Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609278
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
THRIVE Culturally AdapTed Harm Reduction Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Culturally AdapTed Harm Reduction Intervention Community Engaged InterVention for Black Adults That MisusE Opioids and Stimulants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 stimulants The questions it aims to answer include will the culturally adapted harm reduction educational intervention increase overall knowledge of overdose and preventionintervention techniques and increase confidence and willingness to useteach 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 8 Black adults who have misused opioids and stimulants in the past 30 days Participants will be recruited to have 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 48-60 Black adults residing in Louisville KY and Cincinnati OH Each study site will recruit three groups of 8-10 participants to pilot the intervention resulting in 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
Aim 1 is a qualitative design in which investigators will conduct two focus group sessions with a group of 8 Black adults who have misused opioids and stimulants in the past 30 days Participants will be recruited to have 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 48-60 Black adults residing in Louisville KY and Cincinnati OH Each study site will recruit three groups of 8-10 participants to pilot the intervention resulting in 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None