Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
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|ClinicalTrials.gov Identifier: NCT03149757|
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: YouTHrive Behavioral: Information-only Control||Phase 2|
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 six cities: Houston, Chicago, Atlanta, Tampa, Philadelphia, and the Bronx. Assessments will be collected at baseline, 5, 8, and 11-month follow-up.
Specific Aims include:
Primary Aim: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive (YT) to suppress viral load (VL) among YLWH at the 5-month follow-up timepoint, 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 the 5-month follow-up time point.
Secondary Aim 1: Assess whether YT is more beneficial for substance-using than non substance-using YLWH.
H2: Among YLWH in the YT intervention arm, a higher proportion of substance-using YLWH will demonstrate VL suppression at the 5-month follow-up time point compared to non-substance-using YLWH.
Secondary Aim 2: Assess the efficacy of YT to suppress viral load (VL) among YLWH at the 11-month follow-up timepoint, compared to an HIV information-only control condition.
H3: A higher proportion of participants in the YT intervention arm than in the information-only control arm will have undetectable VL at the 11-month follow-up time point.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 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 2020|
|Estimated Study Completion Date :||April 2020|
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.
- Change in Viral Load Among Youth Living with HIV [ Time Frame: Baseline and 5-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 the 5-month follow-up time point compared to an HIV information-only control condition.
- Change in Viral Load Among Substance-using Youth Living with HIV [ Time Frame: Baseline and 5-month follow-up time points ]Among the YT intervention condition, the investigators will assess whether a higher proportion of substance-using youth are virally suppressed at the 5-month follow-up time point compared to non-substance-using youth.
- Long-term Change in Viral Load Among Youth Living with HIV [ Time Frame: Baseline 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 the 11-month follow-up time point compared to an HIV information-only control condition.
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
|Contact: Keith J Horvath, PhDemail@example.com|
|Contact: K. Rivet Amico, PhDfirstname.lastname@example.org|
|United States, Florida|
|University of South Florida||Not yet recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Amayvis Garcia 813-844-4187 email@example.com|
|Principal Investigator: Patricia Emmanuel, MD|
|United States, Georgia|
|Emory University||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Mondie Tharp 404-712-2224 firstname.lastname@example.org|
|Principal Investigator: Patrick S Sullivan, PhD|
|United States, Illinois|
|Cook County Hospital and Health Systems CORE Center||Not yet recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Kelly Bojan 312-572-4716 email@example.com|
|Contact: Rachel Jackson (312) 572-4554 Rjackson@cookcountyhhs.org|
|Principal Investigator: Temitope Oyedele, MD|
|United States, New York|
|Montefiore Children's Hospital||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Helen Nazario, DNP 718-882-0023 firstname.lastname@example.org|
|Contact: Evey Parchment (718) 882-0023 email@example.com|
|Principal Investigator: Donna Futterman, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Anna Schlupp 215-370-6446 SchluppA@email.chop.edu|
|Principal Investigator: Marne Castillo|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Dalisa Santiago 832-824-1143 firstname.lastname@example.org|
|Principal Investigator: Mary Paul, MD|
|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 - Clinical and Translational Science Institute|
|Principal Investigator:||K. Rivet Amico, PhD||University of Michigan|