Adolescent BehaviorATTACHNCT03574129

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

A study testing Adolescent Transition Package in people with Adolescent Behavior and HIV, run by University of Washington at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 10 to 24 years
Conditions the study is for: Adolescent Behavior, HIV, Transition
What is being tested?: Adolescent Transition Package
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,095 participants
Where: 1 siteKenya
Study dates: 18 Nov 2019to 30 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Facility leadership is willing to implement the intervention

Who cannot join

Clinics already actively using transition or disclosure tools

Trial locations and contacts

1 site in 1 country.

Kenya1 site

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

Other trials in Kenya

About this study

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

Read the 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.

Conditions: Adolescent Behavior, HIV, Transition, Adolescent Development, Disclosure
Being tested: Adolescent Transition Package
Medical subject headings: Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adolescent Transition PackageBehavioural
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.

Study groups in NCT03574129
Study group	Role	What they receive
Adolescent transition package	Experimental	Adolescent transition package Receives: Behavioral: Adolescent Transition Package
Standard of care	No intervention	Standard of care adolescent services

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 year

Secondary outcomes (2)

Overall Retention Among 10-24 Year Old Adolescents
Proportion of 10-24 year old adolescents completing visits within 6 months of last visit
Measured: 1 year
Number of Participants With Viral Suppression
Comparisons of time to transition specific milestones between intervention and control
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 201930 Jun 2021

First posted29 Jun 2018
Study start18 Nov 2019
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: An adolescent transition package composed of a disclosure booklet and transition tool
Masking: None (open label)
Enrolment: 1,095 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03574129
Sponsor's protocol ID: STUDY00001756
Other IDs: 1R01HD089850-01
Acronym: ATTACH
Status last verified: Apr 2022
First submitted: 11 Jun 2018
Last updated: 4 May 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37580836
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.
PubMed 37432311
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.
PubMed 36309040
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.
PubMed 33268417

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Adolescent Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adolescent Transition to Adult Care for HIV-infected Adolescents in Kenya
ClinicalTrials.gov ID: NCT03574129
Acronym / sponsor ID: ATTACH / STUDY00001756
Conditions: Adolescent Behavior, HIV, Transition, Adolescent Development, Disclosure
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,095 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 18 Nov 2019 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 29 Jun 2018 (actual)
Results: Posted 31 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: An adolescent transition package composed of a disclosure booklet and transition tool

Arm	Type	Receives
Adolescent transition package	Experimental	Behavioral: Adolescent Transition PackageAdolescent transition package
Standard of care	No intervention	–Standard of care adolescent services

Who may qualify

Ages: 10 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Facility leadership is willing to implement the intervention

Key exclusion criteria (1 listed)

Clinics already actively using transition or disclosure tools

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adolescent Transition PackageClinic 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.	Behavioural	Adolescent transition package

Primary outcome

Transition Readiness Score Overall
Time frame: 1 year
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).
Treatment Literacy Readiness Score
Time frame: 1 year
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).
Self Management Readiness Score
Time frame: 1 year
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).
Communication Readiness Score
Time frame: 1 year
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).
Support Readiness Score
Time frame: 1 year
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).

2 secondary outcomes

Overall Retention Among 10-24 Year Old Adolescents
Time frame: 1 year
Number of Participants With Viral Suppression
Time frame: 1 year

Results and safety

Results posted to the registry on 31 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adolescent Transition Package	578	506
Standard of Care	488	440

Primary outcome: Transition Readiness Score Overall

Time frame: 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Adolescent Transition Package n = 476	Standard of Care n = 416
Value	15.7 (1.8)	13.9 (3.3)

Population analysed: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items

Primary outcome: Treatment Literacy Readiness Score

Time frame: 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Adolescent Transition Package n = 504	Standard of Care n = 440
Value	4.0 (1.0)	3.0 (1.5)

Population analysed: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items

Primary outcome: Self Management Readiness Score

Time frame: 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Adolescent Transition Package n = 487	Standard of Care n = 423
Value	4.7 (0.4)	4.4 (0.8)

Population analysed: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items

Primary outcome: Communication Readiness Score

Time frame: 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Adolescent Transition Package n = 502	Standard of Care n = 438
Value	4.7 (0.5)	4.4 (0.8)

Population analysed: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescent Transition Package	0 of 578 (0%)	0 of 578 (0%)	8 of 578
Standard of Care	0 of 488 (0%)	0 of 488 (0%)	1 of 488

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37580836Mangale 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.
Derived from this study: PubMed 37432311Mburu 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.
Derived from this study: PubMed 36309040Njuguna 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.
Derived from this study: PubMed 33268417Njuguna 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Grace John-Stewart, MD, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Adolescent Transition Package in people with Adolescent Behavior and HIV, run by University of Washington at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transition Readiness Score Overall (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03574129, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.