Clinical trial NCT05405322: Improving Care and Community Representation for Adolescents and Young Adults Living With HIV in West Africa
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infections
Adolescent Behavior
Transition
Keywords: adolescent
HIV infection
transition
west africa
community
peer
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Sidaction
name: EXPERTISE FRANCE, Paris France
name: Children and HIV Network in AFRICA (EVA), Dakar Senegal
name: Cheikh Anta Diop University, Senegal
First posted: 2022-06-06
Enrollment: 267
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of the study is all HIV-infected adolescents (mainly through mother-to-child transmission) aged 15 to 24 years, eligible for transition to care and followed up in the active files of reference centers that are members of the EVA network in Senegal and Burkina Faso.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: retention in care
timeFrame: Month 12
measure: retention in care
timeFrame: Month 21
Secondary outcomes:
measure: virologic suppression
timeFrame: Month 12
measure: virologic suppression
timeFrame: Month 21
measure: quality of life in relation to health
timeFrame: Month 12
measure: quality of life in relation to health
timeFrame: Month 21
measure: level of preparedness to adult care
timeFrame: Month 12
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: CHU CDG
city: Ouagadougou
country: Burkina Faso
facility: CHU YO
city: Dakar
country: Senegal
facility: Chnear Albert Royer
city: Guediawaye
country: Senegal
facility: Centre hospitalier Roi Baudouin
Study officials:
References: