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

NCT03574129 | Completed Results

• 2 other identifiers: STUDY000017561R01HD089850-01
• Study Type: interventional
• Target: 1,095
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Behavior; HIV; Transition; Adolescent Development; Disclosure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Overall Retention Among 10-24 Year Old Adolescents

  1 year

• Number of Participants With Viral Suppression

  1 year

Other Outcomes (3)

• Post-transition Retention

  1 year

• Disclosure

  1 year

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

  1 year

Study Arms (2)

Adolescent transition package

EXPERIMENTAL

Adolescent transition package

Behavioral: Adolescent Transition Package

Standard of care

NO INTERVENTION

Standard of care adolescent services

Interventions

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.

Adolescent transition package

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Facility leadership is willing to implement the intervention

You may not qualify if:

• Clinics already actively using transition or disclosure tools

Sponsors & Collaborators

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

Study Sites (1)

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

Nairobi, Kenya

Location

Related Publications (4)

• Mangale DI, Onyango A, Mugo C, Mburu C, Chhun N, Wamalwa D, Njuguna I, Means AR, John-Stewart G, Weiner BJ, Beima-Sofie K. Characterizing provider-led adaptations to mobile phone delivery of the Adolescent Transition Package (ATP) in Kenya using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS): a mixed methods approach. Implement Sci Commun. 2023 Aug 14;4(1):95. doi: 10.1186/s43058-023-00446-y.

  PMID: 37580836 DERIVED

• Mburu C, Njuguna I, Neary J, Mugo C, Moraa H, Beima-Sofie K, Onyango A, Oyiengo L, Richardson BA, John-Stewart G, Wamalwa D. Mortality and Loss to Follow-Up Among Adolescents and Young Adults Attending HIV Care Programs in Kenya. AIDS Patient Care STDS. 2023 Jul;37(7):323-331. doi: 10.1089/apc.2023.0019.

  PMID: 37432311 DERIVED

• 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.

  PMID: 36309040 DERIVED

• 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.

  PMID: 33268417 DERIVED

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Irene Njuguna
• Organization: University of Washington

irenen@uw.edu

2065191275

Study Officials

• Grace John-Stewart, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Epidemiology, Global Health, Medicine, Pediatrics

Model Details: An adolescent transition package composed of a disclosure booklet and transition tool

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 29, 2018
• Study Start: November 18, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 4, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)