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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001998 | U.S. NIH Grant/Contract | View source | |
| UL1TR001425 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Cincinnati | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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The goal of this study is to develop and test a culturally adapted harm reduction intervention among Black adults who misuse opioids and/or stimulants. The questions it aims to answer include: will the culturally adapted harm reduction educational intervention increase overall knowledge of overdose and prevention/intervention techniques and increase confidence and willingness to use/teach interventions to others at-risk.
The overall study design is a mixed methods pilot developing and testing a culturally adapted intervention to enhance knowledge about and motivation to use opioid overdose harm reduction strategies, including Fentanyl Test Strips (FTS) and Narcan. Given the preliminary nature of this pilot study designed to develop an adapted intervention, subjects will not be randomized and there will be no control group or placebo.
Aim 1 is a qualitative design in which investigators will conduct two focus group sessions with a group of up to 8 Black adults who have misused opioids and stimulants in the past 30 days. Participants will be recruited to have about 50% gender and age representation across four cohorts: born 1996-2006; born 1985-1995; born 1974-1984; and born 1960-1973; with one male and one female in each cohort. A semi-structured qualitative focus group format will be utilized for each focus group session to allow for flexibility in asking additional questions based on participant responses. Individuals are excluded if they do not want to be audio-recorded, since a main component of the study is recording focus groups. Aim 1 will occur in Louisville, Kentucky (KY) and full study visits will be recorded.
Aim 2 is a cross-sectional mixed method design in which the culturally adapted intervention developed during Aim 1 will be piloted after institutional review board (IRB) modification approval of the intervention among about 48-60 Black adults residing in Louisville, Kentucky and Cincinnati, Ohio (OH). Each study site will recruit three groups of up to 8-10 participants to pilot the intervention, resulting in approximately 6 groups and 48-60 participants. Eligible participants for Aim 2 are aged 18-65 and will be recruited to have approximately 50% male and female members overall but not specific to age cohorts. Participants will complete pre-and post-intervention quantitative measures assessing their motivation and comfort using Narcan and Fentanyl Test Strips (FTS). In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. Individuals are excluded if they do not want to be audio-recorded, since a main component of the study is recording focus groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE | Experimental | Participants will complete pre- and post-intervention quantitative measures assessing their motivation and comfort using Narcan and FTS. In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| harm reduction intervention | Behavioral | Each participant will complete a pre-test at Study Visit 1 prior to the intervention, participate in the intervention, then complete a post-test. After the intervention, participants will participate in a recorded focus group. Participants will be offered FTS, Narcan, first aid supplies at the study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Confidence Using Harm Reduction Techniques at Baseline | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | Baseline |
| Participant Confidence Using Harm Reduction Techniques Post Intervention | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | Post-intervention (approximately 2 hours) |
| Participant Willingness to Use Harm Reduction Techniques at Baseline | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Baseline |
| Participant Willingness to Use Harm Reduction Techniques Post-intervention | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Post-intervention (approximately 2 hours) |
| Participant Comfort to Possess Harm Reduction Techniques Baseline | Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable). | Baseline |
| Participant Comfort to Possess Harm Reduction Techniques Post Intervention | Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable). | Post Intervention (approximately 2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brittany Miller-Roenigk, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisville Central Community Center | Louisville | Kentucky | 40203 | United States | ||
| Urban Minority Alcoholism and Drug Abuse Outreach Program (UMADAOP) of Cincinnati |
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Six enrolled individuals participated as members of the Community Advisory Board (CAB) and provided feedback in a focus group capacity only. These individuals did not have participant-level outcome or adverse event data were collected from them.
Aim 1 consisted of the Community Advisory Board (CAB). CAB reviewed the intervention and provided feedback in a focus group capacity only; CAB was not enrolled as participants in the clinical trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | THRIVE | Participants will complete pre- and post-intervention quantitative measures assessing their motivation and comfort using Narcan and Fentanyl Test Strip (FTS). In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. harm reduction intervention: Each participant will complete a pre-test at Study Visit 1 prior to the intervention, participate in the intervention, then complete a post-test. After the intervention, participants will participate in a recorded focus group. Participants will be offered FTS, Narcan, first aid supplies at the study visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This participant count include 57 participants who received the THRIVE Intervention and the 6 participants from the Community Advisory Board (CAB). The CAB was not analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | THRIVE | Participants will complete pre- and post-intervention quantitative measures assessing their motivation and comfort using Narcan and FTS. In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. harm reduction intervention: Each participant will complete a pre-test at Study Visit 1 prior to the intervention, participate in the intervention, then complete a post-test. After the intervention, participants will participate in a recorded focus group. Participants will be offered FTS, Narcan, first aid supplies at the study visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Participant Confidence Using Harm Reduction Techniques at Baseline | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | 2 participants in the FTS group did not provide a response to this outcome measure | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
2 hours
adverse events not collected. participants reported if adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | THRIVE | Participants will complete pre- and post-intervention quantitative measures assessing their motivation and comfort using Narcan and FTS. In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. harm reduction intervention: Each participant will complete a pre-test at Study Visit 1 prior to the intervention, participate in the intervention, then complete a post-test. After the intervention, participants will participate in a recorded focus group. Participants will be offered FTS, Narcan, first aid supplies at the study visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brittany Miller-Roenigk | University of Kentucky | 859-257-7889 | brittany.miller-roenigk@uky.edu |
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| 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 16, 2025 | Mar 26, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2025 | Jul 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D040261 | Harm Reduction |
| D000083682 | Opiate Overdose |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
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|
| Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | Baseline |
| Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | Post intervention (approximately 2 hours) |
| Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Baseline |
| Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Post intervention (approximately 2 hours) |
| Change in Knowledge of How Overdose Occurs | 1 = yes, 0 = no; score on scale ranged 0-1 with a higher score equating to more greater knowledge of how overdose occurs | Baseline and post intervention (approximately 2 hours) |
| Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose | Yes/No/Somewhat with coding 0 = No, 1= Somewhat, 2= yes; score on scale ranged 0-2 with a higher score equating to greater knowledge/confidence how to prevent and intervene with an overdose | Baseline and post intervention (approximately 2 hours) |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Participant Confidence Using Harm Reduction Techniques Post Intervention | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | 2 participants in the FTS group did not provide a response to this outcome measure | Posted | Mean | Standard Deviation | score on a scale | Post-intervention (approximately 2 hours) |
|
|
|
| Primary | Participant Willingness to Use Harm Reduction Techniques at Baseline | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Participant Willingness to Use Harm Reduction Techniques Post-intervention | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Posted | Mean | Standard Deviation | score on a scale | Post-intervention (approximately 2 hours) |
|
|
|
| Primary | Participant Comfort to Possess Harm Reduction Techniques Baseline | Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Participant Comfort to Possess Harm Reduction Techniques Post Intervention | Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable). | Posted | Mean | Standard Deviation | score on a scale | Post Intervention (approximately 2 hours) |
|
|
|
| Primary | Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention | Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident). | Posted | Mean | Standard Deviation | score on a scale | Post intervention (approximately 2 hours) |
|
|
|
| Primary | Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention | Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing). | Posted | Mean | Standard Deviation | score on a scale | Post intervention (approximately 2 hours) |
|
|
|
| Primary | Change in Knowledge of How Overdose Occurs | 1 = yes, 0 = no; score on scale ranged 0-1 with a higher score equating to more greater knowledge of how overdose occurs | Posted | Mean | Standard Deviation | score on a scale | Baseline and post intervention (approximately 2 hours) |
|
|
|
| Primary | Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose | Yes/No/Somewhat with coding 0 = No, 1= Somewhat, 2= yes; score on scale ranged 0-2 with a higher score equating to greater knowledge/confidence how to prevent and intervene with an overdose | Posted | Mean | Standard Deviation | score on a scale | Baseline and post intervention (approximately 2 hours) |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
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| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |
|