JCOIN Study Registration Form Each JCOIN study must be registered. Please register your study after NIDA has approved your protocol. Step 1 of 2 0% Descriptive Title of Research Study* Research Hub*National Institutes of HealthCoordinating and Translation Center (CTC) (Contact PI: Faye Taxman)Methodology and Advanced Analytics Resource Center (MAARC) (Contact PI: John Schneider)Baystate Medical Center (Contact PI: Peter Friedmann)Brown University (Contact PI: Rosemarie Martin)Chestnut Health Systems (Contact PI: Chris Scott)University of Chicago (Contact PI: Harold Pollack)Columbia University (Contact PI: Katherine Elkington)Friends Research Institute (Contact PI: Michael Gordon)Indiana University (Contact PI: Matthew Aalsma)University of Kentucky (Contact PI: Michele Staton)New York University (Contact PI: Joshua Lee)Texas Christian University (Contact PI: Danica Knight)Yale University (Contact PI: Emily Wang)Other (Please Specify Below)Hub/Core Name* Name of Lead Investigator for this Protocol* First Last Lead Investigator’s Institution* Lead Investigator’s Email* Lead Investigator’s Phone Number*Project Manager's Name First Last Project Manager's Institution Project Manager's E-mail Address Project Manager's Phone NumberNIH Grant NumberIf Applicable Clinicaltrials.gov Registration NumberIf Applicable Study Goals*2-3 Sentences, Plain Language30-Line Descriptive Abstract*JCOIN Cluster(s)*Select All That Apply State Policy Rollouts MOUD CER Navigation/Linkage Juvenile Justice Organizational Level Interventions Accelerator Studies - Surveys Accelerator Studies - Modeling and Data Collection Accelerator Studies - Other MAARC Projects CTC D&I Trials Rapid Response Projects Other Other/Specify* Study Type* Comparative Effectiveness Cohort Study Observational Study/Natural Experiment Survey Modeling Pilot Study Program Evaluation Dissemination Trial Other (Please Specify Below) Other/Specify* For Modeling Studies: Please Specify Model Typology*Select All That Apply Agent-Based Model Predictive Analytics/Machine Learning Geospatial Network Model Other (Please Specify Below) Other/Specify* Implementation Focus* Effectiveness only Hybrid 1 (Effectiveness with some Implementation measures) Hybrid 2 (Effectiveness and Implementation Measures) Hybrid 3 (Implementation with some Effectiveness Measures) Implementation/Dissemination only N/A (Not an Implementation or Effectiveness Trial) Expected Study Start Date* MM slash DD slash YYYY Expected Study End Date* MM slash DD slash YYYY DSMB Category*TBD/Coming SoonDefinition of a Serious Adverse Event (SAE) for this Study*Please Enter N/A if Study is Not a Clinical TrialDefinition of a Adverse Event (AE) for this Study* Please Enter N/A if Study is Not a Clinical TrialUnit(s) of Analysis* Client/Individual Staff/Provider Organization/Agency Community Other (Please specify below) Other/Specify* Name the Intervention to be Tested* Brief Description of the Intervention*Number of Study Arms012345678910Brief Description of Study Arm 1Brief Description of Study Arm 2Brief Description of Study Arm 3Brief Description of Study Arm 4Brief Description of Study Arm 5Brief Description of Study Arm 6Brief Description of Study Arm 7Brief Description of Study Arm 8Brief Description of Study Arm 9Brief Description of Study Arm 10MOUD Available to Study SubjectsWhether in corrections setting, in community, or as part of the study (if applicable, select all that apply) Methadone Suboxone (tablet) Suboxone (film) XR-B (Sublocade, injectable) XR-B (Brixadi, injectable) Naltrexone (tablet) XR-NTX (Vivitrol, injection) Total Targeted Number of Subjects to be EnrolledIf ApplicablePlease enter a number greater than or equal to 0.Targeted Number of Clients/Individuals to be EnrolledIf ApplicablePlease enter a number greater than or equal to 0.Targeted Number of Agency Staff/ProvidersIncludes Administrators; If ApplicablePlease enter a number greater than or equal to 0.Targeted Number of Other SubjectsIf ApplicablePlease enter a number greater than or equal to 0.Other Subjects (Please Specify/Describe) Estimated Proportion of Women% of All Subjects; If ApplicablePlease enter a number from 0 to 100.Subject Participation DurationProvide the Number of Months in the Active Intervention PeriodPlease enter a number greater than or equal to 0.Primary Outcomes*Secondary Outcomes*Client/Individual-Level Data SourcesSelect All That Apply Face-to-Face Interviews/Assessments/Surveys Telephone Interviews/Assessments/Surveys EMA Data Biological Specimens Administrative Data - Justice Administrative Data - Treatment/Healthcare Focus Groups Other (Please Specify Below) Other (Please Specify)* Staff/Provider/Administrator-Level Data SourcesSelect all that apply Face-to-Face Interviews/Assessments/Surveys Administrative Data - Justice Administrative Data - Treatment/Healthcare Focus Groups Activity Logs Other (Please Specify Below) Other (Please Specify)* Organizational-Level Data SourcesSelect all that apply Key Informant Interviews/Assessments/Surveys/System Mapping Administrative Data - Justice Administrative Data - Treatment/Healthcare DATCAP/COINS or Similar Costing Inventory Other (Please Specify Below) Other (Please Specify)* Upload your List of Participating Justice Agencies Serving as Study SitesDownload the template (.xlsx). In your document (xlxs, xls, csv, doc, docx, or pdf), please include the following for EACH of the participating Justice Agencies: • Agency Name* • Agency Type* • Agency Contact Information (name, e-mail, address, and phone number) [Optional] • Agency Address (street address, city, state, zip)* Please be sure to complete this for each agency. We are aiming to be able to map study sites. Note: Including contact information is optional.Accepted file types: csv, doc, pdf, xls, xlsx, docx, Max. file size: 256 MB.Upload your List of Participating Health/Treatment Agencies Serving as Study SitesDownload the template (.xlsx). In your document (xlxs, xls, csv, doc, docx, or pdf), please include the following for EACH of the participating Health/Treatment Agencies: • Agency Name* • Agency Type* • Agency Contact Information (name, e-mail, address, and phone number) [Optional] • Agency Address (street address, city, state, zip)* Please be sure to complete this for each agency. We are aiming to be able to map study sites. Note: Including contact information is optional.Accepted file types: csv, doc, pdf, xls, xlsx, docx, Max. file size: 256 MB.Upload your List of Recruitment Sites/Other Agencies Serving as Study Sites. Study Site Refers to Where Enrollment Will Occur or the Intervention Will Be Delivered (If Applicable).Download the template (.xlsx). In your document (xlxs, xls, csv, doc, docx, or pdf), please include the following for EACH of the participating Recruitment Sites/Other Agencies: • Recruitment Site/Other Agency Name* • Recruitment Site/Other Agency Type (Specify)* • Recruitment Site/Other Agency Contact Information (name, e-mail, address, and phone number) [Optional] • Recruitment Site/Other Agency Address (street address, city, state, zip)* Please be sure to complete this for each agency. We are aiming to be able to map study sites. Note: Including contact information is optional. Accepted file types: csv, doc, pdf, xls, xlsx, docx, Max. file size: 256 MB.Full Study Protocol Upload (PDF)*Accepted file types: doc, docx, txt, pdf, Max. file size: 256 MB. Δ
