Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

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.
    

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 eight cities: Atlanta, New York, Chapel Hill, Charlotte, Chicago, Houston,
      Philadelphia, and Tampa. Assessments will be collected at baseline and 5-month follow-up.

      Specific Aims include:

      Primary Objective: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive(YT) to promote
      higher treatment success at month 5 among YLWH, compared to an HIV information-only control
      condition, as defined by higher self-reported ART adherence (primary), higher percent
      suppressed viral load (secondary), and higher HIV care attendance (secondary).

      H1: Participants in the YT intervention arm than in the information-only control arm will
      report higher ART adherence at the 5-month follow-up time point.

      H2: A higher proportion of participants in the YT intervention arm than in the
      information-only control arm will have suppressed viral load at the 5-month follow-up time
      point.

      H3: Participants in the YT intervention arm than in the information-only control arm will
      report higher HIV care attendance at the 5-month follow-up time point.

      H4: A higher proportion of participants in the YT intervention arm than in the
      information-only control arm will demonstrate treatment success on a composite variable of
      primary and secondary outcomes.

      Secondary Objective 1: Assess whether YT has more HIV treatment benefits for substance-using
      than non-substance-using YLWH.

      H5: Among YLWH in the YT intervention arm, a higher proportion of substance-using
      participants will demonstrate improvement on primary and secondary outcomes, and a composite
      variable of these outcomes, at the 5-month follow-up time point compared to
      non-substance-using participants.

      Secondary Objective 2: Examine whether YT has positive impacts on mental health and social
      support.

      H6: Participants in the YT intervention arm will report lower depression and anxiety and
      higher social support at the 5-month follow-up time point compared to those in an
      information-only control arm.
    

Intervention name(s): YouTHrive; Information-only Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): YT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Treatment Adherence; Alcohol or Drugs; Behavioral; Internet; Adolescents; Young Adults; Social Support