Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134767
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Emory 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 or otherwise involved in the criminal justice system. This study will compare people in a health linkage intervention with people who will get overdose (OD) education. Everyone will take part in the baseline and follow-up surveys and receive OD education. Participants will be assigned to one of the two groups by chance based on when they are enrolled to the study and if their county is randomly assigned to an intervention or a comparison condition. By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C virus (HCV), and overdose education to people leaving rural jails or otherwise involved in the criminal justice system 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: Health Linkage Behavioral: Overdose Education Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Case crossover community randomized trial. Six counties will be randomized to start 6 months of enrollment into an intervention condition, and then will shift to 6 months of enrollment into a comparison condition. Six other communities will be assigned to 6 months of a comparison condition, followed by 6 months of enrollment into the intervention. All participants in both the intervention and comparison conditions will be followed for 6 months for 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: Health Linkage
Research staff will: 1) meet with participants in a community setting, by phone, or video call to ask them questions about drug use and related behaviors, access to needed health and social services, and personal goals; provide overdose education and help develop a plan for reducing risks and accessing services; conduct saliva drug testing, offer HIV and hepatitis C testing and counseling, naloxone, and harm reduction supplies, and connect participants with needed services; 2) follow up with participants once a month for three months to help participants overcome challenges; and 3) six months after enrollment to the study, contact participants to conduct saliva drug testing. Participants will complete surveys at baseline, 3 months, and 6 months. The baseline will be conducted in jail for incarcerated participants preparing for re-entry, or in a community setting for those recruited in the community. The 3 and 6-month surveys will be conducted in a community setting.
Behavioral: 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 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Overdose Education

The investigators will initiate the comparison group in Group 2 counties six months before the intervention begins. Research staff will conduct an overdose intervention with the comparison cohort. This will occur pre-release if individual is recruited in jail. The comparison group participants will watch a video 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, the comparison group participants will complete surveys at the baseline (in jail if recruited in jail, in a community setting if recruited in the community), and at 3 months and 6 months after the baseline. Surveys will be identical to those delivered to the intervention cohort.

Behavioral: Overdose Education
Participants will complete a 10-minute overdose education training video 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 and 6 months after the baseline ]

    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 and 6 months after the baseline ]

    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 months and 6 months after the baseline ]

    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 and 6 months after the baseline ]

    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: Measured at 3 months and 6 months after the baseline ]

    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 and 6 months after the baseline ]

    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 and 6 months after the baseline ]

    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 and 6 months after the baseline ]

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

    Source: ROI Harmonized UG3 Survey


  8. Change in number of days carrying naloxone [ Time Frame: Measured at 3 months and 6 months after the baseline ]

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

    Source: Modified from ROI Harmonized UG3 Survey


  9. Change in evidence-based responses to a witnessed overdose [ Time Frame: Measured at 3 months and 6 months after the baseline ]

    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


  10. 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 and 6 months after the baseline ]

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

    Source: Modified from ROI Harmonized UG3 Survey


  11. Change in linkage to follow-up HCV testing among those who test HCV antibody positive [ Time Frame: Measured at 3 months and 6 months after the baseline ]

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

    Source: ROI Harmonized UG3 Survey


  12. Change in linkage to treatment among those who test HCV RNA positive [ Time Frame: Measured at 3 months and 6 months after the baseline ]

    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


  13. Change in proportion of syringes obtained from syringe service program among participants who inject drugs [ Time Frame: Measured at 3 months and 6 months after the baseline ]

    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.


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

Inclusion Criteria:

  • Be aged 18 or older; and
  • A resident of one of the 12 CARE2HOPE counties randomized to intervention or control data collection; and
  • Have used opioids to get high in the past 30 days or have injected any drug to get high during that same period (if incarcerated at home under digital monitoring program or on probation or parole: have used opioids to get high or injected any drug to get high in 30 days before the date of incarceration or start of the probation or parole term); and
  • Have been recently involved in the criminal justice system defined as being arrested, under pre-trial supervision, on probation or parole, or individuals who are incarcerated at home under an electronic monitoring program (i.e., digital jail) in the past 30 days.

OR

  • Be a resident of or anticipate being released to one of the 12 CARE2HOPE counties randomized to intervention or control data collection; and
  • 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; and
  • Be aged 18 or older; and
  • 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; and
  • Be a resident of or anticipate being released to one of the 12 CARE2HOPE counties randomized to intervention or control data collection; and
  • 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; and
  • Be aged 18 or older; and
  • Be incarcerated in a local jail and expected to be released in <21 days

Exclusion criteria:

  1. Previously enrolled in the START-C2H study (i.e., cannot enroll more than once)
  2. Not speaking English fluently
  3. Residence in or move to a county not randomized to intervention or control data collection within 21 days of release
  4. Transfer to prison
  5. Being charged with a violent crime (e.g., homicide, murder, rape and sexual assault, robbery, and assault)
  6. 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
Layout table for location contacts
Contact: Carol R White, MPH 8595622684 crwhit3@uky.edu

Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Principal Investigator: April M Young, PhD, MPH University of Kentucky
Layout table for additonal information
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 15, 2021
Last Verified: January 2021
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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