Clinical trial NCT05925374: Planning a Multi-Level Intervention to Reduce Substance Use Stigma in HIV Prevention and Care
Official title: Planning a Multi-Level Intervention to Reduce Substance Use Stigma in HIV Prevention and Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Stigma
Substance Use Disorders
HIV Infections
Physician-Patient Relations
Keywords: community-engaged research
Provider-based stigma
Structural stigma
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Loyola University Chicago
First posted: 2023-06-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Provider-based stigma (SDS measure)
timeFrame: Change from baseline SDS score (measured 0-7 days prior to training) at 0-7 days post-training (pre/post design)
measure: Provider-based stigma (MCRS measure)
timeFrame: Change from baseline MCRS score (measured 0-7 days prior to training) at 0-7 days post-training (pre/post design)
measure: Provider-based stigma (planned behavior measure)
timeFrame: Change from baseline planned behavior score (measured 0-7 days prior to training) at 0-7 days post-training (pre/post design)
measure: Stigma training feasibility
timeFrame: up to 5 months after the training
Secondary outcomes:
measure: Stigma policy feasibility
timeFrame: One-time interview lasting 45-60 minutes per participant
measure: Qualitative assessment of feasibility of the multi-level stigma intervention trial plan
timeFrame: One-time survey lasting ~15 minutes per participant
measure: Quantitative assessment of feasibility of the multi-level stigma intervention trial plan (FIM measure)
timeFrame: One-time survey lasting ~15 minutes per participant
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: