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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    960
  • sponsor
    University of Kentucky
Updated on 27 January 2021
opioid
hepatitis
substance use
hepatitis c
HIV Vaccine

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.

Description

The overarching objective of this study is to determine the effectiveness of an evidence-based community response project using a case crossover 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 or otherwise recently involved in the criminal justice system (out on bond, under warrant for arrest, arrested, on pre-trial supervision, probation or parole, under home incarceration with digital monitoring). This study will compare people in a health navigation intervention with a comparison group of people who will get overdose education. 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 substance use disorder (SUD) and increase engagement in the SUD care cascade; reduce vulnerability to HIV, sexually transmitted infections (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 or otherwise involved in the criminal justice system. 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 originally targeted incarcerated people preparing to leave correction facilities. The investigators will continue to target individuals who are incarcerated but also expand the target population to people who are involved in other parts of the criminal justice system (e.g. those on probation, parole or pre-trial supervision; who were arrested; individuals under home incarceration with digital monitoring [an ankle monitoring program]). Individuals who are not incarcerated will be recruited in the communities. 3) All intervention sessions will be conducted in the community setting (post-release for those recruited in jails). 4) 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); 5) To enhance START's impact on drug use and HIV/HCV-related harms (e.g., drug injection frequency), the investigators will integrate the NIDA Standard HIV intervention into START, including rapid HIV and HCV antibody testing and counseling. In addition, START interventionists will distribute harm reduction supplies at the first intervention session with people who inject drugs (PWID). The NIDA Standard has been demonstrated to reduce drug use frequency, high-risk injection practices, and sexual risk; 6) 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), at their first intervention session. Interventionists will encompass OD in risk reduction motivational interviewing. 7) To accommodate participants who are not able to visit the study office in-person, data collection and intervention sessions will be conducted remotely via phone or videoconferencing.

CARE2HOPE covers the following counties: Rowan, Bath, Morgan, Menifee, Elliott, Lee, Owsley, Wolfe, Perry, Letcher, Leslie, Knott. Research staff will recruit participants from a) jails, b) Probation, Parole and Pre-Trial Services c) digital jails (i.e. home incarceration with digital monitoring programs); d) peer referral; e) existing participants in CARE2HOPE and other University of Kentucky studies, including PROUD-R2 (Peer-Based Retention of People Who Use Drugs in Rural Research) and SNAP (Social Networks among Appalachian People), who have consented to be contacted to learn about future studies; f) harm reduction and social service programs serving people who use drugs; and g) community-based organizations serving the 12 CARE2HOPE counties. Recruitment in jails will involve jails either located in CARE2HOPE counties or counties that have contracts with them to incarcerate their residents. The intervention sessions and data collection will be delivered by research staff called "Rural Health Navigators" or "REHNs". Participants are assigned to one of the two groups by chance based on when they are enrolled to the study and when their county is randomly chosen to start the project. Counties were originally randomized using a stepped wedge design. The counties were then randomized in November 2020, accounting for a new study design. The investigators randomized 12 study counties to two groups. In Months 1-6 six counties randomly assigned to Group 1 will recruit participants to the intervention, while in the remaining six counties (Group 2) the participants will be enrolled into a control condition. In Months 7-12, Group 1 counties will shift to the control group, and Group 2 counties will receive the intervention. In Months 13-18 the investigators will conduct follow-up assessments in all counties. The investigators anticipate an average enrollment of 40 participants per county per arm, with a total final sample size for the trial of 960 (n=480intervention, n=480comparison) . After a county has met its target enrollment in both conditions, the intervention and comparison activities will no longer be offered in that county.

Details
Condition HIV infection, Immunodeficiency, Hepatitis C, Hepatitis C virus, Venereal disease, Sexually Transmitted Diseases (STDs), Substance Use, Sexually Transmitted Infection, Opioid Use, HCV Infection, Narcotic Use, Primary Immunodeficiency Disorders, HIV Infections, Overdose, Drug, sexually transmitted disease, human immunodeficiency virus, hiv disease, sexually transmitted diseases, sexually transmitted infections, Overdose, Drug, Overdose, Drug
Treatment Re-entry Health Linkage, Overdose Education, Health Linkage
Clinical Study IdentifierNCT04134767
SponsorUniversity of Kentucky
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Sexually Transmitted Diseases (STDs) or Immunodeficiency or Venereal disease or Substance Use or Primary Immunodeficiency Disorders or HIV Infections ...?
Do you have any of these conditions: Venereal disease or sexually transmitted disease or HCV Infection or Sexually Transmitted Diseases (STDs) or Opioid Use or hiv disease or Hepatitis C ...?
Do you have any of these conditions: Sexually Transmitted Diseases (STDs) or Opioid Use or Substance Use or sexually transmitted disease or Hepatitis C virus or hiv disease or HIV infecti...?
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 incarcerated in jail or prison, out on bond, under warrant for arrest, 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
Be incarcerated in a local jail and expected to be released in <21 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

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
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