Skip to main content
OpenTrials
Completed

NCT Number: NCT03574129

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adolescent Behavior Adolescent Development Behavior Disclosure HIV Transition

Age range

10 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

20 HIV clinics in Nairobi, Homabay, Nakuru and Kajiado counties

Nairobi, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Facility leadership is willing to implement the intervention

Exclusion criteria

  • Clinics already actively using transition or disclosure tools

Treatment and study plan

Adolescent Transition Package

Behavioral

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.

Primary outcomes

  1. Transition Readiness Score Overall

    Time frame: 1 year

    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).

  2. Treatment Literacy Readiness Score

    Time frame: 1 year

    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).

  3. Self Management Readiness Score

    Time frame: 1 year

    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).

  4. Communication Readiness Score

    Time frame: 1 year

    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).

  5. Support Readiness Score

    Time frame: 1 year

    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).

Secondary outcomes

  1. Overall Retention Among 10-24 Year Old Adolescents

    Time frame: 1 year

    Proportion of 10-24 year old adolescents completing visits within 6 months of last visit

  2. Number of Participants With Viral Suppression

    Time frame: 1 year

    Comparisons of time to transition specific milestones between intervention and control

Other outcomes

  1. Post-transition Retention

    Time frame: 1 year

    completing and adult clinic visit day after transfer to adult services and at least 1 other visit within 6 months of the adult visit (total of 2 visits)

  2. Disclosure

    Time frame: 1 year

    Time to full disclosure

  3. Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19

    Time frame: 1 year

    Proportions by age group with full disclosure

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: ATTACH

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2018
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.