Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adult… (NCT06139497) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
Côte d’Ivoire180 participantsStarted 2023-10-31
Plain-language 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.
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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility criteria for the intervention :
Inclusion criteria:
* 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.
* Handgrip strength ≤ 35 kg for men or ≤ 24 kg for women.
* WHODAS score ≥ 10.
* SPPB score between 4 and 9.
* Signed informed consent.
Exclusion criteria
* Medical contraindication to physical activity.
* Anticipated unavailability.
* Severe functional limitation (SPPB ≤ 3).
* Another health condition requiring priority care.
Eligibility criteria for the formative research:
Inclusion criteria:
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
Exclusion Criteria:
Participants living with HIV:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.