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

• ClinicalTrials.gov Identifier: NCT04134767
• Recruitment Status: Not yet recruiting
• First Posted: October 22, 2019
• Last Update Posted: October 22, 2019
• Sponsor: University of Kentucky
• 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

Study Description

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

Detailed Description:

The overarching objective of this study is to determine the effectiveness of an evidence-based community response project using a stepped-wedge community randomized trial. Specifically, the investigators will test the effect of an intervention to reduce substance use and related harms among people re-entering the community from rural jails. This study will compare people in a re-entry health navigation intervention with a comparison group of people who will get overdose education in jail. Everyone will take part in follow-up surveys for up to 6 months after release. The intervention is a health navigation intervention designed to reduce SUD and increase engagement in the SUD care cascade; reduce vulnerability to HIV, STIs, and HCV and increase engagement in the HIV, STI, and HCV care cascades; and reduce vulnerability to overdose deaths among adults who use drugs and are leaving local jails. The intervention is based on enhancements to START, a CDC-recognized, evidence-based, individual-level intervention designed to reduce HIV/STI/HCV risk.

START core components: (1) Hold pre- and post-release program sessions with clients transitioning back to the community from a correctional setting; (2) Use a client-focused incremental risk reduction approach; (3) Use assessment & documentation tools to provide structure; (4) Hire program staff that are familiar with HIV/STIs/HCV prevention and with the specific needs of people being released; (5) Staff /client relationships must be maintained post-release; (6) Conduct enrollment and schedule two pre-release program sessions within 60 days of a client's release that: a. give HIV/STI/HCV information; b. review client's HIV/STI/HCV risk; c. identify transitional needs; d. develop a personalized risk reduction and transitional plan; e. make facilitated referrals; (7) Schedule four post-release sessions to review and update the risk reduction/transitional plan(s) and provide facilitated referrals; (8) Provide condoms at each post-release session; (9) Actively maintain contact with clients.

The investigators will modify START a priori as follows: 1) Though originally designed for young men, START has been successfully applied to women leaving correctional settings. The investigators will implement START with all genders; 2) START's post-release sessions primarily occurred in homes and community venues, such as restaurants. Staff who will deliver START will be stationed primarily within the local department of health (DOH); 3) To enhance START's impact on drug use and HIV/HCV-related harms (e.g., IDU frequency),the investigators will integrate the NIDA Standard HIV intervention into START, including rapid HIV and HCV antibody testing and counseling. The NIDA Standard has been demonstrated to reduce drug use frequency, high-risk injection practices, and sexual risk; 4) START was not designed to reduce overdoses. The investigators will integrate an interactive training with animated scenarios and narration on preventing, recognizing, and responding effectively to an opioid OD. Participants in the intervention group will receive naloxone (not all participants will get naloxone),either upon release or at their first post-release session. Interventionists will encompass OD in risk reduction motivational interviewing.

CARE2HOPE covers the following counties: Rowan, Bath, Morgan, Menifee, Elliott, Lee, Owsley, Wolfe, Perry, Letcher, Leslie, Knott. Research staff will recruit participants at jails serving the 12 CARE2HOPE counties; these jails are either located in CARE2HOPE counties or counties have contracts with them to incarcerate their residents. The intervention sessions and data collection will be delivered by research staff called "Re-entry Health Navigators" or "REHNs". Participants are 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. In August 2019, the investigators randomized each of the 12 study counties to a start date. Four counties will be randomized to start the intervention each year. In each wave, four counties will be randomized to start 6 months of enrollment into a control condition, followed by 6 months of enrollment into the intervention condition, with follow-up data collection on both extending 6 months beyond enrollment. The investigators anticipate an average enrollment of 25 participants per county per quarter, with a total final sample size for the trial of 1200 (n=600 intervention, n=600 control). After a county has met its target enrollment in both conditions, the intervention and comparison activities will no longer be offered in that county.

Study Design

• 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
• Estimated Study Start Date: November 1, 2019
• Estimated Primary Completion Date: June 1, 2022
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

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).

Outcome Measures

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 3 months (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 30 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 30 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 30 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 30 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 30 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 30 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 30 days) injections that involved a new, sterile syringe obtained from a syringe service program (continuous, proportion)

    Source: ROI Harmonized UG3 Survey

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

United States, Kentucky

University of Kentucky

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

• Principal Investigator: April M Young, PhD, MPH; University of Kentucky

More 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
• Last Update Posted: October 22, 2019
• Last Verified: October 2019

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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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; Genital Diseases, Male; Genital Diseases, Female; Substance-Related Disorders; Chemically-Induced Disorders; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents