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

HIV Infections Clinical Trial

Official title:

Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) - UH3 PHASE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134767
• Other study ID #: 52439
• Secondary ID: 4UH3DA044798-03
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: October 27, 2022

Study information

• Verified date: December 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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, court-involved, or 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 Center for Disease Control-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 out on bond, under warrant for arrest, arrested, court-involved; those on probation, parole or pre-trial supervision; and 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 (National Institute on Drug Abuse) 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. 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.

Originally, the CARE2HOPE trial gathered data in three waves: at baseline, before the intervention had been delivered in the intervention counties; at three months post baseline, just after the intervention had been completed; and at six months post baseline, to support analyses of intervention decay. On June 24th 2022, the CARE2HOPE Data Safety Monitoring Board (DSMB) met to determine whether the trial could limit data collection to two waves - baseline and the 3-month follow up - and still ethically meet its aims. The DSMB voted to drop the six-month wave of data collection recognizing that:

1. Ending data collection at 3 months permitted the trial to test intervention effectiveness, given that the intervention itself lasted <3 months.

2. The shortened follow-up period allowed the trial to continue to enroll new participants for an additional 3 months, thus increasing capacity to generate a sufficient sample size to power analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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

Related Conditions & MeSH terms

• Communicable Diseases
• Drug Overdose
• HCV Infection
• Hepatitis C
• HIV Infections
• Infections
• Opioid Use
• Overdose, Drug
• Sexually Transmitted Diseases
• Sexually Transmitted Infections (Not HIV or Hepatitis)
• Substance Use
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (6)

Lead Sponsor	Collaborator
April M Young	Appalachian Regional Commission, Centers for Disease Control and Prevention, Emory University, National Institute on Drug Abuse (NIDA), Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Engagement in HIV Risk Behaviors - Receptive Syringe Sharing	Item: Self-reported recent (past 30 days) frequency of engaging in the HIV risk behavior of using a syringe that had been previously used by someone else (continuous; number and proportion); Source: ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Engagement in HIV Risk Behaviors - Condomless Sex	Item: Self-reported recent (past 30 days) frequency of condomless anal or vaginal sex (continuous; number and proportion); Source: ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Engagement in HCV Risk Behaviors - Receptive Syringe Sharing	Item: Self-reported recent (past 30 days) frequency of engaging in the hepatitis C risk behavior of using a syringe that had been previously used by someone else (continuous; number and proportion) Source: ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Engagement in HCV Risk Behaviors - Shared Injection Equipment	Item: Self-reported recent (past 30 days) frequency of shared cookers, cotton, spoon, or water (continuous; number and proportion); Source: ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Frequency of Opioid Overdose	Item:Self-reported recent (past 90 days) number of times overdosed (ordinal, continuous); Source: Modified from ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Frequency of Receptive Syringe Sharing	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	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Frequency of Injection Drug Use	Item: Self-reported recent (past 30 days) frequency of injection (ordinal, continuous); Source: ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Number of Days Carrying Naloxone	Item:Self-reported recent (past 90 days) number of days carrying naloxone (continuous); Source: Modified from ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Evidence-based Responses to a Witnessed Overdose	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	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Number of Days on Medication for Opioid Use Disorder (MOUD) Among Participants for Whom MOUD is Indicated	Item:Self-reported recent (past 90 days) frequency of being on MOUD (continuous); Source: Modified from ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Linkage to Follow-up HCV Testing Among Those Who Test HCV Antibody Positive	Item:Self-reported recent (past 90 days) access to follow-up HCV RNA testing (nominal); (among participants that had been told ever infected with HCV at baseline - our HCV testing item is not specific to RNA testing, ALL reporting HCV diagnosis at baseline were tested at baseline); Source: ROI Harmonized UG3 Survey	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Linkage to Treatment Among Those Who Test HCV RNA Positive	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	assessed at 3 months and 6 months after the baseline, change at 3 months reported
Secondary	Change in Proportion of Syringes Obtained From Syringe Service Program Among Participants Who Inject Drugs	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	assessed at 3 months and 6 months after the baseline, change at 3 months reported