Trial Outcomes & Findings for Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) (NCT NCT04134767)
NCT ID: NCT04134767
Last Updated: 2023-12-21
Results Overview
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
COMPLETED
NA
234 participants
assessed at 3 months and 6 months after the baseline, change at 3 months reported
2023-12-21
Participant Flow
Unit of analysis: C2H Counties
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
111 6
|
123 6
|
|
Overall Study
COMPLETED
|
67 6
|
81 6
|
|
Overall Study
NOT COMPLETED
|
44 0
|
42 0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Removed for harassing staff
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
44
|
40
|
Baseline Characteristics
Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)
Baseline characteristics by cohort
| Measure |
Health Linkage
n=6 C2H Counties
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.
|
Overdose Education
n=6 C2H Counties
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.
|
Total
n=12 C2H Counties
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
123 participants
n=7 Participants
|
233 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=66 Participants
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.
|
Overdose Education
n=81 Participants
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.
|
|---|---|---|
|
Change in Substance Use Frequency
|
-11.2 Days of drug use
Interval -14.8 to -7.7
|
-5.5 Days of drug use
Interval -8.4 to -2.6
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=40 Participants
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.
|
Overdose Education
n=67 Participants
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.
|
|---|---|---|
|
Change in Engagement in HIV Risk Behaviors - Receptive Syringe Sharing
|
-4.0 Receptive syringe shares
Interval -9.0 to 1.0
|
5.1 Receptive syringe shares
Interval -7.0 to 17.3
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
Item: Self-reported recent (past 30 days) frequency of condomless anal or vaginal sex (continuous; number and proportion) Source: ROI Harmonized UG3 Survey
Outcome measures
| Measure |
Health Linkage
n=58 Participants
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.
|
Overdose Education
n=75 Participants
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.
|
|---|---|---|
|
Change in Engagement in HIV Risk Behaviors - Condomless Sex
participants with > 1 sex partner
|
-0.4 Number of times had condomless sex
Interval -4.0 to 3.2
|
-2.0 Number of times had condomless sex
Interval -5.9 to 1.8
|
|
Change in Engagement in HIV Risk Behaviors - Condomless Sex
all participants
|
-0.7 Number of times had condomless sex
Interval -3.9 to 2.5
|
-1.7 Number of times had condomless sex
Interval -4.6 to 1.3
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=40 Participants
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.
|
Overdose Education
n=67 Participants
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.
|
|---|---|---|
|
Change in Engagement in HCV Risk Behaviors - Receptive Syringe Sharing
|
-4.0 Receptive syringe shares
Interval -9.0 to 1.0
|
5.1 Receptive syringe shares
Interval -7.0 to 17.3
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
Item: Self-reported recent (past 30 days) frequency of shared cookers, cotton, spoon, or water (continuous; number and proportion) Source: ROI Harmonized UG3 Survey
Outcome measures
| Measure |
Health Linkage
n=40 Participants
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.
|
Overdose Education
n=67 Participants
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.
|
|---|---|---|
|
Change in Engagement in HCV Risk Behaviors - Shared Injection Equipment
|
-10.6 Number of times shared equipment
Interval -18.2 to -3.0
|
4.5 Number of times shared equipment
Interval -7.7 to 16.8
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
Item:Self-reported recent (past 90 days) number of times overdosed (ordinal, continuous) Source: Modified from ROI Harmonized UG3 Survey
Outcome measures
| Measure |
Health Linkage
n=64 Participants
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.
|
Overdose Education
n=80 Participants
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.
|
|---|---|---|
|
Change in Frequency of Opioid Overdose
|
-0.25 Number of times overdosed
Interval -0.6 to 0.1
|
-0.59 Number of times overdosed
Interval -1.2 to 0.02
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=40 Participants
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.
|
Overdose Education
n=67 Participants
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.
|
|---|---|---|
|
Change in Frequency of Receptive Syringe Sharing
|
-4.0 Receptive syringe shares
Interval -9.0 to 1.0
|
5.1 Receptive syringe shares
Interval -7.0 to 17.3
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
Item: Self-reported recent (past 30 days) frequency of injection (ordinal, continuous) Source: ROI Harmonized UG3 Survey
Outcome measures
| Measure |
Health Linkage
n=40 Participants
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.
|
Overdose Education
n=67 Participants
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.
|
|---|---|---|
|
Change in Frequency of Injection Drug Use
|
-33.7 Number of times injected drugs
Interval -49.2 to -18.3
|
-19.5 Number of times injected drugs
Interval -30.2 to -8.7
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
Item:Self-reported recent (past 90 days) number of days carrying naloxone (continuous) Source: Modified from ROI Harmonized UG3 Survey
Outcome measures
| Measure |
Health Linkage
n=40 Participants
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.
|
Overdose Education
n=59 Participants
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.
|
|---|---|---|
|
Change in Number of Days Carrying Naloxone
|
4.5 Number of days carrying naloxone
Interval -8.5 to 17.5
|
0 Number of days carrying naloxone
Interval -9.7 to 9.7
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=10 Participants
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.
|
Overdose Education
n=19 Participants
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.
|
|---|---|---|
|
Change in Evidence-based Responses to a Witnessed Overdose
|
0.1 Evidence-based responses to overdose
Interval -0.9 to 1.1
|
-0.2 Evidence-based responses to overdose
Interval -0.6 to 0.1
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
Item:Self-reported recent (past 90 days) frequency of being on MOUD (continuous) Source: Modified from ROI Harmonized UG3 Survey
Outcome measures
| Measure |
Health Linkage
n=26 Participants
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.
|
Overdose Education
n=38 Participants
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.
|
|---|---|---|
|
Change in Number of Days on Medication for Opioid Use Disorder (MOUD) Among Participants for Whom MOUD is Indicated
|
23.5 Days on MOUD
Interval -0.4 to 47.3
|
8.2 Days on MOUD
Interval -7.1 to 23.6
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=6 Participants
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.
|
Overdose Education
n=30 Participants
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.
|
|---|---|---|
|
Change in Linkage to Follow-up HCV Testing Among Those Who Test HCV Antibody Positive
|
-40 Percent with follow-up HCV test
|
-33.3 Percent with follow-up HCV test
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=19 Participants
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.
|
Overdose Education
n=17 Participants
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.
|
|---|---|---|
|
Change in Linkage to Treatment Among Those Who Test HCV RNA Positive
|
0 Percent linked to treatment
|
-5.9 Percent linked to treatment
|
SECONDARY outcome
Timeframe: assessed at 3 months and 6 months after the baseline, change at 3 months reportedPopulation: 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).
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
Outcome measures
| Measure |
Health Linkage
n=22 Participants
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.
|
Overdose Education
n=47 Participants
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.
|
|---|---|---|
|
Change in Proportion of Syringes Obtained From Syringe Service Program Among Participants Who Inject Drugs
|
12.4 Percentage of syringes obtained at SSP
Interval -10.9 to 35.7
|
0 Percentage of syringes obtained at SSP
Interval -11.2 to 11.2
|
Adverse Events
Health Linkage
Overdose Education
Serious adverse events
| Measure |
Health Linkage
n=111 participants at risk
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.
|
Overdose Education
n=123 participants at risk
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.
|
|---|---|---|
|
General disorders
Emergency Room visit or Hospitalization
|
2.7%
3/111 • 3 months
|
3.3%
4/123 • 3 months
|
|
General disorders
Non Fatal Overdose
|
6.3%
7/111 • 3 months
|
5.7%
7/123 • 3 months
|
|
General disorders
Death
|
0.00%
0/111 • 3 months
|
0.81%
1/123 • 3 months
|
Other adverse events
| Measure |
Health Linkage
n=111 participants at risk
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.
|
Overdose Education
n=123 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infected with hepatitis C
|
4.5%
5/111 • 3 months
|
19.5%
24/123 • 3 months
|
|
General disorders
Believed correctional officers could hear interview
|
0.00%
0/111 • 3 months
|
0.81%
1/123 • 3 months
|
|
Social circumstances
problems with family members, friends, or partners and infected with hepatitis C
|
0.00%
0/111 • 3 months
|
0.81%
1/123 • 3 months
|
|
General disorders
Believed correctional officers could hear interview and infected with hepatitis C
|
0.00%
0/111 • 3 months
|
0.81%
1/123 • 3 months
|
Additional Information
Dr. Hannah LF Cooper
Rollins School of Public Health at Emory University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place