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

NCT04134767 | Completed Results DMC

• 2 other identifiers: 524394UH3DA044798-03
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use; HIV Infections; HCV Infection; Sexually Transmitted Infections (Not HIV or Hepatitis); Overdose, Drug; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Change in Substance Use Frequency

  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

  assessed at 3 months and 6 months after the baseline, change at 3 months reported

Secondary Outcomes (13)

• Change in Engagement in HIV Risk Behaviors - Receptive Syringe Sharing

  assessed at 3 months and 6 months after the baseline, change at 3 months reported

• Change in Engagement in HIV Risk Behaviors - Condomless Sex

  assessed at 3 months and 6 months after the baseline, change at 3 months reported

• Change in Engagement in HCV Risk Behaviors - Receptive Syringe Sharing

  assessed at 3 months and 6 months after the baseline, change at 3 months reported

• Change in Engagement in HCV Risk Behaviors - Shared Injection Equipment

  assessed at 3 months and 6 months after the baseline, change at 3 months reported

• Change in Frequency of Opioid Overdose

  assessed at 3 months and 6 months after the baseline, change at 3 months reported

Study Arms (2)

Health Linkage

EXPERIMENTAL

Research staff will: 1) meet with participants in person or virtually to ask questions about drug use and related behaviors, service access, and personal goals; provide overdose education and help develop a plan for reducing risks and accessing services; conduct drug testing, offer HIV and HCV testing and counseling, naloxone, and harm reduction supplies, and connection with needed services; 2) follow up with participants monthly for three months to help overcome challenges; and 3) six months post-enrollment, contact participants to conduct drug testing. Participants will complete surveys at baseline, 3 months, and 6 months

Behavioral: Health Linkage; Behavioral: Overdose Education

Overdose Education

OTHER

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

Interventions

Health Linkage BEHAVIORAL

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.

Health Linkage

Overdose Education BEHAVIORAL

Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Health Linkage; Overdose Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be aged 18 or older; and
• A resident of one of the 12 CARE2HOPE (C2H) 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 incarcerated in jail or prison, out on bond, under warrant for arrest, arrested, under pre-trial supervision, on probation or parole, court-involved, or individuals who are incarcerated at home under an electronic monitoring program (i.e., digital jail) in the past 30 days.
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• April M Young: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Appalachian Regional Commission: collaborator
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator
• Centers for Disease Control and Prevention: collaborator
• Emory University: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (2)

• Kesich Z, Ibragimov U, Komro K, Lane K, Livingston M, Young A, Cooper HLF. "I'm not going to lay back and watch somebody die": a qualitative study of how people who use drugs' naloxone experiences are shaped by rural risk environment and overdose education/naloxone distribution intervention. Harm Reduct J. 2023 Nov 10;20(1):166. doi: 10.1186/s12954-023-00900-z.

  PMID: 37946233 DERIVED

• Kesich Z, Ibragimov U, Komro K, Lane K, Livingston M, Young A, Cooper H. "I'm not going to lay back and watch somebody die": A qualitative study of how people who use drugs' naloxone experiences are shaped by rural risk environment and naloxone distribution/overdose education intervention. Res Sq [Preprint]. 2023 Sep 6:rs.3.rs-3310319. doi: 10.21203/rs.3.rs-3310319/v1.

  PMID: 37720025 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; HIV Infections; Hepatitis C; Sexually Transmitted Diseases; Hepatitis; Drug Overdose

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Liver Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prescription Drug Misuse; Drug Misuse

Limitations and Caveats

Because of the impact of the COVID-19 pandemic, we were unable to accrue the target number of participants in either the intervention counties or the comparison counties. As a result, analyses of intervention effectiveness are underpowered. Further, data related to the follow-up HCV testing outcome should be interpreted with caution; measuring RNA-based follow-up testing for HCV is too nuanced to capture via a survey item, as it can be easily misinterpreted by participants.

Results Point of Contact

• Title: Dr. Hannah LF Cooper
• Organization: Rollins School of Public Health at Emory University

hcoope3@emory.edu

404-727-0261

Study Officials

• April M Young, PhD, MPH

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Epidemiology

Model Details: Community randomized trial. Six counties will be randomized to start 6 months of enrollment into an intervention condition. Six other communities will be assigned to 6 months of a comparison condition. All participants in both the intervention and comparison conditions will be followed for 6 months for data collection.

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 22, 2019
• Study Start: November 15, 2019
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)