A Smartphone Application to Support Physical Activity in HIV Infected People
NCT03098095
Behavior, Blood-Borne Infections
Milan, Italy
View Trial DetailsNCT Number: NCT05199831
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.
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Notify Me40 year and older
All sexes
Observational
CHU Treichville, Abidjan, Côte d’Ivoire
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Short Physical Performance battery (SPPB)
Time frame: Baseline
Blood pressure
Time frame: Baseline
haemoglobin glycated
Time frame: Baseline
Body mass index
Time frame: Baseline
Central nervous system abnormality
Time frame: Baseline
Brief Peripheral Neuropathy Score (BNPS)
Time frame: Baseline
6 minutes walk test
Time frame: Baseline
grooved pegboard test
Time frame: Baseline
grip strength
Time frame: Baseline
Color trail tests 1 & 2
Time frame: Baseline
Category words fluency test
Time frame: Baseline
Digit symbol substitution test
Time frame: Baseline
Grober & Buschke test
Time frame: Baseline
Digit span test
Time frame: Baseline
WHODAS-2
Time frame: Baseline
HDQ short form (HDQ-SF)
Time frame: Baseline
IADL assessed using the Epidemca instrument
Time frame: Baseline
Self reported physical activity assessed using the GPAQ instrument
Time frame: Baseline
PHQ-9
Time frame: Baseline
Participant preference for a possible intervention based on peer support or physical activity
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Other
Preliminary Situational Analysis of a Pilot Rehabilitation Intervention Based on Physical Exercise for People Living With HIV in Ivory Coast
Acronym: ViRAGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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