A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM
Condition: Hiv; Adolescent Behavior; Sex, Safe
Study type: Interventional

Summary: 
      This pragmatic trial of an HIV prevention program focuses on HIV risk-reduction in men who
      have sex with men (MSM) ages 13-18. The design is a three-tiered, internet-based HIV
      prevention intervention series that uses a sequential multiple assignment randomized trial
      (SMART) to track adolescent MSM reporting varying degree of sexual risk.The program package
      includes: (1-low risk) a universally-delivered, brief, online sexual health education program
      designed for sexual and gender minority youth regardless of whether they are sexually active
      (Queer Sex Ed); (2-middle risk) a more intensive online intervention designed for diverse
      AMSM engaging in HIV transmission risk behaviors (Keep It Up!), and (3-high risk) the most
      intensive is a motivational interviewing (MI) intervention that will be delivered by MI
      therapists via online videochat (Young Men's Health Project).
    

Detailed description: 
      Adolescent (ages 13-18) men who have sex with men (AMSM) experience a dramatic health
      disparity as they represent 2% of young people but account for almost 80% of HIV diagnoses in
      youth. Despite this disproportionate burden, current evidence-based HIV prevention programs
      focus primarily on adults and heterosexual youth. Because issues affecting sexual health
      decisions among AMSM are unique, interventions need to be designed to ensure appropriate
      content that resonates with AMSM. Prevention programs must also be responsive to minority
      AMSM that experience disparities in incidence or lack of access to prevention services. For
      example, Hispanics represent 27% of HIV infections among MSM, but Spanish speaking MSM face
      significant language barriers to accessing HIV services.

      Implementation issues are particularly critical as traditional HIV prevention delivery
      channels have significant limitations for AMSM: few adolescents attend LGBT youth oriented
      programs, schools place many restrictions on discussions of MSM sexual health, and major
      questions remain as to the feasibility of enrolling parents of AMSM into HIV prevention
      programs. With 92% of adolescents (across all races and income levels) going online every
      day, eHealth interventions represent a critical modality for delivering AMSM- specific
      intervention material where youth "are." Combining online recruitment with intervention
      delivery across a range of devices can overcome many access barriers to engagement of AMSM in
      HIV prevention.

      Unfortunately, there will be no single magic solution that will work for all AMSM and public
      health programmers should not continue to deliver the same fixed intervention when a
      participant is not responding. Alternatively, stepped-care strategies increase in intensity
      to meet the needs of those who do not respond to a less intense intervention. Using a
      Sequential Multiple Assignment Randomized Trial (SMART) design, the investigators will
      evaluate the impact of a package of increasingly intensive interventions that have already
      shown evidence of efficacy with diverse adolescent and young adult MSM. The SMART methodology
      is an ideal approach because SMART designs mimic treatment decisions as they are made in
      real-world clinical settings, components of traditional RCTs are embedded within the design,
      and participant data can be used post-hoc to inform decision rules in order to optimize
      implementation. Collectively the investigators brand this package of eHealth interventions as
      the SMART Program (Sexual Minority Adolescent Risk Taking). The SMART Program package
      includes: (1) a universally-delivered, brief, online sexual health education program designed
      for sexual and gender minority youth regardless of whether they are sexually active ("Queer
      Sex Ed") (2) a more intensive online intervention designed for diverse AMSM engaging in HIV
      transmission risk behaviors ("Keep It Up!"); and (3) a more intensive motivational
      interviewing (MI) intervention that will be delivered by MI therapists via online videochat
      ("Young Men's Health Project"). The investigators will evaluate the impact of the SMART
      Program and carefully document implementation context to inform scale out with the following
      aims:

      Aim 1: Evaluate the impact of the SMART Program and its constituent components at reducing
      HIV risk among AMSM. To do this, the investigators will:

        1. Involve diverse AMSM (e.g., Youth Advisory Council) in developmentally adapting existing
           SMART Program components for AMSM ages 13-18 using the ADAPT-ITT framework.

        2. Culturally and linguistically adapt the SMART Program for Spanish speaking Latino AMSM
           in the US.

        3. Embed the SMART Program content into an eHealth platform that will allow access on a
           range of devices and accommodate updates. Perform alpha and beta testing.

        4. Enroll a national sample of 1,938 AMSM who are diverse in terms of race/ethnicity, age,
           geographic region, socioeconomic status, and sexual experience history.

        5. Test the effectiveness of the SMART Program at reducing HIV risk taking behaviors,
           increasing HIV testing, and improving prevention intentions. Consistent with a SMART
           design, the investigators operationalize and power the primary test of effectiveness as
           the first point of randomization, which tests the effectiveness of "Keep It Up!".
           Additional comparisons will allow the investigators to establish the response rate for
           "Queer Sex Ed", examine whether the more intensive "Young Men's Health Project"
           outperforms the less intensive "Keep It Up!" among non-responders to "Queer Sex Ed," and
           determine whether "Young Men's Health Project" provides added benefit to AMSM who did
           not respond to "Keep it Up!".

      Aim 2: Test if the SMART Program has differential efficacy across important sub-groups of
      AMSM. Consistent with the RFA, the investigators will test intervention effects within each
      of the NIH designated health disparity populations (racial/ethnicity minorities, rural, low
      SES), and by age and language (Spanish).

      Aim 3: Evaluate the delivery of the SMART Program nationally to inform scale out and
      determine cost-effectiveness. To reduce the science-practice gap, the investigators will
      utilize mixed methods to identify facilitators and barriers to the implementation of the
      SMART Program using a Hybrid Type 1 Effectiveness-Implementation trial design. The
      investigators will assess process metrics and indicators of its acceptability among AMSM and
      key national stakeholders, scale out feasibility, sustainability potential, and conduct a
      cost analysis to estimate the cost of program implementation compare to monetized benefits.
    

Intervention name(s): Queer Sex Ed; Keep It Up; Keep It Up-Control; Young Men's Health Project
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Comprehensive sexual health education program condition (Informational); Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral); HIV knowledge control condition, attention-matched to KIU (Informational); Motivational enhancement video interviewing condition (Motivational/behavioral)
Other intervention name(s): QSE, SMART Sex Ed; KIU, SMART Squad; KIU-Control, SMART Sex Ed 2.0; YMHP, SMART Sessions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HIV prevention; Adolescent risk-taking behaviors