Adolescent Transition To Adult Care for HIV-infected Adolescents in Kenya

Study Overview
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Brief Summary
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This study evaluates an adolescent transition package (ATP) to support HIV infected adolescents transitioning form pediatric/adolescent care to adult care. Ten clinics will receive the intervention and 10 will receive standard of care transition services.

Detailed Description
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The Adolescent Transition Package (ATP) will include two components. The validated Namibia comic book for disclosure (to be used with children over 10 years of age) and transition booklet Taking Charge developed by stakeholders in Kenya. The disclosure tool includes a cartoon book, readiness and tracking tools used in clinic and health care worker training material. The intervention progresses from incomplete to complete disclosure using a narrative about soldiers fighting the battle of infection as the rationale for taking medicine. This tool has been validated for use in Namibia. The adapted transition toolkit includes a transition booklet, tracking tools to be used by health care workers and a readiness assessment checklist to be completed by study staff. The booklet has 4 chapters addressing key areas to support adolescents gain the knowledge and skills they need in adult care. The 4 chapters are: HIV treatment literacy, self management, communication and support.

Official Title
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Adolescent Transition to Adult Care for HIV-infected Adolescents in Kenya

Conditions
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Adolescent Behavior, HIV, Transition, Adolescent Development, Disclosure

Intervention / Treatment
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* Behavioral: Adolescent Transition Package


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facility leadership is willing to implement the intervention Exclusion Criteria: Clinics already actively using transition or disclosure tools

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An adolescent transition package composed of a disclosure booklet and transition tool
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adolescent transition package<br>Adolescent transition package | Behavioral: Adolescent Transition Package<br>* Clinic level intervention composed of an adolescent transition package with tools to support health care workers to disclose HIV status to adolescents and to track transition to adult care.<br>|
| No Intervention: Standard of care<br>Standard of care adolescent services | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition Readiness Score Overall | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge and skills to navigate adult care systems. The scale is divided into 4 domains: HIV literacy (maximum score is 5, minimum 0), self-management (maximum score is 9, minimum 0), communication (maximum score is 5, minimum is 0) and support (maximum score 3, minimum is 0). The higher the score the more prepared an adolescent is to transition to adult care. For this outcome, scores across all domains will be summed to get a total readiness score (maximum score 22, minimum 0). | 1 year | 
| Treatment Literacy Readiness Score | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 5, minimum 0). | 1 year | 
| Self Management Readiness Score | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge and skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 9, minimum 0). | 1 year | 
| Communication Readiness Score | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 5, minimum 0). | 1 year | 
| Support Readiness Score | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 3, minimum 0). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Retention Among 10-24 Year Old Adolescents | Proportion of 10-24 year old adolescents completing visits within 6 months of last visit | 1 year | 
| Number of Participants With Viral Suppression | Comparisons of time to transition specific milestones between intervention and control | 1 year |