Trial Outcomes & Findings for THRIVE: Culturally AdapTed Harm Reduction Intervention (NCT NCT06609278)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

Post intervention (approximately 2 hours)

Results posted on

2026-05-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	THRIVE Participants will complete pre- and post-intervention quantitative measures assessing their motivation and comfort using Narcan and Fentanyl Test Strip (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. 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.
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

THRIVE: Culturally AdapTed Harm Reduction Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	THRIVE n=57 Participants 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. 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.
Age, Categorical <=18 years	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=54 Participants
Age, Categorical >=65 years	5 Participants n=54 Participants
Sex: Female, Male Female	23 Participants n=54 Participants
Sex: Female, Male Male	34 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	57 Participants n=54 Participants
Race (NIH/OMB) White	0 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants
Region of Enrollment United States	57 participants n=54 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 2 participants in the FTS group did not provide a response to this outcome measure

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

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Confidence Using Harm Reduction Techniques at Baseline Fentanyl Test Strips (FTS)	5.43 score on a scale Standard Deviation 3.70
Participant Confidence Using Harm Reduction Techniques at Baseline Narcan	6.61 score on a scale Standard Deviation 3.61

PRIMARY outcome

Timeframe: Post-intervention (approximately 2 hours)

Population: 2 participants in the FTS group did not provide a response to this outcome measure

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

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Confidence Using Harm Reduction Techniques Post Intervention Fentanyl Test Strips (FTS)	8.36 score on a scale Standard Deviation 2.90
Participant Confidence Using Harm Reduction Techniques Post Intervention Narcan	8.36 score on a scale Standard Deviation 2.90

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Willingness to Use Harm Reduction Techniques at Baseline FTS	6.02 score on a scale Standard Deviation 3.78
Participant Willingness to Use Harm Reduction Techniques at Baseline Narcan	7.86 score on a scale Standard Deviation 3.39

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Willingness to Use Harm Reduction Techniques Post-intervention FTS	8.46 score on a scale Standard Deviation 2.87
Participant Willingness to Use Harm Reduction Techniques Post-intervention Narcan	8.68 score on a scale Standard Deviation 2.67

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Comfort to Possess Harm Reduction Techniques Baseline FTS	7.26 score on a scale Standard Deviation 3.53
Participant Comfort to Possess Harm Reduction Techniques Baseline Narcan	7.70 score on a scale Standard Deviation 3.39

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Comfort to Possess Harm Reduction Techniques Post Intervention FTS	8.70 score on a scale Standard Deviation 2.55
Participant Comfort to Possess Harm Reduction Techniques Post Intervention Narcan	8.49 score on a scale Standard Deviation 2.92

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline FTS	6.35 score on a scale Standard Deviation 3.81
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline Narcan	6.88 score on a scale Standard Deviation 3.85

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention FTS	8.33 score on a scale Standard Deviation 2.81
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention Narcan	8.68 score on a scale Standard Deviation 2.49

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline FTS	7.25 score on a scale Standard Deviation 3.66
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline Narcan	7.54 score on a scale Standard Deviation 3.62

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention FTS	8.44 score on a scale Standard Deviation 2.73
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention Narcan	8.67 score on a scale Standard Deviation 2.55

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Change in Knowledge of How Overdose Occurs Baseline	.8 score on a scale Standard Deviation .4
Change in Knowledge of How Overdose Occurs Post intervention	.95 score on a scale Standard Deviation .23

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	THRIVE n=57 Participants 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. 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.
Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose Baseline	1.33 score on a scale Standard Deviation .72
Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose Post intervention	1.89 score on a scale Standard Deviation .36

Adverse Events

THRIVE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brittany Miller-Roenigk

University of Kentucky

Phone: 859-257-7889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place