Feasibility and Effectiveness of a Pilot Program of Physical Activity to Improve HIV Related Functional Limitations and Disability in Adults Aged 40 and Older From Côte d'Ivoire

Not Applicable

Recruiting

• Conditions: HIV Infections
• Interventions: Procedure: Quantitative research; Behavioral: Qualitative survey

• Registration Number: NCT06139497
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

The goal of this interventional study is to document the importance of HIV-related disabilities, notably the frequency / nature of functional limitations, neurocognitive impairments, and restrictions of social participation in adults living with HIV aged 40 and older.

Participants will undergo a comprehensive set of cognitive and functional assessments, and approximately twenty particpants will be asked to participate in an anthropological survey conducted through structured interviews.

Researchers will a group of people living with HIV and o reference group without HIV infection.

Detailed Description

This is a mixed-methods study combining a cross-sectional study during which clinical evaluations, functional tests, and quantitative evaluations by questionnaire relating to disability (WHODAS, HDQ), depression (PHQ-9) will be conducted. and an anthropological survey. The study takes place in the Abobo district, Abidjan, in two health centers.

The quantitative evaluation will concern 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 will also be included as a reference group (n = 150).

The qualitative research will include around 20 PLHIV selected so that enough diversity is represented (sex, age, family situation). It will be based on conducting interviews to examine 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.

Study Timeline

• Study Start: 2023-10-31
• Status Verified: 2023-11
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Participants living with HIV:

• Age ≥40 years
• Documented HIV-infection
• Combined ART for ≥12 months
• Written consent to participate to the study

Controls:

• Age ≥40 years
• Negative HIV test within the last 12 months;
• Living in Abobo area
• Written consent to participate to the study

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control	Quantitative research	The following information is gathered during the visit: * Medical evaluation of disabilities and comorbidities: a complete clinical assessment and cognitive evaluation are conducted. * Evaluation of functional and activity limitations * Assessment of social aspects of disability * Evaluation of associated factors
PLHIV	Quantitative research	The following information is gathered during the visit: * HIV infection history * Medical evaluation of disabilities and comorbidities: a complete clinical assessment and cognitive evaluation are conducted. * Evaluation of functional and activity limitations * Assessment of social aspects of disability * Evaluation of associated factors A qualitative interview will be conducted with a subgroup of the study population (20 participants)
PLHIV	Qualitative survey	The following information is gathered during the visit: * HIV infection history * Medical evaluation of disabilities and comorbidities: a complete clinical assessment and cognitive evaluation are conducted. * Evaluation of functional and activity limitations * Assessment of social aspects of disability * Evaluation of associated factors A qualitative interview will be conducted with a subgroup of the study population (20 participants)

Primary Outcome Measures

Name	Time	Method
Performance at the 6' walking test	Day 0	Measures distance covered during a 6-minute period of rapid walking on a flat and hard surface
Performances at the Y balance Test	Day 0	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
Grip strenght	Day 0	Force in kg measured with a dynamometer, twice per limb
Scores of the Neuroscreen app tests	Day 0	Score calculated by the application: that higher scores indicated better performance.
Performances at the 5 stand-up and sit test	Day 0	Time required to perform 5 quick lifts from a seated position
Short Physical Performance Battery (SPPB) score	Day 0	Score between 0 and 12, with 0 indicating the worst performance and 12 the highest degree of functionality
WHO Disability Assessment Schedule - 2.0 (WHODAS) score	Day 0	The higher the calculated score, the more significant the encountered difficulties
HIV Disability Questionnaire - short form (HDQ-SF) score	Day 0	The higher the calculated score, the more significant the encountered difficulties
Performance at the 6' step-up test	Day 0	Number of ascent-descent cycles counted over 6 minutes

Trial Locations

Locations (2)

Formation semi urbaine (FSU) d'Abobo Avocatier; 🇨🇮 Abidjan, Côte D'Ivoire

Centre Médical Spécialisé El Rapha; 🇨🇮 Abidjan, Côte D'Ivoire