Trial Outcomes & Findings for Adolescent Transition To Adult Care for HIV-infected Adolescents in Kenya (NCT NCT03574129)

NCT ID: NCT03574129

Last Updated: 2022-05-04

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1095 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2022-05-04

Participant Flow

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

Participant milestones

Measure	Adolescent Transition Package Received the study intervention	Standard of Care Did not receive study intervention
Overall Study STARTED	578	488
Overall Study COMPLETED	506	440
Overall Study NOT COMPLETED	72	48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Scores are aggregate of total domain scores. Some participants did not respond to all the questions in the score.

Baseline characteristics by cohort

Measure	Adolescent Transition Package n=578 Participants Baseline characteristics of participants in intervention arm	Standard of Care n=488 Participants Baseline characteristics of participants in control arm	Total n=1066 Participants Total of all reporting groups
Age, Continuous	21.1 years n=578 Participants	19.7 years n=488 Participants	20.5 years n=1066 Participants
Sex: Female, Male Female	432 Participants n=578 Participants	338 Participants n=488 Participants	770 Participants n=1066 Participants
Sex: Female, Male Male	146 Participants n=578 Participants	150 Participants n=488 Participants	296 Participants n=1066 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=578 Participants	0 Participants n=488 Participants	0 Participants n=1066 Participants
Race (NIH/OMB) Asian	0 Participants n=578 Participants	0 Participants n=488 Participants	0 Participants n=1066 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=578 Participants	0 Participants n=488 Participants	0 Participants n=1066 Participants
Race (NIH/OMB) Black or African American	578 Participants n=578 Participants	488 Participants n=488 Participants	1066 Participants n=1066 Participants
Race (NIH/OMB) White	0 Participants n=578 Participants	0 Participants n=488 Participants	0 Participants n=1066 Participants
Race (NIH/OMB) More than one race	0 Participants n=578 Participants	0 Participants n=488 Participants	0 Participants n=1066 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=578 Participants	0 Participants n=488 Participants	0 Participants n=1066 Participants
Region of Enrollment Kenya	578 participants n=578 Participants	488 participants n=488 Participants	1066 participants n=1066 Participants
Primary caregiver Parent	227 Participants n=578 Participants	241 Participants n=488 Participants	468 Participants n=1066 Participants
Primary caregiver Sibling	49 Participants n=578 Participants	28 Participants n=488 Participants	77 Participants n=1066 Participants
Primary caregiver Grand parent	31 Participants n=578 Participants	43 Participants n=488 Participants	74 Participants n=1066 Participants
Primary caregiver Spouse	202 Participants n=578 Participants	103 Participants n=488 Participants	305 Participants n=1066 Participants
Primary caregiver Other	69 Participants n=578 Participants	73 Participants n=488 Participants	142 Participants n=1066 Participants
Entry point PMTCT clinics	201 Participants n=578 Participants	129 Participants n=488 Participants	330 Participants n=1066 Participants
Entry point HIV clinic	367 Participants n=578 Participants	344 Participants n=488 Participants	711 Participants n=1066 Participants
Entry point Other	9 Participants n=578 Participants	15 Participants n=488 Participants	24 Participants n=1066 Participants
Entry point missing	1 Participants n=578 Participants	0 Participants n=488 Participants	1 Participants n=1066 Participants
Months since disclosure of HIV status	34 months n=578 Participants	45 months n=488 Participants	42 months n=1066 Participants
Baseline Transition readiness score (overall)	12.1 score on a scale STANDARD_DEVIATION 3.4 • n=524 Participants • Scores are aggregate of total domain scores. Some participants did not respond to all the questions in the score.	11.4 score on a scale STANDARD_DEVIATION 3.7 • n=445 Participants • Scores are aggregate of total domain scores. Some participants did not respond to all the questions in the score.	11.8 score on a scale STANDARD_DEVIATION 3.6 • n=969 Participants • Scores are aggregate of total domain scores. Some participants did not respond to all the questions in the score.
Baseline readiness score (HIV literacy)	2.6 score on a scale STANDARD_DEVIATION 1.5 • n=565 Participants • Some participants did not respond to some of the questions that comprise the score.	2.3 score on a scale STANDARD_DEVIATION 1.5 • n=477 Participants • Some participants did not respond to some of the questions that comprise the score.	2.5 score on a scale STANDARD_DEVIATION 1.5 • n=1042 Participants • Some participants did not respond to some of the questions that comprise the score.
Baseline readiness score (Self-management)	3.9 score on a scale STANDARD_DEVIATION 1.0 • n=558 Participants • Some participants did not respond to some of the questions that comprise the score	3.8 score on a scale STANDARD_DEVIATION 1.1 • n=472 Participants • Some participants did not respond to some of the questions that comprise the score	3.9 score on a scale STANDARD_DEVIATION 1.0 • n=1030 Participants • Some participants did not respond to some of the questions that comprise the score
Baseline readiness score (Communication)	3.9 score on a scale STANDARD_DEVIATION 1.0 • n=564 Participants • Some participants did not respond to some of the questions that comprise the score	3.8 score on a scale STANDARD_DEVIATION 1.1 • n=473 Participants • Some participants did not respond to some of the questions that comprise the score	3.9 score on a scale STANDARD_DEVIATION 1.1 • n=1037 Participants • Some participants did not respond to some of the questions that comprise the score
Baseline readiness score (Support)	1.7 score on a scale STANDARD_DEVIATION 1.0 • n=563 Participants • Some participants did not respond to some of the questions that comprise the score	1.6 score on a scale STANDARD_DEVIATION 1.0 • n=478 Participants • Some participants did not respond to some of the questions that comprise the score	1.6 score on a scale STANDARD_DEVIATION 1.1 • n=1041 Participants • Some participants did not respond to some of the questions that comprise the score
Viral suppression at baseline	382 Participants n=456 Participants • Viral load data not available for all enrolled participants	326 Participants n=401 Participants • Viral load data not available for all enrolled participants	708 Participants n=857 Participants • Viral load data not available for all enrolled participants

PRIMARY outcome

Timeframe: 1 year

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

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).

Outcome measures

Measure	Adolescent Transition Package n=476 Participants Month 12 transition readiness score (Total score)	Standard of Care n=416 Participants Month 12 transition readiness score (Total score)
Transition Readiness Score Overall	15.7 score on a scale Standard Deviation 1.8	13.9 score on a scale Standard Deviation 3.3

PRIMARY outcome

Timeframe: 1 year

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

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).

Outcome measures

Measure	Adolescent Transition Package n=504 Participants Month 12 transition readiness score (Total score)	Standard of Care n=440 Participants Month 12 transition readiness score (Total score)
Treatment Literacy Readiness Score	4.0 score on a scale Standard Deviation 1.0	3.0 score on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 1 year

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

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).

Outcome measures

Measure	Adolescent Transition Package n=487 Participants Month 12 transition readiness score (Total score)	Standard of Care n=423 Participants Month 12 transition readiness score (Total score)
Self Management Readiness Score	4.7 score on a scale Standard Deviation 0.4	4.4 score on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: 1 year

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

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).

Outcome measures

Measure	Adolescent Transition Package n=502 Participants Month 12 transition readiness score (Total score)	Standard of Care n=438 Participants Month 12 transition readiness score (Total score)
Communication Readiness Score	4.7 score on a scale Standard Deviation 0.5	4.4 score on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: 1 year

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

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).

Outcome measures

Measure	Adolescent Transition Package n=500 Participants Month 12 transition readiness score (Total score)	Standard of Care n=438 Participants Month 12 transition readiness score (Total score)
Support Readiness Score	2.3 score on a scale Standard Deviation 0.8	2.1 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Adolescent Transition Package n=543 Participants Month 12 transition readiness score (Total score)	Standard of Care n=454 Participants Month 12 transition readiness score (Total score)
Overall Retention Among 10-24 Year Old Adolescents	506 Participants	440 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 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

Comparisons of time to transition specific milestones between intervention and control

Outcome measures

Measure	Adolescent Transition Package n=275 Participants Month 12 transition readiness score (Total score)	Standard of Care n=277 Participants Month 12 transition readiness score (Total score)
Number of Participants With Viral Suppression	249 Participants	255 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Time to full disclosure

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Proportions by age group with full disclosure

Outcome measures

Outcome data not reported

Adverse Events

Adolescent Transition Package

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Irene Njuguna

University of Washington

Phone: 2065191275

Email: irenen@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place