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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149757
Recruitment Status : Active, not recruiting
First Posted : May 11, 2017
Last Update Posted : May 5, 2020
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 seven 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 Not Applicable

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 seven cities: Houston, Chicago, Atlanta, Tampa, Philadelphia, New York City, and Chapel Hill. Assessments will be collected at baseline and 5, 8, and 11-month follow-up.

Specific Aims include:

Primary Objective: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive(YT) to sustain suppressed viral load (VL) among YLWH, 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 both the 5- and 11-month follow-up time points.

Secondary objective: Assess whether YT is more beneficial for substance-using than non substance-using YLWH.

H2: Among YLWH in the YT intervention arm, a different proportion of substance-using YLWH will demonstrate VL suppression at both the 5- and 11-month follow-up time points compared to non-substance-using YLWH.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 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 2021
Estimated Study Completion Date : May 2021

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. Proportion of Participants with Sustained Suppressed Viral Load [ Time Frame: Baseline and 5- 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 both the 5-month and 11-month follow-up time point compared to an HIV information-only control condition. Viral load will be assessed at baseline, 5-months, and 11-months. Proportion of participants in the YT intervention condition with suppressed viral load at BOTH the 5-month and 11-month time points will be compared to the proportion of participants in the information-only control condition with suppressed viral load at BOTH the 5-month and 11-month time points using differences in proportion test and confidence intervals.


Secondary Outcome Measures :
  1. Proportion of Substance-Using Participants with Sustained Suppressed Viral Load [ Time Frame: Baseline and 5- and 11-month follow-up time points ]
    Among the YT intervention condition, the investigators will assess whether a different proportion of substance-using youth are virally suppressed at both the 5-month and the 11-month follow-up time points compared to non-substance-using youth.Viral load will be assessed at baseline, 5-months, and 11-months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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, or Tampa area and available to meet with SRV staff for visits at baseline, and 5-month and 11-month follow-up assessments;
  4. Evidence of a current ART prescription;
  5. English-speaking (since the intervention will be in English);
  6. Anticipated continuous internet access and SMS messaging for the intervention period (approximately 5 months);
  7. Not enrolled in another ART adherence intervention research study at the time of screening;
  8. Has or is willing to create an e-mail address to use during the study period;
  9. Not a member of an iTech Youth Advisory Board (YAB);
  10. Meets one of the following medical-chart verified or self-reported criteria:

    1. One or more detectable VL test result (above the lower limit of detection for the clinical assay if medical-chart verified) in the past 12-month while on ART for at least 3 months;
    2. Having failed to show up for or missed 1 or more scheduled HIV care appointment in the past 12 months,
    3. Last HIV care visit was more than 6 months ago;
    4. Self-reporting less than 90% ART adherence in the past 4 weeks.

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, or Tampa area and available to meet with SRV staff for visits at baseline, and 5-month and 11-month follow-up assessments;
  4. Has no evidence of a current ART prescription;
  5. Does not speak English;
  6. Does not anticipate having continuous internet access and SMS messaging for the intervention period (approximately 5 months);
  7. Is enrolled in another ART adherence intervention research study at the time of screening;
  8. Does not have or is not willing to create an e-mail address to use during the study period;
  9. Is a member of an iTech Youth Advisory Board (YAB);
  10. Does not meet any of the following medical-chart verified or self-reported criteria:

    1. One or more detectable VL test result (above the lower limit of detection for the clinical assay if medical-chart verified) in the past 12-month while on ART for at least 3 months;
    2. Having failed to show up for or missed 1 or more scheduled HIV care appointment in the past 12 months,
    3. Last HIV care visit was more than 6 months ago;
    4. Self-reporting less than 90% ART adherence in the past 4 weeks.

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


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Cook County Hospital and Health Systems CORE Center
Chicago, Illinois, United States, 60612
United States, New York
Montefiore Children's Hospital
Bronx, New York, United States, 10467
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
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: May 5, 2020
Last Verified: May 2020
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases