THRIVE: Culturally AdapTed Harm Reduction Intervention

NCT ID: NCT06609278

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-02
• Study Completion Date: 2025-06-20

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.

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, 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, KY and Cincinnati, 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.

Conditions

Opioid Use; Stimulant Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

harm reduction intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Brittany Miller-Roenigk

OTHER

Sponsor Role: lead

Responsible Party

Brittany Miller-Roenigk

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brittany Miller-Roenigk, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Louisville Central Community Center

Louisville, Kentucky, United States

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

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

UL1TR001998

Identifier Type: NIH

Identifier Source: secondary_id

View Link

96815

Identifier Type: -

Identifier Source: org_study_id