Trial Outcomes & Findings for iTransition Development (NCT NCT04383223)
NCT ID: NCT04383223
Last Updated: 2025-08-13
Results Overview
Defined dichotomously as having one completed adult clinic appointment or not.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
18 month post-intervention
Results posted on
2025-08-13
Participant Flow
Participant milestones
| Measure |
YLH Historical Control Group
Participants in this group will have the following phases:
* Screening
* Single visit assessment
|
YLH iTransition Intervention Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3 and 9 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Provider Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Transition Champion Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit and Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
33
|
17
|
7
|
|
Overall Study
COMPLETED
|
21
|
33
|
17
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
iTransition Development
Baseline characteristics by cohort
| Measure |
YLH Historical Control Group
n=21 Participants
Participants in this group will have the following phases:
* Screening
* Single visit assessment
|
YLH iTransition Intervention Group
n=33 Participants
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3 and 9 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Provider Group
n=17 Participants
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Transition Champion Group
n=7 Participants
Participants in this group will have the following phases:
* Screening
* Baseline Visit and Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24.73 years
STANDARD_DEVIATION 0.94 • n=99 Participants
|
24.64 years
STANDARD_DEVIATION 1.03 • n=107 Participants
|
41.47 years
STANDARD_DEVIATION 7.71 • n=206 Participants
|
39.00 years
STANDARD_DEVIATION 6.00 • n=7 Participants
|
29.62 years
STANDARD_DEVIATION 0.97 • n=31 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
75 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
33 participants
n=107 Participants
|
17 participants
n=206 Participants
|
7 participants
n=7 Participants
|
78 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 18 month post-interventionPopulation: This outcome only applies to the groups with YLH (Youth Living With HIV) participants.
Defined dichotomously as having one completed adult clinic appointment or not.
Outcome measures
| Measure |
YLH Historical Control Group
n=21 Participants
Participants in this group will have the following phases:
* Screening
* Single visit assessment
|
YLH iTransition Intervention Group
n=33 Participants
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3 and 9 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Provider Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Transition Champion Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit and Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
|---|---|---|---|---|
|
Linkage to Adult Care
|
16 Participants
|
22 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-interventionPopulation: This outcome only applies to the groups with YLH (Youth Living With HIV) participants.
Defined dichotomously as having one completed medical visit in each 6-month period.
Outcome measures
| Measure |
YLH Historical Control Group
n=21 Participants
Participants in this group will have the following phases:
* Screening
* Single visit assessment
|
YLH iTransition Intervention Group
n=33 Participants
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3 and 9 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Provider Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Transition Champion Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit and Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
|---|---|---|---|---|
|
Care Retention Per Each 6-month Period
Number of participants with one completed medical visit from Baseline to 6 month post-intervention
|
17 Participants
|
27 Participants
|
0 Participants
|
0 Participants
|
|
Care Retention Per Each 6-month Period
Number of participants with one completed medical visit from 6 to 12 month post-intervention
|
14 Participants
|
31 Participants
|
0 Participants
|
0 Participants
|
|
Care Retention Per Each 6-month Period
Number of participants with one completed medical visit from 12 to 18 month post-intervention
|
16 Participants
|
22 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1-year post-interventionPopulation: This outcome only applies to the groups with YLH (Youth Living With HIV) participants.
Viral suppression is defined as \<200 copies/ml blood at 1-year post-baseline.
Outcome measures
| Measure |
YLH Historical Control Group
n=21 Participants
Participants in this group will have the following phases:
* Screening
* Single visit assessment
|
YLH iTransition Intervention Group
n=33 Participants
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3 and 9 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Provider Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit
* Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
Transition Champion Group
Participants in this group will have the following phases:
* Screening
* Baseline Visit and Follow-Up visits at 6, 12 and 18 month
* Interview visits for selected YLH around 3, 9 and 15 month
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
|
|---|---|---|---|---|
|
Number of Participants With Viral Suppression
|
10 Participants
|
26 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Provider Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transition Champion Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
YLH Historical Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
YLH iTransition Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place