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

NCT ID: NCT03574129

Last Updated: 2022-05-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1095 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Adolescent Behavior HIV Transition Adolescent Development Disclosure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

An adolescent transition package composed of a disclosure booklet and transition tool
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Adolescent transition package

Adolescent transition package

Group Type EXPERIMENTAL

Adolescent Transition Package

Intervention Type 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.

Standard of care

Standard of care adolescent services

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Facility leadership is willing to implement the intervention

Exclusion Criteria

* Clinics already actively using transition or disclosure tools
Minimum Eligible Age

10 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Grace John-Stewart

Professor, Epidemiology, Global Health, Medicine, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grace John-Stewart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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

Nairobi, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 37580836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37432311 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36309040 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33268417 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01HD089850-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001756

Identifier Type: -

Identifier Source: org_study_id

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