Title: Keep It Up! 3.0: Study Protocol for a Type III Hybrid Implementation-Effectiveness Cluster-Randomized Trial

BackgroundYoung men who have sex with men are disproportionately impacted by the HIV epidemic in the United States. Few rigorously tested HIV prevention interventions have been developed for young men who have sex with men; previous interventions have primarily focused on in-person programming, with high variability in fidelity. With nearly all young men who have sex with men going online daily, eHealth approaches to prevention may successfully bridge research and practice. Keep It Up! is an eHealth HIV Prevention program for young men who have sex with men. Previous research has demonstrated its effectiveness in reducing sexually transmitted infections and condomless anal sex and efficiency in delivering HIV prevention education. Aim 1 is to compare two strategies for implementing KIU—implementation in community-based organizations and a centralized direct-to-consumer recruitment arm. Aim 2 is to examine adoption characteristics which explain variability in implementation success. Our exploratory aim will develop recommendations and materials for sustainment of KIU after completion of the trial.MethodsThis is a Type III Hybrid Effectiveness-Implementation cluster randomized trial. Using estimates of young men who have sex with men per county in the United States, we identified 113 counties for our sample frame. Using an iterative process, we selected 66 counties to randomize 2:1 to our two strategies in Aim 1. The RE-AIM model for implementation science will be used to drive our outcome measurements in reach, effectiveness, implementation variability, and cost. Outcome measures will be collected from community-based organization staff participants, young men who have sex with men participants, and the technology provider. Our second aim will use mixed-methods research mapped onto the domains of the consolidated framework for implementation research. DiscussionThe trial has launched and is ongoing. This study is among the first to use a cluster randomized trial design in HIV implementation science. In comparing the community-based organization and direct to consumer models for recruitment and ongoing participant engagement, we are examining two strategies which have shown effectiveness in delivering health and technology interventions in the past, but with little base knowledge on their comparative advantages and disadvantages in implementation. The results of the trial will further understanding of the implementation of eHealth prevention interventions.Trial RegistrationNCT03896776, clinicaltrials.gov, 1 April 2019