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

NCT06139497 | Active Not Recruiting

• 1 other identifier: ANRS 0396 VIRAGE+
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV Infections; Cardiovascular Diseases; Insulin Resistance Syndrome X

Keywords

HIV; Disabilities; Aging; Readaptation; Resource-limited countries; Physical activity; non-communicable disease

Outcome Measures

Primary Outcomes (1)

• Performance at the 6 minute step-up test

  Number of ascent-descent cycles counted over 6 minutes

  Baseline, Month 6 and Month 12

Secondary Outcomes (13)

• Performance at the 6 minute walking test

  Baseline and Month 12

• Performances at the 6 minute stand up test

  Baseline, Month 6

• Performances at the Y balance Test

  Baseline

• Grip strength

  Baseline, Month 6 and Month 12

• WHO Disability Assessment Schedule - 2.0 (WHODAS) score

  Baseline and Month 12

Study Arms (3)

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).

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.

Behavioral: Home-based physical activity

Control arm

NO INTERVENTION

Health education session every months.

Interventions

Physical activity programme BEHAVIORAL

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.

Groupes-based arm

Home-based physical activity BEHAVIORAL

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.

Home-based arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Medical contraindication to physical activity.
• Anticipated unavailability.
• Severe functional limitation (SPPB ≤ 3).
• Another health condition requiring priority care.
• Eligibility criteria for the formative research:
• 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
• Participants living with HIV:

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut de Recherche pour le Développement (IRD): collaborator
• Programme PAC-CI: collaborator
• Université Paris Cité: collaborator

Study Sites (2)

Centre Médical Spécialisé El Rapha

Abidjan, Côte d’Ivoire

Location

Formation semi urbaine (FSU) d'Abobo Avocatier

Abidjan, Côte d’Ivoire

Location

Related Publications (1)

• 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.

  PMID: 41494181 DERIVED

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases; Metabolic Syndrome; Motor Activity; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Debeaudrap

  IRD

  PRINCIPAL INVESTIGATOR

• Patrick Coffie

  PAC-CI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Hybrid type 2 (dual focus on effectiveness and implementation outcomes)

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 18, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CÔ (2)