Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
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|ClinicalTrials.gov Identifier: NCT03149757|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2017
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: YouTHrive Behavioral: Information-only Control||Not Applicable|
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 seven cities: Houston, Chicago, Atlanta, Tampa, Philadelphia, New York City, and Chapel Hill. Assessments will be collected at baseline and 5, 8, and 11-month follow-up.
Specific Aims include:
Primary Objective: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive(YT) to sustain suppressed viral load (VL) among YLWH, compared to an HIV information-only control condition.
H1: A higher proportion of participants in the YT intervention arm than in the information-only control arm will have undetectable VL at both the 5- and 11-month follow-up time points.
Secondary objective: Assess whether YT is more beneficial for substance-using than non substance-using YLWH.
H2: Among YLWH in the YT intervention arm, a different proportion of substance-using YLWH will demonstrate VL suppression at both the 5- and 11-month follow-up time points compared to non-substance-using YLWH.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Connecting Youth and Young Adults to Optimize ART Adherence: Testing the Efficacy of the Youth Thrive Intervention|
|Actual Study Start Date :||May 16, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||May 2021|
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.
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.
Other Name: YT
Active Comparator: 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.
Behavioral: 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.
- Proportion of Participants with Sustained Suppressed Viral Load [ Time Frame: Baseline and 5- and 11-month follow-up time points ]The investigators will test the efficacy of the YT intervention to suppress viral load (VL) among youth living with HIV (YLWH) at both the 5-month and 11-month follow-up time point compared to an HIV information-only control condition. Viral load will be assessed at baseline, 5-months, and 11-months. Proportion of participants in the YT intervention condition with suppressed viral load at BOTH the 5-month and 11-month time points will be compared to the proportion of participants in the information-only control condition with suppressed viral load at BOTH the 5-month and 11-month time points using differences in proportion test and confidence intervals.
- Proportion of Substance-Using Participants with Sustained Suppressed Viral Load [ Time Frame: Baseline and 5- and 11-month follow-up time points ]Among the YT intervention condition, the investigators will assess whether a different proportion of substance-using youth are virally suppressed at both the 5-month and the 11-month follow-up time points compared to non-substance-using youth.Viral load will be assessed at baseline, 5-months, and 11-months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149757
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33606|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Cook County Hospital and Health Systems CORE Center|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Montefiore Children's Hospital|
|Bronx, New York, United States, 10467|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Study Chair:||Lisa Hightow-Weidman, PhD||University of North Carolina|
|Study Chair:||Patrick S Sullivan, PhD||Emory University|
|Principal Investigator:||Keith J. Horvath, PhD||University of Minnesota|
|Principal Investigator:||K. Rivet Amico, PhD||University of Michigan|