Planning a Multi-Level Intervention to Reduce Substance Use Stigma in HIV Prevention and Care
Phase: NA
Conditions: Social Stigma, Substance Use Disorders, HIV Infections, Physician-Patient Relations
Sponsor: Wayne State University

Study Protocol and Statistical Analysis Plan 
 
Title:  Planning a Multi-Level Intervention to Reduce Substance Use Stigma in HIV 
Prevention and Care 
 
NCT number: NCT05925374 
Date: 05/23/2023 
 
 

Study Protocol 
Background 
Both substance use disorders (SUDs) and HIV are subject to stigma, namely, the process by 
which an attribute is deemed deeply discrediting and prone to prejudice and discrimination. 
Stigma toward SUDs and HIV arises from multiple sources, including policies or individuals who 
carry out policies (“structural stigma”) and health professionals (“provider-based stigma”). 
Stigma from health professionals experienced or anticipated by people with SUDs can create 
barriers to accessing high-quality health services. For people with SUDs who need HIV 
prevention or care, the added stigma of HIV may compound substance use-related stigma to 
enhance social barriers to healthcare. However, few studies have examined the role of 
substance use stigma in HIV healthcare contexts, or how to intervene on substance use stigma 
in this doubly-sensitive area of healthcare. Extant studies on substance use stigma in other 
healthcare contexts found that educational interventions incorporating critical reflection 
techniques and opportunities for contact with people who use drugs may significantly reduce 
provider-based stigma. An even greater limitation is that provider-based stigma intervention 
studies fall short of practical application: they largely focus on attitudinal outcomes among 
professionals, but do not measure the effects of policies or how stigma interventions affect 
healthcare utilization or patient health outcomes. For HIV prevention and care contexts to 
improve healthcare quality and outcomes among people with SUDs, interventions are needed to 
reduce provider-based and structural stigma perennially attached to substance use. 
Objective  
Aim 1: Create a substance use curriculum for HIV prevention and care contexts that pilot testing 
demonstrates significantly improves knowledge, attitudes, and planned actions related to 
professional stigma toward PWUD. 
Aim 2: Use qualitative interviews with facility administrators and personnel to identify 
organizational policies related to clinical interactions and referrals to SUD treatment services that 
may enhance the effects of professional education on SUD stigma reduction. 
Aim 3: Develop, optimize, and finalize a trial design and protocol that is intended to test how the 
multi-level SUD stigma intervention influences intermediate patient SUD outcomes (safer 
substance use, treatment engagement) and professional and patient stigma outcomes (provider 
attitudes and actions, and patient attitudes and experiences) and principal HIV outcomes related 
to prevention (PrEP adherence and syringe services program use) and care (HCV screening and 
linkage to care, ARV adherence). 
Design 
The trial planning process will use a community-engaged and collaborative team approach 
drawing on the expertise of all scientific team members, as well as a community advisory board 
composed of patients living with HIV and/or SUD and a professional advisory board of Michigan 
primary care collaborators to build a multi-level stigma intervention that uses education to 
address bias and alter professional practices, and changes to organizational policy to improve 
the conditions of professional decision-making. Initial planning will focus on developing an 
educational curriculum (Aim 1) that addresses key drivers of provider-based stigma and primary 
care 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). 
Methods 
Training Intervention 
The educational intervention will be pilot-tested in year 2 using a group of 33-35 professionals 
who work in primary care, including providers, nurses and other support staff, and reception staff. 
Pilot participants will not be employed at primary care facilities identified for participation in the 
subsequent trial. Training participants will receive $100 for participation in pre- and post-training 
surveys and attending the training. Training will be held face-to-face and last 2-hours. 
Quantitative data collection 
Pre- and post-training surveys will measure stigma, knowledge, and individual-level factors (Aim 
1). Stigma is complex and requires measurement of multiple dimensions, thus several 
approaches will be used. Enacted provider-based stigma will be measured with questions about 
plans to provide care to PWUD. Endorsed provider-based stigma will be measured using the 
Medical Condition Regard Scale (MCRS) and a modified Bogardus Social Distance Scale (SDS). 
Surveys will also ask about professional roles, years of experience, prior professional work with 
PWUD, burnout, and sex. Pre- and post-training surveys will contain the same questions, with the 
exception of demographic and professional experience questions (only in pre-training survey) and 
several open-ended questions in the post-training survey to allow for qualitative feedback on the 
training. 
Qualitative data collection 
Focus group assessing the training: A sample of 5-10 primary care professionals who participated 
in the training will be invited to participate in a 1-hour focus group providing qualitative feedback 
on the feasibility of the training (Aim 1). The focus group will be held virtually via video call. The 
focus group will follow a Qualitative Description Approach, a methodology used in health services 
research to explore participant perspectives. Focus groups will provide a venue for participants 
to express views on the format and content of the curriculum and provide opportunities for 
participants to suggest changes to the piloted curriculum. Questions for the focus group will be 
guided by the methodology and initial quantitative results, and decided by the project team. 
In-depth interviews on stigma policies: Qualitative interviews will be used to assess feasibility of 
policies that could reduce stigma toward PWUD (Aim 2) The project team will develop a semi-
structured interview guide to collect programmatic information about services for HIV prevention 
and care and PWUD, as well as information about professional perceptions and experiences. 
Interviews will focus on three topics after establishing an overview of current practice: 1) exploring 
experiences with care provision in the context of existing facility policies for PWUD who are at 
risk of HIV or living with HIV; 2) examining perceptions of policies shown to reduce provider-based 
stigma (e.g., reducing time pressure by extending clinical interactions and increasing inter-group 
contact); and 3) allowing participants to propose ideas about how to address stigma toward 
PWUD in the context of their facility. Participants will be recruited using a purposive sampling 
frame that targets individuals with varied roles within the facility, including administrators, 
providers, and non-clinical personnel. In-depth interviews using this guide will last 30-90 minutes 

and be digitally recorded and transcribed. Interview participants will receive $100 for participation. 
Interviews will be conducted until new information no longer emerges from additional data 
collection. While the exact number of interviews cannot be pre-determined, we expect to complete 
between 15 and 20 interviews. 
Qualitative Analysis Plan 
Recorded transcripts of the pilot focus group and qualitative survey responses will be analyzed 
by using thematic analysis to identify opportunities to revise the training. In-depth interviews will 
also be recorded and transcribed and analyzed using thematic analysis, but with the goal of 
identifying feasible policies that could reduce stigma operating in primary care.  
For all data, two team members will code the data independently by hand. Initial themes and 
associated codes will be jointly reviewed and refined by these team mebers before entering 
them into Dedoose qualitative coding software and coding the entire dataset. After all data are 
coded in Dedoose and major themes identified, the results will be reviewed in video call 
meetings with the entire authorship team, followed by recorded 2-hour video calls with the 
patient community advisory board and another with the professional advisory board of primary 
care clinicians and senior administrators for feedback. We will solicit their impressions of the 
validity of the themes and ask them to raise any concerns about our interpretations. If themes 
are not sufficiently elaborated according to concerns raised in these meetings by members of 
our community and professional advisory boards, we will collect additional qualitative data 
(interviews or additional focus groups).  
 
 

Statistical Analysis Plan  
Quantitative survey measures will be analyzed for internal consistency and sample means and 
standard deviations (or medians and interquartile ranges if data are skewed) will be used to 
describe continuous variables while frequencies and relative frequencies will be used to describe 
categorical variables. To evaluate the effect size of the intervention, a paired t-test on the pre and 
post-training outcome scores will be employed overall and by levels of the predicting factors. 
Primary Outcomes: Scores from four survey measures will be used as outcomes to be analyzed. 
These include: quantified measures of stigmatizing attitudes from the SDS, the MCRS, and a 
measure of planned stigmatizing actions. 
Predictors and Covariates: Analyses will examine pre- vs. post-training scores. We will also look 
into how scores may differ by professional factors including role (e.g., physician, other clinical 
support staff, receptionist), years of experience, and prior professional experience caring for 
PWUD, respondent sex, and burnout.