Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05199831 |
| Other study ID # |
VIRAGE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
