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Completed

NCT Number: NCT06609278

THRIVE: Culturally AdapTed Harm Reduction Intervention

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.

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Key information

Conditions

Opioid Use Behavior Chemically-Induced Disorders Drug Misuse Drug Overdose Harm Reduction Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Prescription Drug Misuse Stimulant Use Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisville Central Community Center, Louisville, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Participant Confidence Using Harm Reduction Techniques at Baseline

    Time frame: 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. Participant Confidence Using Harm Reduction Techniques Post Intervention

    Time frame: Post-intervention (approximately 2 hours)

    Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).

  3. Participant Willingness to Use Harm Reduction Techniques at Baseline

    Time frame: 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).

  4. Participant Willingness to Use Harm Reduction Techniques Post-intervention

    Time frame: Post-intervention (approximately 2 hours)

    Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).

  5. Participant Comfort to Possess Harm Reduction Techniques Baseline

    Time frame: 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).

  6. Participant Comfort to Possess Harm Reduction Techniques Post Intervention

    Time frame: Post Intervention (approximately 2 hours)

    Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable).

  7. Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline

    Time frame: 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).

  8. Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention

    Time frame: Post intervention (approximately 2 hours)

    Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).

  9. Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline

    Time frame: 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).

  10. Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention

    Time frame: Post intervention (approximately 2 hours)

    Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).

  11. Change in Knowledge of How Overdose Occurs

    Time frame: Baseline and post intervention (approximately 2 hours)

    1 = yes, 0 = no; score on scale ranged 0-1 with a higher score equating to more greater knowledge of how overdose occurs

  12. Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose

    Time frame: Baseline and post intervention (approximately 2 hours)

    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

Sponsors and collaborators

Lead sponsor

Brittany Miller-Roenigk

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Center for Research Resources (NCRR)
  • University of Cincinnati

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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