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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
Sponsor:
Collaborators:
University of North Carolina
University of Michigan
Emory University
Children's Hospital of Philadelphia
Texas Children's Hospital
Cook County Hospital
Montefiore Medical Center
University of South Florida
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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 with a detectable viral load (VL) across six cities and randomize them to either the intervention condition or control condition. Assessments will be collected at baseline, 5, 8, and 11-month follow-up.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: YouTHrive Behavioral: Information-only Control Phase 2

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: YouTHrive
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.
Behavioral: YouTHrive
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 15-24 years of age at the enrollment visit;
  2. Medical-chart verified HIV-positive status;
  3. Receiving HIV clinical care in the Chicago, Houston, NYC, Philadelphia, Atlanta, or Tampa area;
  4. Medical chart-verified that most recent VL test was detectable (above the lower limit of detection for the clinical assay) within 45 days of enrollment date and an ART prescription for at least 90 days prior to this VL test date;
  5. Medical-chart evidence of an ART prescription with refills that extends from the date of detectable VL to the date of enrollment;
  6. English-speaking;
  7. Anticipated continuous internet access and SMS messaging for the intervention period (approximately 5 months); and
  8. Availability to meet with project staff at baseline and 5-month and 11-month follow-up assessments.

Exclusion Criteria:

  1. Aged 14 years or younger or 25 years or older at time of screening;
  2. HIV-negative or unknown serostatus;
  3. Is not in HIV clinical care or does not receive HIV clinical care in the Philadelphia, Houston, NYC, Atlanta, Tampa, or Chicago area;
  4. Most recent VL test was undetectable (below the lower limit of detection for the clinical assay) within 45 days of enrollment date;
  5. No active prescription for ART medications or has been on ART for less than 90 days;
  6. Does not speak or read English;
  7. Cannot send or receive SMS messages and regularly access the internet for the intervention period (approximately 5 months);
  8. Currently incarcerated; and
  9. Enrolled in another ART adherence intervention research study at the time of screening.

Participants who are or become pregnant during the study period will not be excluded.


Information from the National Library of Medicine

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


Contacts
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Contact: Keith J Horvath, PhD 612-626-1799 horva018@umn.edu
Contact: K. Rivet Amico, PhD 734-615-3240 ramico@umich.edu

Locations
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United States, Florida
University of South Florida Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Amayvis Garcia    813-844-4187    arebolle@health.usf.edu   
Principal Investigator: Patricia Emmanuel, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Mondie Tharp    404-712-2224    mondie.b.tharp@emory.edu   
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    kbojan@sbcglobal.net   
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    hnazario@adolescentaids.org   
Contact: Evey Parchment    (718) 882-0023    eparchment@adolescentaids.org   
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    dxsantia@texaschildrens.org   
Principal Investigator: Mary Paul, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of North Carolina
University of Michigan
Emory University
Children's Hospital of Philadelphia
Texas Children's Hospital
Cook County Hospital
Montefiore Medical Center
University of South Florida
Investigators
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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

Additional Information:
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03149757     History of Changes
Other Study ID Numbers: 1U19HD089881 (SubProject 8781)
1U19HD089881 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Treatment Adherence
Alcohol or Drugs
Behavioral
Internet
Adolescents
Young Adults
Social Support

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases