Situational Analysis of HIV-related Disability in the Context of Ivory Coast

HIV Infections Clinical Trial

— ViRAGE  

Official title:

Preliminary Situational Analysis of a Pilot Rehabilitation Intervention Based on Physical Exercise for People Living With HIV in Ivory Coast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05199831
• Other study ID #: VIRAGE
• Status: Completed
• Start date: February 5, 2021
• Est. completion date: August 10, 2022

Study information

• Verified date: February 2023
• Source: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to document the impairment, functional and activity limitation and disability associated with HIV infection in an African urban context.

It will combine quantitative and a qualitative methods.

The quantitative evaluation will include 300 adults living with HIV of age ≥40 years receiving antiretroviral therapy and followed at the infectious disease department (SMIT), CHU de Treichville, Abidjan, and 200 adults without HIV infection of similar age and sex (control group). This cross-sectional evaluation will combine clinical, functional and cognitive evaluations and questionnaire on disability, depression and physical activity.

The qualitative research will be based on semi-directed interviews and will examine disability perception and biographic reconstruction.

Description:

Background With the scale up of antiretroviral therapy (ART), people living with HIV (PLWHIV) life expectancy has increased dramatically over the last decades and HIV has become a chronic disease. However, the long-term infection with HIV is often associated with a number of health related challenges responsible of impairments and functional limitations. To achieve the ambitious objective that most of the PLWHIV receive ART and have a good quality of life, it is therefore necessary to address the HIV-related disability.

Objectives This research aims to provide a comprehensive analysis of the frequency and nature of the impairments and functional limitation occurring in PLWHIV, and of their impact on participants lives. It will also assess the level of physical activity and the acceptability of an intervention based on physical activity.

It will adopt a multidisciplinary approach, which will combine objective and subjective measurements of disability including bio-clinical data, epidemiological data and qualitative data reflecting PLWHIV's perspective. It will also include an evaluation of the a priori acceptability of using physical exercise with PLWHIV.

Three dimensions of disability will be considered in the analysis: 1) impairment and morbidities (neurological, motor and cognitive), 2) activities (or functional) limitations, 3) social participation restrictions. The evaluation of acceptability will cover perceived relevance, adequacy, perceived efficacy and easiness of use of the intervention.

Design and methods The quantitative evaluation will include 300 PLWHIV receiving ART and followed at the infectious disease department (SMIT), CHU de Treichville, Abidjan. A control group of HV uninfected adults will also be included (n = 150). This cross-sectional evaluation will combine clinical, functional and cognitive evaluations and questionnaire on disability (WHODAS, HDQ), depression (PHQ-9) and physical exercise acceptability.

The qualitative component will include around twenty PLWHIV. Participants will be selected to reflect the diversity of the population living with HIV (regarding sex, age, family situation). The qualitative research will be based on semi-directed interviews and will examine disability perception, biographic reconstruction after the onset of impairment and the acceptability of physical exercise.

Quantitative and qualitative researches will be integrated using an explanatory sequential design. The quantitative results will be used to the qualitative research questions sampling and design. In addition, results of the two components regarding the social participation and the perception and attitude toward physical activity will be integrated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age =40 years

• HIV-1 infection (or negative HIV test within the last 12 months if control)

• Ongoing antiretroviral treatment if HIV-infected participant

Exclusion Criteria:

• Clinical symptoms suggesting an acute infection

• Any severe condition not allowing participation in the study

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Côte D'Ivoire	Centre National de Transfusion Sanguine	Abidjan
Côte D'Ivoire	CHU Treichville	Abidjan

Sponsors (5)

Lead Sponsor	Collaborator
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire	Institut de Sante Publique, d'Epidemiologie et de Developpement, Institute of Research for Development, France, Université de Lille, University of Toronto

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity	Short Physical Performance battery (SPPB)	Baseline
Secondary	Comorbidities: blood pressure	Blood pressure	Baseline
Secondary	Comorbidities: diabetes	haemoglobin glycated	Baseline
Secondary	Comorbidities: obesity	Body mass index	Baseline
Secondary	Neurologic outcomes CNS	Central nervous system abnormality	Baseline
Secondary	Neurologic outcomes BNPS	Brief Peripheral Neuropathy Score (BNPS)	Baseline
Secondary	Other functional scores: gate speed	6 minutes walk test	Baseline
Secondary	Other functional scores: fine motricity	grooved pegboard test	Baseline
Secondary	Other functional scores: strength	grip strength	Baseline
Secondary	Cognitive tests: color trail	Color trail tests 1 & 2	Baseline
Secondary	Cognitive tests: fluency test	Category words fluency test	Baseline
Secondary	Cognitive tests: Digit symbol substitution test (DSST)	Digit symbol substitution test	Baseline
Secondary	Cognitive tests: memory	Grober & Buschke test	Baseline
Secondary	Cognitive tests: digit span test (DST)	Digit span test	Baseline
Secondary	Disability: WHO Disability Assessment Schedule 2 (WHODAS)	WHODAS-2	Baseline
Secondary	Disability: HIV Disability Questionnaire (HDQ)	HDQ short form (HDQ-SF)	Baseline
Secondary	Disability: Instrumental Activities of Daily Life (IADL)	IADL assessed using the Epidemca instrument	Baseline
Secondary	Physical activity	Self reported physical activity assessed using the GPAQ instrument	Baseline
Secondary	Mental health: depression	PHQ-9	Baseline
Secondary	Acceptability and preference for an intervention	Participant preference for a possible intervention based on peer support or physical activity	Baseline