Opioid Use, Stimulant Use
Conditions
Keywords
Harm Reduction, Opioid Overdose, Stimulant Misuse, Opioid Misuse, Narcan, Fentanyl Test Strips
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, 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.
Interventions
BEHAVIORALharm 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.
Sponsors
Brittany Miller-Roenigk
University of Cincinnati
National Center for Advancing Translational Sciences (NCATS)
National Center for Research Resources (NCRR)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Confidence Using Harm Reduction Techniques at Baseline | 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). |
| Participant Confidence Using Harm Reduction Techniques Post Intervention | 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). |
| Participant Willingness to Use Harm Reduction Techniques at Baseline | 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). |
| Participant Willingness to Use Harm Reduction Techniques Post-intervention | 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). |
| Participant Comfort to Possess Harm Reduction Techniques Baseline | 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). |
| Participant Comfort to Possess Harm Reduction Techniques Post Intervention | 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). |
| Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline | 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). |
| Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention | 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). |
| Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline | 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). |
| Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention | 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). |
| Change in Knowledge of How Overdose Occurs | 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 |
| Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrittany Miller-Roenigk, PhD
University of Kentucky
Participant flow
Recruitment details
Aim 1 consisted of the Community Advisory Board (CAB). CAB reviewed the intervention and provided feedback in a focus group capacity only; CAB was not enrolled as participants in the clinical trial.
Pre-assignment details
Six enrolled individuals participated as members of the Community Advisory Board (CAB) and provided feedback in a focus group capacity only. These individuals did not have participant-level outcome or adverse event data were collected from them.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
None listed