Keep it up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial

Brian Mustanski*, Rana Saber, Justin Patrick Jones, Kathryn Macapagal, Nanette Benbow, Dennis H. Li, C. Hendricks Brown, Patrick Janulis, Justin D. Smith, Elizabeth Marsh, Bruce R. Schackman, Benjamin P. Linas, Krystal Madkins, Gregory Swann, Abigael Dean, Emily Bettin, Alexandra Savinkina

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Background: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. Methods: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. Discussion: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation.

Original languageEnglish (US)
Article number107134
JournalContemporary Clinical Trials
Volume127
DOIs
StatePublished - Apr 2023

Funding

This work is supported by the National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), and Office of the Director (OD) of the National Institutes of Health [R01MH118213].Research reported in this publication was supported by the National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), and Office of the Director (OD) of the National Institutes of Health under Award Number R01 MH118213. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We would like to thank the staff at the 22 CBOs at which KIU! is being implemented as well as the many community partners who are assisting in recruitment for the DTC arm. Additionally, we thank the following centers and institutions for their immeasurable contributions to our trial: Center for Prevention Implementation Methodology for Drug Abuse and HIV; Prevention Science and Methodology Group; Third Coast Center for AIDS Research; Research Application Design and Development, Institute for Sexual and Gender Minority Health and Wellbeing; the Institute for Sexual and Gender Minority Health and Wellbeing, Feinberg School of Medicine, and the Department of Medical Social Sciences at Northwestern University; Center for Health Economics of Treatment Interventions for Substance Use Disorders, HCV, and HIV (CHERISH); Department of Population Health Sciences at Weill Cornell Medicine; Boston Medical Center; and Erik Munson of Clinical Laboratory Science at Marquette University. This work is supported by the National Institute of Mental Health (NIMH) , National Institute on Drug Abuse (NIDA) , and Office of the Director (OD) of the National Institutes of Health [ R01MH118213 ]. Research reported in this publication was supported by the National Institute of Mental Health (NIMH) , National Institute on Drug Abuse (NIDA) , and Office of the Director (OD) of the National Institutes of Health under Award Number R01 MH118213 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We would like to thank the staff at the 22 CBOs at which KIU! is being implemented as well as the many community partners who are assisting in recruitment for the DTC arm. Additionally, we thank the following centers and institutions for their immeasurable contributions to our trial: Center for Prevention Implementation Methodology for Drug Abuse and HIV; Prevention Science and Methodology Group; Third Coast Center for AIDS Research; Research Application Design and Development, Institute for Sexual and Gender Minority Health and Wellbeing; the Institute for Sexual and Gender Minority Health and Wellbeing, Feinberg School of Medicine, and the Department of Medical Social Sciences at Northwestern University; Center for Health Economics of Treatment Interventions for Substance Use Disorders, HCV, and HIV (CHERISH); Department of Population Health Sciences at Weill Cornell Medicine; Boston Medical Center; and Erik Munson of Clinical Laboratory Science at Marquette University.

Keywords

  • Cluster randomized trial
  • HIV prevention
  • Implementation science
  • Study protocol
  • Type III hybrid implementation-effectiveness
  • eHealth

ASJC Scopus subject areas

  • Pharmacology (medical)

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