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Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire

NCT06139497

Active Not RecruitingNA

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: HIV Infections, Cardiovascular Diseases, Insulin Resistance Syndrome X

Interventions: Physical activity programme, Home-based physical activity

Countries: 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. 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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Abidjan, Côte d’Ivoire
Abidjan, Côte d’Ivoire