THRIVE: Culturally AdapTed Harm Reduction Intervention

NCT06609278 | Completed

• 2 other identifiers: 96815UL1TR001998
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Opioid Use; Stimulant Use

Keywords

Harm Reduction; Opioid Overdose; Stimulant Misuse; Opioid Misuse; Narcan; Fentanyl Test Strips

Outcome Measures

Primary Outcomes (5)

• Change in participant confidence using harm reduction techniques

  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 and post intervention (approximately 2 hours)

• Change in participant willingness to use harm reduction techniques

  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 and post intervention (approximately 2 hours)

• Change in participant comfort to possess harm reduction techniques

  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 and post intervention (approximately 2 hours)

• Change in participant confidence describing how to use harm reduction techniques to others

  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 and post intervention (approximately 2 hours)

• Change in participant willingness to teach others how to use harm reduction techniques

  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 and post intervention (approximately 2 hours)

Study Arms (1)

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.

Behavioral: harm reduction intervention

Interventions

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.

THRIVE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brittany Miller-Roenigk: lead
• University of Cincinnati: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (3)

Louisville Central Community Center

Louisville, Kentucky, 40203, United States

Location

Urban Minority Alcoholism and Drug Abuse Outreach Program (UMADAOP) of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

MeSH Terms

Conditions

Harm Reduction; Opiate Overdose; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Behavior; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Brittany Miller-Roenigk, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: April 2, 2025
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)