Planning a Multi-Level Intervention to Reduce Substance Use Stigma in HIV Prevention and Care

NCT05925374 | Completed Results

• 2 other identifiers: R34DA0537585R34DA053758-03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This is a community-engaged research project that aims to identify and pilot test interventions that may reduce substance use stigma among professionals at primary care sites serving patients who might be exposed to HIV or are living with HIV. Our goal is to develop a multi-level substance use stigma intervention that leverages 1) education and 2) organizational policy to address structural drivers of stigma and the stigmatizing professional attitudes and behaviors that affect patients. Hypothesis: the results of the trial pilot research and are expected to provide scientific evidence demonstrating feasible and potentially effective substance use stigma reduction interventions that go beyond simple individual-level professional training. We plan to build on the data from this pilot trial study to then further test the multi-level intervention in another larger trial study with primary care organizations to determine whether the intervention addresses multiple complex drivers of substance use stigma that influence HIV prevention and care outcomes among people who use drugs.

Conditions

Social Stigma; Substance Use Disorders; HIV Infections; Physician-Patient Relations

Keywords

community-engaged research; Provider-based stigma; Structural stigma

Outcome Measures

Primary Outcomes (4)

• Provider-based Stigma (Social Distance Scale (SDS) Measure)

  This measure assesses how much "social distance" (level of contact/closeness they would prefer in social situations) that a respondent wants to have from a group of people. Four items from the social distance scale (SDS) adapted to people who use drugs. As reported in surveys taken by primary care professionals. Higher score= less social distance and less stigma. Minimum score on each SDS scale= 4; maximum score= 20. The intervention sought to promote higher scores (less desire for social distance, less stigma).

  Change from baseline SDS score (measured 0-28 days prior to training) at 0-7 days post-training (pre/post design)

• Provider-based Stigma (Medical Condition Regard Scale (MCRS) Measure)

  This measure assesses how positively healthcare professionals perceive a group of patients. Items from the Medical condition regard scale (MCRS) were adapted to patients who use drugs. As reported in surveys taken by primary care professionals. Higher score= more acceptance of the patient and lower stigma. Minimum score=7; maximum score=35. The intervention sought to promote higher scores (more acceptance, less stigma).

  Change from baseline MCRS score (measured 0-28 days prior to training) at 0-7 days post-training (pre/post design)

• Provider-based Stigma (Planned Behavior Measure Assessing Intention to Help Patients Who Use Drugs)

  This measure used a single questions asking their level of agreement with the statement, "I intend to engage with patients who use drugs and help them to get evidence-based services over the next 3 months." This was reported in surveys taken by primary care professionals to assess planned stigmatizing actions based on the Theory of Planned Behavior. Higher score= more intention to help people who use drugs and less stigma. Maximum value=5; minimum value=1. The intervention sought to promote higher scores (more intention to help).

  Change from baseline planned behavior score (measured 0-7 days prior to training) at 0-7 days post-training (pre/post design)

• Number of Participants Who Completed Focus Groups on Training Feasibility

  The feasibility of the training was qualitatively assessed in focus groups using verbal feedback from participants. There was no quantification of this outcome other than counting how many participants provided feedback in the focus groups, and instead the feasibility of the training was assessed using thematic analysis, in which verbatim transcripts are read through and assigned brief analytic "codes" that briefly qualitatively summarize the content of participant feedback.

  up to 5 months after the training

Secondary Outcomes (1)

• Number of Participants Who Completed Qualitative Interviews on Policy Feasibility

  One-time interview lasting 45-60 minutes per participant

Study Arms (1)

Training group

EXPERIMENTAL

Professionals working at a primary care site who has direct interaction with patients. They receive a one-time 2-hour interactive in-person training focused on improving care for patients who use drugs and reducing provider-based stigma. Their baseline attitudes and intended actions are compared to their post-intervention answers to questions in the same domains. Thus, the participants act as their own comparison group, where baseline answers are compared to post-intervention answers.

Behavioral: Substance use stigma training

Interventions

Substance use stigma training BEHAVIORAL

The intervention is an interactive professional educational training that is designed to manipulate behavioral and normative beliefs in order to address bias and alter professional practices towards patients who use drugs.

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Employed at a federally qualified health center (FQHC) or other primary care site
• For training and focus group participants (primary outcomes), volunteer is involved in direct interaction with patients
• For interview and trial feasibility survey participants (secondary outcomes), volunteer is a decision-maker at the FQHC and/or directly interacts with patients

You may not qualify if:

• Not formally employed at a primary care facility (e.g., volunteer position at the site)

Sponsors & Collaborators

• Wayne State University: lead
• Loyola University Chicago: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Social Stigma; Substance-Related Disorders; HIV Infections

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Erin Madden
• Organization: Wayne State University

efmadden@wayne.edu

2156053230

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will pilot test a substance use training that aims to reduce professional stigma towards patients who use drugs. Participants will be professionals working in primary care settings, and all participants will receive the intervention (training). Their stigmatizing attitudes and intended/planned behaviors will be assessed immediately prior to the training and immediately after the training.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 29, 2023
• Study Start: February 1, 2023
• Primary Completion: May 17, 2023
• Study Completion: June 7, 2023
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)