NCT05075330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

September 14, 2021

Last Update Submit

March 3, 2022

Conditions

Keywords

stigmaopioid use disordercommunity

Outcome Measures

Primary Outcomes (1)

  • Stigma score

    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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants who live in the Frayser community of Memphis. No billboards (intervention) were placed here.

Interventions

Billboards with destigmatizing language regarding opioid use disorder placed in the community.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identify as African American or Mixed race
  • Reside in Frayser or Orange Mound Communities
  • Access to telephone for follow-up assessment

You may not qualify if:

  • Unable to understand consent procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSocial Stigma

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Karen Derefinko, PhD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants assigned to intervention or control based on zip code of primary residence.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 12, 2021

Study Start

June 16, 2021

Primary Completion

August 19, 2021

Study Completion

August 19, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share
Time Frame
Available by end of 2021.

Locations