Clinical trial NCT06609278: THRIVE: Culturally AdapTed Harm Reduction Intervention
Official title: Culturally AdapTed Harm Reduction Intervention:
        Community Engaged InterVention for Black Adults That MisusE Opioids and Stimulants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Stimulant Use
Keywords: Harm Reduction
Opioid Overdose
Stimulant Misuse
Opioid Misuse
Narcan
Fentanyl Test Strips
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
name: National Center for Advancing Translational Sciences (NCATS)
name: National Center for Research Resources (NCRR)
First posted: 2024-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in participant confidence using harm reduction techniques
timeFrame: Baseline and post intervention (approximately 2 hours)
measure: Change in participant willingness to use harm reduction techniques
timeFrame: Baseline and post intervention (approximately 2 hours)
measure: Change in participant comfort to possess harm reduction techniques
timeFrame: Baseline and post intervention (approximately 2 hours)
measure: Change in participant confidence describing how to use harm reduction techniques to others
timeFrame: Baseline and post intervention (approximately 2 hours)
measure: Change in participant willingness to teach others how to use harm reduction techniques
timeFrame: Baseline and post intervention (approximately 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Louisville Central Community Center
state: Kentucky
city: Cincinnati
country: United States
facility: Urban Minority Alcoholism and Drug Abuse Outreach Program (UMADAOP) of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Kentucky
name: Brittany Miller-Roenigk, PhD
role: PRINCIPAL_INVESTIGATOR
References: