Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03149757|
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: YouTHrive Behavioral: Information-only Control||Not Applicable|
|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 :||December 2021|
|Estimated Study Completion Date :||May 2022|
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.
- Participants with Self-Reported ART Adherence [ Time Frame: Baseline and 5-month follow-up time points ]The investigators will test the efficacy of the YT intervention to elicit higher self-reported ART adherence among youth living with HIV (YLWH) at the 5-month follow-up time point compared to an HIV information-only control condition. Self-reported ART adherence will be assessed at baseline and 5-months.
- Participants with Viral Load [ 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. Viral load will be assessed at baseline and 5-months.
- Participants with HIV Care Attendance [ Time Frame: Baseline and 5-month follow-up time points ]The investigators will test the efficacy of the YT intervention to elicit higher HIV care attendance among youth living with HIV (YLWH) at the 5-month follow-up time point compared to an HIV information-only control condition. HIV care attendance will be assessed at baseline and 5-months.
- Substance-Using Participants with Outcome Measures [ Time Frame: Baseline and 5-month follow-up time points ]Among the YT intervention participants, the investigators will assess whether a different proportion of substance-using youth demonstrate improvement on primary (Outcome 1) and secondary outcomes (Outcomes 2 and 3) at the 5-month follow-up timepoints compared to non-substance using participants.
- Participants with Mental Health and Social Support [ Time Frame: Baseline and 5-month follow-up time points ]Among the YT intervention participants, the investigators will assess whether intervention participants report lower depression and anxiety scores, and higher social support at the 5-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||Recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Amayvis Garcia 813-844-4187 email@example.com|
|Principal Investigator: Patricia Emmanuel, MD|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Marc Padilla firstname.lastname@example.org|
|Principal Investigator: Patrick S Sullivan, PhD|
|United States, Illinois|
|Cook County Hospital and Health Systems CORE Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Antionette McFadden 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: Rosa Nieves firstname.lastname@example.org|
|Contact: Tina Alford Talford@adolescentaids.org|
|Principal Investigator: Donna Futterman, MD|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27514|
|Contact: Jacob Stocks email@example.com|
|Principal Investigator: Lisa Hightow-Weidman, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kim Desir firstname.lastname@example.org|
|Contact: Elijah Brittingham email@example.com|
|Principal Investigator: Marne Castillo|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Litty Koshy Litty.Koshy@bcm.edu|
|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|
|Principal Investigator:||K. Rivet Amico, PhD||University of Michigan|