• Hannah K Knudsen, Mari-Lynn Drainoni, Louisa Gilbert, Timothy R Huerta, Carrie B Oser, Alison M Aldrich, CampbellAimee N CANCColumbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA. Electronic address: anc2002@cumc.columbia.edu., Erika L Crable, Bryan R Garner, LaShawn M Glasgow, Dawn Goddard-Eckrich, Katherine R Marks, Ann Scheck McAlearney, Emmanuel A Oga, Ariel L Scalise, and Daniel M Walker.
• Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Room 204, Lexington, KY, 40508, USA. Electronic address: hannah.knudsen@uky.edu.
• Drug Alcohol Depend. 2020 Dec 1; 217: 108330.

BackgroundIn response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity.MethodsHCS measures key domains of the internal and external CTH implementation context with repeated annual surveys and qualitative interviews with community coalition members and key stakeholders. Core constructs of fidelity include dosage, adherence, quality, and program differentiation-the adaptation of the CTH intervention to fit each community's needs. Fidelity measures include a monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes. Training and technical assistance delivered by the research sites to the communities are tracked monthly.DiscussionTo help attenuate the nation's opioid epidemic, the adoption of EBPs must be increased in communities. The HCS represents one of the largest and most complex implementation research experiments yet conducted. Our systematic examination of implementation context and fidelity will significantly advance understanding of how to best evaluate community-level implementation of EBPs and assess relations among implementation context, fidelity, and intervention impact.Copyright © 2020 Elsevier B.V. All rights reserved.

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