Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
2 other identifiers
interventional
208
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started May 2017
Longer than P75 for not_applicable hiv-infections
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedResults Posted
Study results publicly available
July 3, 2023
CompletedJuly 3, 2023
June 1, 2023
5 years
May 9, 2017
May 11, 2023
June 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale (VAS) of Self-Reported Antiretroviral Adherence
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.
5-month follow-up
Secondary Outcomes (1)
Percentage of Participants With Undetectable HIV Viral Load
5-month follow-up
Study Arms (2)
YouTHrive
EXPERIMENTALYouTHrive 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.
Thrive Tips
ACTIVE COMPARATORParticipants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- years of age at the enrollment visit;
- HIV-positive status;
- Residing in Chicago, Houston, NYC, Philadelphia, Atlanta, Tampa, or Raleigh/Durham/Chapel Hill areas and available to meet in-person or virtually with SRV staff for visits at baseline and 5-month follow-up assessment;
- English-speaking (since the intervention will be in English);
- Anticipated continuous internet access and SMS messaging for the intervention period (approximately 5 months);
- Not enrolled in another ART adherence intervention research study at the time of screening;
- Has or is willing to create an e-mail address to use during the study period;
- Did not attend an iTech Youth Advisory Board (YAB) or Youth Advisory Council (YAC) meeting where the YouTHrive study was presented or YouTHrive study materials were discussed.
You may not qualify if:
- Is younger than 15 years old or older than 24 years old at the enrollment visit;
- does not have an HIV-positive status;
- Does not reside in Chicago, Houston, NYC, Philadelphia, Atlanta, Tampa, or Raleigh/Durham/Chapel Hill areas and not available to meet with SRV staff for visits at baseline, and 5-month follow-up assessment;
- Does not speak English;
- Does not anticipate having continuous internet access and SMS messaging for the intervention period (approximately 5 months);
- Is enrolled in another ART adherence intervention research study at the time of screening;
- Does not have or is not willing to create an e-mail address to use during the study period;
- Is a member of an iTech Youth Advisory Board (YAB) or Youth Advisory Council (YAC).
- Participants who are or become pregnant during the study period will not be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- University of North Carolinacollaborator
- University of Michigancollaborator
- Emory Universitycollaborator
- Children's Hospital of Philadelphiacollaborator
- Baylor College of Medicinecollaborator
- Cook County Hospitalcollaborator
- Montefiore Medical Centercollaborator
- University of South Floridacollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (7)
University of South Florida
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30322, United States
Cook County Hospital and Health Systems CORE Center
Chicago, Illinois, 60612, United States
Montefiore Children's Hospital
The Bronx, New York, 10467, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Horvath KJ, MacLehose RF, Martinka A, DeWitt J, Hightow-Weidman L, Sullivan P, Amico KR. Connecting Youth and Young Adults to Optimize Antiretroviral Therapy Adherence (YouTHrive): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jul 30;8(7):e11502. doi: 10.2196/11502.
PMID: 31364601DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keith Horvath
- Organization
- University of Minnesota
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 11, 2017
Study Start
May 16, 2017
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
July 3, 2023
Results First Posted
July 3, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the data set. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.