Clinical trial NCT03574129: Adolescent Transition To Adult Care for HIV-infected Adolescents in Kenya
Official title: Adolescent Transition to Adult Care for HIV-infected Adolescents in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
HIV
Transition
Adolescent Development
Disclosure
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-06-29
Enrollment: 1095
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An adolescent transition package composed of a disclosure booklet and transition tool
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Facility leadership is willing to implement the intervention

Exclusion Criteria:

* Clinics already actively using transition or disclosure tools

Primary outcomes:
measure: Transition Readiness Score Overall
timeFrame: 1 year
measure: Treatment Literacy Readiness Score
timeFrame: 1 year
measure: Self Management Readiness Score
timeFrame: 1 year
measure: Communication Readiness Score
timeFrame: 1 year
measure: Support Readiness Score
timeFrame: 1 year
Secondary outcomes:
measure: Overall Retention Among 10-24 Year Old Adolescents
timeFrame: 1 year
measure: Number of Participants With Viral Suppression
timeFrame: 1 year
Other outcomes:
measure: Post-transition Retention
timeFrame: 1 year
measure: Disclosure
timeFrame: 1 year
measure: Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19
timeFrame: 1 year
Locations:
city: Nairobi
country: Kenya
facility: 20 HIV clinics in Nairobi, Homabay, Nakuru and Kajiado counties
Study officials:
affiliation: University of Washington
name: Grace John-Stewart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.