Trial Outcomes & Findings for Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial (NCT NCT03149757)
NCT ID: NCT03149757
Last Updated: 2023-07-03
Results Overview
Participants were presented with a visual analog scale (VAS) of the percentage of antiretroviral therapy (ART) adherence in the past 30 days on a scale from 0% to 100% (with 10% increments as response options) and asked to choose the level of ART adherence they achieved in the past 30 days. The mean percentage of ART adherence across all participants was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
5-month follow-up
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
YouTHrive
YouTHrive is a five-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV medication adherence.
YouTHrive: The YT website is a mobile-enhanced private social networking website. Participants on the site are anonymous and choose alternate usernames and personalized profile features for a new online identity within YT. The investigators designed YouTHrive to encourage social support, reduce isolation, improve HIV medication adherence, and promote general well being. The study involves rolling recruitment so that new members are continuously entering the intervention. Participants use YT for five months before "graduating" from the program. The core components of YT are: 1) peer-to-peer interaction in a shared feed; 2) daily monitoring of HIV medication adherence and real-time mood; 3) daily mixed-media content with strategies to improve medication adherence' and 4) goal setting and monitoring.
|
Thrive Tips
Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being.
Information-only Control: Participants will receive 21 emails, once per week, for five months. The emails will include static informational content relatable to YLWH, but informational content will not be focused on ART medication adherence.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
105
|
|
Overall Study
COMPLETED
|
96
|
100
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
Baseline characteristics by cohort
| Measure |
YouTHrive
n=103 Participants
YouTHrive is a five-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV medication adherence.
YouTHrive: The YT website is a mobile-enhanced private social networking website. Participants on the site are anonymous and choose alternate usernames and personalized profile features for a new online identity within YT. The investigators designed YouTHrive to encourage social support, reduce isolation, improve HIV medication adherence, and promote general well being. The study involves rolling recruitment so that new members are continuously entering the intervention. Participants use YT for five months before "graduating" from the program. The core components of YT are: 1) peer-to-peer interaction in a shared feed; 2) daily monitoring of HIV medication adherence and real-time mood; 3) daily mixed-media content with strategies to improve medication adherence' and 4) goal setting and monitoring.
|
Thrive Tips
n=105 Participants
Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being.
Information-only Control: Participants will receive 21 emails, once per week, for five months. The emails will include static informational content relatable to YLWH, but informational content will not be focused on ART medication adherence.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.97 years
STANDARD_DEVIATION 2.34 • n=99 Participants
|
21.32 years
STANDARD_DEVIATION 2.21 • n=107 Participants
|
21.15 years
STANDARD_DEVIATION 2.28 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5-month follow-upParticipants were presented with a visual analog scale (VAS) of the percentage of antiretroviral therapy (ART) adherence in the past 30 days on a scale from 0% to 100% (with 10% increments as response options) and asked to choose the level of ART adherence they achieved in the past 30 days. The mean percentage of ART adherence across all participants was calculated.
Outcome measures
| Measure |
YouTHrive
n=77 Participants
YouTHrive is a five-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV medication adherence.
YouTHrive: The YT website is a mobile-enhanced private social networking website. Participants on the site are anonymous and choose alternate usernames and personalized profile features for a new online identity within YT. The investigators designed YouTHrive to encourage social support, reduce isolation, improve HIV medication adherence, and promote general well being. The study involves rolling recruitment so that new members are continuously entering the intervention. Participants use YT for five months before "graduating" from the program. The core components of YT are: 1) peer-to-peer interaction in a shared feed; 2) daily monitoring of HIV medication adherence and real-time mood; 3) daily mixed-media content with strategies to improve medication adherence' and 4) goal setting and monitoring.
|
Thrive Tips
n=77 Participants
Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being.
Information-only Control: Participants will receive 21 emails, once per week, for five months. The emails will include static informational content relatable to YLWH, but informational content will not be focused on ART medication adherence.
|
|---|---|---|
|
Visual Analog Scale (VAS) of Self-Reported Antiretroviral Adherence
|
85.71 Unit on a scale
Standard Deviation 19.29
|
85.53 Unit on a scale
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: 5-month follow-upPopulation: The number of participants on which the study team was able to collect HIV viral load measure on was lower than the number of participants who completed the self-report surveys. As such, the number reported on for HIV viral load is smaller than the number of participants available for the primary outcome measure.
HIV viral load was abstracted from participants' medical records or a blood draw as part of research protocols (if no recent viral load measure was available from the medical record). A participant was recorded as having an undetectable HIV viral load if the level of HIV was so low that the test used by that clinic did not detect HIV in the participant (between \<20 and \<50 HIV copies depending on the clinic's viral load test).
Outcome measures
| Measure |
YouTHrive
n=65 Participants
YouTHrive is a five-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV medication adherence.
YouTHrive: The YT website is a mobile-enhanced private social networking website. Participants on the site are anonymous and choose alternate usernames and personalized profile features for a new online identity within YT. The investigators designed YouTHrive to encourage social support, reduce isolation, improve HIV medication adherence, and promote general well being. The study involves rolling recruitment so that new members are continuously entering the intervention. Participants use YT for five months before "graduating" from the program. The core components of YT are: 1) peer-to-peer interaction in a shared feed; 2) daily monitoring of HIV medication adherence and real-time mood; 3) daily mixed-media content with strategies to improve medication adherence' and 4) goal setting and monitoring.
|
Thrive Tips
n=55 Participants
Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being.
Information-only Control: Participants will receive 21 emails, once per week, for five months. The emails will include static informational content relatable to YLWH, but informational content will not be focused on ART medication adherence.
|
|---|---|---|
|
Percentage of Participants With Undetectable HIV Viral Load
|
56 Participants
|
43 Participants
|
Adverse Events
YouTHrive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Thrive Tips
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