Kentucky Communities and Researchers Engaging to Halt the... | NCT04134767

ID	Type	Description	Link
4UH3DA044798-03	U.S. NIH Grant/Contract		View source

Kentucky Communities and Researchers Engaging to Halt the... | NCT04134767 | Trialant

Sponsor/Collaborators Module

Name	Class
National Institute on Drug Abuse (NIDA)	NIH
Appalachian Regional Commission	OTHER
Substance Abuse and Mental Health Services Administration (SAMHSA)	FED

Description Module

Detailed 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:

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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.

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

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/Locations Module

Name	Affiliation	Role
April M Young, PhD, MPH	University of Kentucky	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40506	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37946233	Derived	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.
37720025	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.

Arm/Group Information

ID	Title	Description
FG000	Health Linkage	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 (OD) education and help develop a plan for reducing risks and accessing services; conduct drug testing, offer HIV and Hepatitis C (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 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.
FG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000111 subjects6 units FG001123 subjects6 units
COMPLETED		FG00067 subjects6 units FG00181 subjects6 units
NOT COMPLETED		FG00044 subjects0 units FG00142 subjects0 units

Type	Comment	Reasons
Death		FG0000 subjects FG0011 subjects
Removed for harassing staff		FG0000 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Health Linkage	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 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

The section of the baseline data instrument that captured baseline substance use was corrupted for one intervention arm participant, therefore they could not be included in the outcome assessment. During the trial, the Data Safety Monitoring Board (DSMB) approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Days of drug use

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

ID	Title	Description
OG000	Health Linkage	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 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Health Linkage	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 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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Emergency Room visit or Hospitalization	General disorders		Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Infected with hepatitis C	Infections and infestations		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Hannah LF Cooper	Rollins School of Public Health at Emory University	404-727-0261		hcoope3@emory.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 25, 2023	Oct 26, 2023	Prot_SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Jul 13, 2022	Jan 20, 2023	ICF_000.pdf

Condition Browse Module

ID	Term
D019966	Substance-Related Disorders
D015658	HIV Infections
D006526	Hepatitis C
D012749	Sexually Transmitted Diseases
D006505	Hepatitis
D062787	Drug Overdose

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D000086982	Blood-Borne Infections
D003141	Communicable Diseases

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0010 BG0022
Not Hispanic or Latino	BG000107 BG001122 BG002229
Unknown or Not Reported	BG0001 BG0011 BG0022

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG0021
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0001 BG0010 BG0021
White	BG000106 BG001120 BG002226
More than one race	BG0000 BG0012 BG0022
Unknown or Not Reported	BG0002 BG0011 BG0023

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

N = 107 injecting at baseline (those with missing N/A responses due to no injection at 3 month follow up categorized as receptive syringe sharing = 0 at follow up).

During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Receptive syringe shares

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

ID	Title	Description
OG000	Health Linkage	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 connect them with needed services; 2) follow up with participants monthly for three months to help them 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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00040 OG00167

Title

Denominators

Categories

Title	Measurements
	OG000-4.0(-9.0 to 1.0) OG0015.1(-7.0 to 17.3)

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

N = 133 (condomless sex item derived from baseline 2, there were n=137 participant IDs in both baseline 2 and 3-month follow up - 10 fewer than in baseline 1 and 3 month follow-up; those reporting 0 sex partners categorized as condomless sex = 0, 4 subject IDs did not report a number of sex partners and skipped condomless sex item thus n = 133) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Number of times had condomless sex

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00058 OG00175

Title

Denominators

Categories

all participants

- ParticipantsOG00058
- ParticipantsOG00175

Title	Measurements
	OG000-0.7(-3.9 to 2.5)

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

N = 107 injecting at baseline (those missing N/A responses due to no injection at 3 month follow up categorized as receptive syringe sharing = 0 at follow up) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Receptive syringe shares

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00040 OG00167

Title

Denominators

Categories

Title	Measurements
	OG000-4.0(-9.0 to 1.0) OG0015.1(-7.0 to 17.3)

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

N = 107 injecting at baseline (those missing N/A responses due to no injection at 3 month follow up categorized as shared injection equipment = 0 at follow up) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Number of times shared equipment

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00040 OG00167

Title

Denominators

Categories

Title	Measurements
	OG000-10.6(-18.2 to -3.0) OG0014.5(-7.7 to 16.8)

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

N = 144 (those that NEVER overdosed and skipped past 90 day overdose categorized as 0 overdoses in past 90 days , n = 3 missing ever overdosed AND past 90 day overdose) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Number of times overdosed

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00064 OG00180

Title

Denominators

Categories

Title	Measurements
	OG000-0.25(-0.6 to 0.10) OG001-0.59(-1.2 to 0.02)

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

N = 107 injecting at baseline (those with missing N/A responses due to no injection at 3 month follow up categorized as receptive syringe sharing = 0 at follow up) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Receptive syringe shares

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00040 OG00167

Title

Denominators

Categories

Title	Measurements
	OG000-4.0(-9.0 to 1.0) OG0015.1(-7.0 to 17.3)

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

N = 107 injecting at baseline (those with missing N/A responses due to no injection at 3 month follow up categorized as injection times = 0 at follow up) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Number of times injected drugs

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00040 OG00167

Title

Denominators

Categories

Title	Measurements
	OG000-33.7(-49.2 to -18.3) OG001-19.5(-30.2 to -8.7)

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

N=99 (If subject IDs had naloxone at home but missing/NA for carrying naloxone, at home response was counted to reduce missing; 46 subject IDs did NOT have a response to categorize on BOTH baseline Naloxone possession items - carrying [don't know, refuse, N/A] and having it at home [don't know, refuse, skipped] so this could not be compared to the to 3 month follow up response; 1 had no response at follow-up) DSMB approved shortened follow up period from 6 to 3 months (see Study Description).

Posted

Mean

95% Confidence Interval

Number of days carrying naloxone

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00040 OG00159

Title

Denominators

Categories

Title	Measurements
	OG0004.5(-8.5 to 17.5) OG0010(-9.7 to 9.7)

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

N = 29 witnessed an overdose at baseline AND 3-month follow up During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Evidence-based responses to overdose

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0000.1(-0.9 to 1.1) OG001-0.2(-0.6 to 0.1)

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

N = 35 with daily opioid use at baseline and 3-month follow up (those reporting no opioid treatment in past 90 days and NA for number of days on opioid treatment categorized as MOUD days = 0) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Days on MOUD

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00026 OG00138

Title

Denominators

Categories

Title	Measurements
	OG00023.5(-0.4 to 47.3) OG0018.2(-7.1 to 23.6)

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

N = 36 (among participants that had been told ever infected with HCV at baseline, n=13 skipped the testing item at follow-up and were excluded, ALL reporting HCV at baseline were tested at baseline) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Number

Percent with follow-up HCV test

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG0006 OG00130

Title

Denominators

Categories

Title	Measurements
	OG000-40 OG001-33.3

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

N = 36 (n = 49 HCV positive AND not cleared at baseline - of those 36 responded to the follow up item on seeing a medical provider for HCV in the past 90 days) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Number

Percent linked to treatment

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00019 OG00117

Title

Denominators

Categories

Title	Measurements
	OG0000 OG001-5.9

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

N = 69 (no. injecting at baseline AND follow-up) During the trial, the DSMB approved the follow-up period to be shortened from six to three months (see Study Description for rationale).

Posted

Mean

95% Confidence Interval

Percentage of syringes obtained at SSP

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

ID	Title	Description
OG000	Health Linkage	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 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.
OG001	Overdose Education	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. Overdose Education: Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.

Units	Counts
Participants	OG00022 OG00147

Title

Denominators

Categories

Title	Measurements
	OG00012.4(-10.9 to 35.7) OG0010(-11.2 to 11.2)