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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT03574129
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 1,095
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.4
• Patients Per Site Per Month: 56.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Behavior; HIV; Transition; Adolescent Development; Disclosure	Behavioral: Adolescent Transition Package	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1095 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: An adolescent transition package composed of a disclosure booklet and transition toolAn adolescent transition package composed of a disclosure booklet and transition tool
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Adolescent Transition to Adult Care for HIV-infected Adolescents in Kenya
• Actual Study Start Date: Nov 18, 2019
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adolescent transition package 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

Outcome Measures

Primary Outcome Measures

1. Transition Readiness Score Overall [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).

2. Treatment Literacy Readiness Score [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).

3. Self Management Readiness Score [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).

4. Communication Readiness Score [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).

5. Support Readiness Score [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).

Secondary Outcome Measures

1. Overall Retention Among 10-24 Year Old Adolescents [1 year]

   Proportion of 10-24 year old adolescents completing visits within 6 months of last visit

2. Number of Participants With Viral Suppression [1 year]

   Comparisons of time to transition specific milestones between intervention and control

Other Outcome Measures

1. Post-transition Retention [1 year]

   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)

2. Disclosure [1 year]

   Time to full disclosure

3. Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19 [1 year]

   Proportions by age group with full disclosure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Facility leadership is willing to implement the intervention

Exclusion Criteria:

• Clinics already actively using transition or disclosure tools

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	20 HIV clinics in Nairobi, Homabay, Nakuru and Kajiado counties	Nairobi		Kenya

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Grace John-Stewart, MD, PhD, University of Washington

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 29, 2020

More Information

Publications

None provided.

• Responsible Party: Grace John-Stewart, Professor, Epidemiology, Global Health, Medicine, Pediatrics, University of Washington
• ClinicalTrials.gov Identifier: NCT03574129
• Other Study ID Numbers: STUDY00001756; 1R01HD089850-01
• First Posted: Jun 29, 2018
• Last Update Posted: May 4, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Pre-assignment Detail	Of 1095 enrolled, we have excluded 25 who did not meet age criteria for the intervention (15-24) or who withdrew consent.

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Received the study intervention	Did not receive study intervention
Period Title: Overall Study
STARTED	578	488
COMPLETED	506	440
NOT COMPLETED	72	48

Baseline Characteristics

Arm/Group Title	Adolescent Transition Package	Standard of Care	Total
Arm/Group Description	Baseline characteristics of participants in intervention arm	Baseline characteristics of participants in control arm	Total of all reporting groups
Overall Participants	578	488	1066
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	21.1	19.7	20.5
Sex: Female, Male (Count of Participants)
Female	432 74.7%	338 69.3%	770 72.2%
Male	146 25.3%	150 30.7%	296 27.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	578 100%	488 100%	1066 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Kenya	578 100%	488 100%	1066 100%
Primary caregiver (Count of Participants)
Parent	227 39.3%	241 49.4%	468 43.9%
Sibling	49 8.5%	28 5.7%	77 7.2%
Grand parent	31 5.4%	43 8.8%	74 6.9%
Spouse	202 34.9%	103 21.1%	305 28.6%
Other	69 11.9%	73 15%	142 13.3%
Entry point (Count of Participants)
PMTCT clinics	201 34.8%	129 26.4%	330 31%
HIV clinic	367 63.5%	344 70.5%	711 66.7%
Other	9 1.6%	15 3.1%	24 2.3%
missing	1 0.2%	0 0%	1 0.1%
Months since disclosure of HIV status (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	34	45	42
Baseline Transition readiness score (overall) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	12.1 (3.4)	11.4 (3.7)	11.8 (3.6)
Baseline readiness score (HIV literacy) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	2.6 (1.5)	2.3 (1.5)	2.5 (1.5)
Baseline readiness score (Self-management) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	3.9 (1.0)	3.8 (1.1)	3.9 (1.0)
Baseline readiness score (Communication) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	3.9 (1.0)	3.8 (1.1)	3.9 (1.1)
Baseline readiness score (Support) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	1.7 (1.0)	1.6 (1.0)	1.6 (1.1)
Viral suppression at baseline (Count of Participants)
Count of Participants [Participants]	382 66.1%	326 66.8%	708 66.4%

Outcome Measures

1. Primary Outcome

Title	Transition Readiness Score Overall
Description	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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Month 12 transition readiness score (Total score)	Month 12 transition readiness score (Total score)
Measure Participants	476	416
Mean (Standard Deviation) [score on a scale]	15.7 (1.8)	13.9 (3.3)

2. Primary Outcome

Title	Treatment Literacy Readiness Score
Description	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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Month 12 transition readiness score (HIV literacy)	Month 12 transition readiness score (HIV literacy)
Measure Participants	504	440
Mean (Standard Deviation) [score on a scale]	4.0 (1.0)	3.0 (1.5)

3. Primary Outcome

Title	Self Management Readiness Score
Description	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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Month 12 transition readiness score (self management)	Month 12 transition readiness score (self management)
Measure Participants	487	423
Mean (Standard Deviation) [score on a scale]	4.7 (0.4)	4.4 (0.8)

4. Primary Outcome

Title	Communication Readiness Score
Description	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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Month 12 transition readiness score (communication)	Month 12 transition readiness score (communication)
Measure Participants	502	438
Mean (Standard Deviation) [score on a scale]	4.7 (0.5)	4.4 (0.8)

5. Primary Outcome

Title	Support Readiness Score
Description	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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Month 12 transition readiness score (support)	Month 12 transition readiness score (support)
Measure Participants	500	438
Mean (Standard Deviation) [score on a scale]	2.3 (0.8)	2.1 (1.0)

6. Secondary Outcome

Title	Overall Retention Among 10-24 Year Old Adolescents
Description	Proportion of 10-24 year old adolescents completing visits within 6 months of last visit
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Month 12 retention in study	Month 12 retention in study
Measure Participants	543	454
Count of Participants [Participants]	506 87.5%	440 90.2%

7. Secondary Outcome

Title	Number of Participants With Viral Suppression
Description	Comparisons of time to transition specific milestones between intervention and control
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unavailable program level data on viral suppression

Arm/Group Title	Adolescent Transition Package	Standard of Care
Arm/Group Description	Proportion with viral suppression	Proportion with viral suppression
Measure Participants	275	277
Count of Participants [Participants]	249 43.1%	255 52.3%

8. Other Pre-specified Outcome

Title	Post-transition Retention
Description	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)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Disclosure
Description	Time to full disclosure
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	1 year
Arm/Group Title	Adolescent Transition Package		Standard of Care
Arm/Group Description	Proportion with adverse event		Proportion with adverse event
All Cause Mortality
	Adolescent Transition Package		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/578 (1.4%)		1/488 (0.2%)
Serious Adverse Events
	Adolescent Transition Package		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/578 (0%)		0/488 (0%)
Other (Not Including Serious) Adverse Events
	Adolescent Transition Package		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/578 (0%)		0/488 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.