- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05405322
Improving Care and Community Representation for Adolescents and Young Adults Living With HIV in West Africa (TRANSITIONS)
Inclusive Programme for the Optimisation of Health and Well-being of HIV-positive Young People (15-24 Years) and for the Promotion of Their Community Representation in Senegal and Burkina Faso (2021 => 36 Months) (TRANSITIONS)
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Cécile CAMES, PhD
- Phone Number: +33670282877
- Email: cecile.cames@ird.fr
Study Contact Backup
- Name: Aminata DIACK, MD
- Email: adiackmbaye@gmail.com
Study Locations
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Ouagadougou, Burkina Faso
- CHU CDG
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Ouagadougou, Burkina Faso
- CHU YO
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Dakar, Senegal, 00000
- Chnear Albert Royer
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Guediawaye, Senegal
- Centre hospitalier Roi Baudouin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
retention in care
Time Frame: Month 12
|
percent of adolescents who remain in care
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Month 12
|
retention in care
Time Frame: Month 21
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percent of adolescents who remain in care
|
Month 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
virologic suppression
Time Frame: Month 12
|
percent of adolescents who maintain or reach undetectable viral load
|
Month 12
|
virologic suppression
Time Frame: Month 21
|
percent of adolescents who maintain or reach undetectable viral load
|
Month 21
|
quality of life in relation to health
Time Frame: Month 12
|
percent of adolescents who improve their score of quality of life in relation to health
|
Month 12
|
quality of life in relation to health
Time Frame: Month 21
|
percent of adolescents who improve their score of quality of life in relation to health
|
Month 21
|
level of preparedness to adult care
Time Frame: Month 12
|
percent of adolescents who improve their score of preparedness to adult care
|
Month 12
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- 999999
Plan for Individual participant data (IPD)
Study Data/Documents
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podcasts
Information comments: Experiences of participatoy research with the participants included in the Transitions Study and their peers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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