HIV InfectionsTRANSITIONSNCT05405322
Improving Care and Community Representation for Adolescents and Young Adults Living With HIV in West Africa
An observational study of HIV Infections and Adolescent Behavior, run by Institut de Recherche pour le Developpement at 4 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- HIV Infections, Adolescent Behavior, Transition
- How many people
- 267 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 7 Apr 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- mental illness
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Senegal2 sites
Chnear Albert Royer
Dakar, 00000
Centre hospitalier Roi Baudouin
Guédiawaye
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- HIV Infections, Adolescent Behavior, Transition
- Keywords
- adolescent, HIV infection, transition, west africa, community, peer
- Medical subject headings
- HIV Infections, Adolescent Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
retention in care
percent of adolescents who remain in care
Measured: Month 12
retention in care
percent of adolescents who remain in care
Measured: Month 21
Secondary outcomes (5)
virologic suppression
percent of adolescents who maintain or reach undetectable viral load
Measured: Month 12
virologic suppression
percent of adolescents who maintain or reach undetectable viral load
Measured: Month 21
quality of life in relation to health
percent of adolescents who improve their score of quality of life in relation to health
Measured: Month 12
quality of life in relation to health
percent of adolescents who improve their score of quality of life in relation to health
Measured: Month 21
level of preparedness to adult care
percent of adolescents who improve their score of preparedness to adult care
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start7 Apr 2021
- Primary completion1 Jan 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Sidaction, Expertise France, Children and HIV Network in AFRICA (EVA), Dakar Senegal, Cheikh Anta Diop University, Senegal
- Responsible party
- Principal investigator, Cecile Cames, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405322
- Sponsor's protocol ID
- 999999
- Acronym
- TRANSITIONS
- Status last verified
- Jun 2024
- First submitted
- 10 Nov 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05405322
- Acronym / sponsor ID
- TRANSITIONS / 999999
- Conditions
- HIV Infections, Adolescent Behavior, Transition
- Keywords
- adolescent, HIV infection, transition, west africa, community, peer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Sidaction, Expertise France, Children and HIV Network in AFRICA (EVA), Dakar Senegal, Cheikh Anta Diop University, Senegal
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- being HIV-infected
- aged 15 to 24 years
- on antiretroviral treatment
- HIV status disclosed
- caretaker's written consent (if < 18 years)
Key exclusion criteria (1 listed)
- mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
retention in care
Time frame: Month 12
percent of adolescents who remain in care
retention in care
Time frame: Month 21
percent of adolescents who remain in care
5 secondary outcomes
virologic suppression
Time frame: Month 12
virologic suppression
Time frame: Month 21
quality of life in relation to health
Time frame: Month 12
quality of life in relation to health
Time frame: Month 21
level of preparedness to adult care
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Adolescent Behavior, run by Institut de Recherche pour le Developpement at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Burkina Faso, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retention in care (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.