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

HIV Infections Clinical Trial

— VIRAGE+  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139497
• Other study ID #: ANRS 0396 VIRAGE+
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: Joseph Tegbe
• Phone: +225 7 57 77 77 00
• Email: joseph.tegbe[@]pac-ci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• Quantitative research
A quantitative cross-sectional assessment of disability will be carried out.

Behavioral:
• Qualitative survey
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.

Locations

Country	Name	City	State
Côte D'Ivoire	Centre Médical Spécialisé El Rapha	Abidjan
Côte D'Ivoire	Formation semi urbaine (FSU) d'Abobo Avocatier	Abidjan

Sponsors (3)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Centre Population et Développement (CEPED/IRD), Programme PAC-CI

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

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