SMART Trial: Community Stigma Reduction

March 3, 2022 updated by: Karen Derefinko, PhD

SMART Trial: Reducing Stigma Towards Opioid Use Disorder at the Community Level

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stigma score
Time Frame: 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
Change from baseline stigma score at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karen Derefinko, PhD

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Karen Derefinko, PhD, University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Actual)

August 19, 2021

Study Completion (Actual)

August 19, 2021

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-08181-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Available by end of 2021.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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