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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Substance Use Disorders; Social Stigma; Physician-Patient Relations
• Intervention / Treatment: Behavioral: Substance use stigma training

Detailed Description

This planning project aims to develop and pilot test elements of a multi-level substance use stigma reduction intervention. This study builds on past research indicating educational interventions can meaningfully reduce provider stigma related to substance use by examining the extent to which educational interventions may be enhanced by organizational policies addressing structural drivers of stigma toward people who use drugs operating in the health sector. The ultimate goal of this pilot study is to identify feasible and potentially effective substance use stigma reduction interventions that go beyond simple individual-level professional training and that could be tested in a larger subsequent trial study.

This project will use a community-engaged approach with federally-qualified health centers (FQHCs) and other primary care sites to generate pilot data and establish protocols that not only measure self-reported changes in attitudes among health professionals but also use patient surveys and electronic medical records to measure the effect of educational and policy interventions on changes to clinical practice and patient outcomes.

Initial planning will focus on developing and pilot testing an educational curriculum (Aim 1) that addresses key drivers of provider-based stigma and FQHC facility recruitment and participation in policy development to address structural stigma (Aim 2). The latter half of the planning process will focus on refining and finalizing the trial design, survey instruments, data collection and management procedures, and drafting the trial protocol (Aim 3).

For Aim 1, the project team will design a curriculum addressing stigma related to substance use among the primary care workforce. The study team will prepare a 2-hour interactive curriculum to be used in an education session for individuals in any professional role (providers, other clinical support staff, and receptionists). The lead PI, Dr. Madden, will co-teach the course with a community consultant who has firsthand experience with SUD and harm reduction work. Including a co-teacher with such firsthand experience provides a contact-based approach to reducing stigma, which has been shown to reduce stigmatizing professional attitudes in several past studies. The curriculum will be piloted with ~35 primary care professionals, including physicians, other clinical support staff, and reception staff to assess changes to attitudes and intended behaviors that are indicative of substance use stigma. These changes will be assessed using validated surveys of provider-based stigma and new survey measures using the Theory of Planned Behavior to assess factors influencing professional behavior. A focus group with 6-10 pilot participants will be used to obtain qualitative feedback on the curriculum in order to refine and revise the training for the subsequent trial. The focus group will follow a Qualitative Description Approach, a methodology used in health services research to explore perspectives and experiences among people directly involved in a health/social phenomenon.

For Aim 2, FQHCs and other primary care sites providing HIV prevention and care services will be identified and approached in year 1 by the PIs. PIs will meet with interested FQHC administrators to explain the trial planning project and those administrators who agree to participate in trial planning will be asked to allow administrators and personnel to volunteer for qualitative interviews regarding facility policies and practices affecting stigma and HIV prevention and care for people who use drugs. In-depth semi-structured interviews with 15-20 FQHC professionals will be conducted in order to identify a suitable stigma policy to test in a larger subsequent trial study. Interviews will also be guided by the Qualitative Description Approach. Analyses will occur simultaneously with data collection and use thematic analysis. A policy proposal based on the qualitative analysis will be provided to FQHCs, and revised based on their feedback.

For Aim 3, the study team will collaborate with designated representatives ("champions") from each primary care site to design and finalize a trial protocol that tests a multi-level stigma intervention combining professional education and policy changes aimed at stigma reduction. The study team will work with the site champions in quarterly or monthly meetings (depending on scheduling availability of the champions) to review results from the training surveys, focus groups, and policy interviews, and to assure protocol feasibility and that site feedback is integrated into the pilot study and the ultimate goal of planning a larger subsequent trial study plans. A draft of the trial protocol will be provided to FQHC personnel along with anonymous online surveys soliciting feedback. The feedback will be analyzed by the project team and the organizational project champions, and the protocol will be revised.

The initial plan for the larger trial study that this pilot trial will inform includes a cluster randomized trial with 8 primary care sites and 80 primary care providers. Primary care providers will be the primary sampling units (i.e., the clusters), and patients will be the secondary sampling units. Randomization will first happen at the FQHC level so that all providers at a facility receive the same intervention in one of four arms: 1) facilities where personnel receive an educational intervention addressing provider-based stigma and facilities implement policy change aimed at reducing structural stigma toward PWUD; 2) facilities where personnel receive an educational intervention, but do not alter policies; 3) facilities that implement policy change, but personnel do not receive an educational intervention; and 4) control facilities without intervention implementation. For 20 random providers, 20 patients with substance use disorders (~400 patients total) will be selected in a second stage of randomization for survey participation. Patient surveys will include validated measures of anticipated, received, and internalized stigma, as well as validated tools to assess treatment adherence and use of harm reduction and substance use treatment services. Aggregated de-identified electronic medical records data from all patients of all participating providers will also be assessed as secondary sampling units. These patient outcomes for each primary care provider will be assessed to determine the effect of the multi-level stigma intervention. Electronic medical records and survey data will be collected for all arms at baseline and every 6 months for 24 months. Other clinical staff (e.g., nurses) and reception staff who interact with patients will be included in educational interventions, and may too be affected by policy changes (to be determined by outcomes of Aim 2), but will not be a primary sampling unit. The trial will require a separate IRB approval, and the current IRB approval is only for the pilot trial and planning activities in the R34.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Training group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Completed Qualitative Interviews on Policy Feasibility	Qualitatively assessed in in-depth interviews with primary care personnel. There was no quantification of this outcome other than counting how many participants provided feedback in the interviews, 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.	One-time interview lasting 45-60 minutes per participant

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: National Institute on Drug Abuse (NIDA); Loyola University Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 17, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: community-engaged research; Provider-based stigma; Structural stigma
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Chemically-Induced Disorders; Behavior; Social Behavior; HIV Infections; Substance-Related Disorders; Social Stigma
• Other Study ID Numbers: R34DA053758 (U.S. NIH Grant/Contract); 5R34DA053758-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make the pilot training survey data or the qualitative interview data about the stigma policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No