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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 : August 12, 2021
Sponsor:
Collaborators:
University of North Carolina
University of Michigan
Emory University
Children's Hospital of Philadelphia
Baylor College of Medicine
Cook County Hospital
Montefiore Medical Center
University of South Florida
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: YouTHrive Behavioral: Information-only Control Not Applicable

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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 : December 2021
Estimated Study Completion Date : May 2022

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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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. HIV-positive status;
  3. 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;
  4. English-speaking (since the intervention will be in English);
  5. Anticipated continuous internet access and SMS messaging for the intervention period (approximately 5 months);
  6. Not enrolled in another ART adherence intervention research study at the time of screening;
  7. Has or is willing to create an e-mail address to use during the study period;
  8. 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.

Exclusion Criteria:

  1. Is younger than 15 years old or older than 24 years old at the enrollment visit;
  2. does not have an HIV-positive status;
  3. 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;
  4. Does not speak English;
  5. Does not anticipate having continuous internet access and SMS messaging for the intervention period (approximately 5 months);
  6. Is enrolled in another ART adherence intervention research study at the time of screening;
  7. Does not have or is not willing to create an e-mail address to use during the study period;
  8. 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.


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 619.594.3346 khorvath@sdsu.edu
Contact: K. Rivet Amico, PhD 734-615-3240 ramico@umich.edu

Locations
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United States, Florida
University of South Florida 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 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Marc Padilla       marc.a.padilla@emory.edu   
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       amcfadden2@cookcountyhhs.org   
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       rnieves@adolescentaids.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       jacob_stocks@med.unc.edu   
Principal Investigator: Lisa Hightow-Weidman, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kim Desir       desirk@email.chop.edu   
Contact: Elijah Brittingham       brittinghe@email.chop.edu   
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         
Sponsors and Collaborators
University of Minnesota
University of North Carolina
University of Michigan
Emory University
Children's Hospital of Philadelphia
Baylor College of Medicine
Cook County Hospital
Montefiore Medical Center
University of South Florida
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Principal Investigator: K. Rivet Amico, PhD University of Michigan
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03149757    
Other Study ID Numbers: 16-3136
1U19HD089881 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
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:
Treatment Adherence
Alcohol or Drugs
Behavioral
Internet
Adolescents
Young Adults
Social Support
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases