Purpose

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

Eligibility

Eligible Ages
Between 15 Years and 24 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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:
  11. 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;
  12. Having failed to show up for or missed 1 or more scheduled HIV care appointment in the past 12 months,
  13. Last HIV care visit was more than 6 months ago;
  14. 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:
  11. 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;
  12. Having failed to show up for or missed 1 or more scheduled HIV care appointment in the past 12 months,
  13. Last HIV care visit was more than 6 months ago;
  14. 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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.

Recruiting Locations

Montefiore Children's Hospital
Bronx, New York 10467
Contact:
John Jost
718-882-0032
jjost@montefiore.org

More Details

NCT ID
NCT03149757
Status
Recruiting
Sponsor
University of Minnesota - Clinical and Translational Science Institute

Study Contact

Keith J Horvath, PhD
612-626-1799
horva018@umn.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.