Clinical trial NCT06139497: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Disabilities
Aging
Readaptation
Resource-limited countries
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Centre Population et Développement (CEPED/IRD)
name: Programme PAC-CI
First posted: 2023-11-18
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance at the 6' step-up test
timeFrame: Day 0
measure: Performance at the 6' walking test
timeFrame: Day 0
measure: Performances at the 5 stand-up and sit test
timeFrame: Day 0
measure: Performances at the Y balance Test
timeFrame: Day 0
measure: Grip strenght
timeFrame: Day 0
measure: Short Physical Performance Battery (SPPB) score
timeFrame: Day 0
measure: Scores of the Neuroscreen app tests
timeFrame: Day 0
measure: WHO Disability Assessment Schedule - 2.0 (WHODAS) score
timeFrame: Day 0
measure: HIV Disability Questionnaire - short form (HDQ-SF) score
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: Centre Médical Spécialisé El Rapha
city: Abidjan
country: Côte D'Ivoire
facility: Formation semi urbaine (FSU) d'Abobo Avocatier
Study officials:
affiliation: IRD
name: Pierre Debeaudrap
role: PRINCIPAL_INVESTIGATOR
affiliation: PAC-CI
name: Patrick Coffie
role: PRINCIPAL_INVESTIGATOR
References: