THRIVE: Culturally AdapTed Harm Reduction Intervention

Culturally AdapTed Harm Reduction Intervention: Community Engaged InterVention for Black Adults That MisusE Opioids and Stimulants

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Stimulant Use
• Intervention / Treatment: Behavioral: harm reduction intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40203
      • Louisville Central Community Center
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45219
      • Urban Minority Alcoholism and Drug Abuse Outreach Program (UMADAOP) of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Identify as Black or African American
• Currently a resident of study areas
• Report misuse of stimulants and/or opioids in the last six months

Exclusion Criteria:

• Do not identify as Black or African American
• If they participated in Aim 1 of the study
• Do not want to be audio-recorded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Brittany Miller-Roenigk
• Collaborators: University of Cincinnati; National Center for Research Resources (NCRR); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Brittany Miller-Roenigk, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Opioid Misuse; Opioid Overdose; Harm Reduction; Narcan; Stimulant Misuse; Fentanyl Test Strips
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Drug Misuse; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drug Overdose; Prescription Drug Misuse; Behavior; Opiate Overdose; Opioid-Related Disorders; Harm Reduction
• Other Study ID Numbers: 96815; UL1TR001998 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No