NCT05405322

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1.7 years

First QC Date

November 10, 2021

Last Update Submit

June 26, 2024

Conditions

Keywords

adolescentHIV infectiontransitionwest africacommunitypeer

Outcome Measures

Primary Outcomes (2)

  • retention in care

    percent of adolescents who remain in care

    Month 12

  • retention in care

    percent of adolescents who remain in care

    Month 21

Secondary Outcomes (5)

  • virologic suppression

    Month 12

  • virologic suppression

    Month 21

  • quality of life in relation to health

    Month 12

  • quality of life in relation to health

    Month 21

  • level of preparedness to adult care

    Month 12

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU CDG

Ouagadougou, Burkina Faso

Location

CHU YO

Ouagadougou, Burkina Faso

Location

Chnear Albert Royer

Dakar, 00000, Senegal

Location

Centre hospitalier Roi Baudouin

Guédiawaye, Senegal

Location

MeSH Terms

Conditions

HIV InfectionsAdolescent Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 10, 2021

First Posted

June 6, 2022

Study Start

April 7, 2021

Primary Completion

January 1, 2023

Study Completion

December 31, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations