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Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)

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ClinicalTrials.gov Identifier: NCT04134767
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Emory University
Temple University
Information provided by (Responsible Party):
April M Young, University of Kentucky

Brief Summary:
This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails. This study will compare people in a re-entry health linkage intervention with people who will get overdose education in jail. Everyone will take part in follow-up surveys after release. Participants will be assigned to one of the two groups by chance based on when they are released from jail and when their county is randomly chosen to start the project.By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C, and overdose education to people leaving rural jails will reduce substance use and related harms.

Condition or disease Intervention/treatment Phase
Substance Use HIV Infections HCV Infection Sexually Transmitted Infections (Not HIV or Hepatitis) Overdose, Drug Opioid Use Behavioral: Re-entry Health Linkage Behavioral: Overdose Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped wedge community randomized trial. Each year, 4 counties will be randomized to start 6 months of enrollment into a control condition, followed by 6 months of enrollment into the intervention, with 6 months of follow-up data collection.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) - UH3 PHASE
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Re-entry Health Linkage
In the re-entry health linkage intervention, research staff will: 1) meet with participants in jail before they are released to ask them questions about drug use and related behaviors, access to needed health and social services, and personal goals; they will provide overdose education and help develop a plan for reducing risks and accessing services after release from jail; 2) meet with participants within one week of their release to conduct urine or saliva drug testing, offer HIV and hepatitis C testing and counseling, naloxon, and harm reduction supplies, and to connect participants with needed services; 3) follow up with participants once a month for three months to help participants overcome challenges; and 4) six months after release from jail, contact participants to conduct saliva or urine drug testing. Participants will complete surveys at pre-release, and at 1 week, 3 months and 6 months weeks post-release.
Behavioral: Re-entry Health Linkage
Research staff will: 1) help participants set goals and reduce their health risks by helping them to reflect on personal drug use, sexual relationships, and their consequences in the context of personal values and goals; 2) help link participants to services that they need and want; 3) offer participants the option of HIV and hepatitis C testing, provide the test result, and provide post-test counseling; and 4) provided participants nasal spray naloxone (Narcan) to carry with them in case they encounter someone who has an opioid overdose or in case they have an opioid overdose and a friend can use the naloxone to respond.

Behavioral: Overdose Education
Participants will complete a 20-minute overdose education training (i.e.,an interactive training with animated scenarios and narration on preventing, recognizing, and responding effectively to an opioid OD).

Overdose Education
The investigators will initiate the comparison group in each county six months before the intervention begins. Research staff will conduct a pre-release overdose intervention with the comparison cohort. The comparison group participants will complete an interactive training with animated scenarios and narration on preventing, recognizing, and responding effectively to an opioid OD, accompanied by information about Kentucky's Good Samaritan Law and Naloxone Access Law. Research staff will answer questions after the video. Individuals will receive a Community Resource Guide at this visit. As in the intervention group, comparison group participants will complete surveys at pre-release, and at 1 week, 3 months and 6 months weeks post-release. Surveys will be identical to those delivered to the intervention cohort
Behavioral: Overdose Education
Participants will complete a 20-minute overdose education training (i.e.,an interactive training with animated scenarios and narration on preventing, recognizing, and responding effectively to an opioid OD).




Primary Outcome Measures :
  1. Change in substance use frequency [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item:Self-reported frequency of substance use to get high in past 30 days (continuous variable)

    Source: Rural opioid initiative (ROI Harmonized UG3 Survey) Harmonized UG3 Survey



Secondary Outcome Measures :
  1. Change in engagement in HIV risk behaviors - receptive syringe sharing [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item: Self-reported recent (past 30 days) frequency of using a syringe that had been previously used by someone else (continuous; number and proportion)

    Source: ROI Harmonized UG3 Survey


  2. Change in engagement in HIV risk behaviors - condomless sex [ Time Frame: Measured at 3-month and 6-month survey assessments ]

    Item: Self-reported recent (past 30 days) frequency of condomless anal or vaginal sex (continuous; number and proportion)

    Source: ROI Harmonized UG3 Survey


  3. Change in engagement in HCV risk behaviors - receptive syringe sharing [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item: Self-reported recent (past 30 days) frequency of using a syringe that had been previously used by someone else (continuous; number and proportion)

    Source: ROI Harmonized UG3 Survey


  4. Change in engagement in HCV risk behaviors - shared injection equipment [ Time Frame: easured at 3 months post-release and 6 months post-release ]

    Item: Self-reported recent (past 30 days) frequency of shared cookers, cotton, spoon, or water (continuous; number and proportion)

    Source: ROI Harmonized UG3 Survey


  5. Change in frequency of opioid overdose [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item:Self-reported recent (past 90 days) number of times overdosed (ordinal, continuous)

    Source: Modified from ROI Harmonized UG3 Survey


  6. Change in frequency of receptive syringe sharing [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item:Self-reported recent (past 30 days) frequency of using a syringe that had been previously used by someone else (continuous; number and proportion)

    Source: ROI Harmonized UG3 Survey


  7. Change in frequency of injection drug use [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item: Self-reported recent (past 30 days) frequency of injection (ordinal, continuous)

    Source: ROI Harmonized UG3 Survey


  8. Change in frequency of condomless sex [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item: Self-reported recent (past 30 days) frequency of condomless anal or vaginal sex (continuous; number and proportion)

    Source: ROI Harmonized UG3 Survey


  9. Change in number of days carrying naloxone [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item:Self-reported recent (past 90 days) number of days carrying naloxone (continuous)

    Source: Modified from ROI Harmonized UG3 Survey


  10. Change in evidence-based responses to a witnessed overdose [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item: Self-reported recent (past 90 days) engagement in evidence-based responses (i.e., called 911, gave naloxone, stayed until an ambulance or police arrived, transported person to the hospital) to a witnessed overdose by self or other bystanders (nominal)

    Source: CDC NHBS Supplemental overdose items


  11. Change in number of days on medication for opioid use disorder (MOUD) among participants for whom MOUD is indicated [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item:Self-reported recent (past 90 days) frequency of being on MOUD (continuous)

    Source: Modified from ROI Harmonized UG3 Survey


  12. Change in linkage to follow-up HCV testing among those who test HCV antibody positive [ Time Frame: Measured at 3-month and 6-month survey assessments ]

    Item:Self-reported recent (past 90 days) access to follow-up HCV RNA testing (nominal);

    Source: ROI Harmonized UG3 Survey


  13. Change in linkage to treatment among those who test HCV RNA positive [ Time Frame: Measured at 3 months post-release and 6 months post-release ]

    Item: Self-reported recent (past 90 days) frequency of receiving treatment among those who test RNA positive (binary)

    Source: Modified from ROI Harmonized UG3 Survey


  14. Change in proportion of syringes obtained from syringe service program among participants who inject drugs [ Time Frame: Measured at 3-month and 6-month survey assessments ]

    Item: Self-reported proportion of recent (past 90 days) injections that involved a new, sterile syringe obtained from a syringe service program (continuous, proportion)

    Source: ROI Harmonized UG3 Survey




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be a resident of or anticipate being released to one of the 12 CARE2HOPE counties randomized to intervention or control data collection
  • Have used opioids to get high in the 30 days before they were incarcerated, or have injected any drug to get high during that period
  • Be aged 18 or older
  • Be incarcerated in a local jail and expected to be released in <21 days

OR

  • Be a participant in the CARE2HOPE longitudinal survey who consented to be contacted for future research
  • Be a resident of or anticipate being released to one of the 12 CARE2HOPE counties randomized to intervention or control data collection
  • Be incarcerated in a local jail and expected to be released in <21 days

Exclusion criteria:

  • Previously enrolled in the START-C2H study (i.e., cannot enroll more than once)
  • Not speaking English fluently
  • Residence in or move to a county not randomized to intervention or control data collection within 21 days of release
  • Transfer to prison
  • Being charged with a violent crime (e.g., homicide, murder, rape and sexual assault, robbery, and assault)
  • Having been incarcerated for one year or more

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134767


Contacts
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Contact: Carol R White, MPH 8595622684 crwhit3@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: April Young, PhD    859-218-2090    april.young@uky.edu   
Sponsors and Collaborators
University of Kentucky
National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Emory University
Temple University
Investigators
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Principal Investigator: April M Young, PhD, MPH University of Kentucky
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Responsible Party: April M Young, Associate Professor, Department of Epidemiology, University of Kentucky
ClinicalTrials.gov Identifier: NCT04134767    
Other Study ID Numbers: 52439
4UH3DA044798-03 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from the University of Kentucky are required to be submitted to the University of Washington as part of the NIH-funded Rural Opioid Initiative (ROI) data harmonization project. The University of Washington Data Harmonization Coordinating Center will be harmonizing data across 8 ROI studies in order to create new, harmonized datasets to be used for analyses across the consortium. The University of Washington and other ROI grantees will perform data analyses on these data for peer-reviewed publication. The harmonized datasets will be provided to other ROI grantees as required for analysis and will be considered under the umbrella of mandated DCC activities. No third parties outside of the ROI will be given access to this harmonized data. Harmonized datasets will be built to specific project concept proposals, and all project proposals must be reviewed and approved by the ROI consortium's Publications Working Group before distribution of the customized dataset.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Sexually Transmitted Diseases
Hepatitis C
Drug Overdose
Hepatitis
Liver Diseases
Digestive System Diseases
RNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Substance-Related Disorders
Chemically-Induced Disorders
Genital Diseases, Male
Genital Diseases, Female