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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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: Baseline Evaluation

Conditions
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HIV Infections

Intervention / Treatment
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* Procedure: Quantitative research
* Behavioral: Qualitative survey


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLHIV<br>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) | Procedure: Quantitative research<br>* A quantitative cross-sectional assessment of disability will be carried out.<br>Behavioral: Qualitative survey<br>* A qualitative survey will be conducted on the impact of functional limitations on participants' lives, on biographical reconstruction strategies and on PLWHIV's perception of the intervention and its implementation.<br>|
| Active Comparator: Control<br>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 | Procedure: Quantitative research<br>* A quantitative cross-sectional assessment of disability will be carried out.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Disabilities, Aging, Readaptation, Resource-limited countries