their adherence and perception on the programme. | Behavioural | Home-based arm |
Primary outcome
Performance at the 6 minute step-up test
Time frame: Baseline, Month 6 and Month 12
Number of ascent-descent cycles counted over 6 minutes
13 secondary outcomes
Performance at the 6 minute walking test
Time frame: Baseline and Month 12
Performances at the 6 minute stand up test
Time frame: Baseline, Month 6
Performances at the Y balance Test
Time frame: Baseline
Grip strength
Time frame: Baseline, Month 6 and Month 12
WHO Disability Assessment Schedule - 2.0 (WHODAS) score
Time frame: Baseline and Month 12
HIV Disability Questionnaire - short form (HDQ-SF) score
Time frame: Day 0
Short Physical Performance Battery (SPPB) score
Time frame: Baseline and Month 12
Scores of the Neuroscreen app tests
Time frame: Baseline and Month 12
Fasting blood glucose
Time frame: Baseline and Month 12
IDIR test
Time frame: Baseline, Month 6 and Month 12
WHO-QoL
Time frame: Baseline, Month 6 and Month 12
PHQ-9
Time frame: Baseline, Month 6 and Month 12
Satisfaction and acceptability of physical activity
Time frame: Week 12, Month 6 and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 41494181Diadhiou N, Assoumou N, Tegbe J, Boa HE, Bao ML, Amador-Paz S, Vitiello D, Coffie P, Debeaudrap P. Effectiveness and Implementation of Adapted Physical Activity Delivery Strategies for Older Adults Living With HIV in Ivory Coast: Protocol for a Type 2 Hybrid Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 6;15:e84677. doi: 10.2196/84677.
- Individual participant dataSharing planned: No
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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.
Pierre Debeaudrap principal investigator
IRD
Patrick Coffie principal investigator
PAC-CI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity programme and Home-based physical activity in people with HIV Infections and Cardiovascular Diseases, run by ANRS, Emerging Infectious Diseases 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 19 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Performance at the 6 minute step-up test (time frame: Baseline, Month 6 and Month 12). 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 NCT06139497, 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 22 Sep 2025; AzTrials last refreshed its copy on 4 Nov 2026.