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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Adolescent Behavior; Adolescent Development; Transition; Disclosure
• Intervention / Treatment: Behavioral: Adolescent Transition Package

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1095
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Facility leadership is willing to implement the intervention

Exclusion Criteria:

• Clinics already actively using transition or disclosure tools

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adolescent transition package	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.
No Intervention: Standard of care; Standard of care adolescent services

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Disclosure	Time to full disclosure	1 year
Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19	Proportions by age group with full disclosure	1 year

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• Njuguna IN, Beima-Sofie K, Mburu CW, Mugo C, Itindi J, Onyango A, Neary J, Richardson BA, Oyiengo L, Wamalwa D, John-Stewart G. Transition to independent care for youth living with HIV: a cluster randomised clinical trial. Lancet HIV. 2022 Dec;9(12):e828-e837. doi: 10.1016/S2352-3018(22)00244-2. Epub 2022 Oct 26.
• Njuguna IN, Beima-Sofie K, Mburu CW, Mugo C, Neary J, Itindi J, Onyango A, Richardson BA, Rubin Means A, Sharma M, Weiner BJ, Wagner AD, Oyiengo L, Wamalwa D, John-Stewart G. Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH): study protocol for a hybrid effectiveness-implementation cluster randomised trial. BMJ Open. 2020 Dec 2;10(12):e039972. doi: 10.1136/bmjopen-2020-039972.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00001756; 1R01HD089850-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No