Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3
Phase: NA
Conditions: Drug Use Disorders, Hepatitis C, Harm Reduction, Opioid-use Disorder
Sponsor: University of Wisconsin, Madison

Wisconsin Rural Opioid Project – Study Protocol v2-01-2023  
 
 
 
1 
 
 
 
Community-based, client-centered prevention homes to address the 
rural opioid epidemic 
 
ClinicalTrials.gov registration number: NCT04268173 
 
 
Study Protocol 
 
 
Principal Investigators: 
 
 
Ryan Westergaard, M.D., Ph.D., M.P.H. 
University of Wisconsin - Madison 
Departments of Medicine & Population Health Sciences 
5223 UW Medical Foundation Centennial Bldg 
1685 Highland Avenue 
Madison, WI 53705 
608-265-7927 
rpw@medicine.wisc.edu 
 
David W. Seal, PhD 
1440 Canal Street, Suite 2200 
Mailstop #8319 
Office 2224 
New Orleans, LA   70112 
504-988-6260 
dseal@tulane.edu 
 
  
 
 
 
 
 
Sponsors:  
 
National Institutes of Health: NIDA 
 
 
 
Wisconsin Partnership Program 
 
Grant numbers: 
UG3DA044826  
 
 
 
UH3DA044826 
WPP 4803 
 
 
 
 
 
UW-Madison Health Science Institutional Review Board Approval ID: 2017-0866 

Wisconsin Rural Opioid Project – Study Protocol v2-01-2023  
 
 
 
2 
 
TABLE OF CONTENTS       
 
 
Abbreviations…… …………………………………………………………………………….3 
 
Study Summary………………………………………………………………………… 4 
 
1.0 
Background & Significance .................................................................................... 5 
 
2.0    Study Objectives .................................................................................................... 9 
 
3.0    Selection of Subjects ............................................................................................ 13 
 
4.0 
Registration Procedures ....................................................................................... 13 
 
5.0    Data Collection ..................................................................................................... 18 
 
6.0    Measurement Considerations............................................................................... 26 
 
7.0    Statistical Considerations ..................................................................................... 28 
 
8.0    Records to be Kept ............................................................................................... 29 
 
9.0    Protections Against Risk ...................................................................................... 29 
 
10.0  References ........................................................................................................... 37 
 
Appendix 1: Data Safety Monitoring Plan…………………….………………………………………41 
 
Appendix 2: Proposed Outcome Measures for Aim 3.........……………….………………………..48 
 
Appendix 3: Data elements to be shared with University of Washington DCC……...........……..52 
 
 
 

 
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ABBREVIATIONS 
 
ACASI 
Audio computer-assisted self-interview  
ARCW 
Aids Resource Center of Wisconsin 
DCC 
Data coordinating center 
DSMP/B 
Data safety monitoring plan/board 
HCV 
Hepatitis C virus 
HIV 
Human immunodeficiency virus 
MAT 
Medication-assisted treatment 
OBBT 
Office-based buprenorphine treatment 
PN 
Prevention Navigator 
PS 
Prevention Specialist 
PWID 
People who inject drugs 
RDS 
Respondent driven sampling 
ROI 
Rural Opioid Initiative 
SSP 
Syringe service programs 
STI 
Sexually transmitted infection 
UW 
University of Wisconsin 
WEDSS 
Wisconsin Electronic Disease Surveillance System 
WI DHS 
Wisconsin Department of Health Services 
WSLH 
Wisconsin State Laboratory of Hygiene 
 
 

 
4 
 
STUDY SUMMARY 
 
In response to RFA-DA-17-014, HIV, HCV and Related Comorbidities in Rural Communities Affected 
by Opioid Injection Drug Epidemics in the United States: Building Systems for Prevention, Treatment 
and Control (UG3/UH3), our research team has proposed a multi-phase, mixed-methods study that 
aims to implement and evaluate a novel community response model, which we have named the 
Community-Based, Client-Centered Prevention Home.  
 
Using the organizational infrastructure of a large, multi-site syringe service program serving a 
geographically disperse population of people who inject drugs in rural communities across Northern 
Wisconsin, we will build locally responsive systems to facilitate uptake of evidence-based prevention 
services for high-risk clients. The Client-Centered Prevention Home model incorporates prevention 
case management and mobile health information technology into traditional harm-reduction services 
delivered at syringe service programs, which we hypothesize will increase use prevention services. 
During the first 2 years the project (UG3 phase), we will perform needs assessments in 6 rural 
Wisconsin counties in partnership with local stakeholders, and use respondent driven sampling to 
conduct a cross-sectional epidemiologic evaluation to estimate the prevalence of HIV, viral hepatitis 
and sexually transmitted infections. Contingent upon meeting recruitment and data collection goals, 
during years 3-5 (UH3 phase) of the project we will deploy and evaluate the Client-Centered 
Prevention Home model in the 3 counties demonstrating highest vulnerability to worsening epidemics 
of opioid injection. The 3 remaining counties not selected for implementation will serve as comparison 
sites in a quantitative evaluation of program effectiveness during year 5.  
 
The growing problem of opioid injection in rural Wisconsin is highly significant because it exemplifies 
trends observed nationally indicating severe vulnerability to worsening epidemics of HIV, HCV, and 
opioid overdose deaths in rural communities that are substantially underserved by evidence-based 
prevention interventions.  This proposal is highly innovative because it will be the first study to use an 
evidence-based mHealth strategy and a formal implementation science approach to enhance 
coordination of prevention services in syringe service programs.  It has potential for high impact 
because of our team’s state-wide reach, broad access to at-risk individuals, and robust infrastructure 
for conducting a rigorous, multi-site evaluation of our proposed model. 
 
 

 
5 
 
1.0 
BACKGROUND & SIGNIFICANCE 
 
HIV, hepatitis C virus (HCV) infection, and opioid injection represent interdependent epidemics of 
enormous and increasing public health significance. In the past decade, HCV surpassed HIV/AIDS as 
the leading cause of infectious death among U.S. adults,1 while opioid overdose overtook motor 
vehicle accidents as the number one injury-related cause of death.2,3 Evidence-based strategies to 
effectively prevent4-7 and manage8-11 these conditions exist, yet recent outbreaks of HCV and HIV 
among young people who inject opioids in rural areas of the U.S. demonstrate the failure to 
implement these tools in communities where they are needed.12-15 The scientific premise of the 
proposed research is that multiple social, structural, and behavioral factors prevent opioid-injecting 
rural residents from receiving evidence-based strategies for prevention of HIV, viral hepatitis, and 
overdose. Through an innovative, dual-phase, mixed methods study design, we propose to test 
whether a novel community response model, the Client-Centered Prevention Home, can improve 
uptake of essential prevention services when implemented in syringe service programs serving rural 
communities.  
 
1.1 Opioid injection has devastating consequences on patients, family members, and 
communities. In the U.S. in 2012, an estimated 2.1 million people had opioid use disorder related to 
prescription painkillers and 467,000 to heroin.16 Healthcare costs related to prescription opioid abuse 
were estimated at $25 billion in 2007, and total societal costs at $55.7 billion.17 Opioid use has risen 
steeply in recent years. From 1991 to 2013, opioid prescriptions rose from 76 million to 207 million.18 
Emergency department visits related to the nonmedical use of opioids rose from 144,600 in 2004 to 
305,900 in 2007.19 From 2000 to 2013, unintentional prescription opioid overdose deaths tripled and 
heroin overdoses more than quadrupled.20  
 
In Wisconsin (WI), increases in opioid use disorder have 
also risen, and are accompanied by substantial increases in 
the incidence of HCV among young adults and adolescents 
(Figure 1). The proportion of drug and alcohol treatment 
admissions in WI for heroin and other opioids tripled between 
2005 and 2014.21 In late 2010, WI detected a cluster of new 
HCV infections in six contiguous rural counties, driven 
primarily by injection of heroin and other opioids by adults 
under 30.22 In 2014, 53% of HCV infections in young people 
and 42% of opioid overdoses or deaths occurred among 
residents of rural counties.  
 
1.2. Increases in opioid injection consequences represent a failure to translate evidence into 
practice. Although the global epidemic of injection opioid abuse is heterogeneous and dynamic,23 
there is scientific consensus about a package of evidence-based interventions that are efficacious for 
preventing the spread of HIV. The World Health Organization (WHO), The United Nations office on 
Drugs and Crime (UNODC), and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have 
endorsed universal access to 9 interventions for people who inject drugs, and have issued technical 
guidance for evaluation monitoring of this goal.24 This “Comprehensive Package,” listed in Table 1, 
includes biomedical interventions (e.g. HIV antiretroviral therapy, viral hepatitis immunizations) that 
tend to be delivered in health care settings, and lower-cost, “harm reduction” strategies such as 
needle and syringe programs that are in most cases delivered in community-based, non-clinical 
settings.  
 
Figure 1. Increases in HCV cases reported 
among people ages 15-29 and heroin overdose 
deaths, Wisconsin, 2005-14 

 
6 
 
Medication-assisted treatment (MAT) for opioid use disorder, referred to as opioid substitution therapy 
(OST) in the WHO document, has demonstrated significant clinical, societal, and financial impact 
through increased abstinence rates,25,26 reduced relapse rates,27 
and reduced criminal costs.28 Yet, MAT has experienced low 
adoption rates and, in many areas, is not a standard part of 
addiction treatment.29,30 Despite strong evidence of 
effectiveness, it is estimated that fewer than one-quarter of 
opioid-dependent persons are enrolled in methadone 
maintenance. This is largely due to a limited distribution to a 
relatively small number of highly-regulated clinics, restrictive 
dosing schedules, and its high stigmatization. Buprenorphine, 
approved by the FDA in 2002, provides an effective alternative 
to methadone and can be implemented in treatment settings 
outside the traditional methadone maintenance framework.10 
Recent investigations show that among addiction treatment 
organizations that offer buprenorphine therapy, many patients 
are turned away due to limited physician prescribing 
capacity.31,32  
 
1.3. Rural opioid injectors are particularly underserved by health systems. Formative research 
by our group found that, while comparable numbers of rural and urban syringe service program (SSP) 
clients reported they had never been tested for HCV, geographic inaccessibility appeared to play a 
particularly important role among rural clients.33,34 We found that for every 10 miles a rural client lived 
from the location of a SSP, the odds of ever being tested for HCV decreased by 20%,33 whereas no 
such association was observed for urban clients. Comparable research in numerous North American 
settings confirm that non-urban residents have inferior access to not only sterile injection equipment, 
but also ancillary services facilitated by SSPs such as clothing, food, referrals, and social support.15,35 
Shortages of providers with specialty training in HIV,36 viral hepatitis,37 and addiction treatment38,39 
are also commonplace in rural areas.  
 
1.4. Theoretical frameworks  
 
Framework for UG3 Phase: A social ecologic model 
of prevention services delivery.  The social-ecological 
framework, drawn from ecological systems theory40 
(Figure 2), guides many public health prevention 
efforts. This framework posits that targeted outcomes 
are influenced by factors in four distinct spheres: (1) 
individual, (2) interpersonal, (3) community, and (4) 
societal. Our community response model serving opioid 
drug users incorporates aspects of care at all four 
levels. Societally, the legality of SSPs, laws governing 
opioid and naloxone access and drug paraphernalia possession, and safe access to treatment 
services, including methadone or buprenorphine, can impact safe injection drug use and/or treatment. 
On a community level, stigmas associated with opioid use, HIV/HCV testing, and drug treatment can 
impede willingness to access available services. Interpersonally, social support for safe injection use 
within drug using networks can influence injection practices or help people access support services. 
Individually, people who inject opioids often face many barriers to safety, such as lack of health 
insurance, employment, and low education. 
Table 1. Comprehensive package of 
prevention services for people who 
inject drugs 
1. Needle and syringe programs (NSP) 
2. Opioid substitution therapy (OST) and other 
evidence-based drug dependence treatment 
3. HIV testing and counseling (HTC) 
4. Antiretroviral therapy (ART) 
5. Prevention and treatment of sexually 
transmitted infections (STIs) 
6. Condom programs for people who inject 
drugs and their sexual partners. 
7. Targeted information, education and 
communication for people who inject drugs 
and their sexual partners. 
8. Prevention, vaccination and treatment for viral 
hepatitis 
9. Prevention, diagnosis and treatment of 
tuberculosis. 
Figure 2. The social-ecological framework  
 

 
7 
 
 
Framework for UH3 Phase:  Applying the Chronic Care Model to comprehensive prevention 
services. Recognition of opioid use disorder as a chronic, relapsing condition in need of 
management over the life-course is a fundamental component of effective prevention strategies for 
people who inject opioids. The U.S. health system currently has critical deficiencies in its capacity to 
meet the prevention needs of rural opioid users. There have, however, been important lessons 
learned over the past decade about how systems of care can be improved overall to better deliver 
treatment for complex, chronic health problems. The current opioid crisis demands that we find 
alternative service delivery models to “fill the gaps” left by the mainstream health system. To have 
optimal impact, these new models should incorporate evidence-based strategies known to effectively 
meet the needs of people with chronic conditions.  
 
The Chronic Care Model--developed in the early 2000s 
as part of initiatives to reduce costs and improve 
outcomes for treatment of diabetes, heart failure, and 
other conditions--emphasizes a team-based, longitudinal 
care approach.41,42 The model’s 6 elements emphasize 
patient empowerment, community engagement, and 
efficient use of information resources to enhance quality 
of services (Table 2). While the Chronic Care Model was 
designed to improve medical care for complex chronic 
illnesses, its central features are clearly applicable to 
prevention services.43 In the following sections, we 
describe how this framework is applied to the proposed 
model of Client-Centered Prevention Homes within SSPs. 
 
1.5. The Community-Based, Client-Centered Prevention Home incorporates elements of the 
Chronic Care Model into the delivery and coordination of community-based services to prevent HIV, 
viral hepatitis, and opioid overdose. It leverages unique strengths of community-based organizations, 
and SSPs in particular, to engage marginalized and stigmatized communities that are underserved by 
the health care system. It also seeks to enhance the quality, efficiency, and reach of community-
based services by incorporating evidence-based strategies shown to improve chronic illness 
management in primary care clinical settings.  
 
Client-centeredness refers to services that are “culturally competent,” “linguistically specific,” and 
tailored to the client’s stage of behavior change.44 In many communities, SSPs exemplify these 
characteristics. By providing non-judgmental and compassionate services, occasionally in 
unauthorized or clandestine settings, SSPs have engendered the trust of drug-injecting clients who 
live in communities where drug use is criminalized, and provide a venue where clients feel welcomed 
and supported. Unfortunately, SSPs typically lack resources and infrastructure to monitor and 
improve quality using tools which have been embraced in primary care settings, indicating that a 
health systems approach to enhancing service delivery to prevent HCV and HIV within SSPs could 
have a major impact. 
Prevention Case Management is a client-centered intervention combining intensive risk reduction 
counseling and case management to people at high risk for HIV infection.45 Evidence from 
demonstration projects, including data published by the Wisconsin AIDS/HIV program,46 support its 
effectiveness for reducing needle-sharing46,47 and overall drug use.48,49 Prevention case management 
interventions have also shown benefit by reducing homelessness50 and other unmet service needs,51 
and by improving psychological and emotional symptoms.50 Care coordination strategies 
Table 2. Six Elements of the Chronic Care Model 
applicable to opioid epidemics 
1. Health Systems: Create an organization that provides 
safe, high-quality services 
2. The Community: Mobilize community resources to 
meet the needs of clients 
3. Self-Management: Empower and prepare clients to 
manage their health needs 
4. Delivery System Design: Assure effective, efficient 
service and self-management support 
5. Decision support: Promote services consistent with 
scientific data and client services 
6. Health information systems: Organize data to 
facilitate efficient and effective services 

 
8 
 
incorporating case management approaches have been shown to be effective for linking patients 
receiving methadone maintenance to hepatitis prevention and care services.52 
 
Health homes seek to integrate and coordinate services using a person-centered philosophy. 
Introduced in 1967 by the American Academy of Pediatrics, the concept has since expanded to 
describe care that can be operationally characterized as accessible, comprehensive, family-centered, 
coordinated, compassionate and culturally effective.53 Developed and endorsed by the four major 
primary care physician associations in the U.S. in 2007, the Patient-Centered Medical Home 
approach is now actively promoted by the Agency for Healthcare Research and Quality (AHRQ) as a 
standard of excellence in primary care.54 In WI, the State AIDS/HIV Program and Vivent Health 
collaborated with the state legislature to gain approval for the Wisconsin Health Home State Plan 
Amendment (SPA), taking advantage of the opportunity provided under the Affordable Care Act of 
2010 for states to receive funding for “coordinated care through a health home for individuals with 
chronic conditions.”55  
 
The Wisconsin SPA, one of only 26 Medicaid Health Homes approved to date in the U.S., focuses 
exclusively on comprehensive care coordination for people diagnosed with HIV/AIDS and at least one 
other chronic condition.56 Vivent Health, as the lone agency administering Medicaid Health Home 
services for people living with HIV/AIDS in Wisconsin, is ideally positioned to translate its service 
coordination expertise into prevention home services to people who inject opioids in rural 
communities. The proposed prevention home model is inspired by and based on the same principles 
as the patient- centered medical home, but its scope is limited to coordination of essential services 
needed to prevent HIV, hepatitis, and other consequences of opioid injection (see Table 3). It is not 
an alternative to comprehensive medical care; rather, the prevention home model is an adjunct to 
clinic-based care for a specific population with extraordinary prevention needs, in the context of a 
public health crisis. Next, we describe enhancements to traditional SSP services which form the 
foundation of the Client-Centered Prevention Home model. 
 
1.6 COVID-19 Outbreak and Amended Intervention (Aim 3) 
In February 2020 the Minnesota Department of Health announced an outbreak of HIV among people 
who inject drugs in Hennepin and Ramsey Counties. Many of the cases were co-infected with HCV 
and struggled with homelessness. Due to its close proximity to Wisconsin and the transient nature of 
the population, local SSP in Wisconsin have increased efforts in testing for HIV and tracking new 
HCV infections. Concurrently, an increase in new cases of the novel Coronavirus, or COVID-19, 
began to appear throughout the state. On March 13, 2020, Wisconsin reported 18 confirmed cases 
Table 3. Emphasized features of medical and prevention health homes 
AHRQ 
Definitions 
Patient-centered medical home (health care 
settings) 
Client-centered prevention home 
(community-based settings) 
Comprehensiv
eness 
Addresses all of patient’s medical and 
prevention needs 
Comprehensive, evidence-based services for 
specific conditions 
Person-
centeredness 
Relationship-based, oriented to the whole 
person 
Relationship-based, non-judgmental, tailored to 
stage of change 
Care-
coordination 
Provider-led, team based clinical care over the 
life course 
Community-based prevention case mgt. during 
periods of risk 
Accessibility 
Ensuring access to clinical care, e.g., after-
hours availability 
Reducing geographic barriers, e.g., through 
mobile services 
Quality & 
Safety 
Decision support tools, QI activities, population 
health mgt. 
Strategic use of available health IT resources, 
mHealth tools 

 
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and the Governor declared a Public Health Emergency, mandating closures of all K-12 schools in the 
state. Many organizations began changing operations to ensure that their staff began working from 
home. By March 23, 2020 the Governor issued a Safer at Home order to decrease the spread of 
COVID-19.  
 
At Vivent Health, where the Wisconsin Rural Opioid Initiative is housed, operations decreased to two 
days a week and staff have minimized face-to-face time with clients. PWID are expected to call ahead 
of time to pick up a prepackaged syringe kit along with naloxone. However, little is known on the long-
term effects of limited operations on people who inject drugs. The prospect of sheltering in place and 
measures put in place by the SSP and other organizations poses a disruption to syringe services, 
access to essential preventative services, and other face-to-face support needed by PWID. By 
offering a crisis-response based virtual navigation program, we are fulfilling our ethical duty to prevent 
HIV, HCV, and overdose in a novel way with PWID in rural WI.  
 
1.7 Measuring the impact of the COVID-19 Pandemic on people who inject drugs 
We are now approaching the third year of the COVID-19 pandemic, which collided with a worsening, 
ongoing overdose epidemic that killed 9,260 people in Wisconsin from 2000-2019 from opioid 
overdose alone. Consistent with national and state-level trends indicating increases in fatal and 
nonfatal overdoses,65,66 overdose mortality in Wisconsin increased by 28% during 2020 relative to 
201967 Unfortunately, provisional 2021 data suggest it will be the deadliest year for drug overdose 
deaths in Wisconsin and the US.67 Beyond exacerbations to overdose mortality, prior studies also 
suggest that COVID-19 itself has disproportionately impacted people who use drugs, and that low 
vaccine confidence may continue to drive poor outcomes. Studies have shown that people who use 
drugs are at increased risk for COVID-19 infection, hospitalization, and death.68 Regarding 
vaccination, a survey of people who inject drugs in Wisconsin conducted by our team in March-May 
2021 indicated that 50% of respondents were hesitant to be vaccinated for COVID-19, consistent with 
prior studies.69 Actual COVID-19 vaccination rates and predictors of vaccine uptake have not yet 
been examined. However, prior studies suggest the potential for considerable under-vaccination for 
COVID-19 and other infectious diseases that disproportionately impact people who inject drugs (e.g., 
hepatitis A and B70). The extent to which people who inject drugs have accessed other recommended 
vaccines (i.e., hepatitis A and B) is also unknown, yet has important implications for understanding 
access to preventive care during the COVID-19 pandemic and potential long-term impacts on liver-
related morbidity and mortality. 
 
 
2.0 
STUDY OBJECTIVES 
 
The overall objective of this project is to leverage our team’s successful track record of research, 
surveillance, and service delivery in Wisconsin to implement an innovative yet widely replicable 
service delivery model for rural opioid users, which we have named the Community-Based, Client-
Centered Prevention Home. The key features of this approach are its implementation in community-
based organizations rather than traditional clinical settings, its focus on client-centered service 
coordination, and the incorporation of a mobile health (mHealth) information system to optimize 
quality and comprehensiveness. Building on our prior success engaging “hidden” populations of rural 
opioid injectors in research, our specific aims are:  
Aim1: To estimate the prevalence of HIV, viral hepatitis, and sexually transmitted infections among 
people who inject drugs to get high, and the availability of essential prevention services, in 6 rural 
Wisconsin counties. 

 
10 
 
Aim 1a: To quantify the impact of the COVID-19 pandemic on participants by summarizing 
COVID-19, overdose, and vaccination rates and risk and protective factors for these outcomes. 
We will achieve this aim via linkage of identifiable information from Aim 1 participants with 
several registries from the Wisconsin Department of Health Services (vital records, 
hospitalization data, Wisconsin Electronic Disease Surveillance System, Wisconsin 
Immunization Registry). 
 
Aim 2: To comprehensively assess unmet needs and available resources for the provision of 
essential prevention services for people who inject drugs to get high in rural communities: 
Aim 2a – We will analyze diverse sources of public health surveillance and administrative data to 
characterize areas at greatest community-level vulnerability to worsening epidemics of injection 
drug use. 
 
Aim 2b – We will engage key stakeholders from affected communities to identify provider-level 
characteristics that facilitate person-centered (e.g. relationship-based, culturally sensitive) service 
delivery. 
 
Aim 2c – We will use ethnographic methods and validated questionnaires to describe individual-
level barriers to optimal engagement in prevention and treatment services. 
Aim 3: To evaluate the impact of the Client-Centered Prevention Home model, deployed within 
syringe service programs in counties with high burden of injection drug use, on the proportion of 
clients who receive the package of 9 essential services endorsed by the World Health Organization to 
prevent HIV/HCV in people who inject drugs. We will use input from local stakeholders and a proven 
implementation science framework (NIATx) to translate lessons learned through Aims 1 and 2 into a 
service model that is responsive to the unique needs of rural residents and adaptable to communities 
with varying degrees of resource limitation. 
This project will be conducted by an experienced, interdisciplinary team working across academic, 
public health, and non-governmental sectors. The main community partner Vivent Health, formerly 
known as the AIDS Resource Center of Wisconsin (ARCW), is a unique, state-wide organization that 
provides harm reduction services, including syringe services and confidential HIV and HCV testing, to 
clients at 10 fixed sites and numerous mobile units reaching all 72 Wisconsin Counties. Based on our 
preliminary studies and prior collaborations, we have selected 6 rural counties as the focus of the 
epidemiologic evaluation and community needs assessment during the UG3 phase. Contingent upon 
meeting recruitment and data collection goals, in the UH3 phase of the project we will select the 3 
counties demonstrating the highest need, then deploy and evaluate the Client-Centered Prevention 
Home model at Vivent Health field offices located within these service areas. Service areas not 
selected for implementation will serve as comparison sites in the assessment of program 
effectiveness during Year 5. 
 
Study Coordination 
The Division of Infectious Diseases at the University of Wisconsin School of Medicine and Public 
Health is the coordinating center for this study. 
 
Investigators from numerous academic departments at UW-Madison and Tulane University will 
collaborate to refine study methodologies and adapt data collection and laboratory infrastructure 
during the fall of 2017, with a goal of commencing recruitment of subjects in January 2018.  
 

 
11 
 
Investigators will also participate in national working groups as part of a multi-site collaborative 
agreement including researchers in other states and Scientific Staff from the National Institute on 
Drug Abuse. 
 
Study Phases 
 
Phase 1 (UG3) 
September 2017 – August 2019 
 
Study activities 
• Creation of working groups 
• Building stakeholder support in 6 
target communities 
• Client survey and seroprevalence 
study in syringe service programs 
• Community needs assessment  
 
Phase 2 (UH3) 
September 2019 – August 2023 
 
Study activities 
• Development of Prevention Case 
Management Protocol 
• Enrollment of syringe service 
program clients in Prevention Case 
Management Program at 3 Vivent 
Health offices 
• Adaption of A-CHESS mobile health 
application (2021 Pilot).  
• Virtual Prevention Navigation 
Implementation Cohort Study 
(during COVID-19 Pandemic) 
 
Additional Phase 1 Activities (UG3)  
February 2022 – December 2023 
 
Study Activities 
• Link UG3 data with several 
registries from the WI Department of 
Health Services to ascertain 
longitudinal outcomes of interest 
during the COVID-19 pandemic 
• Quantify rates of COVID-19 
infection, testing, vaccination, and 
mortality from DHS data 
• Quantify fatal overdose rates and 
nonfatal overdose hospitalization 
rates 
• Quantify hepatitis A and B 
vaccination prevalence 
 
 
 
Phase 2 (UH3) Objectives 
Participants in the intervention will undergo a 12-week intensive multilevel harm reduction case-
management intervention geared towards coordinating referrals to reduce substance use disorder 
and increase engagement in the substance use disorder care cascades, and reduce vulnerability to 
HIV, STIs, and HCV and increase in engagement in the HIV, STI, and HCV care cascades. As shown 
in Figure 3, participants in the intervention arm will work with Prevention Navigators to undergo a risk 
assessment and identify problems that they will create goals to achieve. Each session after that will 

 
12 
 
be used to review the needs assessment and goals. During their last meeting, participants and 
prevention navigators will develop a discharge plan that will enable the participant to work on their 
goals on their own. 
 
COVID-19 Response and Amended Intervention. Wisconsin’s Shelter in Place mandate has 
statewide closure effects, including the limiting of services delivered by Vivent Health, our main 
community partner. To best respond to this crisis and help PWID in rural WI, we will adjust our 
prevention navigation model to a virtual, COVID-19 risk related navigation for a short period of time 
(through Sep 2020).  
 
Participants enrolled in the COVID-19 virtual navigation study will work with a navigator 4 times over 
the course of one month (1x/week) to reduce the risk of HIV, HCV, and overdose during this 
especially difficult time. Navigation will be focused on crisis response, safe drug seeking and sharing 
behaviors, at home HIV and HCV testing, overdose risk reduction, safe housing, stable food sources, 
and other relevant topics for PWID during the pandemic. After a trial of this model (ending Sep 2020), 
we will resume the original UH3 model (3 month intervention, and baseline, 3-month, and 6-month 
assessments) in a virtual format.  
 

 
13 
 
 
 
3.0 
SELECTION OF SUBJECTS 
In preparation for this study, our team analyzed WI county-level data reflecting various aspects of the 
opioid epidemic to (1) understand geographic heterogeneity of opioid injection and its consequences 
in order to prioritize communities in greatest need of prevention services; (2) build capacity to monitor 
changes in opioid-related disease burden over time on a state-wide level; and (3) establish a 
framework to assess the impact of the community response model in counties served by the new 
model in comparison to those not served. In Table 4, we list the 6 counties we have selected as high-
priority candidates for implementation of the Client-Centered Prevention Home model. They were 
Figure 3. Phase 2 (UH3) Study Flow 
Intervention participants enrolled between February 1, 2023 and March 31, 
2023 are excluded from the 6 months post baseline assessments. The final 
study assessments for these participants is 3 months post baseline. 
 
 

 
14 
 
chosen because county-level data indicate a high burden of opioid injection and HCV infection, and 
because they are located in close proximity to a Vivent Health prevention office that could feasibly 
deliver services to the majority of residents. 
 
In the first phase of the study, we identified sufficient resources to ensure the feasibility of our 
proposed intervention in 5 of the 6 counties we have studied, and have selected 3 service regions for 
which the intervention will be ideally suited. The 3 study sites include La Crosse County, Marathon 
County, and Brown County.   
 
In addition to confirming there are sufficient resources in the study areas, our research showed that 
the 3 selected communities differ from each other in notable ways, which will provide opportunities to 
study how implementation strategies may differ in varying contexts. For example, Brown County was 
unique in that the RDS survey engaged a much higher than expected number of Native American 
respondents. Respondents in Brown County also more commonly listed heroin as their “drug of 
choice,” while respondents in all other sites indicated methamphetamine was their preferred drug. 
 
COVID-19 Response and Amended Intervention.  In response to the national crisis, and to best 
serve PWID in rural WI, we will recruit subjects in our 3 intervention sites (Brown, Marathon, and La 
Crosse Counties). Additionally, we will be resampling participants who were enrolled in the UG3 
phase of the study and who have given permission to be contacted about future research 
opportunities. Each navigator will have a case load of no more than 15 participants at one time 
throughout the course of this pilot. Once we have concluded the pilot in Sept 2020, we will resume 
aim 3 procedures. 
 
4.0 
REGISTRATION PROCEDURES 
Participant recruitment for Aim 1 (UG3 Phase).  
Using a cross-sectional study design, we will enroll 1,200 people who inject drugs to get high and live 
in rural communities. Based on the volume of syringes distributed in 2016 at the six rural Vivent 
Health offices listed above, we anticipate enrolling 200 individuals at each site.  
Eligibility screening and enrollment of seeds. Individuals will be eligible for enrollment if they are 
15 years of age or older, have injected any drug to get high in the past 1 month, and reside in a rural 
community. Rural residence will be determined by ZIP code, which will be programmed in the 
screening instrument on REDCap.  The system will classify the ZIP code as rural if the ZIP Code 
RUCA Approximation is >4 or the participant lives in a catchment ZIP code for the SSP.  
A research assistant will screen clients for eligibility, either on site at Vivent Health or by phone. 
Vivent Health staff will notify clients of the opportunity to speak with research staff by phone if they 
Table 4. County-level data describing opioid epidemic in Vivent Health syringe service program. 
Variable 
Douglas 
 County† 
Eau Claire  
County† 
Marathon 
County† 
La Crosse 
 County 
Outagamie 
County 
Brown 
County 
HCV cases in ages 15-29 (per 100,000 
156.1 
92.7 
92.7 
72.0 
68.5 
60.0 
Opioid-related hospital visits (per 100,000 
pop.) 
205 
79.9 
48.7 
83.8 
67.4 
70.8 
Opioid prescriptions filled (per 1,000 pop.)‡ 
968.3 
745.2 
801.4 
753 
649.1 
760.9 
Percent of opioid prescriptions >90 MME 
daily‡ 
6.2 
4.3 
5.6 
6.3 
7.4 
4.7 
Syringes distributed by Vivent SSP in 2016 
Q3 
64,426 
53,867 
49,261 
53,567 
48,807 
46,317 
† Expected UH3 implementation site based on preliminary data (subject to change);  ‡ Data obtained from WI 
Prescription Drug Monitoring Program 

 
15 
 
report living in a rural community, are 15 or older, and are actively injecting drugs. To minimize the 
involvement of Vivent Health staff in the screening process at sites where having Vivent Health staff 
engaged in research would interfere with routine prevention activities, we have developed a flexible 
screening process that can be done without the involvement of Vivent Health staff. At certain sites, 
Vivent Health staff may become engaged in research and fulfill the research assistant role for the 
purpose of screening, if the agency determines this is the best strategy for managing the flow of 
clients and study participants. Specifically: 
1. As a matter of routine (i.e. independently of the study), syringe program staff collect the 
following information from clients: Age, zip code of residence, whether the client is actively 
injecting drugs, whether they are interested in referrals to drug treatment. Staff members also 
participate in several outreach testing events that are outside of the SSP centers, while testing for 
HCV and HIV at these events, staff collect information on age, zip code of residence, and whether 
the client is actively injecting drugs. During the study enrollment period, staff will notify clients of 
the opportunity to participate in the study if they report that they inject drugs, are 15 years of age 
or older, and reside in one of the targeted rural zip codes. Among those in testing events, SSP 
staff will pass along information telling the participant that they may be eligible to participate in the 
study. We have hired research staff to be on site who will help in screening and enrollment into 
the study.  
2. Questionnaire by telephone. The screening questionnaire has been uploaded as part of the 
application.  
3. If clients are determined to be eligible, then the research staff will collect their name and date of 
birth, and assign them a study ID number. They will then provide detailed information about the 
study procedures by reading the consent document. Copies of the consent document will be 
available in the private room at the Vivent Health prevention office, so that the client can read 
along and ask questions. Among participants recruited from outreach events, UW research staff 
will provide them the consent document and go over the study procedures in detail.  
4. If the client agrees to participate, they will write down their assigned study ID and end the 
phone call. They will then notify the SSP staff that they have agreed to participate. SSP staff will 
direct them to the study computer, where they will complete the study questionnaire using the 
ACASI interface. The first step of the computerized questionnaire will be to review the full text of 
the consent document and to submit their electronic signature and study ID number, which will be 
stored with the study data. In alternative settings such as outreach events where internet 
connectivity is not reliable, a paper version of the consent form will be signed and securely stored 
by a research assistant before proceeding with any study procedures. 
5. Rapid testing for HIV, hepatitis C and syphilis will be conducted by SSP staff, using standard 
procedures used by the agency that are independent of the research protocol. The data collection 
forms used by the SSP staff will be shared with the research team. Rather, specific data elements 
needed for the study will be securely transmitted to researchers at the time of data analysis.  
Recruitment via respondent-driven sampling (RDS). Upon study completion, participants will be 
asked to refer up to 4 eligible peers to participate in the study. As part of the ACASI questionnaire 
interface, they will view a brief training video that introduces the concept of RDS and emphasizes the 
goals of the study, which is to identify people in their rural social network who also inject drugs to get 
high.  
Seeds will receive $20 remuneration for survey participation on the day of enrollment, and will receive 
$10 for each eligible peer recruit who enrolls in the study. With customization of existing RDS coupon 
software,57 computerized tracking of study coupons allows monitoring recruitment chains, allocation 

 
16 
 
of incentives, and collection of data necessary to generate weighted sample statistics. By adjusting 
the number of coupons provided to recent recruits, we will be able to limit or accelerate the rate of 
referrals, which assists in maintaining appropriate workload of SSP and research staff and achieving 
recruitment goals. 
 
Participant recruitment for Aim 2 (UG3 Phase). 
 
The research team will conduct individual elicitation interviews with SSP clients, SSP staff, and local 
professionals involved in providing prevention and treatment services to people who use drugs in each 
of the 6 selected communities. A more rigorous approach to quantitatively assess barriers for medical 
providers, we will conduct a mail-based and email survey among 1,500 family medicine providers.  
 
SSP staff, comprised of prevention specialists in the Vivent Health participating field offices, will be 
the points of first contact in each community. We have developed a semi-structured interview guide 
that will elicit staff perceptions about the target population, and the availability of prevention resources 
and health services. We will use these interviews as a starting point to collect names of providers and 
local agencies that provide services to people who inject drugs. This will allow us to build a referral 
network for provider interviews (Aim 2b), and to complete the local needs assessment.  
 
A quantitative assessment of provider-level barriers will be conducted via a mail and email based 
survey among family medicine providers in WI in order to characterize barriers to optimal care and 
investigate opportunities to reduce health disparities among people who inject drugs (PWID). We will 
survey approximately 1,500 physicians specializing in family medicine who have a practice location in 
Wisconsin, as identified through an electronic database purchased from SK&A. To make specific 
comparisons among providers who have adopted office-based buprenorphine treatment (OBBT) in 
their primary care practice to those who have not, we will use a case-control study design, matching 
providers who have received a DEA waiver to prescribe buprenorphine to up to 2 non-waivered 
providers who practice in the same county. Cases have been identified through the Substance Abuse 
and Mental Health Services Administration’s (SAMHSA) website. SAMHSA’s database will be 
crosschecked by internet searches and phone confirmation to ensure that each provider is still 
practicing at reported location. We theorize that providers who have adopted office-based 
buprenorphine treatment have general awareness of the epidemic, and understanding barriers they 
face may be imperative. Controls (non DEA-waivered providers) will be drawn from the SK&A 
database. To achieve the target sample size of 1,500 providers, additional family medicine physicians 
will be sampled from the database, with priority given to providers practicing in the rural counties 
targeted in the parent study. 
 
SSP clients will be recruited for individual-level interviews (Aim 2c) among participants who consent 
to participate in the client survey and seroprevalence study, described in Aim 1. Clients who 
participate in the cross-sectional study described above will be systematically invited (e.g., every nth 
person) to also participate in a qualitative interview. We anticipate conducting qualitative interviews 
with 5% of the cross-sectional sample (n=60) divided among the 6 counties. Additional interviews will 
be conducted if warranted by the data but a sample size of 30-50 is usually sufficient to achieve 
saturation and redundancy, a marker of sufficient sample size.58 
 
Participant recruitment for Aim 3 (UH3 Phase, 2019-2021). 
Based on preliminary data, burden of opioid-related illness, and familiarity with supportive local 
stakeholders, we selected La Crosse County, Marathon County, and Brown County as the 
implementation sites for this study. Eau Claire, Douglas, and Outagamie Counties will serve as the 

 
17 
 
nonintervention sites, where participants will receive services as usual. In the fall of 2019, 3 full-time 
Prevention Navigators were hired and trained to conduct the intervention. Participants in this phase of 
the study will be recruited into one of two groups, 
Prevention Navigation, or usual services. Beginning 
in year 3, SSP clients at the 6 selected Vivent Health 
sites will be notified about the study by prevention 
specialists or SSP staff if the client 1) tests for HCV 
or HIV at the SSP, 2) inquires about services that 
may be in the prevention home through casual 
conversation, 3) the client engages in naloxone 
training, 4) through posted materials of the availability 
of new resources for improving prevention services 
and linkages to treatment in the SSP and community 
offices, 5) recruit through flyers and posted materials 
in the SSP and local community resource offices, and 
public areas, 6) through Vivent Health Facebook 
advertisements, 7) through our study website listed 
on our flyers, and/or 8) through respondent-driven 
sampling (RDS). Upon the completion of the first two 
attended Prevention Navigation sessions, 
participants will be given a referral coupon and asked to refer one eligible peers per coupon to 
participate in the study. Vivent Health will dispense coupons that have been prepared by UW 
research staff. SSP clients at the nonintervention sites will be recruited at the time the Vivent Health 
staff member assists them with regular exchange services. Nonintervention sites will aim to enroll 
about one participant every-other week. 
   
 
Figure 5. Parallel crossover (wait-list control) and cross-site study design 
 
 
 
Eligibility screening and enrollment at baseline. Individuals will be eligible for enrollment if they 
are 18 years of age or older, have injected any drug to get high in the past 1 month, and reside in a 
rural community. All persons who access services at the northern Wisconsin SSPs will be considered 
rural community members, so long as they reside in the state of Wisconsin. County of residence and 
zipcode will be collected, stored in the participant file, and recorded in REDCap. 

 
18 
 
Among nonintervention sites, eligibility criteria will be the same as intervention sites, with the 
exception of allowing Minnesota residents to participate in the Douglas County office.  
At intervention sites the PN will administer the screening questionnaire in person or over the phone 
with the client. If the PN is not available, the client may answer the screening questionnaire on their 
own and immediately validate their answers with the PN before eligibility is determined (not applicable 
if virtual). Eligibility requirements will not be listed or shared with the clients. The screening 
questionnaire has been uploaded as part of the application. If the PN is unavailable, Vivent Health 
SSP staff will also be research trained and able to administer the screening questionnaire in person 
or over the phone.  
If clients are determined to be eligible, then the research staff will collect their name and date of birth, 
and assign them a study ID number. They will then provide detailed information about the 
intervention, study procedures, and the consent document.  
If the client agrees to participate, they will be read a verbal consent script over the phone, by video 
conference, or in-person by the prevention navigator, SSP staff, or UW staff. They will be required to 
answer T/F questions regarding the consent before giving verbal consent. Participants will fill out a 
locator form at this time to help SSP staff contact the participant for follow up visits. 
Rapid testing for HIV and hepatitis C will be conducted by Vivent Health SSP staff, using standard 
procedures determined by the agency that are independent of the research protocol. The data 
collection forms used by the SSP staff will be shared with the research team in order to retrieve 
specific data elements needed for the study. Study forms will be securely transmitted to researchers 
after each research assessment.  
Clients at the nonintervention sites who are determined to be eligible after SSP staff administer the 
screening questionnaire will have their name and date of birth collected and assigned a study ID 
number. The SSP or UW staff member will go through the study procedures and read a verbal 
consent script over the phone, by video conference, or in-person. They will be required to answer T/F 
questions regarding the consent before giving verbal consent. A locator form will be filled out at this 
time. Rapid testing for HIV and hepatitis C will be conducted by the SSP staff member using the 
same standard procedures as above. The data collection forms will again be shared with the research 
team securely after each research assessment. 
All clients who are determined to be eligible will have a SSP or UW staff member go through the 
ACHESS specific activities (surveys and option activities) and read a verbal consent script over the 
phone, by video conference, or in-person. The participant will be required to provide verbal consent. 
COVID-19 Pilot Intervention. Participants will be recruited to the virtual prevention navigation 
implementation pilot program through three avenues. 
1) Participants who participated in phase 1 and consented to future contact will be recruited for 
the study  
2) Clients who access current SSP services will receive a flyer in their safe injection supply bags 
with contact information to call if interested in the study  
 
3) SSP staff may engage clients about the study if a client calls into the SSP asking for services  
Participants will be eligible for enrollment if they are 18 years of age or older, have injected drugs in 
the past month, reside in a rural WI community, and can speak and understand the English language. 
Clients will speak with the Prevention Navigator to determine eligibility, consent to the study, and 
schedule their first navigation session. If the client agrees to participate, their name, DOB, county and 
zip code of residence, and phone number will be collected. Navigators will have a case load of no 
more than 15 participants at one time to ensure workload is manageable, with a final recruitment 

 
19 
 
number of n=108 intervention participants and n=108 control participants. Navigators may take down 
a client’s phone number, per Vivent Health policy, in order to contact the individual when spots open.  
We will pause recruitment for our originally proposed UH3 protocol until at least Sep 2020 when the 
pilot has ended. 
 
5.0 
DATA COLLECTION   
5.1 
Data collection for Aim 1. 
Epidemiologic survey and needs assessment for rural WI. During years 1 and 2 of this project, 
we will conduct a cross-sectional prevalence study among residents of rural communities in the 
catchment areas surrounding 6 Vivent Health Prevention Offices (Figure 3). Four of these offices are 
located in counties (Eau Claire, La Crosse, Marathon, Outagamie) classified by the National Center 
for Health Statistics (NCHS) as rural. Douglas and Brown Counties are not classified as rural by virtue 
of their proximity to the larger cities of Duluth, MN and Green Bay, WI, respectively. Both counties 
have total populations of fewer than 250,000 residents, however, and our analysis of residential ZIP 
codes provided by SSP clients showed that the Vivent Health offices in these counties served clients 
from a large geographic area across rural Northern Wisconsin, where the prevalence of HCV among 
young people who inject drugs is highest.  
Rapid testing for infectious diseases. Upon enrollment, participants will provide 3 fingerstick whole 
blood samples for rapid testing of HIV, HCV and syphilis. Vivent Health prevention staff are trained to 
perform point-of-care tests for these infections using the Alere Determine™ HIV-1/2 Ag/AB Combo 
(Alere Inc., Waltham, MA); the OraQuick® HCV Rapid Antibody Test (OraSure Technologies, 
Bethlehem, PA); and the Syphilis Health Check™ (Trinity Biotech, Bray, Co Wicklow, Ireland), 
respectively. During the 20 minutes while awaiting test results, participants will complete an 
interviewer-administered survey (described below). If all 3 rapid tests are non-reactive, then the study 
visit will end after he or she has completed the questionnaire and received recruitment training and 
referral coupons. If any of the 3 rapid tests are reactive, then SSP staff will perform venipuncture to 
collect a blood specimen to be sent to the Wisconsin State Laboratory of Hygiene (WSLH) for 
confirmatory testing, record multiple methods of re-contacting the client, and arrange a follow-up visit 
to review confirmatory test results and provide linkage to care, if needed. In the event that a 
participant cannot provide a blood specimen for confirmatory testing due to poor venous access, they 
will be invited to return at a later date for another blood draw attempt. Those confirmed to have active 
HIV, HCV, or syphilis infection will be linked to a local provider with the assistance of a Vivent Health 
case manager.  
Laboratory-based confirmatory testing and specimen handling. Specimens received by WSLH 
will be processed for confirmatory testing per standard protocols (see Facilities and Resources for 
details). After completing the required testing and reporting test results to the testing agency and the 
WI Surveillance System, WSLH staff will store plasma specimens in preparation for shipping to the 
CDC and/or GHOST laboratories, as described in Section 5.2 
Collection of baseline demographic and risk behavior data.  We worked closely with the Vivent 
Health Director of Prevention and syringe program staff to develop strategies to ensure that research 
activities are minimally-disruptive to the daily, core prevention activities of ARCW staff. Our pilot 
studies within SSPs have shown that this is essential for ensuring study protocol fidelity, maintaining 
high-quality data collection, and maximizing client willingness to participate. We will take advantage of 
existing data collection forms that are used during HIV and HCV testing encounters to capture 
necessary individual-level data elements. All publicly-funded HIV testing sites in WI are required to 
use a uniform data collection and reporting system called Evaluation Web (Luther Consulting, LLC, 
Carmel, IN). Rapid HCV testing supported by WI DHS requires that agencies report client-level data 

 
20 
 
using the Wisconsin Electronic Disease Surveillance System (WEDSS). With participant consent, the 
paper data collection forms used to capture the required demographic and risk behavior information 
will be transmitted to the UW-Madison based study coordinator via secure fax-to-PDF system, and 
will be stored on an encrypted server in a directory separate from other study data. 
Additionally, the laboratory infrastructure upon which the Wisconsin UG3 study was developed allows 
an opportunity to undertake a broader epidemiologic investigation that will more fully characterize the 
HCV epidemic in rural Wisconsin. All blood samples collected for HCV RNA confirmatory testing in 
the state of Wisconsin undergo testing at the Wisconsin State Laboratory of Hygiene (WSLH). The 
WSLH retains serum specimens from positive and negative confirmatory HCV RNA tests for up to 5 
years. Using stored serum specimens collected during 2016-2017, we will conduct a baseline 
investigation of transmission clusters involving residents of rural Wisconsin communities. 
Baseline Survey. Data elements not captured through existing workflows of SSP staff but necessary 
to achieve the research aims will be collected using a research team administered phone survey. At 
least two staff member will be available at all times during business hours. We will have 3 
researchers available most days and develop an “on call” system to facilitate 2 phone-based study 
assessments by phone at a time. The survey will consist of short answer and multiple choice 
questions designed to efficiently assess drug use history, access and utilization of prevention 
services, and injection related risk behaviors (see Appendix 2 for proposed measures). 
To maximize willingness of clients to participate within the context of a routine Vivent Health 
prevention encounter, we will pilot-test the survey to ensure it can be completed within 20-25 minutes. 
To facilitate recruitment of participants who have difficulty traveling to Vivent Health offices, we will 
begin recruiting and enrolling participants at outreach events that are organized by Vivent Health. We 
described the steps for recruitment and enrollment above. The survey will be administered during the 
outreach event via computer if there is an adequate internet connection. To increase flexibility in 
these settings, the survey may also be conducted via telephone with a UW-Madison researcher, who 
will administer the questionnaire verbally and enter responses directly into the Qualtrics survey. If 
internet or phone communication is not feasible, then a research assistant may administer the 
questionnaire in person using a pen-and-paper version. In this situation, the research assistant will 
subsequently perform data entry.  
A data use agreement has been set forth between the University of Wisconsin-Madison and 
University of Washington, where a limited dataset from the University of Wisconsin is required to be 
submitted to the University of Washington as part of the NIH-funded Rural Opioid Initiative data 
harmonization project. The University of Washington Data Harmonization Coordinating Center (DCC) 
will be harmonizing data across eight sites in order to create new, combined datasets to be used for 
analyses across the consortium. Only data from this study (#2017-0866) will be sent to the DCC from 
UW-Madison. 
Harmonization means the DCC will be combining similar data domains and questions across all sites 
in order to build large data sets that will be useful in answering questions that individual sites are not 
able to answer alone, either due to the nature of the question or sample size limitations.  The 
University of Washington and other grantees will perform data analyses on these data for peer-
reviewed publication. The harmonized datasets will be provided to other investigators funded under 
this study as required for analysis and will be considered under the umbrella of mandated DCC 
activities. 
Upon execution of the agreement, the team’s data manager will upload study datasets to the Rural 
Opioid Initiative (ROI) Upload Server through a web interface. Access to the interface is controlled by 
usernames and passwords. Access is assigned to individual, designated ROI staff by the University 

 
21 
 
of Washington Data Coordinating Center (DCC).  The web page uses the HTTPS protocol to transfer 
ROI data files securely to the Upload Server. HTTPS transfers are encrypted using Transport Layer 
Security (TLS, the successor to SSL), protecting the data en route to the server. The Upload Server is 
managed in accordance with the DCC’s information security policies (https://uwcirg.github.io/hipaa-
policies), and authorization for specific DCC staff is based on their project-related needs and 
responsibilities. 
Data documentation will also be uploaded in the form of a data dictionary specifying all data elements 
within the dataset, including their description, valid values, and data type. Upon receipt of the dataset 
and documentation, the DCC data manager will work with the Wisconsin ROI data manager to 
understand the data structures so that the DCC may harmonize the dataset with those from other 
sites. A list of data elements that will be sent to the DCC is included in Appendix 3.  
 
5.1.1 Additional Data Collection for DHS Linkage Study on COVID-19 Pandemic Impact Among 
UG3 Participants 
We will use data collected by the Wisconsin Department of Health Services (DHS) to estimate the 
rates of COVID-19 infection, testing, hospitalization, and death, fatal and nonfatal drug overdoses, 
and vaccination against COVID-19, Hepatitis A and Hepatitis B in the UG3 cohort. To achieve our 
objectives, we propose a retrospective cohort study that will be facilitated by linking data from several 
DHS registries with UG3 participants. We propose to provide DHS colleagues with identifiable data 
from 991 of our prior research participants (identifiers: participant name, date of birth, gender, race, 
ethnicity, previous address, previous phone number, date of participation in our study) to facilitate 
linkage with several DHS registries. We are seeking approval for the DHS data linkage via a partial 
waiver of authorization, waiver of consent, and by maintaining a log of the protected health 
information provided to DHS per standardized disclosure logs (see here: 
https://compliance.wisc.edu/wp-content/uploads/sites/102/2019/02/Accounting-for-Disclosures-Log-
Research.pdf). The linkage process is described below:  
1. UW will provide a dataset containing a unique study identification number and participant name, 
date of birth, gender, race, ethnicity, previous address, previous phone number, and date of study 
participation to colleagues at DHS. 
Table 6. Quantitative measures collected for Aim 1  
Variable 
Source 
Measure/Operational Definition 
Prevalence of HIV, HCV, , syphilis 
Point-of-care screening + 
laboratory confirmation 
Number of confirmed active cases / total number 
screened 
Access to 9 prevention services 
Participant questionnaire 
Perceived accessibility using 5-pt Likert scales 
Health insurance 
Participant questionnaire 
Access to Care Scale†59 
Addiction severity 
Participant questionnaire 
Severity of Dependence Scale60 
Barriers to care 
Participant questionnaire 
Kalichman’s Barriers to Care Scale†61 
HIV/HCV/STI risk behaviors 
HIV/HCV Testing Data 
Collection Forms 
NHME Data Variable Set‡ 
Demographic characteristics 
HIV/HCV Testing Data 
Collection Forms 
NHME Data Variable Set‡ 
† NIDA STTR Data Harmonization Measure; ‡ NHME=National HIV Prevention Program Monitoring and Evaluation  

 
22 
 
2. DHS will link identifiers with vital records data to identify the date (from study participation date 
through present day) and cause of any deaths that have occurred among participants of our prior 
study, from study participation date through present day. 
3. DHS will link identifiers with COVID-19 data captured in WEDSS to identify the date of any COVID-
19 tests, confirmed or probable infections, and hospitalizations. 
4. DHS will link identifiers with WIR to identify the dates of all COVID-19 vaccination doses received 
and type of vaccine (brand or whether an mRNA/adenovirus vector vaccine). 
5. DHS will link identifiers with WIR to identify the dates of all vaccine doses for hepatitis A or B 
received (including doses received before study participation, if possible). 
6. DHS will link identifiers with hospitalization data to identify overdose events involving an 
emergency department visit or hospitalization. 
7. DHS will remove and destroy identifiers and return the dataset(s) to UW containing the unique 
study identification number. 
8. UW researchers will link the new dataset with variables collected in our prior cross-sectional survey 
using the unique study identification number, including sociodemographic (i.e., age, gender, 
race/ethnicity, housing, education, employment, income, marital status, health insurance coverage) 
and behavioral correlates (i.e., substances used and mode of use, mental health indicators and 
symptoms, addiction treatment history, personal and witnessed overdose history, awareness of how 
to respond to an overdose and access to naloxone, self-reported HIV and hepatitis C infection and 
treatment, where the participant primarily receives medical care, barriers to engaging in medical care, 
criminal justice involvement history, access to the internet and a cell phone, and self-stigma).  
We will also be requesting that DHS provide an aggregate dataset with COVID-19 data to facilitate 
comparison of COVID-19 burden between the general population of Wisconsin and UG3 participants. 
Specifically, we will with monthly age-, sex-, racial/ethnic-, and county-stratified numbers of COVID-
19 tests, vaccinations, confirmed or probable infections, hospitalizations, and deaths for Wisconsin 
(i.e., fully stratified by combined categories of these demographic variables within each county). For 
the vaccination outcome, we would like to have the number vaccinated with 2 doses of mRNA or 1 
dose of Johnson&Johnson and the number with a 3rd mRNA dose or second shot of any type 
following 1 dose of a Johnson & Johnson vaccine. We hope to obtain the following categories of age 
(18-29, 30-39, 40-49, 50-59, 60-69, 70+), race/ethnicity (Non-Hispanic/Unknown ethnicity + white, 
Non-Hispanic/Unknown ethnicity + African American, Non-Hispanic/Unknown ethnicity + American 
Indian or Alaskan Native, Non-Hispanic/Unknown ethnicity + Other or Multiple races, Hispanic + any 
race), sex (male, female) within each county in Wisconsin by month, beginning March 1, 2020 to 
present. We will also request estimates of the monthly population size within each stratum. 
5.2. Global Hepatitis Outbreak Surveillance Technology (GHOST).  
This research study is part of a collaboration with scientists at other institutions including the U.S. 
Centers for Disease Control and Prevention (CDC) and the Global Hepatitis Outbreak and 

 
23 
 
Surveillance Technology (GHOST) Center located at the Ragon Institute of MGH, MIT and Harvard. 
Blood collected as part of the testing for HIV, Hepatitis and Syphilis may be sent to these other 
institutions for additional testing. These research tests include, but are not limited to, HIV, HCV, 
Syphilis and/or other tests for research purposes only. All blood and information will be coded with a 
number and no directly identifiable information will be shared outside of UW-Madison. The GHOST 
lab will use specialized technology that identifies transmission links between HCV infected research 
subjects. The GHOST platform is a secure cloud-based public health research tool to allow state and 
local health departments to act more quickly to detect and fight the spread of Hepatitis C. Specimens 
utilized for this laboratory-based initiative will be collected and shared in the context of two 
complementary protocols: 
1. A baseline, retrospective evaluation of HCV transmission clusters using remnant serum 
specimens currently stored at the Wisconsin State Laboratory of Hygiene. 
2. An analysis of prospectively collected blood specimens obtained from individuals who undergo 
rapid testing for HIV, HCV and syphilis as part of their participation in this study. 
5.2.1. Retrospective analysis of HCV transmission clusters in Wisconsin. 
We have analyzed data reported to the Wisconsin Electronic Disease Surveillance System (WEDSS) 
to identify cases of HCV infection that were reported for the first time between January 2016 and 
December 2017. Approximately 15% of all HCV cases reported to the surveillance system during this 
time represented individuals who underwent fee-exempt confirmatory HCV RNA testing through 
WSLH; these instances typically reflect testing done in public health settings such as syringe 
exchange programs and correctional facilities, and not traditional health care settings. This results in 
a sample that is enriched for younger people with a history of injection drug use. By contrast, birth 
cohort testing in WI has been conducted mostly in primary care settings, which utilize commercial or 
hospital based laboratories for confirmatory testing. 
We have identified 241 individuals residing in one of the targeted rural catchment areas who were 
confirmed to have an HCV RNA+ sample analyzed at WSLH during 2016-17. In addition, we have 
identified an additional cohort of 218 individuals who we consider likely to represent recent or acute 
infections because of younger age, higher HCV viral load, or having received a designation of acute 
HCV infection at the time of reporting to WEDSS. The rationale for including the latter group, who 
were identified regardless of their geographic area of residence, is that they may enhance the overall 
likelihood of detecting transmission clusters. Characterization of transmission clusters that include 
residents of rural and non-rural communities would be highly informative for development of services 
in the proposed UH3 phase of the study. 
Pending approval by the funding agencies and the appropriate institutional review boards, we will 
identify residual serum specimens corresponding to these 459 cases and ship samples to the 
GHOST laboratory at MGH. Specimens will be labeled with a unique identifying code and year of 
collection prior to shipping. GHOST investigators will be sent a corresponding database that specifies 
the year of collection and quantitative HCV RNA result, but will not receive other information that 
could be used to identify study participants. After GHOST investigators perform genetic sequencing of 

 
24 
 
the virus to understand transmission networks, data will be uploaded to a secured web interface in 
order for researchers and the Department of Health Services to access, according to procedures 
described below (5.2.2.) 
5.2.2. Prospective data collection and analysis of HCV transmission clusters in Wisconsin. 
Remnant blood specimens from the confirmatory testing procedures collected from prospectively 
enrolled study participants will also be used to support the GHOST-related research aims of the multi-
site collaborative research program. Upon receipt of a reactive rapid antibody detection test, Vivent 
Health staff will draw 5 mL of blood into each of up to 3 serum separator tubes (SST), depending on 
how many of the 3 rapid antibody detection tests had a reactive result. 
SST tubes will be centrifuged within 2 hours at the Vivent Health prevention office, according to the 
Standard Operating Procedures developed between Vivent Health and the Wisconsin State 
Laboratory of Hygiene. After centrifugation, the SST tubes will be kept cold (4-8°C) and shipped 
together with the appropriate requisition forms to WSLH via overnight delivery. Confirmatory testing 
will be performed on specimens on the day of receipt, and aliquots of residual serum will be 
transferred to secondary tubes and placed in a -80°C laboratory freezer for indefinite storage. 
Stored serum specimens for HIV, hepatitis C, and Syphilis positive participants will be shipped to 
GHOST laboratories for phylogenetic testing on a monthly basis. GHOST laboratories are housed at 
Massachusetts General Hospital and the CDC. They will perform genetic sequencing of the virus to 
understand networks. The data will then be uploaded to a secured web interface in order for 
researchers and the Department of Health Services to access sequence data.   
Access to the sequencing data by the Wisconsin Project team will be allowed through the National 
Healthcare Safety Network’s system, known as SAMS. The Centers for Disease Control and 
Prevention’s (CDC) Secure Access Management Services (SAMS) is a federal information 
technology (IT) system that gives authorized personnel secure access to non-public CDC 
applications. The SAMS partner portal is a website designed to provide centralized access to public 
health information and computer applications operated by the CDC. For the National Healthcare 
Safety Network (NHSN) Program, SAMS will provide healthcare facilities and other partners, such as 
state health departments and QIOs, with secure and immediate access to the NHSN application. 
The UW-Madison-based PI and partners at WI DHS HIV and Viral Hepatitis Program will be granted 
access to SAMS by CDC after completing the required NHSN training. Data accessed through SAMS 
will be limited to the viral sequence data derived from the coded HCV RNA-positive samples sent to 
the GHOST laboratory. No direct identifiers will be associated with data that is accessible through 
SAMS. Additional information about SAMS is available at https://www.cdc.gov/nhsn/sams/sams-user-
faq.html#a1. 
5.3. 
Data collection for Aim 2. 
Guided by the social ecologic framework (see Section 1.4), we will assess (a) community-level 
vulnerability to consequences of injection drug use and (b) availability of essential prevention services 
through data collection at the county-level, health system and provider-level, and client-level. 
Interview guides for clients and local service providers will be developed collaboratively by the 

 
25 
 
research team and Vivent Health staff after the SSP staff interviews have been conducted and 
analyzed. 
Aim 2a. County-level data. We will map out and organize project-related resources within our 
designated counties. An assessment of service needs and gaps will be conducted. We will identify 
additional sources of county-level data to complement our preliminary compilation of data that guided 
the proposal, including use of PDMP and State opioid treatment authority to identify capacity to 
prescribe MAT and the current level of utilization. Availability of these data sources are reflected in 
letters of support from WI DHS collaborators.  
Aim 2b/Aims 2c. Provider- and client-level data. Semi-structured individual elicitation interviews 
will be administered to obtain insight from providers of services to injection drug users and clients of 
these agencies about the context of opioid use and barriers and facilitators of service access and 
usage. 
Aim 2b. Provider interviews will be conducted in person or by phone, and are expected to last 30-
45 minutes in duration.  They will be audio-recorded and transcribed for later analysis. The goals are 
to assess (1) services provided to opioid users, (2) barriers and facilitators of access to their services, 
(3) gaps in service, and (4) strategies to address these gaps. We also will assess the agency’s 
willingness to support a community-based, client-centered prevention home approach to reducing 
opioid use and infectious disease transmission risk among opioid users. The provider interviews, 
along with the county-level resource mapping, will inform the readiness and ability of the county to 
implement a comprehensive prevention program. Agencies will be purposively recruited to represent 
multiple service domains, including HIV/HCV/STI testing and treatment, medical and mental health, 
substance misuse treatment, psychosocial assistance, health officials, and law enforcement. The 
specific provider sample size will depend on the number and variability in the county resources 
mapped out in Aim 2a.  
Aim 2b. Provider mail and email-based surveys. A survey investigating willingness to screen and 
treat PWID for HCV and opioid use disorder will be developed in collaboration with other UG3 sites. 
The goals of this mail and email-based survey are to quantitatively asses (1) the willingness of rural 
primary care providers to provide treatment for HCV infection and/or opioid use disorder as primary 
prescribers, (2) the prevalence and correlates of failure to provide appropriate screening for HIV, viral 
hepatitis, and sexually transmitted diseases for people who inject drugs, and (3) negative provider 
attitudes towards people who inject drugs that may serve as a barrier to effective primary care in rural 
communities. A cover letter, paper survey, and a $5 incentive will be mailed to selected providers 
along with materials and instructions for mailing completed surveys back to study staff at UW-
Madison. To increase the response rate of the provider survey, providers who have not responded to 
the survey will be emailed with a web-link to the same survey.  
Aim 2c. Client interviews will be conducted in-person in a private setting agreed upon in advance by 
participants and research staff.  Interviews will be digitally audio recorded and transcribed for 
subsequent qualitative analysis. Respondents will be paid an incentive of $30 for each interview. 
Interview guides will explore: (1) Individual characteristics and circumstances. We will ask people 
to tell us about themselves, their life circumstances (e.g., housing, employment or school, 
transportation, financial support), and their daily routine. We also will assess the impact of positive 
and negative life experiences on their injection drug use. The relationship of these factors to risk 
behavior will be explored. (2) Family and other interpersonal relationships. We will ask 
participants to tell us about their family and other significant interpersonal relationships they have, 
including the nature of the relationship, things they do together, and things they talk about. We will 
explore substance use and sexual risk behavior patterns within the participant’s extended family and 
among significant others. (3) Community contexts. We will explore participant’s perceptions of the 

 
26 
 
neighborhood(s) in which they live and socialize, including the types of people that live there, their 
social interaction patterns, and the places that people go to hang out and use drugs. We also will 
explore the availability and usage of social services, employment opportunities, and programs that 
promote community (e.g., churches). (4) State policy. We will ask about people’s experiences with 
the legal system, including both incarcerated and non-incarcerated jurisdiction. We will explore the 
impact that involvement with the legal system has on their injection drug use. (5) Sexual behavior. 
We will explore participant’s sexual behavior patterns, and the contexts or factors increasing or 
decreasing sexual risk likelihood. We also will assess participants’ HIV/STD/hepatitis risk perceptions 
and concerns. Risk reduction behavioral and negotiation strategies will be explored. (6) Substance 
use behavior. We will explore participants’ substance use patterns with a focus on injection drug 
use, and the contexts or factors increasing or decreasing use likelihood. We will assess (un)safe 
injection practices. We also will assess the saliency and centrality of substance use in participant’s 
lives and the lives of their family and significant others. 
A limited dataset of transcripts will be sent to the University of Washington DCC as part of the data 
harmonization project after the School of Medicine and Public Health’s honest broker has reviewed 
them to assess PHI.  
 
5.4 
Data Collection for Aim 3 (Phase 2 - UH3)  
 
Prevention Navigation. The health-related goals for PWID in the context of this study are multi-
faceted, reflecting the heterogeneous needs of this vulnerable population. Accordingly, there is not a 
single, primary outcome which can be measured to evaluate the impact or effectiveness of the 
intervention. We therefore have proposed a study design that allows us to evaluate the influence of 
prevention navigation on progress toward a number of health goals. Because no single study design 
can account for all of the biases inherent in a non-randomized, multi-county intervention trial, we have 
proposed 2 different types of comparisons in our evaluation strategy (Appendix 1). Prevention 
Navigators will collect case notes and worksheets as part of the intervention, but this will only be 
accessible to them. These documents will be analyzed as data or shared with the UW-Madison 
research team. 
The preferred method for intervention sessions is one-on-one in person, with optional one-on-one 
phone or video interventions when needed (ex: COVID-19 Pandemic). Staff will only contact the 
participant by their preferred method of contact, getting permission to leave messages before doing 
so. All virtual interventions and follow up calls will be performed on the navigators’ cell phones or 
laptops provided by Vivent Health. Staff may also text participants to remind them of appointments, 
request a follow up call, or other short communication purposes. No messages will be sent without 
consent from the participant while filling out the locator form. Per Vivent Health policy, staff are 
permitted to communicate with clients about their care and treatment via Facebook messenger 
utilizing a professional Facebook account that is separate from any personal accounts. Staff are not 
permitted to use personal accounts to communicate with clients in a professional capacity. No data 
will be collected over social media accounts. Facebook conversations will not count as an intervention 
session.  
Survey and needs assessment. The primary source of data collection in all three groups of the 
study will be from the ACASI questionnaire, administered at 0 months (baseline), 3 months, and 6 
months from enrollment. All surveys will be administered on a tablet using the ACHESS application, 
by the participant accessing the survey in ACHESS on their smartphone or web browser on their own 
time, or over the phone. The data will be securely stored at UW-Madison and erased from the tablet if 

 
27 
 
applicable. The survey will consist of multiple choice questions designed to efficiently assess drug 
use history, access and utilization of prevention services, readiness for intervention, and injection 
related risk behaviors. The final survey a participant takes will include exit questions to help us 
evaluate and improve the program. Participants enrolled in the intervention between February 1, 2023 
and March 31, 2023 will complete the baseline and 3 months ACASI questionnaire only. 
 
ACHESS. All participants will complete study assessments using the ACHESS application. ACHESS 
can be accessed by downloading the application to a smartphone or via a web browser. Participants 
may also take part in optional non-research activities within the ACHESS app. These activities 
include: 1) posting on discussion boards, 2) utilizing the private message function to communicate 
with study staff or other participants, 3) viewing local community resources and their contact 
information, 4) viewing and saving motivational quotes of the day and logging thoughts of gratitude, 
and 5) accessing study staff contact information. 
Rapid testing for infectious diseases. Upon enrollment, participants will provide 2 finger stick 
whole blood samples for rapid testing of HIV and HCV at baseline, 3-months, and 6-month follow up. 
Participants enrolled in the intervention between February 1, 2023 and March 31, 2023 will complete 
the baseline and 3-month rapid testing only. Vivent Health prevention staff are trained to perform 
point-of-care tests for these infections using the Alere Determine™ HIV-1/2 Ag/AB Combo (Alere Inc., 
Waltham, MA) and the OraQuick® HCV Rapid Antibody Test (OraSure Technologies, Bethlehem, PA. 
During the 20 minutes while awaiting test results, participants may complete the ACASI questionnaire 
(described above). If testing by appointment, participants should complete the survey before arriving 
to their appointment. If both rapid tests are non-reactive, then the study visit will end for non-
intervention clients and an appointment will be made for their 3-month visit. Among intervention 
clients, the study visit will end and an appointment will be made for intervention visit or phone/video 
call. If either of the 2 rapid tests are reactive, then SSP staff will perform venipuncture to collect a 
blood specimen to be sent to the Wisconsin State Laboratory of Hygiene (WSLH) for confirmatory 
testing, and arrange a follow-up visit to review confirmatory test results and provide linkage to care, if 
needed. In the event that a participant cannot provide a blood specimen for confirmatory testing due 
to poor venous access, they will be invited to return at a later date for another blood draw attempt. 
Those confirmed to have active HIV or HCV infection will be linked to a local provider with the 
assistance of a Vivent Health case manager or Prevention Navigator.  
The test results and risk data collected on the HCV and HIV test forms will be entered into Vivent 
Health’s standard of practice database, ServicePoint. Study ID numbers will be included to identify 
the results as study participants. ServicePoint will securely send data to WEDSS regularly. Only 
those on the HCV team at WI DHS, which consists of three research team members, will have access 
to the data. Test forms will be securely faxed to UW-Madison and mailed to DHS, then securely 
locked at Vivent Health, UW-Madison, and DHS. 
Laboratory-based confirmatory testing and specimen handling. Specimens received by WSLH 
will be processed for confirmatory testing per standard protocols (see Facilities and Resources for 
details). After completing the required testing and reporting test results to the testing agency and the 
WI Surveillance System, WSLH staff will store plasma specimens in preparation for shipping to the 
CDC and/or GHOST laboratories, as described in Section 5.2 
Collection of baseline demographic and risk behavior data.  Similar to Aim 1, we developed 
strategies to ensure that research activities are minimally-disruptive to the daily, core prevention 
activities of Vivent Health staff. Our pilot studies within SSPs have shown that this is essential for 
ensuring study protocol fidelity, maintaining high-quality data collection, and maximizing client 
willingness to participate. We will take advantage of existing data collection forms that are used 

 
28 
 
during HIV and HCV testing encounters to capture necessary individual-level data elements. All 
publicly-funded HIV testing sites in WI are required to use a uniform data collection and reporting 
system called Evaluation Web (Luther Consulting, LLC, Carmel, IN). Rapid HCV testing supported by 
WI DHS requires that agencies report client-level data using the Wisconsin Electronic Disease 
Surveillance System (WEDSS). With participant consent, the paper data collection forms used to 
capture the required demographic and risk behavior information will be transmitted to the UW-
Madison based study coordinator via secure fax-to-PDF system, and will be stored on an encrypted 
server in a directory separate from other study data. 
Medicaid and Health Care Utilization Analysis. We will link multiple existing datasets at the 
individual-level to evaluate the effects of the intervention health care use. These include the WI 
Department of Corrections (DOC) administrative dataset, Medicaid enrollment and claims data, WI 
State Laboratory of Hygiene (WSLH) HCV test records, WI Department of Health Services HCV 
Surveillance data, and the new county-level data resource developed through the activities under Aim 
2a. 
Based on our work with the JCOIN supplement, the UW-Institute for Research on Poverty (IRP) will 
assist in constructing the study dataset. The IRP has longstanding technical expertise in the 
construction and secure use of integrated person-level electronic datasets that combine State of 
Wisconsin administrative data including Department of Corrections and Medicaid administrative and 
health care claims data. Specifically, the IRP maintains the Multi-Sample Person File (MSPF) dataset 
which combines data for the universe of individuals interacting with several WI state agencies, 
including the Department of Health Services (home of the Medicaid program) and the Department of 
Corrections, at the person-level dating back to the late 1990’s through the present. The MSPF is 
structured at the person-level, and each individual has a unique ID over time and across state 
agencies (e.g., a person who is incarcerated in a WI state prison and later enrolled in WI Medicaid) 
which supports longitudinal analysis. 
For Aim 3, we will provide the UW IRP programming staff with our sample selection criteria. They will 
query the MSPF dataset with these criteria to identify possible linkages to our study participants along 
with a comparison group to evaluate the intervention itself. In addition to basic program participation 
information (e.g., dates of participation), the MSPF includes identifying variables for each unique 
person including Social Security number, date of birth, name, and the individual’s identification 
number for each state agency that contributes to the MSPF in which s/he receives or has received 
services. The IRP will submit a finder file with the relevant identification information to each entity that 
is providing person-level data for the study. Upon receipt of these data, the IRP will then merge data 
from all sources at the person level, assign a unique, study number to each subject, and remove the 
personal identifying information used to match data across sources from the analytic dataset that is 
provided to the investigators.  
The exchange of data between the IRP and state agencies is governed by the Data Use Agreements 
between the IRP and the respective agencies and follows a strict data security protocol to protect the 
confidentiality of individuals. The DUA between the IRP and the WI Medicaid program was modified 
and approved for this study in September 2018.  
COVID-19 Pilot Intervention. All data will be collected in REDCap, ServicePoint, Vivent Health’s 
secure server, or on a secure server only accessed by UW research staff. Sessions will happen via 
phone or Microsoft teams, Vivent Health’s approved secure video call resource.  
Screening data and locator forms will be stored on the Vivent Health server or secure PHI box and 
entered into REDCap for analysis by UW staff.  
COVID-19 Pilot Navigation Participants will undergo a risk and needs assessment during the first 

 
29 
 
and last session of the intervention, as well as 30 days after Vivent returns to their full service model 
(if deemed appropriate post pandemic). The assessment will ask a shortened version of ACASI 
survey questions specifically relevant to the pandemic. The rest of the assessment will follow the 
same risk and needs outline as designed for UH3, just with goals specific to the pandemic. Data will 
be stored on the Vivent Health secure server before being uploaded to a PHI box for analysis. All 
participant data will be collected by the prevention navigators on their Vivent Health provided devices.  
At home testing data will be collected online using Vivent Health’s testing protocol. Testing forms will 
be filled out online, and collected by SSP staff. Individual data will be uploaded to the PHI box, 
REDCap, or Vivent Heath server by the prevention navigators.  
Data Matching We will combine data for participants who completed both Phase 1 and Phase 2 of 
the study. Combining information across studies could potentially increase the value of individual’s 
participation beyond what is learned in any individual study and increase knowledge about health 
problems that can result from injecting drugs and ways to reduce the risk of HIV, hepatitis C, and 
overdose. 
6.0 
MEASUREMENT CONSIDERATIONS 
Data analysis for Aim 1.  
The research questions under Aim 1 are descriptive rather than hypothesis-driven. The data collected 
for this Aim will be used in the UG3 phase to describe burden of infectious consequences of injection 
drug use, and self-reported access to essential prevention services in the selected rural communities. 
The same data will be used to establish baseline values in the pre/post analyses for the UH3 phase, if 
selected to proceed, described below (see Section 3.5.4). We will evaluate baseline statistics for 
participants recruited from the catchment areas associated with each Vivent Health prevention office, 
to determine if variation exists among rural regions of the state for each of the key variables of 
interest.  
Prevalence estimates and standard errors will be calculated using RDSAT version 7.1. RDS accounts 
for a source of bias that is especially severe when sampling hard-to-reach groups; namely, that well-
connected individuals tend to be over-sampled because many recruitment paths lead to them. RDS 
draws statistically valid samples of previously unreachable groups by keeping track of who recruited 
whom and their numbers of contacts eligible for recruitment. The recruitment process mathematical 
model weights the sample to compensate for non-random recruitment patterns. Based on Markov 
chain theory and biased network theory, the analysis provides unbiased population estimates and 
measures of the precision of the estimates. 
 
Data analysis for Aim 1 DHS Linkage Study on COVID-19 Pandemic Impact Among UG3 
Participants.  
To estimate the impact of the COVID-19 pandemic on UG3 participants, we will use merged UG3-
DHS data to determine several rates and correlates of interest, which are described in detail below.  
 
COVID-19 outcomes. To examine risk and protective factors for COVID-19 related outcomes among 
people who inject drugs, we will use a time-to-event analysis approach (i.e., Kaplan Meier curves and 
survival analysis with Cox Proportional Hazards regression models) to quantify COVID-19 testing, 
infection, vaccination, hospitalization, and mortality rates and predictors of these outcomes among 
participants of our prior study. This will involve excluding our prior study participants who were 
deceased prior to the start of the US COVID-19 pandemic (March 1, 2020) and calculating person-

 
30 
 
time as the number of days from March 1, 2020 through the date of outcome data provided from 
DHS.  
To describe disparities in COVID-19 related outcomes between the general population of Wisconsin 
and people who inject drugs, we will create a dataset from the linked dataset and the aggregate 
dataset provided. Each row of data in the analytic dataset will represent the monthly number and 
person-time estimate of COVID-19 outcomes within people who inject drugs or the general population 
in Wisconsin, by strata defined by age group, racial-ethnic group, sex, and county. We will graphically 
summarize average monthly rates of COVID-19 infections, hospitalizations, deaths, tests, and 
vaccination among the general population in Wisconsin and among people who inject drugs stratified 
by age group, sex, racial-ethnic group, and county. We will fit Poisson models (or negative binomial if 
needed due to overdispersion) with each COVID-19 outcome and the following covariates: age group, 
sex, racial-ethnic group, county, month/year, and an indicator representing whether the row of data 
corresponds to data form people who inject drugs vs. general population. The coefficient for the 
indicator variable will be exponentiated to quantify an incidence rate ratio interpretable as the 
magnitude of disparity between people who inject drugs and the general Wisconsin population for 
each COVID-19 outcome, adjusted for age, sex, racial-ethnic group, county, and time. We will 
additionally examine how age group, sex, and racial-ethnic group status modifies the magnitude of 
disparity by examining interaction terms between the indicator variable and these sociodemographic 
variables. We may also describe results by county by creating maps. Any rates or counts involving 
fewer than 5 individuals will be suppressed (i.e., the results will not be viewable on a map), consistent 
with confidentiality standards of DHS. 
 
Overdose outcomes. We will use a time-to-event analysis approach (i.e., Kaplan Meier curves and 
survival analysis with Cox Proportional Hazards regression models) to quantify fatal overdose rates 
(from vital records data) and nonfatal overdose rates (from hospitalization data) and predictors of 
these outcomes among people who inject drugs. This will involve calculating person-time as the 
number of days from study participation date through the date of outcome data provided from DHS. 
We will examine sociodemographic and behavioral risk and protective factors (covariate list provided 
in the appendix) by quantifying hazard ratios. We will also examine whether overdose rates changed 
pre- and post-COVID-19 by including a time covariate with an interaction term indicative of the period 
(before March 1, 2020 vs. on/after March 1, 2020). If there are a sufficient number of fatal and 
nonfatal overdose events per county of residence (>5 events), we will also create maps of overdose 
rates by county. We may also describe results by county by creating maps. Any rates or counts 
involving fewer than 5 individuals will be suppressed (i.e., the results will not be viewable on a map), 
consistent with confidentiality standards of DHS. 
 
Hepatitis vaccination outcomes. We will describe vaccination prevalence and use a time-to-event 
analysis approach (i.e., Kaplan Meier curves and survival analysis with Cox Proportional Hazards 
regression models) to quantify predictors of hepatitis A and B vaccination among people who inject 
drugs. We will calculate vaccination prevalence overall (defined as being vaccinated on or before 

 
31 
 
participation in our prior study). If there are a sufficient number of individuals vaccinated per county of 
residence (>5 events), we will also create maps of vaccination prevalence by county. For the time to 
event analysis seeking to understand predictors of vaccination, we will exclude persons vaccinated 
prior to study enrollment from the predictor analysis to ensure temporality (i.e., that predictors 
measured during our prior study occurred before the outcome of vaccination). This will involve 
calculating person-time as the number of days from study participation date through the date of 
outcome data provided from DHS. We will examine sociodemographic and behavioral risk and 
protective factors (covariate list provided in the appendix) by quantifying hazard ratios. We may also 
describe results by county by creating maps. Any rates or counts involving fewer than 5 individuals 
will be suppressed (i.e., the results will not be viewable on a map), consistent with confidentiality 
standards of DHS. 
 
Data analysis for Aim 2.  
Guided by principles of grounded theory,62,63 interviews will be analyzed for emergent themes as 
soon as interviews are transcribed. We will examine study transcripts to identify primary coding 
categories as well as a range of themes present within each category. Identified coding categories 
and themes will be organized into a formal code book, and we will extract illustrative quotes. 
Transcripts then will be formally content coded. If suggested by the data, thematic categories will be 
refined, merged, or subdivided, and/or new themes created. To ensure coding reliability, summaries 
will be coded by at least two raters who will discuss discrepancies and reach consensus. Decision 
trails will be noted and documented. 
Quantitative data collected and returned via mail and email by rural primary care providers will be 
manually converted to an electronic format for data analysis. This data will be used to describe 
provider-level barriers, such as unawareness of the burden of HIV, HCV and sexually transmitted 
infections, a related tendency to under-screen for these conditions, and possibly stigmatizing attitudes 
towards people who inject drugs that may contribute to under-utilization of primary care services by 
high risk individuals. Insight gained through these surveys may be used for the design of the UH3 
phase. 
Triangulation of data.  
Data from the cross-sectional survey and biological specimen testing (Aim 1) will inform disease 
prevalence and associated risk behaviors in our initial catchment counties. Data from the quantitative 
mail and email-based primary care provider survey and qualitative provider and client interviews 
(Aims 2b/2c) will provide contextual information about drug use, risk behavior, and service access 
and utilization. These data will be layered onto the compilation of the county-level data and resources 
(Aim 2a) and a comprehensive summary report will be generated to guide evaluation of which 
counties are best suited for the implementation phase. 
Benchmarks for progressing to UH3 phase.  
If the research proposed above is successful, by the end of year 2 we will have established estimates 
of the burden of infectious diseases in six rural counties, and described service gaps that must be 
filled in order to ensure that people who inject drugs have access to the complete package of 
prevention services. We believe that transition to the UH3 phase of the study, which is described 
below, will be justified if we achieve the following milestones: (1) Client reachability: We will enroll 
no fewer than 800 SSP clients who reside in rural communities during the 12-month recruitment 
period of the UG3 phase. Based on current and historical volume of prevention encounters at Vivent 

 
32 
 
Health offices, we expect to be able to achieve the recruitment target of 1,200 individuals without 
difficulty. However, if enrollment is substantially slower than expected, we believe that recruiting at 
least 2/3 of this number will demonstrate our ability to engage SSP clients in sufficient numbers to 
answer our research questions and guide implementation of the Client-Based Prevention Home 
model. (2) Local service capacity: We will confirm there are sufficient resources in at least 3 of the 6 
targeted counties to ensure it is feasible that SSP clients can utilize all 9 of the essential prevention 
services. For example, we might not be able to move forward with implementation of the service 
delivery model if we cannot identify providers who provide MAT or are willing to start provision of this 
service with support and consultation from the UW Addiction Medicine Program (see “Provider-level 
interventions” below). (3) Community stakeholder willingness: We will confirm that key 
stakeholders (e.g., MAT providers, County Public Health Officers, Criminal Justice Agencies, others) 
are supportive of the new prevention services model participating counties. We will obtain letters of 
support if requested by funders.  
Data Analysis for Aim 3.  
There is not a single, primary outcome which can be measured to fully evaluate the impact or 
effectiveness of the intervention. We therefore have proposed a study design that allows us to 
evaluate the influence of prevention navigation on progress toward a number of health goals. 
Appendix 2 shows outcomes we propose to measure.   
We will use generalized linear mixed models that will allow us to establish linear growth models. 
Using quarterly assessments, we will analyze growth rates for each outcome and control for time-
variant covariates. Additionally the analysis will allow us to assess the effects of interventions outside 
of our study that may play a role in our outcome. 
Data Analysis for COVID-19 Pilot Cohort. 
 
The objectives of the analysis are consistent with the UH3 study design to evaluate the influence of 
virtual prevention navigation on progress toward a number of health goals. However, given the 
restricted timeline for prevention navigation with two assessments one month apart, we will assess 
pre-and post-changes in factors associated with the risk of HCV, HIV, and overdose death among 
PWID.  
7.0  
STATISTICAL CONSIDERATIONS 
 
Sample size and power considerations for Aim 1. Power to detect a significant impact of the 
client-centered prevention home model is based on the change in proportion of clients in the 3 target 
counties who receive the 9 essential services (see Table 1, pg. 2) compared to clients in the 3 non-
targeted counties. The design effect for respondent-driven sampling is a complex function of the 
network structure in the population, and thus, it is difficult to precisely estimate the sample size 
requirements. Nevertheless, simulation research indicates that the design effect for respondent-
driven sampling is likely to be 2 or less,64 which suggests that a sample twice that of simple random 
sampling should provide adequate power. We estimate that approximately 10% of all clients will have 
access to all 9 essential services prior to the study. Applying a design effect of 2, and given a sample 
size of 800-1200 clients, the study will be powered to detect an increase in service provision of 8-10% 
(424 subjects per group is sufficient to detect a 10% difference in essential service provision rates; 
582 subjects per group is sufficient to detect an 8% difference), assuming 80% power and 5% type I 
error. 
Sample size and power considerations for Aim 3. The complexity of our study design requires 
multiple longitudinal approaches to account for independent and dependent samples. Based on our 
formative work, an average of 2 clients enrolled per week into the study is feasible for the SSP staff. 

 
33 
 
With a sample size of 405 (270 intervention and 135 controls), we would have 80% power to detect a 
difference between 28% and 42% in the same outcome, an effect size that we believe is meaningful 
and realistic to achieve. In other words, the sample size was chosen to ensure that the Primary Aim 1 
comparisons of “Strongly Agree” vs all others of a factor would have sufficient power to detect 
clinically meaningful increases in accessibility. To address Primary Aim 1, we used preliminary data 
from the first phase of the study to assume that the base rate of a participant who will strongly agree 
that it is easy for them to access addiction treatment services is 26%.  
COVID-19 Pilot. Given the uncertainty of the timeline for prevention navigation, it is unclear how 
large our sample size will be. Understanding that there will be two assessments one month 
apart, we will use matched pair t-test to assess differences between the first and second 
assessments. Using the same process as above, comparisons of “Strongly Agree” vs all others 
of a factor would have sufficient power to detect meaningful increases in accessibility. We 
expect a total sample size of 216 PWID, which provides adequate statistical power (0.83) to 
detect a 20% difference between three time points of interest (two-sided alpha=0.05). 
 
8.0 
RECORDS TO BE KEPT 
 
• Subject demographics & locator forms 
• Subject consent forms 
• ACASI questionnaires 
• HIV testing forms 
• Hepatitis C testing forms 
• Audio recordings of interviews 
• De-identified transcriptions of interviews 
• Paper-based primary care provider surveys 
• Handwritten notes from individual interviews 
• Agency and service provider referral lists 
• Participant intervention files (paper and virtual)  
• DHS data on UG3 participants 
• COVID-19 infection, death, hospitalization, testing, and vaccination data 
• Fatal and nonfatal drug overdose data 
• Hepatitis vaccine records 
 
9.0  
PROTECTIONS AGAINST RISK 
 
A.  Characteristics of human participants 
Individuals in the cross-sectional and client interview (UG3) phases will be eligible for enrollment 
if they are 15 years of age or older, have injected any drug in the past 1 month, and reside in a rural 
community. Rural residence will be determined by ZIP code, which will be programmed in the 
screening instrument on REDCap. The eligibility form will classify a participant as a rural resident if 
the ZIP Code’s RUCA Approximation is greater than or equal to 4, or if they live in a catchment area 
of the SSP. Providers will be eligible if they are employed by an agency that serves opioid users. All 
study participants must be capable of communicating in English.   

 
34 
 
Individuals in Phase 2 (UH3) will be eligible if they are 18 years of age or older, have injected any 
drug in the past 1 month, and reside in a rural community. 
B.  Inclusion of Women and Minorities 
Minorities: The study will include people of all races and ethnicities proportional to rural population of 
injection drug users accessing services.  
Women: Women will be included in the study proportional to rural population of injection drug users 
accessing services.  
C.  Participation of Minors 
Phase 1 (UG3). Minors ages 15-17 will be eligible to participate if they meet other eligibility criteria.  
Under the applicable federal regulations (45 CFR § 46.402(a)) “children” are persons who have not 
attained the legal age for consent to treatments or procedures involved in the research, under the 
applicable law of the jurisdiction in which the research will be conducted. Under Wisconsin statutes, 
minors age 15-17 may consent for STI testing and treatment, HIV testing, and alcohol or drug abuse 
assessment, evaluation, or treatment (outpatient). Thus, minors ages 15-17 are not “children” for 
purposes of the applicable regulations with respect to these tests.  Additionally, the IRB will be asked 
to determine if this research protocol is designed for a subject population for which parental or 
guardian permission is not a reasonable requirement to protect participants and may waive the 
parent/guardian consent requirement.   Federal regulation requires an “appropriate mechanism for 
protecting the children who will participate as subjects” as a substitute for parental consent. This will 
be accomplished by having an adult counselor from an advocacy organization available by telephone 
for minors to discuss the consent or other concerns. The consent document will notify minor 
participants that such resources are available if needed, and all research staff will be prepared to link 
clients to a local agency belonging to the Child Advocacy Centers of Wisconsin 
(http://www.cacsofwi.org).  
Phase 2 (UH3). No minors will be participating in this phase of the study. 
D. Protection of Incarcerated Individuals  
For Aim 3, our program is a 12-week intensive case-management program. Therefore we want to 
ensure that participants who become incarcerated have a way to re-engage with the study and 
intervention once they are released from jail or prison. If it is learned that a research participant is 
incarcerated at any time in the study, they will be immediately un-enrolled and research activities will 
be suspended. Participants in the intervention arm may receive contact from the prevention navigator 
to notify them of this and explain the process. No data will be collected from the participant during this 
time. Upon release, participants may contact Vivent Health staff to re-enroll in the study. The consent 
document will be reviewed with the participant at this time to re-assess willingness to participate. 
Participants can take their assessment after 2.5-5.5 months from baseline or follow up assessment. If 
the opportunity to take the assessment is no longer available, then we treat it as missing.  
E.  Participant recruitment and consent 

 
35 
 
Provider interviews. Directors or other key contacts at identified agencies providing services to 
opioid users will be contacted and asked to have one or more designated representatives from their 
agency participate in the qualitative interview. Providers will not be asked to provide any personal 
information, and therefore are not considered research subjects. 
Provider surveys. Providers that will be invited to participate in the survey will be mailed a survey 
that will explain the study using a cover letter. The contact information of the study team will be 
provided for the participant to use, should they have any questions. The consent script will be 
provided at the beginning of the survey. If a provider agrees to take part in the project, they will simply 
fill out the survey and mail it back.  
The provider survey will be administered by the UW Survey Center (UWSC). UWSC will administer, 
track, enter, and code the survey data. Questionnaires handled by data entry staff are tracked via 
case identification numbers only.  Completed questionnaires are stored in locked file cabinets or 
locked storage rooms within their secure data entry facility for up to 7 years as required by Human 
Subjects protocols.  After this period, hard copies of questionnaires will be destroyed.  Sample files 
will be handled only by the UWSC project director and programmer for this study, and will not be 
merged with study data files for delivery to their clients. UWSC will send us a SAS database of our 
data using a secured file transmitting system. A last attempt to increase our response rate will include 
an email explaining the study and a website hyperlink to fill out a survey. The web-based survey will 
be housed on the same platform of the ACASI survey. 
Client interviews. People who participate in the cross-sectional study described above will be 
systematically invited (e.g., every nth person) to also participate in a qualitative interview. Interested 
participants will be contacted by study staff to set up an interview appointment. Clients will be asked 
to sign an additional consent prior to enrollment in this study activity. 
Phase 1 (UG3) Participants. Vivent Health prevention staff will meet with the person in a private 
room to explain more about the study. If they are interested, they will be given a consent document to 
read, and a phone call will be placed by Vivent Health staff to a study coordinator at UW-Madison. 
The participant and the researcher will then speak by phone in a private location to complete the 
eligibility screening and informed consent process. This will be done to minimize the impact of the 
research activities on the routine prevention activities of Vivent Health staff, and ensure that potential 
participants have enough time to have their questions answered prior to deciding whether or not to 
participate.  During the initial phone call, potential participants will be provided with a detailed 
explanation of the study and questions will be answered. People who are willing to participate will be 
given formal informed consent using an iPad. Participants undergo a comprehension quiz on the iPad 
that assesses their understanding of the consent documentation. If a person agrees to take part in the 
project, he/she will be asked to sign the consent and HIPAA forms, which after the conclusion of the 
phone call with UW-Madison research staff, will be handed to the Vivent Health prevention team 
member to be filed in a locked file cabinet. Copies of the signed consent documents will be sent via 
secure fax to the study coordinator in Madison. A signed copy of the consent and HIPAA forms will 
provided to the participant upon request. For participants ages 15 to 17, the consent form may be 
used to obtain consent of the minor, provided the study personnel determines that those minors can 

 
36 
 
comprehend the consent form. The consent form will be modified for participants ages 15-17 by 
adding a separate authorization section for the minor and the person obtaining assent. 
For the retrospective analysis of stored HCV+ serum specimens obtained from WSLH and shared 
with GHOST laboratory collaborators, a waiver of consent and authorization is requested. 
If participants are screened using a paper form at Vivent Health or at an outreach event, a paper copy 
of the consent document will be given to them and the Vivent Health staff will go over the study 
procedures. A study coordinator will be on standby to speak to the participant over the phone if they 
have any questions. If the participant agrees to be part of the study, the participant will be asked to 
sign the paper copy of the consent form. The form will be kept in the participant's folder in a double 
locked cabinet. Vivent Health already has a process in place since they work with HIV testing and 
case management. During outreach events, Vivent Health staff will securely transport screening 
documents and rapid test forms in a locked briefcase and store the forms in the participant's folders in 
a double locked cabinet. Once the participant has signed the paper copy of the consent form the iPad 
will begin at the ACASI survey, therefore the consent documentation will not be replicated. 
DHS Linkage Study on COVID-19 Pandemic Impact Among UG3 Participants. For the analysis of the 
impact of the COVID-19 pandemic on the UG3 cohort, we will be providing DHS with identifiable data 
on UG3 participants, including participant name, date of birth, gender, race, ethnicity, previous 
address, previous phone number, date of participation in our study to facilitate linkage with approved 
registries (vital records, hospitalization, Wisconsin Electronic Disease Surveillance System, 
Wisconsin Immunization Registry). We are unable to re-obtain consent from participants for this data 
linkage because of the transient nature of this population and their lack of consistent access to a 
phone or other communication devices. It is not uncommon for the phone number that was used to 
initially recruit the participant to be inactive or out-of-date within days. It would be unfeasible to re-
obtain consent participants from this cohort more than two years after initial recruitment. Considering 
this, we seek a Waiver of Consent and a partial waiver of authorization to link original cohort data with 
DHS data. We have also provided a justification as to how the original study’s Certificate of 
Confidentiality is aligned with this linkage study. These justifications can be found within the Arrow 
application. Prior to sharing data or receiving data from DHS, we will obtain a signed Data Use 
Agreement that outlines the terms of the data sharing. A log of disclosures will be maintained in 
accordance with guidance from the HIPAA privacy officers consulted in the design of this study (Ryan 
Moze, Staci Lowe; using the template: https://compliance.wisc.edu/wp-
content/uploads/sites/102/2019/02/Accounting-for-Disclosures-Log-Research.pdf).   
 
Phase 2 (UH3) Participants. Vivent Health staff will meet with participants in a private location within 
the SSP office for all aspects of the study. All forms will be delivered in person, and staff will gauge 
comprehension throughout the enrollment and verbal consent process. Participants will be given a 
copy of the verbal consent if they choose to participate. Paper copies of all documents will be stored 
in a locked cabinet, only accessible by the research team. Protections for the ACASI survey and 
blood specimens will be protected in the same manner as phase 1. The screening questionnaire will 
be the first document with both a name and study ID on them, and subsequent documents will only 
have one or the other, aside from testing documents. If necessary, all of the above activities may take 
place virtually, with electronic record keeping privacy considerations. 

 
37 
 
COVID-19 Pilot. All activities related to recruitment and consent will be conducted virtually either over 
the phone or via Microsoft Teams video call. Prevention navigators will hold responsibility for 
recruitment, unless UW staff assist by calling UG3 participants if necessary. UG3 participants who 
consented to future contact will be called using a random list by navigators. Additionally, participants 
will be passively recruited by study fliers distributed in prevention kits to clients, and by Vivent staff 
services. Those who are interested will be given a detailed description of what virtual navigation 
would look like, and will be screened for eligibility. If eligible, verbal consent will be taken only after 
the participant answers a series of questions about what the study involves to confirm 
comprehension. If ineligible, name and demographics will be retained on REDCap and a DOM secure 
drive to monitor duplicate screens and compare ineligible participants to those who enrolled. A paper 
copy of the consent form will be mailed to the participant upon authorization to do so or sent by text 
message/email if that is the client’s preferred method of contact.  
ACHESS. Upon account setup, participants will be able to choose a unique username that does not 
need to include their name or any other identifiable information. This username will be the name that 
appears in the pick list of participants available to private messaging, and listed on any discussion 
board posts. To protect participant's identity, it will be recommended that participants choose a 
username that will not include identifiable information such as first or last name, etc. 
 
All subjects will have the option to contact study staff to turn off private messaging. This would 
prevent any incoming private messages, along with removing the participant’s username from the 
picklist of participants who can be contacted by private message. Study staff will be able to monitor 
private messages, and participants can report any inappropriate or unwanted messages to study 
staff. The study team also has the option to turn off the private messaging function to those who send 
inappropriate or unwanted content to other participants to prevent future unwanted content. 
 
F.  Sources of research data 
The source of research data is clients’ (injection drug users) biological specimens and their self-
reported survey data (all clients); and the qualitative interview (for people who complete this activity). 
Provider participant data will be limited to their qualitative interview and quantitative mail and email-
based survey. For phase two we will also be collecting demographic information, program data from 
intervention sessions (upon completion of the study), testing data, and contact information from all 
participants.  
DHS Linkage Study on COVID-19 Pandemic Impact Among UG3 Participants. For this analysis, we 
will obtain external data from Wisconsin DHS via linkage of identifiable data from UG3 participants 
will several DHS registries, as described in detail above. 
G.  Potential risks 
Potential psychological risks to participants in this study are: (1) negative consequences if 
confidentiality of information obtained in this study were violated; (2) embarrassment, discomfort, or 
distressed emotional reactions to the study assessment measures; (3) increased anxiety about 
personal safety and wellness resulting from the interview or survey; and (4) potential for minor 
bruising or irritation from a phlebotomy blood draw if confirmatory HIV test is required due to a 

 
38 
 
reactive rapid test. Emotional distress is common after a person learns he or she is HIV or HCV-
positive. 
COVID-19 Response. In addition to the above risks, if a participant may go into the community for 
treatment, confirmatory testing, or any other reason related to the study there is a risk of COVID-19 
transmission. In order to mitigate this, Vivent Health is providing as many virtual services at possible, 
at home testing, and referrals to tele-medicine sources when available.  
 
H.  Steps to protect against or minimize potential risks 
Confidentiality protections. A number of steps will be taken to protect the confidentiality of 
participants’ data and their identity. All investigators have extensive experience in the safe collection, 
handling, and storage of sensitive and highly confidential data. All name-identified information (e.g., 
informed consent) will be kept in a locked file, separate from any data. Data-related materials will be 
identified by a unique Research Identification Number (RIN) and stored in a second locked file. All 
materials will be kept in a locked room, ensuring two locking measures. Access to these two files will 
be limited to the research team. All data files will be securely transferred using encryption. Computer 
databases will be password protected and accessible only to the research team. No individual 
identities will be used in any reports or publications that may result from this research project. Data 
requested from researchers from organizations not formally collaborating on this research project will 
only be shared in aggregate form per NIH and federal data sharing regulations.  
Prevention Navigation materials will utilize study ID only, and will not include a name on them, as to 
prohibit this link from being made again in another location and to protect the individual’s identity 
should a breech occur. Navigation files will be double locked and stored separately from any forms 
containing the participant’s name if a physical copy. All virtual copies will be stored in a secure Vivent 
Health server. Because of the nature of the participant’s lives, navigation sessions may need to occur 
outside of the office in a public location. Only essential documents will be brought with the navigator 
in a locked binder with a secure code. Documents will be immediately returned to the office to be 
double locked and stored properly. Should a prevention navigator need to work from home (for 
example, due to COVID-19 restrictions) essential files with study IDs and not names may be brought 
home in a secured binder and locked in a secure location inside their home. Files may not be left in a 
vehicle or outside of a locked room or cabinet.  
We recognize that we are asking participants to provide sensitive information about private behavior 
and health. Our research team is experienced in the collection of this type of information, and we will 
implement multiple safeguards to protect participants’ confidentiality. All project protocols will be 
subject to review by the institutional IRB at the University of Wisconsin-Madison. The UW-Madison 
IRB will approve research involving children only if the IRB finds that the research includes any 
required additional safeguards outlined in ethical principles and applicable federal regulations, state 
laws and institutional policies. An inter-institutional agreement will be signed between the University 
of Wisconsin-Madison and Tulane University for IRB oversight; and a data sharing agreement will be 
obtained for any information shared with the Wisconsin Department of Health Services AIDS/HIV 

 
39 
 
Program, the Wisconsin Division of Care and Treatment Services, and any outside jurisdictions (e.g., 
GHOST lab) with which data will be shared. Vivent Health staff will be included in the University of 
Wisconsin-Madison IRB protocol. A Certificate of Confidentiality has been obtained as a condition of 
the NIH grant award. All study participants will be fully informed of the project goals and procedures, 
and of their rights as research participants, including the right to not participate without penalty. 
Signed consent will be obtained prior to the collection of any data, or the conduct of any research 
activities.  
Pregnant women are a vulnerable population whose inclusion in this research is justified by the 
increasing incidence of neonatal abstinence syndrome, and increased prevalence of opioid use 
among women of childbearing age. Although drug use in pregnant women does not require 
mandatory reporting under state law, study team members may choose to voluntarily report it.  The 
possibility of this and the risks if this were to be reported will be clearly outlined in the consent form. 
Prevention navigators will also communicate with the participant the risk of medical providers 
reporting such drug use when initiating referrals for care.  
Per HIPAA, participants will be advised during the consent process of our intent to collect biological 
specimens to test for HIV, HCV, and other STIs. Positive tests will be reported to the health 
department per state and local regulations. 
Follow up contacts will be performed with participants in both the intervention and control groups. 
Vivent Health study staff will perform all follow up contacts with intervention participants. These follow 
ups include appointment reminders, appointment scheduling, checking in after an important 
appointment, booster sessions via phone, and discussing test results. These contacts will be made in 
accordance to the participants’ preferred contact method. Contacts with the control group will all be 
performed by the project manager on the designated study phone to enhance trust with participants 
who may not want calls from strangers. Calls will be made to remind them to schedule follow up 
visits. Control participants will be called no more than 3 times between each research visit to 
eliminate disruption to their daily lives. All social media interactions will occur using a professional 
Facebook account separate from personal accounts. Facebook’s privacy policy will be given to the 
participant if they choose to contact their PN via Facebook, and they will be reminded that it is not a 
secure form of communication. PNs will suggest alternative ways to privately discuss treatment and 
care in detail. All phone calls and text messages performed by Vivent Health staff will be done on a 
Vivent Health provided work phone, separate from staff’s personal information. These phones have 
secure codes and laptops have two-factor authentication. Phone calls and text messages sent by the 
UW research team will be performed on a study phone only accessed by one person with a secure 
code. No names will be stored in the phone. 
DHS Linkage Study on COVID-19 Pandemic Impact Among UG3 Participants. Given the transient 
nature of people who inject drugs, re-consenting participants for this data linkage study and analysis 
would not be feasible, as the proposed analysis will occur at least two years after original recruitment 
of UG3 participants when contact information is no longer valid. Moreover, the need for this analysis 
stems from the COVID-19 pandemic emergency, which was not foreseeable at the time of original 
recruitment. As such, we will carry out the linkage via a waiver of consent and partial waiver of 

 
40 
 
authorization. Identifiable information that will facilitate the linkage will be shared within the purview of  
Data Use Agreements that will be established prior to any data transfers. Study activities for this data 
linkage have been reviewed and approved by the Data Governance Board at DHS, pending 
subsequent IRB approval and the establishment of the aforementioned agreements. Once the linkage 
is completed, participant data will be destroyed and not kept on file by DHS. Our study team will 
receive the linked dataset containing only a unique research identification number (identifiers will be 
removed before DHS provides the linked dataset).  
 
Steps to reduce discomfort or anxiety resulting from study participation. Assessment measures 
involve sensitive topics related to safety and wellness. Some participants may feel awkward or 
embarrassed when discussing, hearing about, or being asked to provide information related to their 
safety and wellness. Staff are trained to employ techniques that prevent, reduce, or minimize 
embarrassment, discomfort, or atypical stress associated with study participation. Staff will be trained 
to observe for any evidence that a participant may be overly anxious and to assess whether threat 
sensitization and vulnerability perceptions are realistic. Vivent Health and research field staff will be 
required to have extensive research- or program-based experience with the conduct of HIV-related 
research. The project will be guided by a detailed procedural manual, and field staff will receive 
intensive training focused on the specific project protocols and materials to ensure that they are being 
rigorously and consistently implemented, including extensive role-play rehearsal of recruitment, 
enrollment, and consent procedures and assessment procedures and materials. Staff will be required 
to demonstrate competence with project protocols prior to implementation. Investigators and field staff 
have or will be required to complete the NIH required CITI web-based ethics training. Interviews will 
be supervised by the lead project investigators to ensure protocol adherence. The field team will meet 
regularly to discuss implementation issues and areas warranting additional training. If research 
personnel change during the course of the study, new staff will be required to complete the training 
described above prior to conducting any research activities. 
HIV, HCV, and syphilis testing and counseling safeguards. All testing staff have completed the 
Wisconsin AIDS/HIV Program state HIV test counselor training to ensure that HIV pre- and post-test 
counseling is conducted in accordance with state guidelines. Testing staff will be further required to 
complete training and demonstrate competence with the fingerstick collection of whole blood 
specimens (i.e., rapid HIV, HCV, and syphilis point-of-care testing methodology) and phlebotomy 
blood draws prior to study Implementation; and complete annual training in blood borne pathogen 
control (“universal precautions”) to ensure adherence to the Occupational Safety and Health 
Administration Occupational Exposure to Blood borne Pathogen standards. Any new staff who are 
hired will be required to complete the training package described above, and demonstrate 
competency with HIV, HCV, and syphilis testing and counseling. James Sosman, M.D., will provide 
on-going review of counseling and testing procedures, as well as the interpretation and provision of 
test results to study participants. If any adverse physical harm results from the administration of the 
rapid HIV, HCV or syphilis tests, free medical follow-up will be provided to participants. Vivent Health 
is a CLIA-certified HIV test site funded, in part, by the Wisconsin Division of AIDS/HIV’s HIV testing 
program. 

 
41 
 
Specimens will only be sent for confirmatory testing for those rapid tests that they are already positive 
for, therefore, no new health information will be generated by analysis of these samples. 
COVID-19 Pilot. All data collected from participants will be stored on a secure server, REDCap, 
Qualtrics, and/or Client Point. Participants will be assigned a unique study ID, which will be linked to 
their name in on the screening form, housed on the Vivent Health server, PHI box, and REDCap. All 
other forms used for these participants will only have their study ID attached. Testing forms will follow 
Vivent Health’s virtual testing protocol.  
All calls for virtual navigation, and originally proposed UH3 navigation performed virtually, will be 
conducted through a cell phone provided by UW or Vivent Health, or on Vivent Health’s approved 
video conferencing platform, Microsoft teams. Staff may conduct reminders or follow ups via their 
work telephone. Facebook messenger from a business profile, or mail if the client consents to that 
form of contact.  
All other privacy and protection safeguards listed in above sections involving testing, staff training, 
and reducing anxiety related to the study will be followed as outlined above.  
I.  Data safety and monitoring plan 
See Appendix 1. 
J. Data Safety Monitoring Board (DSMB) 
For the second phase (UH3), a DSMB will be convened for this study in collaboration with the 
University of Wisconsin Institute for Clinical and Translational Research (UW ICTR). The ICTR Data 
Monitoring Committee (DMC) meets the requirements for an independent Data and Safety Monitoring 
Committee or a Data and Safety Monitoring Board. The committee is comprised of experienced 
clinical researchers representing a diversity of backgrounds, skills and knowledge. The DMC helps 
investigators ensure subject safety, research integrity, and compliance with federal regulations and 
local policies. The DMC also makes recommendations to the PI that could include actions of 
continuation, modification, suspension, or termination. Prior to submission of the final protocol and 
IRB application to the UW Health Sciences Institutional Review Board, the PI will request a DMC 
consultation using the online application form. Once convened, the DMC will meet annually to review 
study procedures and provide a report to the PI, which will be then submitted to the UW IRB and the 
NIDA PO within a month after each meeting. 
K.  Costs and alternatives 
There are no costs to the participants for taking part in this research project. The participants have 
the alternative NOT to participate in this project or seek services independently from other agencies. 
L.  Incentives 
Aim 1 and 2. Participants will receive $20 remuneration for survey participation on the day of 
enrollment, and will receive a smaller incentive of $10 for each eligible peer recruit who enrolls in the 
study. For participants who have a reactive HCV rapid test and are unable to provide a blood sample 
for HCV confirmatory testing due to phlebotomy difficulties, a one-time incentive of $10 will be 
provided if they return at a later date and attempt a second blood draw. Syringe program clients and 
local service providers who agree to participate in qualitative interviews will be paid an incentive of 

 
42 
 
$30 each for one hour-long interview. All primary care providers who are selected to participate in the 
quantitative mail-based survey will receive an incentive of $5 at the time the survey is mailed to them. 
Aim 3. Participants will receive $20 remuneration for survey participation and rapid testing on the day 
of enrollment, and will receive an additional incentive of $20 for 3-month, and 6-month assessments. 
Participants may also receive a monthly incentive of $5 to update their contact information so we 
have the most up to date information to decrease the risk of loss to follow up if it is deemed 
necessary to do so. For participants who have a reactive HCV rapid test and are unable to provide a 
blood sample for HCV confirmatory testing due to phlebotomy difficulties, a one-time incentive of $10 
will be provided if they return at a later date and attempt a second blood draw. Additionally, 
participants will receive $10 for each eligible peer recruit who enrolls in the study. 
COVID-19 Pilot. Participants will receive $10 for each research assessment (baseline, 4 weeks, and 
30-days post service resumption). There will be no incentives for testing during this sub-phase of the 
study.  
L.  Potential benefits in relation to risk of the proposed research to the participants and others 
There are no direct intended personal benefits from participation in the UG3 phase of this study. 
Although participants may not individually benefit from the study, the information obtained will guide 
the development of a comprehensive program aimed at protecting the health of PWID. In the UH3 
phase of the study who receive the Client-Centered Prevention Home intervention are expected to 
achieve more positive health outcomes and better linkages to services and care than people who do 
not receive this intervention. 
 
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Volkow N D, National Institute on Drug Abuse (NIDA),. America's addiction to opioids: heroin 
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Substance Abuse and Mental Health Services Administration (SAMHSA). Drug Abuse Warning 
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Hedegaard H, Chen LH, Warner M. Drug poisoning deaths involving heroin: United States, 
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Mathers BM, Degenhardt L, Phillips B, et al. Global epidemiology of injecting drug use and HIV 
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47 
 
APPENDIX 1:  DATA AND SAFETY MONITORING PLAN 
 
PI Name: 
Westergaard, Seal (MPI) 
Grant Number: UH3DA044826 
Grant Title: 
Community-based client-centered prevention homes to address the rural opioid epidemic 
Institution:  
University of Wisconsin - Madison 
  
1.0. Project Overview 
 
1.1. PI Statement of responsibility for developing and executing DSMP. As contact PI for this application, Dr. 
Westergaard accepts responsibility for implementation of the data and safety monitoring plan, and acknowledges the 
requirement to request and receive permission from the PO for protocol or DSMP changes in advance of their 
implementation. 
 
1.2. Brief protocol description. In response to RFA-DA-17-014, HIV, HCV and Related Comorbidities in Rural 
Communities Affected by Opioid Injection Drug Epidemics in the United States: Building Systems for Prevention, 
Treatment and Control (UG3/UH3), our research team proposed a multi-phase, mixed-methods study that aims to 
implement and evaluate a novel community response model, which we have named the Community-Based, Client-
Centered Prevention Home, or Prevention Navigation.  
 
Using the organizational infrastructure of Vivent Health, a geographically dispersed population of people who inject drugs 
in rural communities across Northern Wisconsin, we are building locally responsive systems to facilitate uptake of 
evidence-based prevention services for high-risk clients. The Client-Centered Prevention Home (CCPH) model 
incorporates prevention case management (called Prevention Navigators) into traditional harm-reduction services 
delivered at syringe service programs, which we hypothesize will increase use of treatment and prevention services. 
During the first 2 years of the project (UG3 phase), we performed needs assessments in six rural Wisconsin counties in 
partnership with local stakeholders, and conducted a survey among people who inject drugs. In the next three years of the 
project we will deploy and evaluate the CCPH model. The growing problem of opioid injection in rural Wisconsin is highly 
significant because it exemplifies trends observed nationally indicating severe vulnerability to worsening epidemics of HIV, 
HCV, and opioid overdose deaths in rural communities that are substantially underserved by evidence-based prevention 
interventions. 
 
1.3. Study aims and study outcomes. The aims of the intervention is to evaluate the impact of the Client-Centered 
Prevention Home model, deployed within syringe service programs in counties with high burden of opioid injection, on the 
proportion of clients who receive the package of essential preventative services to prevent HIV/HCV in PWID.  
The goal of the Client-Centered Prevention Home program is to increase the knowledge of people who inject drugs on 
navigating prevention and treatment services for HIV, HCV, and drug overdose. We describe measures for our study 
population in the Appendix. Key sources for measurement will come from the ACASI survey that will be adapted from the 
ROI Harmonized UG3 survey, surveillance data gathered from the state of Wisconsin, and Medicaid health utilization 
data.  
 
1.4. Study data collection sites. The main community partner, Vivent Health, will serve as the data collection and study 
site. Vivent Health is a statewide organization that provides harm reduction services, including syringe services and 
confidential HIV and HCV testing. As shown in Figure 1, three sites will be used for the intervention of the study: Brown 
County (Green Bay), Marathon County (Wausau), and La Crosse County (City of La Crosse). The 3 other Vivent Health 
offices that participated in the UG3 study phase, including Outagamie County (Appleton), Eau Claire County (City of Eau 
Claire), and Douglas County (Superior), will serve as recruitment sites for control group participants during the UH3 
phase, but will not provide the prevention navigation intervention. 
 
1.5. Study sample description and inclusion and exclusion criteria. Leveraging relationships developed among 
Vivent Health clients and community partners during the UG3 phase, we will recruit participants using Vivent Health staff 
at all six counties. In order to be part of the study, participants must meet the following eligibility criteria: 1) clients must be 
at least 18 years old, 2) have injected drugs to get high in the past 30 days, and 3) reside in one of the participating 
communities in or around one of the six participating counties. 
 
Exclusion criteria are: (1) not speaking English fluently, (2) residing outside or being unwilling or unable to travel for study 
visits at one of the participating communities. 
 

 
48 
 
1.6. Sample size. A total of 405 participants will be enrolled to evaluate the intervention (Figure 1). Study procedures will 
vary for participants based on enrollment into 2 study groups, as follows: 
 
(a) 270 participants enrolled at intervention sites, who will receive prevention navigation. 
 
 
(b) 135 participants enrolled across the 3 non-intervention sites, who will serve as a contemporaneous control 
group. 
 
 
1.7. Study design. In order to measure the impact of the Client-Centered Prevention Home we will prospectively assess 
the 12-week intervention by measuring outcomes at baseline, 3-months, and 6-months. We will target participants who 
engage in syringe services at Vivent Health and may be interested in additional services that may be offered in our 
multilevel harm reduction intervention. At intervention sites, the Prevention Navigator will engage prospective clients by 
screening them for the study, having the participant sign the consent form and performing baseline assessments along 
with rapid testing for HIV, HCV, and syphilis Using the same infrastructure used in the UG3 phase, a second group of 
controls will be enrolled at the three non-intervention sites. Syringe service program staff at the non-intervention sites will 
recruit participants for baseline, 3-month, and 6-month assessments during the two year study period.  
 
The health-related goals for PWID in the context of this study are multi-faceted, reflecting the heterogeneous needs of this 
vulnerable population. Accordingly, there is not a single, primary outcome which can be measured to evaluate the impact 
or effectiveness of the intervention. We therefore have proposed a study design that allows us to evaluate the influence of 
prevention navigation on progress toward a number of health goals. Because no single study design can account for all of 
the biases inherent in a non-randomized, multi-county intervention trial, we have proposed 2 different types of 
comparisons in our evaluation strategy:  
 
(A)  A within-person comparison using a pre/post study design  
Participants among intervention sites will serve as within-person comparisons as they will participate in baseline 
assessments, including self-reported outcomes evaluated using ACASI questionnaire, and then again in 3 and 6 
months This is ideally suited for short-term outcomes that we hypothesize will be immediately influenced by 
prevention navigation, such as perceived accessibility of services, and readiness/motivation to initiate addiction 
treatment. These self-reported outcomes are listed in Appendix 2.  
 
(B)  A comparison of participants enrolled at sites with and without prevention navigation 
In separate analyses, we will compare the self-reported outcomes of individuals enrolled at Vivent Health offices 
offering only standard prevention services without prevention navigation. This is advantageous for detecting changes 
over 6 months of follow-up. 
 
(C)  A cohort-study design comparing longer term outcomes using external data sources 
To detect changes in so-called “hard” outcomes such as enrollment in insurance, HCV cure, hospitalization, and 
initiation of medication assisted treatment, we will access sources such as the Wisconsin Medicaid data for all 
enrolled participants for up to 2 years after enrollment. This strategy is enabled by the data sharing agreements and 
database resources created through our JCOIN Supplement award in 2018-19. Additional data sources include the 
Wisconsin Electronic Disease Surveillance System and the Wisconsin Immunization Registry.  
 
1.8. Consent documents. When a client agrees to participate in the Client-Centered Prevention Home, he or she will be 
informed about the research aims of the project by the Prevention Navigator during the intake encounter, they will be 
asked to provide informed consent to participate, and authorize the research team to use their health information. The 
consent form will cover information on the protocol, risks, benefits, and protections for the participant. It will also note the 
existence of a Certificate of Confidentiality for the intervention. The consent document will remind participants that their 
participation is voluntary, and that their decision of not participating will not jeopardize their relationship with ARCW and 
UW-Madison. Consenting participants will verbally consent, and a copy of the consent form will be available to them upon 
request. Additional consent documents will be signed for rapid HIV and HCV testing as per procedures from the 
Wisconsin Department of Health Services.  
 
1.9 Collection of data for research/evaluation, In order to evaluate the effectiveness of the Client-Centered Prevention 
Home, data will be collected data using various tools throughout the UH3 phase. Interested participants will first be 
screened for the study by the Prevention Navigator or research staff by phone or in person, respectively. Once screened 
eligible, participants will be tested for HIV, HCV, and syphilis at baseline, 3-month, and 6-month follow up. Testing forms 

 
49 
 
provided by Wisconsin Department of Health Services for routine testing will be used and information from the forms will 
be collected for research. At baseline, 3-month, and 6-month follow up, participants will complete an audio computer-
assisted self-interview (ACASI) survey that will assess substance use, injection behavior, past overdoses, addiction 
treatment, stigma, infectious diseases, access to health care, sexual risk behavior, mental health, criminal justice, and 
basic demographics.  
 
1.10. Collection of data for intervention implementation. The RE-AIM framework will be used to measure adoption 
and implementation of the intervention. In order to assess whether Prevention Navigators’ fidelity to the various elements 
of the intervention’s protocol are met, we will use program data to measure consistency of delivery as intended for the 
intervention. After the participant has screened eligible and have provided informed consent, participants will engage with 
the Prevention Navigator at their first intake. During that time, participants will be asked to sign an agreement of services, 
fill out a locator form, release of information form, and service request form. At the second session, participants will come 
back to assess their risk for infectious diseases and overdose, and will develop a service plan using a problem solving 
worksheet and goals sheet. The problem solving and goals sheet will be amended at each session to assess progress to 
goals. Once the participant is ready to be discharged from the program, Prevention Navigators will fill out a discharge form 
that will consist of a checklist to make sure that there is plan in place for each goal that was set. Communications logs will 
document every successful and unsuccessful attempt in contacting participants and will be used to measure fidelity of the 
protocol.   
 
1.11. Projected timetable. During the three year study period, the first quarter will be used for protocol development, 
hiring, and training of staff. Open enrollment for recruitment will begin during the second quarter and will continue through 
the second year. Enrollment for the study will end during the summer of the second year in order to have a full 6-month 
assessment for each participant. The last year will be used to close out the intervention, analyze the data, and 
disseminate our findings. The timetable is presented in Table 1. 
 
Activity 
UH3 Phase 
Quarter 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Develop protocol and IRB 
▲ 
 
 
 
 
 
 
 
 
 
 
 
Hire and training staff 
▲ 
▲ 
 
 
 
 
 
 
 
 
 
 
Collect county-level data 
 
 
 
 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Recruitment of intervention and 
control participants  
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
 
Test for HIV, HCV, ,  
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
 
Resource mapping in 6 counties 
 
 
 
 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Develop PCM manual 
▲ 
 
 
 
 
 
 
 
 
 
 
 
Implementation coaching 
▲ 
▲ 
 
 
 
 
 
 
 
 
 
 
Enroll clients in CCPH  
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
 
Analysis of intervention effect 
 
 
 
 
 
 
 
 
▲ 
▲ 
▲ 
▲ 
Manuscripts and dissemination 
 
 
 
 
 
 
 
 
▲ 
▲ 
▲ 
▲ 
 
2.0. Data Security  
 
2.1. Data collection. The source of research data is clients’ biological specimens and their self-reported survey data  
along with all intervention materials used.  For all research components, data will be gathered remotely on personal 
devices or in private spaces where white noise machines will be placed outside the door to reduce the risk that others will 
overhear data collection activities. Self-administered surveys will be conducted using ACHESS and will be administered 
via the ACHESS app on a smartphone or web browser, or using wifi-enabled iPads with headphones. Data from the self-
administered survey are automatically stored in a password protected, HIPAA-compliant server that is accessible to UW-
Madison research staff. Information from rapid tests for HIV and hepatitis will be securely faxed to UW-Madison and 
entered into a secured HIPAA-compliant database.  
 
Each participant will receive a unique identifying number that will be used in all materials related to the study. A master list 
matching identifiers to participants will be maintained on a database that is only accessible to research staff. All staff will 
be trained in HIPAA compliance and best practices for human subjects research data in order to ensure that they will not 
disclose information about participants to others outside of the study team.  
 
2.2. Data management and storage. The Project Manager and shall be responsible for ensuring that the data for the 
project are securely stored, that storage is in compliance with University and federal regulations and that no unauthorized 
persons have access (electronic or physical) to any participant-identifiable data. All HIPAA regulations and guidelines will 
be followed, and all study staff must complete approved human subjects and HIPAA training programs.  
Table 1. CCHP Project Timetable   

 
50 
 
Inter-site data transfers are accomplished via secure file transfer protocols (SFTP) using an internet server maintained by 
the UW School of Medicine and Public Health (UWSMPH) Department of Medicine. To protect the privacy of database 
records and the integrity of the network, this server is firewall-protected and is stored in a locked server room with a 
numeric keypad to restrict entry. The server is continuously scanned for the presence of viruses. A complete virus scan of 
all workstations also takes place once a week. Server system log files are scanned for unusual activity, which is 
immediately investigated. Network and Server Administration staff members apply critical and non-critical patches as 
needed. In addition, the study staff also have multiple mechanisms for preserving confidentiality of research participants 
and providing data security in the transfer of data from participant machines to the SFTP server. The Department of 
Medicine web servers use Secure Socket Layer (SSL or https) technology to encrypt data exchanged between the client 
and the server. In addition, all online and offline components of the data systems described in the proposal will be 
accessible only through a login and password unique to each user. The security access levels for these login accounts 
are tiered and the features and privileges given to each staff member will be determined by the PIs and data Manager. To 
further protect confidentiality, only the PI and data manager will be permitted to transmit data to the SFTP server. Finally, 
the Department of Medicine employs extensive data backup and server redundancy procedures and performs full 
backups to tape weekly of all servers, along with incremental and daily backups. 
 
2.3. Data entry methods. The PIs will develop and implement protocols for assuring data collection accuracy and 
protocol compliance. Data will be entered through REDCap. Data entry staff will be automatically logged out after a 
specified time of inactivity. Consent forms and rapid testing forms will be securely faxed using a HIPAA compliant, 
confidential fax line located at the University of Wisconsin-Madison.  
 
2.4. Quality assurance plan. Investigators and staff will have weekly team meetings to update study progress, discuss 
and problem-solve barriers to successful field implementation, and receive group training on cross-cutting QA issues. 
Staff also will receive individual training as needed.  
To monitor assessment quality assurance, staff will record process notes on a standardized form, including 
documentation of any questions or problems raised by the participant during the interview or survey. 
 
3.0. Participant Safety and Monitoring 
 
3.1. Potential risks and benefits to study participants.  
 
Potential psychological risks to participants in this study are: (1) negative consequences if confidentiality of information 
obtained in this study were violated; (2) embarrassment, discomfort, or distressed emotional reactions to the study 
assessment measures; (3) increased anxiety about personal safety and wellness resulting from the intervention or survey; 
and (4) potential for minor bruising or irritation from a phlebotomy blood draw if confirmatory HIV test is required due to a 
reactive rapid test. Emotional distress is common after a person learns he or she is HIV or HCV-positive. 
 
Confidentiality protections. A number of steps will be taken to protect the confidentiality of participants’ data and their 
identity. All investigators have extensive experience in the safe collection, handling, and storage of sensitive and highly 
confidential data. All name-identified information (e.g., informed consent) will be kept in a locked file, separate from any 
data. Data-related materials will be identified by a unique Research Identification Number (RIN) and stored in a second 
locked file. Access to these two files will be limited to the research team. All data files will be securely transferred using 
encryption. Computer databases will be password protected and accessible only to the research team. No individual 
identities will be used in any reports or publications that may result from this research project. Data requested from 
researchers from organizations not formally collaborating on this research project will only be shared in aggregate form 
per NIH and federal data sharing regulations. 
 
We recognize that we are asking participants to provide sensitive information about private behavior and health. Our 
research team is experienced in the collection of this type of information, and we will implement multiple safeguards to 
protect participants’ confidentiality. All project protocols will be subject to review by the institutional IRB at the University of 
Wisconsin-Madison. The UW-Madison IRB will approve research involving children only if the IRB finds that the research 
includes any required additional safeguards outlined in ethical principles and applicable federal regulations, state laws and 
institutional policies. An inter-institutional agreement that was used during the first phase of the study between the 
University of Wisconsin-Madison and Tulane University for IRB oversight; and a data sharing agreement for any 
information shared with the Wisconsin Department of Health Services AIDS/HIV Program, the Wisconsin Division of Care 
and Treatment Services, Vivent Health, and the GHOST lab will be used. CCHP staff will be included in the University of 
Wisconsin-Madison IRB protocol. A Certificate of Confidentiality will be obtained as a condition of the NIH grant award. All 
study participants will be fully informed of the project goals and procedures, and of their rights as research participants, 
including the right to not participate without penalty. Consent will be obtained prior to the collection of any data, or the 

 
51 
 
conduct of any research activities. 
 
Pregnant women are a vulnerable population whose inclusion in this research is justified by the increasing incidence of 
neonatal abstinence syndrome, and increased prevalence of opioid use among women of childbearing age. Although drug 
use in pregnant women does not require mandatory reporting under state law, study team members may choose to 
voluntarily report it.  The possibility of this and the risks if this were to be reported will be clearly outlined in the consent 
form. 
 
Per HIPAA, participants will be advised during the consent process of our intent to collect biological specimens to test for 
HIV and HCV. Positive tests will be reported to the health department per state and local regulations. 
 
Steps to reduce discomfort or anxiety resulting from study participation. Assessment measures involve sensitive 
topics related to safety and wellness. Some participants may feel awkward or embarrassed when discussing, hearing 
about, or being asked to provide information related to their safety and wellness. Staff are trained to employ techniques 
that prevent, reduce, or minimize embarrassment, discomfort, or atypical stress associated with study participation. Staff 
will be trained to observe for any evidence that a participant may be overly anxious and to assess whether threat 
sensitization and vulnerability perceptions are realistic. Vivent Health and research field staff will be required to have 
extensive research- or program-based experience with the conduct of HIV-related research. The project will be guided by 
a detailed procedural manual, and field staff will receive intensive training focused on the specific project protocols and 
materials to ensure that they are being rigorously and consistently implemented, including extensive role-play rehearsal of 
recruitment, enrollment, and consent procedures and assessment procedures and materials. The field team will meet 
regularly to discuss implementation issues and areas warranting additional training. If research personnel change during 
the course of the study, new staff will be required to complete the training described above prior to conducting any 
research activities. 
 
HIV and HCV testing and counseling safeguards. All testing staff have completed the Wisconsin AIDS/HIV Program 
state HIV test counselor training to ensure that HIV pre- and post-test counseling is conducted in accordance with state 
guidelines. Vivent Health is a CLIA-certified HIV test site funded, in part, by the Wisconsin Division of AIDS/HIV’s HIV 
testing program. 
Specimens will only be sent for confirmatory testing for those rapid tests that they are already positive for, therefore, no 
new health information will be generated by analysis of these samples. 
 
In the UH3 phase of the study, participants who receive the Client-Centered Prevention Home intervention are expected 
to achieve more positive health outcomes and better linkages to services and care than people who do not receive this 
intervention. 
 
3.2. Potential adverse events (AEs) and Serious adverse events (SAEs). Unanticipated problems will be reported to 
the IRB in accordance with posted guidance. SAEs also may constitute unanticipated problems, depending on the nature 
of the event. In general, SAEs do not require reporting to the IRB unless they also potentially meet the definition of an 
unanticipated problem.  
 
An unanticipated problem is an event that meets all of the following criteria: 
• 
Reasonably related to the research; 
• 
Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the 
study-related documents, such as the IRB-approved research protocol and informed consent document, and the 
characteristics of the participant population being studied; AND 
• 
Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, 
economic, or social harm) related to the research than was previously known or recognized 
Adverse events (AEs) may occur during data collection may include: 
• 
Violation of confidentiality,  
• 
Discomfort due to assessment procedures,  
• 
Embarrassment in disclosing sensitive personal information,  
• 
Disclosure of information about current and/or intended physical harm persons,  
• 
Current and/or intended abuse of children (that would be reported to child welfare agency)  
• 
Dissatisfaction with the assessment procedures or intervention activities. 
The population of focus in this research is at high risk for multiple health consequences that are associated with 

 
52 
 
substance use disorder, which may constitute serious adverse events. These include development of bacterial infections, 
blood-borne viral infections including HIV and hepatitis, and sexually transmitted infections. This population is also known 
to have an elevated risk of drug overdose and death from all causes.Because of this, we will only be reporting death as an 
adverse event. 
 
Adverse events will be solicited from the study participants using a standardized case report form. Study document review 
will be performed to abstract additional information as necessary. A contact number for the research program manager and 
PI will be provided to each subject to contact the study in case of an unanticipated serious adverse event (SAE).  
Potential adverse events will be reviewed as to the assigned treatment group and further classified by severity (life-
threatening, serious, non-serious) and expected vs. unexpected. Expected and unexpected adverse events will be 
monitored at each enrolling site and reported to overseeing agencies as required by federal regulations and local 
requirements.  
 
3.6. Staff training. Staff will be required to demonstrate competence with project protocols prior to implementation. 
Investigators and field staff have or will be required to complete the NIH required CITI web-based ethics training. 
Interviews will be supervised by the lead project investigators to ensure protocol adherence. Testing staff will be further 
required to complete training and demonstrate competence with the fingerstick collection of whole blood specimens (i.e., 
rapid HIV, HCV, and syphilis point-of-care testing methodology) and phlebotomy blood draws prior to study 
Implementation; and complete annual training in blood borne pathogen control (“universal precautions”) to ensure 
adherence to the Occupational Safety and Health Administration Occupational Exposure to Blood borne Pathogen 
standards. Any new staff who are hired will be required to complete the training package described above, and 
demonstrate competency with HIV, HCV, and syphilis testing and counseling. Adverse event assessment, recording, 
reporting, and investigation will be accomplished through staff training, structured/standardized assessments of untoward 
occurrences/events, and regular monitoring by the study team. 
 
4.0 Reporting Procedures to NIDA 
 
4.1. Procedures and timeline for reporting AEs and SAEs to NIDA. Reportable adverse events will be 
submitted to NIDA annually as part of the annual progress report. This report will describe the event, when it 
occurred, whether the participant was part of the control of intervention arm, and the outcome/resolution.  If 
there were no AEs that year, a statement that no AEs occurred will be included in the progress report or 
communicated to NIDA in writing.  
 
In this research, all deaths and unanticipated SAEs determined by the PIs to be likely directly related to study participation 
will be reported to the IRB and NIDA within 24 hours after the PIs are made aware of the incident. The notification will 
include a brief explanation of the SAE and when it occurred. A written follow up will be sent within 72 hours of the event. 
The written follow up will include  information on the date of the event, what occurred, actions that were taken by the field 
staff, any planned follow up, whether the participant was part of the intervention or control arm, whether the event appears 
to be related to the intervention, and whether the participant will continue in the study. Additionally, the IRB will receive an 
annual report of all SAEs and AEs meeting the criteria listed above. 
 
4.2. Reporting of IRB actions to NIDA. After the IRB has reviewed and determined the course of action for reportable 
SAEs, the PIs will inform NIDA within 24 hours of the course of action.  
 
5.0 Data Safety and Monitoring Board. A DSMB will be convened for this study in collaboration with the University of 
Wisconsin Institute for Clinical and Translational Research (UW ICTR). The ICTR Data Monitoring Committee (DMC) 
meets the requirements for an independent Data and Safety Monitoring Committee or a Data and Safety Monitoring 
Board. The DMC is available for UW-Madison investigators when a funding agency, the PI, or IRB requires such a 
committee or board. The committee is comprised of experienced clinical researchers representing a diversity of 
backgrounds, skills and knowledge. The DMC helps investigators ensure subject safety, research integrity, and 
compliance with federal regulations and local policies. The DMC also makes recommendations to the PI that could include 
actions of continuation, modification, suspension, or termination. Prior to submission of the final protocol and IRB 
application to the UW Health Sciences Institutional Review Board, the PI requested a DMC consultation using the online 
application form. After an initial consultation with the DMC, there are no conflicts of interest with the current committee. 
None of the current board members has no financial and/or scientific ties to the outcome of the study. A list of current 
voting members are provided in the Appendix. The DMC will alert the investigation team if there is change in membership. 
If a conflict of interest arises, the PIs will inform NIDA within 24 hours of becoming aware of it. That member will abstain 
from voting or providing input to the study. As the protocol is refined and/or if a serious adverse event occurs, the DMC 
will work with the PIs and research team to determine whether or not there is a need to meet more than annually. After 

 
53 
 
each meeting, the DMC will review emerging data, make recommendations about the trial’s conduct, including possibly 
stopping the trial.  At the close of each meeting, the DMC will make one of four recommendations: continue as is, continue 
but with specific modifications; stop temporarily until specific conditions are met; or terminate. The PIs will report DMC 
activity as part of their annual project progress report to NIDA.   
 
A report on DMC meetings and activities will be sent to NIDA within 30 days of the meeting. The update will include the 
following: meeting dates (past and upcoming if known), meeting minutes or summary, current board membership, 
changes in membership (if applicable), information about any new member(s) (if applicable) including statement that new 
members have no conflict of interest, and specific board recommendations regarding the research project (if any). 
 
 

 
54 
 
 
APPENDIX 2.  Proposed outcome measures for Aim 3 
 
Outcome Type 
Data Source± 
Unit of Analysis 
Measure 
for Cost 
Analysis  
Time Period 
for Analysis* 
Addiction treatment accessibility and utilization 
 
If I wanted to start a 
medical treatment for 
opioid or heroin addiction, 
I could easily get into a 
methadone program.  
Short-term 
Client-level 
ACASI Survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
In the last 3 months, have 
you gone to a self-help 
group like Narcotics 
Anonymous, Alcoholics 
Anonymous, Celebrate 
Recovery, or Rational 
Recovery? 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 
 
In the past 3 months, 
have you received 
outpatient counseling 
from a provider or 
program? 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 
 
In the past 3 months, 
have you stayed overnight 
at a residential or 
inpatient drug treatment 
facility? 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 
 
In the past 3 months, 
have you been in detox? 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 
 
In the past 3 months, 
have you stayed overnight 
at a sober house? 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 
 
In the past 3 months, 
have you gotten 
buprenorphine 
maintenance medication–
like Suboxone or 
Subutex–from a doctor or 
program? 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 
 
In the past 3 months, 
have you gotten 
methadone maintenance 
from a clinic? 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 
 
In the past 3 months, 
have you gotten 
buprenorphine shots – 
like Sublocade –   from a 
doctor or program? 
 
Intermediate  
Client-level 
ACASI Survey 
Change in frequency 
✓ 
T0, T1, T2 

 
55 
 
 
If I wanted to start medical 
treatment for opioid or 
heroin addiction, I could 
easily get buprenorphine 
or Suboxone or Subutex. 
Short-term 
Client-level 
ACASI survey  
Change in Likert-
scale 
 
T0, T1, T2 
 
If I wanted to start a 
medical treatment for 
opioid or heroin addiction, 
I could easily get into a 
methadone program 
Short-term 
Client-level 
ACASI survey  
Change in Likert-
scale 
 
T0, T1, T2 
 
Any outpatient visit for 
MAT for opioid use 
disorder post initiation of 
CCPH or control 
Intermediate Client-level 
Medicaid 
Change in frequency 
✓ 
T-2, T0, T2 
 
Prescription fill for 
methadone, 
buprenorphine, 
naltrexone, probuphine 
post initiation of CCPH or 
control 
Long-term community-
level 
Medicaid 
Change in frequency  
✓ 
T-2, T0, T2 
Treatment for hepatitis C 
 
Utilization of HCV 
treatment among 
participants  
Intermediate 
Client-level 
Medicaid  
Change in rate of 
HCV treatment 
✓ 
T0, T1, T2 
 
Successful HCV 
treatment among 
participants 
Long-term 
Client-level 
WEDSS 
Change in cure rate 
of HCV treatment 
 
T-4, T0, T4 
 
Decrease in prevalence of 
HCV 
Long-term  
County-level 
WEDSS 
Change in rate of 
HCV by county 
 
T-4, T0, T4 
 
Do you currently have 
health insurance or health 
care coverage? 
Short-term 
Client-level 
ACASI Survey 
Change in rate of 
health insurance 
 
T0, T1, T2 
 
If I ever tested positive for 
hepatitis C, I'm confident I 
could get linked to a 
medical expert and start 
hepatitis C treatment. 
Short-term 
Client-level 
ACASI Survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
Number of appointments 
made for HCV treatment 
Short-term 
Client Level 
CCPH Program 
data 
Change in frequency 
 
T0, T1, T2 
 
Prescription fill for DAAs 
post initiation of CCPH or 
control  
Intermediate Client-level 
Medicaid 
Change in frequency 
✓ 
T-2, T0, T2 
Lower risk of viral hepatitis 
 
 
 
 
 
 
Uptake of hepatitis A 
immunization 
Long-term 
County-level 
WIR 
Change in rate of 
hepatitis A 
immunization among 
15-39 year olds 
 
T-4, T0, T4 
 
Uptake of hepatitis B 
immunization  
Long-term 
County-level 
WIR  
Change in rate of 
hepatitis B 
 
T-4, T0, T4 

 
56 
 
immunization among 
15-39 year olds 
 
I am certain that I got all 3 
recommended shots for 
Hepatitis B. 
Intermediate  
Client-level 
ACASI survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
Health department 
referrals for hepatitis A 
and B immunization 
Short-term 
Client-level 
CCPH Program 
data 
Number of referrals 
 
T0, T1, T2 
 
Any outpatient visit that 
includes immunization for 
hepatitis A or B 
Long-term 
Client-level 
Medicaid 
Change in frequency  
✓ 
T-2, T0, T2 
Lower risk of HIV 
 
 
 
 
 
 
Have you ever heard of 
medicine people can take 
to prevent HIV? 
Short-term 
Client-level 
ACASI survey 
Change in rate of 
knowledge of PrEP 
 
T0, T1, T2 
 
It’s easy for me to get 
new, clean syringes or 
needles. 
Short-term 
Client-level 
ACASI survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
It’s easy for me and my 
sex partners to get 
condoms. 
Short-term 
Client-level 
ACASI survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
PrEP utilization  
Long-term 
County-level 
IQVIA 
Change in number 
of prescriptions for 
PrEP 
 
T-4, T0, T4 
 
Safe injection drug use 
practices  
Intermediate 
Client-level 
ACASI survey 
Change in rate of 
safe injection drug 
use practices 
 
T0, T1, T2 
 
Have you had sex without 
a condom? 
Intermediate 
Client-level 
ACASI survey 
Change in rate of 
sex without a 
condom 
 
T0, T1, T2 
 
Were you diagnosed with 
an STD in the past? 
Intermediate 
Client-level 
ACASI survey 
Change in rate of 
STD diagnoses 
 
T0, T1, T2 
 
Have you had sex with 
more than one person in 
the past 6 months? 
Intermediate 
Client-level 
ACASI survey 
Change in rate of 
sex with more than 
one person 
 
T0, T1, T2 
 
Syringe distribution 
Intermediate 
County-level 
Lifepoint  
Change in rate of 
syringe distribution 
 
T-2, T0, T2 
 
HIV prevalence 
Long-term 
County-level 
WEDSS 
Change in rate of 
HIV incidence 
 
T-4, T0, T4 
Lower risk of drug 
overdose 
 
 
 
 
 
 
If I wanted the overdose 
reversal drug naloxone or 
Narcan, I could easily get 
it. 
Short-term 
Client-level 
ACASI survey  
Change in Likert-
scale 
 
T0, T1, T2 
 
Narcan distribution 
Intermediate 
County-level 
Lifepoint 
Change in narcan 
distribution 
 
T-2, T0, T2 
 
Overdose hospitalizations 
Long-term 
County-level 
Wisconsin 
Hospital 
Administration 
Data 
Change in rate of 
overdose-related 
hospitalizations 
 
T-4, T0, T4 

 
57 
 
±Data sources used to measure the effectiveness of intervention include: 
ACASI Survey: the harmonized survey used in the UG3 phase 
WEDSS: Wisconsin Electronic Disease Surveillance System 
Medicaid: Wisconsin Medicaid Program 
IQVIA: Purchased prescriber data  
WIR: Wisconsin Immunization registry 
Lifepoint: Syringe service program database of needle exchange encounters and narcan distribution 
BRFSS: Behavioral Risk Factor Surveillance System 
SAMHSA: Database of DATA-Waived Practitioners 
 
*Time is measured in 3-month intervals based on the intervention assessment phases 
T-4 a year prior to the intervention 
T-2 6 months prior to the intervention 
T0 Start of the intervention 
T1 3 month follow up 
T2 6 month follow up 
T4 12 month after intervention 
 
Probable opioid overdose 
Long-term 
County-level 
Wisconsin 
Ambulatory 
Run Data 
System 
Change in rate of 
overdose-related 
ambulatory run 
 
T-4, T0, T4 
 
Overdose death 
Long-term 
County-level 
Wisconsin 
Mortality data 
Change in rate of 
overdose-related 
death 
 
T-4, T0, T4 
Smoking cessation 
 
Quit-line encounters 
Short-term 
Community-level 
Quit-line 
database 
Change in number 
of quit-line uses 
 
T-4, T0, T4 
 
Do you smoke cigarettes? 
Intermediate 
Client-level 
ACASI Survey 
Change in 
prevalence 
 
T0, T1, T2 
 
On average, how many 
cigarettes do you smoke a 
day? 
Intermediate 
Client-level 
ACASI Survey 
Change in median 
number of cigarettes 
 
T0, T1, T2 
 
Overall smoking 
prevalence by county 
Long-term 
County-level 
BRFSS 
Change in 
prevalence 
 
T-4, T0, T4 
Self-stigma 
 
How much do you feel 
ashamed of using drugs? 
Intermediate 
Client-level 
ACASI Survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
How much do you feel 
people avoid you because 
you use drugs? 
Intermediate 
Client-level 
ACASI Survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
How much do you fear 
you will lose your friends 
because you use drugs? 
Intermediate 
Client-level 
ACASI Survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
How much do you fear 
family will reject you 
because you use drugs? 
Intermediate 
Client-level 
ACASI Survey 
Change in Likert-
scale 
 
T0, T1, T2 
 
How much do you think 
other people are 
uncomfortable being 
around you because you 
use drugs? 
Intermediate 
Client-level 
ACASI Survey 
Change in Likert-
scale 
 
T0, T1, T2 

 
58 
 
APPENDIX 3. Data elements to be shared with University of Washington Data Coordinating Center 
 
Please refer to the ACASI questionnaire for review of exact wording of questions. Identifiers are 
highlighted in yellow.  
 
 
Screener data  
Variable Name/Category 
Description of Variable/Category 
RECORD_ID 
Participant’s ID Number  
SCRDATE 
Date of screening  
REFERRAL CODE  
Code number that traces participant to their recruiter 
RELATIONSHIP TO RECRUITER 
We ask how the participant is related to the recruiter 
AGE 
Two digit age  
GENDER 
The participant’s gender 
SCREDU/SCRGRDE 
The highest grade or degree the participant attained 
SCRRACE/SCRHISP 
The participant’s race and ethnicity 
SCRZIP/SCRCO 
Participant’s zipcode and county of residence 
SCR10 
Drugs taken in the past 30 days 
INJECTED_DRUGS/SCRINJDT 
Date of the last time participant injected drugs to get high  
Quantitative Survey Data (ACASI) 
Variable Name/Category 
Description of Variable/Category 
ID 
Same as RECORD_ID 
SCRGEN 
The participant’s gender 
EVERUSED (SCR SERIES) 
Ever used drugs  
SUBDRCH 
Drug of choice 
USED PAST 30 DAYS (SUB SERIES) 
Used drugs in the past 30 days 
SUBALCMD/SUB_ALC_B30 
Alcohol use in the past 30 days 
CIGARETTE USE 
Cigarette use, number of cigarettes, type of tobacco products 
SUBSTANCE DEPENDENCY 
Questions regarding whether or not participants worry about their 
drug use, and whether or not they wish to stop  
INJECTED PAST 30 DAYS 
Injected drugs in the past 30 days  
AGE FIRST INJECTED 
Age first injected heroin, methamphetamine, and cocaine 
SYRINGES LAST 30 DAYS 
Where participant received syringes in the last 30 days 
INJECTING BEHAVIOR 
Questions on whether or not participant used clean syringes, 
shared syringes, had someone else prepare their drugs, injected 
more than one time in one sitting.  
SKIN PREPERATIONS 
Questions on how participants cleaned their skin, water source, 
whether they injected into muscle or skin, and whether they’ve had 
a skin infection in the past 
OVERDOSE 
Ever overdosed, times overdosed, trained to recognize and 
respond to an overdose, ever call 911, number of people that have 
died from an overdose 
SUBSTANCE USE TREATMENT 
Ever used a self help group, received outpatient counseling, 
stayed overnight at a residential drug treatment center, etc  
REASONS FOR TREATMENT 
Reasons why the participant has not used buprenorphine, 
methadone, and/or Vivitrol 
STIGMA (STG SERIES) 
Questions address self shame for using drugs 
HIV DIAGNOSIS AND TREATMENT 
(HHIHIV SERIES) 
Questions on whether participant has been tested for HIV, last HIV 
test date, test results, date of diagnosis, HIV treatment  
HCV DIAGNOSIS AND TREATMENT 
(HHIHCV SERIES) 
Questions on HCV diagnosis, treatment for HCV, and main place 
for medical care for HCV 
BACTERIAL INFECTIONS 
Hospitalization of serious bacterial infection, date of hospitalization  
ACCESS TO MEDICAL CARE 
Main place participant received medical care, barriers to care 

 
59 
 
KESSLER DISTRESS SCALE (KES 
SERIES) 
Questions on participants anxiety and depressive symptoms in the 
last 30 days 
PTSD SCALE 
Questions on whether participant experienced adverse event, and 
symptoms experienced after adverse event 
ACCESS TO PREVENTION AND 
TREATMENT (ACC SERIES) 
Questions on accessibility to condoms, HIV treatment, HCV 
treatment, STI treatment, buprenorphine, naloxone, clean 
syringes, vaccinations, infection information 
CRIMINAL JUSTICE 
Times law enforcement has stopped and searched participant, 
number of arrests, probation in the last 6 months, days they were 
in jail  
SEXUAL RISK (SXR SERIES) 
Number of partners in the past 30 days, trade sex for drugs, last 
time they had vaginal or anal sex, sex without a condom, sex 
without a condom and injected drugs, sex with HIV+ 
DEMOGRAPHICS 
Main source of income, services received, relationship status, 
student status, pregnancy status, forms of birth control, 
homelessness, transportation, health insurance  
RDS 
Questions on their network of people who inject drugs 
RAPID RESULTS 
Results from HIV, HCV, and Syphilis testing that was done that 
day  
DUP_ID 
Possible participants that entered the study more than once  
Qualitative Participant Interviews  
All transcripts were stripped of the 
following information:  
Names 
Geographic subdivisions smaller than a state 
All Dates 
Telephone numbers  
FAX numbers 
Email addresses 
Social security numbers 
Medical record numbers 
Health plan number 
Account number 
Certificate/license number  
License plate number 
Device identifiers/serial numbers 
Web urls 
Internet protocol addresses 
Biometric identifiers 
Full face photos and comparable images