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

HIV Clinical Trial

— ATTACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574129
• Other study ID #: STUDY00001756
• Secondary ID: 1R01HD089850-01
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1095
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 24 Years

Eligibility

Inclusion Criteria:

• Facility leadership is willing to implement the intervention

Exclusion Criteria:

• Clinics already actively using transition or disclosure tools

Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Development
• Disclosure
• HIV
• Transition

Intervention

Behavioral:
• Adolescent Transition Package
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.

Locations

Country	Name	City	State
Kenya	20 HIV clinics in Nairobi, Homabay, Nakuru and Kajiado counties	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-transition Retention	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)	1 year
Other	Disclosure	Time to full disclosure	1 year
Other	Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19	Proportions by age group with full disclosure	1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Number of Participants With Viral Suppression	Comparisons of time to transition specific milestones between intervention and control	1 year