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 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

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. 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.

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:
Helen Nazario, DNP
718-882-0023
hnazario@adolescentaids.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 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.

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.