SMART Trial: Community Stigma Reduction

• Sponsor: Karen Derefinko, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT05075330
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 199
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 94.6

Study Details

Study Description

Brief Summary

The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder; Stigma, Social	Behavioral: Opioid Use Disorder Stigma Reduction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 199 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants assigned to intervention or control based on zip code of primary residence.Participants assigned to intervention or control based on zip code of primary residence.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: SMART Trial: Reducing Stigma Towards Opioid Use Disorder at the Community Level
• Actual Study Start Date: Jun 16, 2021
• Actual Primary Completion Date: Aug 19, 2021
• Actual Study Completion Date: Aug 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants who live in the Orange Mound community of Memphis. Billboards targeting stigma reduction were posted in the community for one month.	Behavioral: Opioid Use Disorder Stigma Reduction; Billboards with destigmatizing language regarding opioid use disorder placed in the community.
No Intervention: Control Participants who live in the Frayser community of Memphis. No billboards (intervention) were placed here.

Outcome Measures

Primary Outcome Measures

1. Stigma score [Change from baseline stigma score at 8 weeks]

   Pre- and post-intervention stigma assessments using the Exposure to Drug Users Index, Drug Use Stigmatization Scale, and the Stigma of Drug Users Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Identify as African American or Mixed race

• Reside in Frayser or Orange Mound Communities

• Access to telephone for follow-up assessment

Exclusion Criteria:

• Unable to understand consent procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38163

Sponsors and Collaborators

• Karen Derefinko, PhD
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Karen Derefinko, PhD, University of Tennessee Health Science Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karen Derefinko, PhD, Associate Professor, University of Tennessee
• ClinicalTrials.gov Identifier: NCT05075330
• Other Study ID Numbers: 21-08181-XP
• First Posted: Oct 12, 2021
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Karen Derefinko, PhD, Associate Professor, University of Tennessee: stigma; opioid use disorder; community
• Additional relevant MeSH terms: Opioid-Related Disorders; Substance-Related Disorders; Analgesics, Opioid

Study Results

No Results Posted as of Mar 18, 2022