N/A
Completed N=234
Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)
Substance Use Disorder · HIV · HCV Infection · Sexually Transmitted Infections (Not HIV or Hepatitis)
Source: ClinicalTrials.gov NCT04134767 ↗
Enrolled (actual)
234
Serious AEs
9.4%
Results posted
Dec 2023
Primary outcomePrimary: Change in Substance Use Frequency — -11.2; -5.5 Days of drug use
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Substance Use Frequency |
-11.2; -5.5 | — |
| SECONDARY Change in Engagement in HIV Risk Behaviors - Receptive Syringe Sharing |
-4.0; 5.1 | — |
| SECONDARY Change in Engagement in HIV Risk Behaviors - Condomless Sex |
-0.7; -1.7; -0.4; -2.0 | — |
| SECONDARY Change in Engagement in HCV Risk Behaviors - Receptive Syringe Sharing |
-4.0; 5.1 | — |
| SECONDARY Change in Engagement in HCV Risk Behaviors - Shared Injection Equipment |
-10.6; 4.5 | — |
| SECONDARY Change in Frequency of Opioid Overdose |
-0.25; -0.59 | — |
| SECONDARY Change in Frequency of Receptive Syringe Sharing |
-4.0; 5.1 | — |
| SECONDARY Change in Frequency of Injection Drug Use |
-33.7; -19.5 | — |
| SECONDARY Change in Number of Days Carrying Naloxone |
4.5; 0 | — |
| SECONDARY Change in Evidence-based Responses to a Witnessed Overdose |
0.1; -0.2 | — |
| SECONDARY Change in Number of Days on Medication for Opioid Use Disorder (MOUD) Among Participants for Whom MOUD is Indicated |
23.5; 8.2 | — |
| SECONDARY Change in Linkage to Follow-up HCV Testing Among Those Who Test HCV Antibody Positive |
-40; -33.3 | — |
| SECONDARY Change in Linkage to Treatment Among Those Who Test HCV RNA Positive |
0; -5.9 | — |
| SECONDARY Change in Proportion of Syringes Obtained From Syringe Service Program Among Participants Who Inject Drugs |
12.4; 0 | — |
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT04134767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.