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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05405322
Other study ID # 999999
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 7, 2021
Est. completion date April 2024

Study information

Verified date September 2023
Source Institut de Recherche pour le Developpement
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Context: HIV-positive young people aged 15 to 24 are a heterogeneous population in terms of gender, age, mode of transmission, sexual orientation and risk-taking. This most vulnerable age group is at greater risk of disruption of medical care and poor compliance, and has greater needs for psychosocial support and differentiated health services. It remains highly invisible in West African countries, both in the definition of care policies and in the allocation of resources and community representation. Objectives: The overall objective of the project is to contribute to the improvement of retention in care, health and well-being of adolescents and young adults living with HIV (AYAHIV) and to support their integration into the community space. SO1: Support the operationalisation of the transition of HIV-infected adolescents from paediatrics to adult medical services in a stakeholder inclusive, participatory and responsive approach SO2: Contribute to the empowerment and autonomy of adolescents and young adults living with HIV in the project environment SO3: Contribute to the generation and dissemination of evidence-based information and recommendations on the situation and needs of adolescents and young adults, including key populations, living with HIV Target: Approximately 67 caregivers∙e∙s ≥ 25 years old, of which 64%F, 30 peer-referent associations of 20-24 years old (ratio F/H= 1:1), 700 AYAHIV ≥ 15 years old, of which 47%F, in paediatrics and 500-600 AYAHIV aged 15-24 years old in adult medicine, of which 41%F, and including AYAHIV associations Summary of activities: Based on the capitalisation and pooling of experiences of partner teams, the project proposes to support the implementation of transition in a pragmatic approach, adapted to the needs of adolescents and inclusive of carers, adolescents and community peers. More globally, it contributes to improving the health, empowerment and autonomy of HIV-positive youth, including key populations, in particular through support to training, structuring and community representation of youth associations, documentation of the conditions of entry into care and their specific needs, including digital health, production and availability of evidence and recommendations in this West African context and advocacy building. A multidisciplinary and participatory research-action project, carried out by the IRD in Senegal and financed by Sidaction, accompanies the three specific objectives of the project.


Description:

Context: HIV-positive young people aged 15 to 24 are a heterogeneous population in terms of gender, age, mode of transmission, sexual orientation and risk-taking. This most vulnerable age group is at greater risk of disruption of medical care and poor compliance, and has greater needs for psychosocial support and differentiated health services. It remains highly invisible in West African countries, both in the definition of care policies and in the allocation of resources and community representation. Objectives: The overall objective of the project is to contribute to the improvement of retention in care, health and well-being of adolescents and young adults living with HIV (AYAHIV) and to support their integration into the community space. SO1: Support the operationalisation of the transition of HIV-infected adolescents from paediatrics to adult medical services in a stakeholder inclusive, participatory and responsive approach SO2: Contribute to the empowerment and autonomy of adolescents and young adults living with HIV in the project environment SO3: Contribute to the generation and dissemination of evidence-based information and recommendations on the situation and needs of adolescents and young adults, including key populations, living with HIV Target: Approximately 67 caregivers∙e∙s ≥ 25 years old, of which 64%F, 30 peer-referent associations of 20-24 years old (ratio F/H= 1:1), 700 AYAHIV ≥ 15 years old, of which 47%F, in paediatrics and 500-600 AYAHIV aged 15-24 years old in adult medicine, of which 41%F, and including AYAHIV associations Summary of activities: Based on the capitalisation and pooling of experiences of partner teams, the project proposes to support the implementation of transition in a pragmatic approach, adapted to the needs of adolescents and inclusive of carers, adolescents and community peers. More globally, it contributes to improving the health, empowerment and autonomy of HIV-positive youth, including key populations, in particular through support to training, structuring and community representation of youth associations, documentation of the conditions of entry into care and their specific needs, including digital health, production and availability of evidence and recommendations in this West African context and advocacy building. A multidisciplinary and participatory research-action project, carried out by the IRD in Senegal and financed by Sidaction, accompanies the three specific objectives of the project. Expected impact : - Seamless operationalisation of the supported and coordinated transition in care process and scaling up to the level of the 12 countries of the EVA network. - Young associative actors are able to advocate to guide decision-makers, based on the evidence they have helped to produce (participatory approach) - The ultimate change, expected at the end of the project, is that institutional stakeholders will integrate these recommendations into the national programme for the care of PLHIV, both operationally and financially.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 267
Est. completion date April 2024
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 24 Years
Eligibility Inclusion Criteria: - being HIV-infected - aged 15 to 24 years - on antiretroviral treatment - HIV status disclosed - caretaker's written consent (if < 18 years) - adolescent's written consent Exclusion Criteria: - mental illness

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Burkina Faso CHU CDG Ouagadougou
Burkina Faso CHU YO Ouagadougou
Senegal Chnear Albert Royer Dakar
Senegal Centre hospitalier Roi Baudouin Guediawaye

Sponsors (5)

Lead Sponsor Collaborator
Institut de Recherche pour le Developpement Cheikh Anta Diop University, Senegal, Children and HIV Network in AFRICA (EVA), Dakar Senegal, EXPERTISE FRANCE, Paris France, Sidaction

Countries where clinical trial is conducted

Burkina Faso,  Senegal, 

Outcome

Type Measure Description Time frame Safety issue
Primary retention in care percent of adolescents who remain in care Month 12
Primary retention in care percent of adolescents who remain in care Month 21
Secondary virologic suppression percent of adolescents who maintain or reach undetectable viral load Month 12
Secondary virologic suppression percent of adolescents who maintain or reach undetectable viral load Month 21
Secondary quality of life in relation to health percent of adolescents who improve their score of quality of life in relation to health Month 12
Secondary quality of life in relation to health percent of adolescents who improve their score of quality of life in relation to health Month 21
Secondary level of preparedness to adult care percent of adolescents who improve their score of preparedness to adult care Month 12
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