Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-04 @ 7:07 AM
Study NCT ID:
NCT03149757
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2017-05-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Connecting Youth and Young Adults to Optimize ART Adherence: Testing the Efficacy of the Youth Thrive Intervention
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants will have access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website aimed at improving medication adherence for YLWH. The investigators will enroll up to 60 YLWH for formative work on YT, and 300 YLWH (15-24 years old) of all genders living in eight cities and randomize them to either the intervention condition or control condition. Assessments will be collected at baseline and 5-month follow-up.
Detailed Description:
Youth between the ages of 13 and 24 accounted for 22% of all new HIV infections in 2015. Less than half (44%) of youth living with HIV (YLWH) in the US are estimated to be virally suppressed, which is a well recognized critical factor in individual health and non-infectiousness. Given the high demands of social identity development during adolescence and early adulthood, as well as the increasing use of social media as important and influential communication channels, there is an ongoing need for innovative programs that leverage current communication channels to foster social support for ART adherence behaviors.
The investigators developed a program first called Thrive With Me (TWM) as an intervention that leverages enhanced peer-to-peer interaction, ART adherence reminders and self-monitoring, and ART and HIV informational content to improve ART adherence. Given youth's broad acceptance and adoption of many of the components of the TWM intervention, and the critical need for novel and scalable ART adherence interventions for this population, we have adapted TWM for a younger audience and all genders in a program called YouTHrive (YT).
Focus groups will provide insights into what features and functions of the current TWM study youth like and dislike to assist intervention adaptation. The investigators will conduct focus groups in three cities (Houston, Bronx, and Chicago) and will recruit up to 16 YLWH per city, and use the results to develop the YT intervention. Ahead of the RCT, the investigators will conduct usability testing on YT to gain feedback about the developed intervention. The investigators will recruit 12 YLWH in six cities to use the intervention for a two-week period for usability testing.
The randomized controlled efficacy trial will compare YT (N=150) to a control group (N=150). YLWH in the control arm will receive weekly static information-only emails, compared to daily use of the dynamic YT social network site for the intervention group. Participants will be recruited from eight cities: Atlanta, New York, Chapel Hill, Charlotte, Chicago, Houston, Philadelphia, and Tampa. Assessments will be collected at baseline and 5-month follow-up.
Specific Aims include:
Primary Objective: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive(YT) to promote higher treatment success at month 5 among YLWH, compared to an HIV information-only control condition, as defined by higher self-reported ART adherence (primary), higher percent suppressed viral load (secondary), and higher HIV care attendance (secondary).
H1: Participants in the YT intervention arm than in the information-only control arm will report higher ART adherence at the 5-month follow-up time point.
H2: A higher proportion of participants in the YT intervention arm than in the information-only control arm will have suppressed viral load at the 5-month follow-up time point.
H3: Participants in the YT intervention arm than in the information-only control arm will report higher HIV care attendance at the 5-month follow-up time point.
H4: A higher proportion of participants in the YT intervention arm than in the information-only control arm will demonstrate treatment success on a composite variable of primary and secondary outcomes.
Secondary Objective 1: Assess whether YT has more HIV treatment benefits for substance-using than non-substance-using YLWH.
H5: Among YLWH in the YT intervention arm, a higher proportion of substance-using participants will demonstrate improvement on primary and secondary outcomes, and a composite variable of these outcomes, at the 5-month follow-up time point compared to non-substance-using participants.
Secondary Objective 2: Examine whether YT has positive impacts on mental health and social support.
H6: Participants in the YT intervention arm will report lower depression and anxiety and higher social support at the 5-month follow-up time point compared to those in an information-only control arm.
The investigators developed a program first called Thrive With Me (TWM) as an intervention that leverages enhanced peer-to-peer interaction, ART adherence reminders and self-monitoring, and ART and HIV informational content to improve ART adherence. Given youth's broad acceptance and adoption of many of the components of the TWM intervention, and the critical need for novel and scalable ART adherence interventions for this population, we have adapted TWM for a younger audience and all genders in a program called YouTHrive (YT).
Focus groups will provide insights into what features and functions of the current TWM study youth like and dislike to assist intervention adaptation. The investigators will conduct focus groups in three cities (Houston, Bronx, and Chicago) and will recruit up to 16 YLWH per city, and use the results to develop the YT intervention. Ahead of the RCT, the investigators will conduct usability testing on YT to gain feedback about the developed intervention. The investigators will recruit 12 YLWH in six cities to use the intervention for a two-week period for usability testing.
The randomized controlled efficacy trial will compare YT (N=150) to a control group (N=150). YLWH in the control arm will receive weekly static information-only emails, compared to daily use of the dynamic YT social network site for the intervention group. Participants will be recruited from eight cities: Atlanta, New York, Chapel Hill, Charlotte, Chicago, Houston, Philadelphia, and Tampa. Assessments will be collected at baseline and 5-month follow-up.
Specific Aims include:
Primary Objective: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive(YT) to promote higher treatment success at month 5 among YLWH, compared to an HIV information-only control condition, as defined by higher self-reported ART adherence (primary), higher percent suppressed viral load (secondary), and higher HIV care attendance (secondary).
H1: Participants in the YT intervention arm than in the information-only control arm will report higher ART adherence at the 5-month follow-up time point.
H2: A higher proportion of participants in the YT intervention arm than in the information-only control arm will have suppressed viral load at the 5-month follow-up time point.
H3: Participants in the YT intervention arm than in the information-only control arm will report higher HIV care attendance at the 5-month follow-up time point.
H4: A higher proportion of participants in the YT intervention arm than in the information-only control arm will demonstrate treatment success on a composite variable of primary and secondary outcomes.
Secondary Objective 1: Assess whether YT has more HIV treatment benefits for substance-using than non-substance-using YLWH.
H5: Among YLWH in the YT intervention arm, a higher proportion of substance-using participants will demonstrate improvement on primary and secondary outcomes, and a composite variable of these outcomes, at the 5-month follow-up time point compared to non-substance-using participants.
Secondary Objective 2: Examine whether YT has positive impacts on mental health and social support.
H6: Participants in the YT intervention arm will report lower depression and anxiety and higher social support at the 5-month follow-up time point compared to those in an information-only control arm.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U19HD089881 | NIH | None | https://reporter.nih.gov/quic… | View |