A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
Condition: HIV/AIDS; Gonorrhea; Chlamydia
MeSH terms: Gonorrhea
Study type: Interventional

Summary: 
      This study evaluates and compares two implementation strategies of an online HIV prevention
      intervention: Strategy 1 in which community-based organizations apply, and are selected, for
      funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is
      a "direct-to-consumer" model where centralized staff at Northwestern University recruit
      participants nationally through online advertising campaigns and manage engagement.
    

Detailed description: 
      Substantial effort has gone into developing and testing the efficacy of eHealth HIV
      prevention interventions, but these interventions will not affect the spread of the epidemic
      unless implemented effectively to reach the most at-risk populations. Despite emerging
      evidence that eHealth approaches can be highly effective in reducing HIV risk or improving
      care engagement, implementation requirements do not fit within established strategies for
      public health scale up, leaving it an open question as to how to bring these programs into
      practice. To date, little to no implementation science has examined strategies to effectively
      scale up eHealth HIV prevention programs.

      The overarching goal of this study is to address this need by developing and evaluating novel
      strategies for implementing eHealth HIV prevention programs. Keep It Up! (KIU!) is an online
      program proven to reduce HIV risk among diverse young men who have sex with men (YMSM). KIU!
      was designed for YMSM who just tested HIV negative to keep it up and maintain negative status
      by reducing risk and enacting protections. Strong evidence of effectiveness on behavioral
      (decreased condomless sex) and biomedical outcomes (reduced STI incidence) makes KIU! an
      ideal eHealth intervention for implementation research. Lessons learned from KIU!
      implementation will set the pathway for implementing the many HIV eHealth programs currently
      undergoing efficacy testing.

      Implementation strategies need to be evaluated using rigorous research designs. Through
      formative research with community-based organizations (CBOs), health departments, the CDC,
      and researchers, the investigators have identified two pragmatic implementation strategies
      that will be evaluated and compared:

      In Strategy 1, CBOs apply for, and are selected for, funding to deliver KIU! through current
      HIV testing programs. Because CBOs do not have the capacity to host the technology, KIU! is
      hosted centrally at Northwestern and deployed by local CBO staff. Training and coaching of
      CBO staff on how to use the technology and integrate it into routine HIV testing is provided
      through capacity building assistance.

      Strategy 2 is a "direct-to-consumer" (DTC) model where centralized staff at Northwestern
      primarily recruit participants nationally through online advertising campaigns and manage
      participants' engagement. HIV/STI testing kits are shipped directly to YMSM, and upon
      documentation of an HIV negative test result, participants are delivered KIU! This DTC model
      has been widely adopted in technology dissemination but it is innovative in terms of
      implementation of HIV prevention programs.

      The investigators will accomplish the goal to inform eHealth intervention implementation with
      two specific aims:

      Aim 1: Compare two implementation strategies using a quasi-experimental trial.

      The investigators selected a type III hybrid implementation-effectiveness design, which
      prioritizes empirical comparison of implementation strategies while also collecting evidence
      of effectiveness. KIU will be delivered using Strategy 1 (CBOs) in 22 counties for two years;
      simultaneously, the investigators will deliver KIU nationally using Strategy 2 (DTC). YMSM
      participants in the DTC strategy will be matched to CBO strategy participants based on
      post-hoc propensity scores. Implementation and effectiveness outcome data will be collected
      from YMSM participants, CBOs, and the technology vendor. The primary outcomes are public
      health impact (defined as reach X effectiveness) and cost per infection averted, a key
      component of CDC decision making about which HIV prevention programs will be supported. There
      continues to be equipoise for the trial (i.e., either strategy could be superior). Because
      implementation success can be defined differently for different stakeholders, the
      investigators will also continue to collect and report as secondary outcomes multiple metrics
      of reach, effectiveness, and implementation.

      Aim 2: Examine adoption characteristics that explain variability in implementation outcomes.

      There is remarkable variability in implementation success when CBOs adopt evidence-based
      interventions. The investigators will seek to explain variability in implementation success
      across counties by conducting mixed-methods research on the domains from the consolidated
      framework for implementation research (CFIR), such as county characteristics, adaptations,
      support from organization leadership, and approach to planning adoption. Data on CFIR
      characteristics will be collected through administrative data, surveys, and telephone
      interviews with key stakeholders.

      In addition to these 2 specific aims, the investigators will explore sustainment of KIU! at
      the completion of the study. CBOs will be provided with materials to facilitate applying for
      external funding to continue to provide KIU! after study completion, including an Impact Tool
      to estimate local impact and costs. The investigators will also examine factors that predict
      applying for funding and ongoing sustainment. For Strategy 2, through consultation with the
      CDC, capacity building assistance providers, health departments, and small businesses
      involved in Health 2.0 initiatives, the investigators will examine models for ongoing
      sustainment of the DTC model.
    

Intervention name(s): Keep It Up! 3.0
Intervention type(s): Behavioral
Intervention description(s): KIU! is an online HIV prevention intervention developed for high-risk young men who have sex with men (YMSM) who recently tested HIV negative. Content was developed in collaboration with YMSM-serving CBOs and subjected to usability testing with diverse YMSM. The Information-Motivation-Behavioral Skills model and eLearning principles guided development of highly interactive, engaging, and culturally relevant health messages. KIU! involves 7 modules completed across 3 sessions, totaling ~1 hour of main content, plus 2 booster sessions at 6- and 12-week follow-ups. Each module is based on a setting or situation relevant to YMSM (e.g., connecting to the gay community and meeting guys through apps), with developmentally appropriate behavior change content embedded. KIU! uses diverse delivery methods (e.g. videos, animation, games) to address HIV knowledge gaps, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors.
Other intervention name(s): KIU! 3.0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention