Combination Primary Care and Prevention Services for Women Who Inject Drugs and Exchange Sex in Seattle, Washington
Phase: NA
Conditions: Opioid Use Disorder, HIV Infections, Chlamydia, Gonorrhea, Syphilis, Trichomonas
Sponsor: University of Washington

 
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PROTOCOL 
 
Combination primary care and prevention services for women who inject drugs and exchange 
sex in Seattle, Washington 
 
Funded by the US National Institutes of Health 
 
Version 3.0 
 
Last updated: February 13, 2026 
 
 
 
 

 
2
Table of Contents 
 
Study Team Members 
 
 
 
 
 
 
 
 
3 
 
Study Organizations  
 
 
 
 
 
 
 
 
3 
 
Summary and Primary Objectives 
 
 
 
 
 
 
 
4 
 
Study Design  
 
 
 
 
 
 
 
 
 
7 
 
Screening and Recruitment  
 
 
 
 
 
 
 
9 
 
Informed Consent 
 
 
 
 
 
 
 
 
 
9 
 
Study Visits 
 
 
 
 
 
 
 
 
 
 
10 
 
Standard of Care  
 
 
 
 
 
 
 
 
 
12 
 
Lab Processing and Results Delivery 
 
 
 
 
 
 
13 
 
Management of New Diagnoses 
 
 
 
 
 
 
 
14 
 
Research Reimbursement and Incentives 
 
 
 
 
 
 
15 
 
Protection of Human Subjects 
 
 
 
 
 
 
 
15 
 
Important Definitions  
 
 
 
 
 
 
 
 
18 
 
Data Safety Monitoring Board 
 
 
 
 
 
 
 
19 
 
Analysis Plan  
 
 
 
 
 
 
 
 
 
20 
 
 

 
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STUDY TEAM 
 
University of Washington  
 
 
 
 
  
Maria Corcorran, MD, MPH (MPI) 
 
 
 
 
 
Lauren Violette, MPH (Research Coordinator) 
 
Shireesha Dhanireddy, MD (co-I) 
 
Sara Glick, PhD (co-I) 
 
Emily Williams, PhD (co-I) 
 
Elizabeth Austin, MPH (qualitative data analyst) 
 
Hennepin Healthcare 
Jenell Stewart, DO, MPH (MPI) 
 
University of California San Francisco 
Monica Gandhi, MD, MPH (key personnel) 
 
 
Study Organizations 
 
UW 
Dr. Maria Corcorran, MPI, is an Assistant Professor in the Division of Allergy and Infectious 
Diseases and oversees grant management with the Division’s grant management team. Data 
management and use of the REDCap Database are through University of Washington. 
Additionally, the co-investigators and the project manager are University of Washington 
employees.  
 
SHE Clinic 
Dr. Maria Corcorran, MPI, and Dr. Shireesha Dhanireddy, co-I, are physicians and clinical 
directors of collocated clinics at the Aurora Commons, our community partner. For this project, 
medical record encounters for clinical visits will be extensions of SHE Clinic. Participants can 
follow up at SHE Clinic for any clinical care and/or test results on days when the SHE Mobile 
intervention is not available.  
 
Aurora Commons 
A nonprofit organization located in north Seattle on Aurora Avenue. Participants for formative 
work, informing this intervention, were recruited from Aurora Commons.  
 
Public Health Seattle & King County (PHSKC) 
PHSKC has agreed to use of a medical van for this research project. Additionally, the PHSKC 
will supply rapid HIV/syphilis tests and naloxone.  
 
Hennepin Healthcare Research Institute (HHRI) 
Dr. Jenell Stewart, MPI, is an Assistant Professor in the Division of Infectious Diseases at 
Hennepin Healthcare and the University of Minnesota, and is assisting in protocol development, 
project oversight, and analysis.  

 
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SUMMARY 
Combination primary care and prevention services for women who inject drugs and exchange 
sex in Seattle, Washington 
 
 
Design:  
Pilot of novel care model for low-barrier care and adherence support for 
uptake and sustained use of biomedical HIV prevention and medications 
for opioid use disorder for women who inject drugs 
 
Study Population:  50 female-identifying people ≥18 years of age and older who have ever 
injected drugs and are not known to be HIV-positive  
 
Study Site:   
Community-based clinic on north Aurora Avenue in Seattle, WA 
 
Primary Study Objectives: 
1. Evaluate uptake of PrEP and MOUD 
2. Evaluate sustained use of PrEP and MOUD  
3. Evaluate treatment completion rate and time to completion after POC STI testing 
4. Assess acceptability of pilot community-based care model 
5. Assess acceptability of POC STI testing at community-based site. 
 
Approach: 
We will conduct a pilot study of a community-based novel care model developed 
with community feedback and a community advisory board (CAB) co-design 
process during phase I of this project. We will enroll 50 female-identifying people 
and follow them for 6 months. We will assess uptake of PrEP and buprenorphine; 
POC STI testing and treatment completion rates; sustained use of PrEP and 
buprenorphine at months 3 and 6 (n=50). We will conduct surveys, guided by 
CFIR, to assess and characterize the acceptability and feasibility of venue-based 
primary and HIV prevention care among women who inject drugs (WWID). 
 
 
 

 
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Background and rationale 
Women who inject drugs (WWID) experience frequent barriers to receiving primary care, 
especially sexual health and addiction services, because of perceived stigma, competing needs, 
and structural inequities within the healthcare system. Barriers to care among WWID are often 
exacerbated by the additional social chaos of unstable housing and engagement in 
transactional sex. These structural realities promote exclusion from traditional primary care 
systems, increase risk of HIV acquisition, and have led to rising rates of syphilis infections and 
overdose deaths among WWID in recent years. PrEP, buprenorphine, and STI control are key 
components of the End the HIV Epidemic prevention pillar and proven tools for reducing risk of 
HIV acquisition and opioid overdose, but uptake and sustained use of these interventions are 
low among WWID.  
A recent HIV outbreak among WWID in Seattle exposed the ongoing HIV risk faced by this 
population and highlighted major gaps in access to care. In response to this substantial, unmet 
need for combination primary care and prevention services, in 2018 we established the Safe. 
Healthy. Empowered. (SHE) Clinic, a weekly pop-up clinic for WWID. Operating only 4 hours 
per week, this walk-in primary care clinic, co-located with a day shelter, was able to engage 
over 190 socially and medically marginalized women in care. Preliminary data demonstrated a 
significant reduction in nonemergent emergency department visits among SHE Clinic patients 
as well as high initial uptake of HIV prevention and addiction treatment interventions, including 
PrEP, buprenorphine, and STI testing. Nevertheless, the impact of these interventions has been 
limited by poor adherence and follow-through, and preliminary needs assessment data indicate 
that many WWID would find an evening clinic, closer to where they sleep and work, more 
accessible and desirable.  
 
Despite being at high risk for HIV acquisition, WWID face multiple barriers to accessing 
primary care. Common structural barriers, such as poverty, unstable housing, limited 
transportation, and the cost of medical care are compounded by a multitude of competing needs 
related to drug use and general safety and survival that impede WWIDs ability to access both 
traditional and non-traditional healthcare settings. These structural and individual-level barriers 
are exacerbated by the perceived stigma associated with injection drug use and exchange sex, 
and by the fact that harm reduction services are often targeted towards men and fail to incorporate 
gender-specific care for women. This gender disparity not only results in limited availability of 
reproductive healthcare, childcare services, and other services focusing on women’s needs within 
harm reduction structures, but it also results in a lack of trauma-informed care for WWID. 
Furthermore, WWID lack access to much needed reproductive services, with prior studies in 
Seattle showing low rates of contraceptive use and high rates of unplanned pregnancies among 
this marginalized population. Engaging WWID in combination primary care and HIV 
prevention is a challenge, and acceptability and reduced stigma are essential components 
to successful uptake and sustained use of evidence-based interventions. 
  
Pre-exposure prophylaxis (PrEP), buprenorphine, and sexually transmitted infection (STI) 
control are proven interventions for reducing risk of HIV acquisition, but their use among 
WWID remains low. PrEP reduces HIV acquisition among women, including WWID, and the 
Centers for Disease Control and Prevention (CDC) recommend the use of PrEP in PWID who 
share injection equipment and/or have overlapping sexual risk factors. Nevertheless, multiple U.S. 
cities report extremely low rates of PrEP use among PWID, ranging from 0 – 3%. Similarly, results 
of a recent systematic review revealed that PrEP uptake among PWID was low, between 0 – 3% 
across 23 studies, despite this populations’ high willingness to use PrEP. Despite this, there are 
currently no recommendations or guidelines for how to best support PWID, in particular WWID, 
with PrEP use and adherence. Most domestic studies on PrEP for PWID characterized awareness 

 
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of, interests in and determinants of PrEP use, but lack novel interventions to improve PrEP uptake 
and sustained use. Medications for opioid use disorder (MOUD), including buprenorphine, 
similarly reduce the risk of HIV acquisition in WWID through a reduction in both needle-sharing 
and sexual risk behaviors. However, women are under-represented in both inpatient and 
outpatient substance use treatment programs, and, in comparison to their cisgender male 
counterparts, women delay treatment until further on in their addiction. The provision of low-barrier 
buprenorphine can improve uptake; however, sustained use of buprenorphine, and rates of 
adherence and retention in care may be less than 50% at 6 months across all genders of PWID. 
In addition to PrEP and MOUD, robust data supports the use of STI control in HIV prevention, 
due to the substantial increased risk of HIV acquisition associated with STI coinfection. Despite 
the existence of proven interventions, comprehensive sexual and reproductive healthcare tailored 
to WWID is lacking, even among those who exchange sex and experience high rates of STIs. 
Point-of-care (POC) testing provides an important opportunity to leverage venue-based 
healthcare to provide comprehensive services on a walk-in basis. The use of rapid POC STI 
testing nearly eliminates issues with patient loss to follow-up and incomplete or missing treatment, 
which continues to be a problem for STI case-detection based public health efforts.  
In 2018, our team at the University of Washington established a weekly clinic, the Safe. 
Healthy. Empowered. (SHE) Clinic, to provide care for WWID and exchange sex. SHE Clinic 
is co-located and operated in collaboration with Aurora Commons, a not-for-profit drop-in center 
that provides basic needs and day-shelter for unhoused individuals in Seattle. HIV prevalence is 
approximately 10% among SHE Clinic patients, with 80% of patients engaging in injection drug 
use and 69% reporting exchange sex; although internal, unpublished estimates suggest the 
prevalence of exchange sex may be >90% in the SHE Clinic population. Initially operating only 
four hours per week, SHE Clinic, under the direction of Dr. Dhanireddy (co-I), has provided care 
to over 190 socially and medically marginalized women in Seattle. Nonemergent emergency 
department visits among SHE Clinic patients significant declined over a six-month period when 
compared with similar visits among WWID in north Seattle who had never received care at SHE 
Clinic. Uptake of PrEP (33%) and buprenorphine (49%) among SHE Clinic patients has improved 
significantly. Significant barriers to care remain for these socially and medically marginalized 
women. Despite the availability of PrEP and the high prevalence of HIV and HIV-risk factors in 
this population, sustained use of PrEP is exceedingly low (0-5%) among SHE Clinic patients after 
six months, as is sustained use of buprenorphine (12%) (Preliminary Results).  
 
Addressing the gap in prevention and addiction services for PWID is a priority for reducing 
HIV incidence in King County, particularly in the wake of the recent cluster of linked infections 
among PWID. Through funding received from Ending the HIV Epidemic (EHE): A Plan for 
America, Public Health – Seattle and King County (PHSKC) plans to collaborate with SHE Clinic 
to expand daytime clinical services at the Aurora Commons drop-in center. The expansion of 
clinical care at Aurora Commons will add further opportunity for referral and linkage to care for 
WWID; however, it will not reach WWID who are unable to seek care during the day and are 
staying in exchange-sex venues even further north from Aurora Commons. Furthermore, how 
to best optimize HIV prevention services, specifically for WWID, remains an unanswered 
question and a top research priority for PHSKC (Letter of Support). The PHSKC HIV/STD 
Program is looking to researchers and partner organizations (e.g., SHE Clinic) for guidance and 
support on evidenced-based practices and has a long history of collaboration with University of 
Washington (UW) researchers, with several dually-appointed researchers, including Dr. Sara 
Glick, a UW faculty member, PHSKC epidemiologist, and a study co-investigator. 
 
WWID in north Seattle favor evening clinic hours at a location closer to where they sleep 
and exchange sex (Preliminary Results). These preferences highlight key accessibility and 
opportunity challenges created by traditional models of care within the United States – models 
that are not conducive to socially and medically marginalized populations. Although not yet 

 
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adopted in U.S. cities, there is considerable international experience providing care for female 
sex workers (FSWs) in venues for exchange sex. This form of co-located care helps to break 
down accessibility and opportunity challenges and has been shown to reduce the incidence of 
sexually transmitted infections (STIs), increase HIV prevention behaviors, improve linkage to 
care, and reduce the incidence of HIV among FSWs in countries across South America and sub-
Saharan Africa. Leveraging lessons learned through the provision of venue-based care in the 
international setting, our multidisciplinary team will use a global to local approach to expand SHE 
Clinic through the creation and implementation of an evening pop-up clinic near venues for 
exchange sex and drug use in Seattle. Informed by a formative evaluation of the barriers, 
facilitators, and client-centered approaches to sustained PrEP and buprenorphine use, this novel 
venue-based clinic aims to increase uptake and sustained use of proven HIV prevention 
interventions, including PrEP and buprenorphine, improve rates of STI testing and 
treatment among WWID, many of whom exchange sex, and serve as a model that can be 
further tested at scale. 
 
Study Design 
General Overview 
We will implement a pilot clinic one evening per week, with the primary goal of measuring a 
community-based extension of SHE Clinic’s impact on uptake and sustained use of HIV pre-
exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD). The clinic will be 
dispatched with a driver, nurse, physician, and research assistant. The van clinic will be outfitted 
with space to obtain a confidential history and physical exam and include a space for sample 
collection. Similarly, the van clinic will be equipped with a WiFi hotspot with a laptop linked to 
University of Washington’s EMR system for clinical documentation, orders, and referrals. In 
addition to standard of care, (Table 1), we will provide participants with rapid point-of-care HIV 
and STI testing. All people presenting for a walk-in clinic visit who do not enroll will be offered 
laboratory-based testing and prescription medications, which are subject to insurance/billing. 
Women enrolled in the research study will be instructed on self-collection of vaginal swab 
specimens, which will be tested for C. trachomatis and N. gonorrhoeae using the 30-minute 
Binx Health rapid PCR platform.  OSOM swabs for trichomonas will be placed into a sterile tube 
and processed on site with rapid testing kits (Sekisui Diagnostics) along with POC HIV and 
syphilis testing via finger prick (Chembio Diagnostic Systems). Any samples that cannot be 
tested using point-of-care methods will be transported to Harborview Medical Center laboratory 
following clinic sessions. Results will be delivered to participants, either immediately, via cell 
phone for lab-based tests or when a participant follows up at the mobile clinic or at SHE Clinic. 
STI treatment will be given per clinical guidelines. Treatment of gonorrhea will consist of 
intramuscular ceftriaxone 500mg x1. Participants who test positive for chlamydia will be 
recommended to take doxycycline 100mg PO BID for 7 days; however, azithromycin 1g PO x1 
will be offered as an alternative if participants are unable to complete a 7-day course of 
antibiotics. Similarly, participants who test positive for trichomonas will be recommended to take 
metronidazole 500mg PO BID for 7 days; however, metronidazole 2g PO x1 will be offered as 
an alternative if participants are unable to complete 7 days of antibiotics. Early syphilis will be 
treated with 2.4 million units of benzathine penicillin x1 or oral doxycycline 100mg BID for 14 
days, pending benzathine penicillin availability. Late latent syphilis will be treated with 2.4 million 
units of benzathine penicillin weekly for 3 weeks or oral doxycycline 100mg BID for 28 days, 
pending benzathine penicillin availability.  
 
Results will be noted in participants’ EMR for improved continuity of care across the healthcare 
system. Study participants who return for results (or receive them via phone) and undergo 
appropriate treatment, if necessary, will be eligible for a $15 travel reimbursement, as per SHE 
Clinic standard of care. This novel venue-based clinic will be integrated within the larger 

 
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University of Washington (UW) healthcare system, and necessary referrals will be made to UW 
facilities, including a large UW medical campus located two miles north of Aurora Commons. 
Participants not already registered in the UW system will receive a medical record number and 
clinical portions of study visits will be documented in electronic medical records to improve 
overall continuity of care. Referrals for syringe services will similarly be made to a local syringe 
service program. Additional dedicated research activities taking place in this care model will 
include surveys and adherence monitoring via dried blood spot (DBS), as detailed below. 
Adherence support will be incorporated into this model using established evidence-based 
approaches in response to the analysis of formative qualitative work and recommendations of 
the community advisory board. 
 
Data Collection Overview 
Clinical study visits will occur at enrollment, a follow-up study visit at month-3, and an exit visit at 
6-months post-enrollment. For participants who are prescribed buprenorphine, additional brief 
refill visits will occur at monthly intervals. All assessments will occur during in-person visits in the 
pilot clinic. Each study visit will consist of a short survey, an eligibility assessment for oral PrEP 
and MOUD, standard clinical care, and biological sample collections (i.e., DBS sample 
collection for research only, self-collected vaginal swabs for point-of-care STI testing, and blood 
samples for blood born infection testing). To test the impact of this pilot clinic model on 
improving uptake and sustained use of HIV prevention services, we will utilize medical record 
data and DBS drug (buprenorphine and tenofovir) levels. Prior to enrollment, participants will be 
asked to provide consent for participation in the study, review of electronic medical record 
(EMR) data, and review of pharmacy records. Consent will be collected using electronic data 
capture (REDCap) and participant data will be collected by medical record number (MRN) 
utilizing an EMR querying technology (Leaf) generated by the University of Washington as well 
as manual chart review. Participants meeting CDC eligibility criteria for PrEP will be counselled 
on HIV risk, offered HIV testing, and if negative and interested, oral PrEP will be prescribed per 
clinical guidelines. Additionally, participants with active self-reported use of opioids will be 
counselled on options for opioid use disorder treatment, and those interested in MOUD, will be 
provided with a prescription for buprenorphine-naloxone or buprenorphine, per clinical 
guidelines. Uptake of PrEP and buprenorphine will be measured by review of pharmacy and 
EMR records and will be defined by filling a prescription for PrEP or buprenorphine. In 
collaboration with Dr. Monica Gandhi and the University of California San Francisco (UCSF) 
Hair Analytical Laboratory (HAL), we will measure sustained use of PrEP and buprenorphine via 
tenofovir disoproxil fumarate (TDF) and buprenorphine levels in samples of 150 hairs. The 
UCSF-HAL can simultaneously test for buprenorphine, fentanyl, and tenofovir from the same 
specimen, and we will measure these drug levels at 3- and 6- months to evaluate adherence to 
PrEP and buprenorphine. Additionally, dried blood spots (DBS) will be collected and archived to 
ensure that drug levels are collected during this study in the event there are any complications 
with hair testing.  
 
 
At each visit, brief demographic and behavioral surveys will be administered to women enrolled 
in the study via tablets, with responses recorded in REDCap. At the end of each visit an 
additional survey assessing acceptability of venue-based care will be administered to each 
participant. Questions will be informed by the CFIR and designed to assess the acceptability 
and relative priority of venue-based primary and HIV prevention care among women seeking 
services. As part of an assessment of acceptability, questions will also focus on the perceived 
stigma associated with receipt of care at the pop-up van clinic near a venue for drug use and 
exchange sex. Following completion of the intervention, information on feasibility, 
implementation barriers and facilitators will be collected using semi-structured interviews with 

 
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clinical staff to contextualize logistical and structural barriers faced by venue-based service 
delivery. 
 
Screening and Recruitment 
Overview of screening and recruitment 
Flyers advertising the venue-based clinic will be posted at local harm-reduction and social 
service sites: the Aurora Commons, People’s Harm Reduction Alliance, Mary Pilgrim Inn, The 
Gateway, WeCare Methadone Clinic, and at other locations within the community, based on the 
suggestions of the community advisory board. All women who present to the venue-based clinic 
will be screened for possible enrollment using a brief survey programed into REDCap. 
Screening surveys will be self-administered, unless the participant requests that a clinic team 
member assist them in filling out responses to screening questions. Women who meet inclusion 
criteria will be provided with brief information about the study and asked if they would like to 
learn more. Women who express interest in the study will then be connected to the research 
assistant, who will explain the study in more detail and go through the informed consent 
process. Women who agree to participate will provide informed consent via REDCap on a study 
tablet housed within the clinic. Women who are ineligible for the study, or those who do not wish 
to participate, will still be allowed to access standard of care medical services within the venue-
based clinic.  
 
Screening questions 
1. How old are you? 
2. What’s your gender identity? 
3. Have you ever injected drugs, even just once, in your lifetime? 
4. Have you ever been tested for HIV? 
a. If yes, when and what was the result? 
 
Inclusion Criteria 
• 
≥18 years of age 
• 
Female identifying 
• 
Ever injected drugs  
• 
Not known to have HIV 
• 
Willing and able to provide informed consent to participate in the study 
 
Exclusion Criteria 
• 
<18 years of age 
• 
Never injected drugs 
• 
HIV positive  
• 
Medical or psychological co-morbidities that prevent participation per study team 
assessment.  
• 
Non-English speaking  
 
Informed Consent 
 
Consent will be obtained by trained research staff from participants who meet all inclusion 
criteria. Care will be taken to ensure that the treating physician and nurse do not obtain consent 
from potential participants and that the informed consent conversation can occur in a private 
space. The study will be thoroughly described by research staff to potential participants. The 
research staff will give the subjects adequate time to look at and read the electronic consent 
form, summarize each section, and ask the subjects if they understand. Potential participants 

 
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will have the opportunity to ask questions about the study and study procedures. Individuals 
who choose to participate and are deemed able to provide informed consent will fill out and sign 
an electronic informed consent document in REDCap (via a study tablet).  
 
After the participant has signed, the research staff will have the opportunity to review the form to 
ensure that it is correctly signed and dated. A copy of the consent form will be given to the 
participant in print or via email, per their preference. Completed consent forms will be stored 
electronically in the UW REDCap account.  
 
Study Visits 
 
Enrollment study visit 
Enrollment will occur at the time the informed consent document is electronically signed. 
Following enrollment, each participant will be given a unique study ID to prevent duplicate 
enrollments. The study ID will consist of the patient’s last initial, first initial, and the day they 
were born. The baseline study visit will occur immediately following enrollment and will consist 
of completing a baseline health questionnaire, counseling for HIV risk reduction, counseling for 
treatment of opioid use disorder (if applicable), point of care (POC) STI testing, POC HIV 
testing, offering oral PrEP for HIV risk reduction (if applicable), and offering buprenorphine for 
treatment of opioid use disorder (if applicable). All participants will also be offered laboratory-
based STI testing of the oral and rectal sites. Participants who consent for PrEP will also have 
phlebotomy performed for serum creatinine, hepatitis B serologies, and a 4th generation HIV 
antigen/antibody assay. Clinic staff will also address any immediate medical concerns of the 
participant and treat as able per standard of care. At the enrollment study visit, each participant 
will be given a $25 Visa gift card for their participation.  
 
In addition to reimbursement for each study visit, participants will receive a financial incentive of 
$15 for returning to receive any test results that required off-site lab testing, as is standard of 
practice at our community partner, Aurora Commons/SHE Clinic. Participants on buprenorphine 
will also receive $15 each time they return for monthly refills. Financial incentives will be paired 
with low-barrier, walk-in care and adherence counseling at each visit 
 
Baseline study visit data collection 
An electronic health questionnaire will be filled out by participants in REDCap using a clinic 
tablet. Research staff will be allowed to assist the participant in filling out the electronic health 
questionnaire, if the participant chooses. The questionnaire will assess for risk factors for HIV, 
PrEP eligibility, prior use of PrEP, history of substance use, prior use of medications for opioid 
use disorder (MOUD), and current use of MOUD. At the end of the study visit, each participant 
will complete a brief electronic survey in REDCap. This survey will assess the patient’s overall 
experience receiving care at the venue-based clinic and assess the level of acceptability and 
perceived stigma associated with venue-based care.  
 
During or immediately following the visit, the clinic staff will fill out a visit summary report in 
REDCap, indicating the results of POC STI and HIV testing, any STI treatment given, if the 
participant was prescribed PrEP or reasons they were not prescribed PrEP, and if the 
participant was prescribed buprenorphine or reason the participant was not prescribed 
buprenorphine. 
 
Follow-up study visits, Month 3 and Month 6 (Exit visit) 
All patients will be asked to return to the clinic 3 months and 6 months following enrollment. At 
these follow-up study visits, patients will undergo additional counseling for HIV risk reduction 

 
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and treatment of opioid use disorder, as indicated based on their individual risk and substance 
use behaviors. At both the Month 3 and Month 6 visits, all patients will fill out a brief 
questionnaire self-reporting substance use and sexual behavior in the past three months. 
Participants who were previously prescribed PrEP through the venue-based clinic will fill out 
questions about their adherence to PrEP and barriers/facilitators to taking PrEP. Participants 
who were previously prescribed buprenorphine will similarly fill out questions about their 
adherence to buprenorphine and barriers/facilitators to taking buprenorphine. All participants 
who received a prescription for PrEP or buprenorphine will be asked to provide a 150-strand 
hair sample and a DBS sample for tenofovir and/or buprenorphine drug level checking.  Any 
participant not previously initiated on PrEP or buprenorphine will be offered PrEP and/or 
buprenorphine at the follow-up study visits, as indicated per practice guidelines. Participants will 
be tested for STIs using POC testing, and any participant diagnosed with an STI will received 
prompt treatment prior to leaving clinic, as outlined in the “Study Design: General Overview” 
section of this protocol. Additionally, participant will be offered laboratory-based STI testing of 
the oral and rectal sites. Participants who initiated PrEP will have phlebotomy performed for a 
4th generation HIV antigen/antibody assay. Participants who did not initiate PrEP at baseline 
but initiate PrEP at month 3 or 6 will also have phlebotomy for serum creatinine and hepatitis B 
virus (HBV) serologies. Clinic staff will similarly address any immediate medical concerns of the 
participant, as per standard of care. At the end of each follow-up study visit, participants will be 
given a $25 Visa gift card for their participation. 
 
In addition to reimbursement for each study visit, participants will receive a financial incentive of 
$15 for returning to receive any test results that required off-site lab testing, as is standard of 
practice at our community partner, Aurora Commons/SHE Clinic. Financial incentives will be 
paired with low-barrier, walk-in care and adherence counseling at each visit. 
 
Hair samples and DBS samples will be placed in individual, labeled small plastic bags and 
returned to study facilities at Harborview Medical Center for safe, secure storage following each 
clinic session.  
 
Follow-up study visit data collection 
An electronic follow-up health questionnaire will be filled out by participants in REDCap using a 
clinic tablet. This will occur at both the 3 and the 6-month follow-up visits. Research staff will be 
allowed to assist the participant in filling out the electronic health questionnaire, if the participant 
chooses. The questionnaire will assess sexual practices and substance use behaviors in the 
prior 3 months, as well as self-reported adherence to PrEP (if prescribed), barriers and 
facilitators to taking PrEP (if prescribed), self-reported adherence to buprenorphine (if 
prescribed), and barriers and facilitators to taking buprenorphine (if prescribed). At the end of 
the study visit, a short survey will be complete to assess the patient’s overall experience 
receiving care at the venue-based clinic and assess acceptability and the level of perceived 
stigma associated with venue-based care.  
 
During or immediately following the visit, the clinic staff will fill out a visit summary report in 
REDCap, indicating the results of POC STI / HIV testing, if the participant was prescribed PrEP, 
reason they were not prescribed PrEP (if applicable), if the participant was prescribed 
buprenorphine, and reason the participant was not prescribed buprenorphine (if applicable). 
 
Refill visits 
Due to prescribing laws, participants who initiate buprenorphine-naloxone or buprenorphine will 
be given a maximum of one month of therapy at a time. As such, they will be asked to come 

 
12 
back for brief refill visits every month. No additional research data collection will occur during 
these refill visits. Participants will receive a $15 incentive for returning for buprenorphine refills.  
 
Standard of Care  
All female identifying persons who present to the venue-based clinic will be eligible for receipt of 
HIV and STI testing, as well as oral PrEP and MOUD, regardless of participation in the research 
study. Similarly, study participants will be eligible for care if they visit the venue-based clinic for 
interim visits outside of their designated study visits (e.g., baseline, 3-months, 6-months, montly 
refills for buprenorphine). Standard of care will include checking vital signs, addressing any 
immediate health concerns as able/feasible within the van clinic, laboratory-based HIV 
screening, laboratory-based STI testing, and prescription of oral PrEP and/or MOUD, though 
many services will require billing and insurance claims through the healthcare system and 
women will be made aware of these prior to initiating these services (e.g., laboratory-based 
testing, prescription drugs) (Table 1). 
 
Table 1. Study Procedures 
Study Visit Month 
0 
3 
6 
Refill 
visits 
and 
Interim 
non-
study 
visits 
General Research Activities 
 
Obtain informed consent 
X 
 
 
 
Screen for inclusion/exclusion 
X 
 
 
 
Collect updated contact information 
X 
X 
X 
X 
Reimbursement 
X 
X 
X 
 
Research Questionnaires 
 
Demographic information 
X 
 
 
 
Behavior (sexual and drug use and risk perception) 
X 
X 
X 
 
Adherence to PrEP and/or MOUD 
 
Xb 
Xb 
 
Acceptability of venue-based care 
X 
X 
X 
 
Health and acute healthcare need 
X 
X 
X 
X 
Provider clinical summary report 
X 
X 
X 
X 
Standard of care 
 
Medication review 
X 
X 
X 
X 
General symptom assessment 
X 
X 
X 
X 
Blood pressure checks 
X 
X 
X 
X 
Supply condoms 
X 
X 
X 
X 
Contraception counseling and provision/referral 
Xab 
Xab 
Xab 
 
Laboratory Pregnancy testing 
Xab 
Xab 
Xab 
Xab 
Narcan prescription 
Xa 
Xa 
Xa 
Xab 
Laboratory HIV test 
Xab 
Xab 
Xab 
Xab 
Laboratory STI (CT/GC and TV) genital testing 
Xab 
Xab 
Xab 
Xab 
Laboratory STI (CT/GC) pharyngeal and rectal testing 
Xab 
Xab 
Xab 
Xab 
Laboratory Syphilis testing (IgG and/or RPR) 
Xab 
Xab 
Xab 
Xab 

 
13 
Laboratory Hepatitis B serologies 
Xab 
 
 
 
Laboratory Creatinine check 
Xab 
 
Xab 
 
Laboratory Hepatitis C testing  
Xab 
 
 
Xab 
Suboxone prescription 
Xab 
Xab 
Xab 
Xab 
PrEP prescription 
Xab 
Xab 
Xab 
Xab 
STI treatment 
Xab 
Xab 
Xab 
Xab 
Referral to specialty care 
Xab 
Xab 
Xab 
Xab 
Research Clinical Care 
 
POC HIV/Syphilis testing (rapid test) 
X 
X 
X 
 
POC Trichomonas screening (self-collected vaginal swab) 
X 
X 
X 
 
POC CT/NG testing (self-collected vaginal swab)  
X 
X 
X 
 
Hair sample collection (for TFV and Bupe levels) 
X 
X 
X 
 
Dried Blood Spot (for TFV and Bupe levels) 
X 
X 
X 
 
Financial Incentive for Returning for Results (following study visits) 
Xb 
Xb 
Xb 
Xb 
aonly for those who consent to billing/insurance claim 
bIf clinically indicated 
 
Lab Processing and Results Delivery 
 
Study specific labs will include hair sample and DBS collection for detection of tenofovir and 
buprenorphine levels, as well as self-collected vaginal swabs for POC STI testing and POC 
fingerstick HIV and syphilis testing.  
 
Hair testing: 
Hair samples will be sent to the Hair Analytical Laboratory (HAL) at the University of California 
San Francisco (UCSF-HAL). The HAL uses liquid chromatography-tandem mass spectrometry 
(LC-MS/MS) for testing. The HAL has found high rates of acceptability and feasibility (>95%) of 
collecting hair samples among U.S. adolescents and women. Our group has experience with 
hair collection across studies and has found it acceptable. 
 
HAL will test hair sample for tenofovir and buprenorphine levels, as indicated based on 
medications prescribed to each participant. Results of hair sample testing will be used for 
research purposes only to determine adherence to prescribed medications, and results will not 
be returned to the individual participant. 
 
DBS testing: 
Dried blood spots will be obtained at baseline and at quarterly follow-up visits (Month 3 and 
Month 6) using a lancet finger stick to express drops of blood onto a 5-spot DBS card. This will 
be done following collection of a blood droplets from finger for the HIV/syphilis rapid test. The 
card will be labeled with participant ID and transported to PI's locked office where they will be 
securely stored for possible TFV and buprenorphine testing.  
 
POC STI testing:  
Chlamydia and Gonorrhea testing 
Participants will give their self-collected vaginal swab specimen to clinic staff prior to survey 
completion. Participants will collect a vaginal swab in a private space in the study clinic. POC 
STI tests for C. trachomatis and N. gonorrhoeae will be available within 30 minutes using a 
small, FDA approved, CLIA waived PCR machine supplied by Binx Health. POC STI samples 

 
14 
will be processed in real time, with results delivered to participants during the study visit, and no 
samples stored.  
 
Trichomoniasis testing 
POC STI test for T. vaginalis will be available within 10 minutes using individual FDA approved, 
CLIA waived lateral flow OSOM tests. This trichomonas rapid antigen test does not require 
equipment or a machine to process and is an immunochromatographic capillary-flow enzyme 
immunoassay based on trichomonas membrane proteins. Women will be instructed on self-
collection of vaginal swab specimens. OSOM swabs will be placed into a sterile tube and 
processed on site. Results will be delivered in real-time and no samples will be stored.  
 
Syphilis testing: 
A rapid combination HIV/syphilis test (Chembio Diagnostic Systems) will be used to evaluate for 
Treponema pallidum antibodies. Any positive syphilis antibody test will be followed by 
laboratory-based confirmatory testing. Using shared decision making empiric treatment may be 
given (or initiating depending on stage of syphilis) prior to receiving confirmation of diagnosis.  
 
HIV testing:  
A rapid combination HIV/syphilis test (Chembio Diagnostic Systems) will be used to evaluate for 
incident HIV infections. Samples will be processed using the Chembio microreader kit. Any 
positive HIV test will be considered a possible seroconversion. Participants will be counseled on 
unconfirmed possible HIV diagnosis, the need to stop taking PrEP, and the need for laboratory-
based confirmatory testing, which can be drawn on-site. All questions on HIV and HIV testing 
will be answered. Laboratory-based 4th generation HIV Ab/Ag test and HIV viral load will be 
drawn with samples sent to Harborview Medical Center, and participants will be linked to the 
SHE Clinic for next day follow-up.  
 
Laboratory studies for clinical care: 
Phlebotomy samples for standard of care labs will be centrifuged (as indicated), labeled, and 
transported back to Harborview Medical Center (HMC) on ice, where they will be delivered 
directly to the HMC lab for processing. Results will be reported out in the electronic medical 
record (EMR). The research team medical provider will call patients to deliver critical and urgent 
results. If the patient/participant is not reachable by phone, the research team medical provider 
will enlist the assistance of SHE Clinic staff to help in locating the patient/participant. 
Patients/participants will be asked to return the venue-based clinic the following week, or they 
can present to SHE Clinic during daytime hours, to follow-up on results.  
 
 
Management of new diagnoses 
Participants found to have a diagnosis of chlamydia, gonorrhea, trichomoniasis, or syphilis will be 
offered prompt treatment. Treatment of gonorrhea will consist of intramuscular ceftriaxone 500mg 
x1 provided in clinic. Participants who test positive for chlamydia will be recommended to take 
doxycycline 100mg PO BID for 7 days; however, azithromycin 1g PO x1 will be offered as an 
alternative if participants are unable to complete a 7-day course of antibiotics. Similarly, 
participants who test positive for trichomonas will be recommended to take metronidazole 500mg 
PO BID for 7 days; however, metronidazole 2g PO x1 will be offered as an alternative if 
participants are unable to complete 7 days of antibiotics. Early syphilis will be treated with 2.4 
million units of benzathine penicillin x1 or oral doxycycline 100mg BID for 14 days, pending 
benzathine penicillin availability. Late latent syphilis will be treated with 2.4 million units of 
benzathine penicillin weekly for 3 weeks or oral doxycycline 100mg BID for 28 days, pending 
benzathine penicillin availability. Single dose medications will be available in clinic. Otherwise 

 
15 
prescriptions will be sent to the Harborview Long-term Care Pharmacy for delivery to SHE Clinic 
within 48 hours. Participants with clinical concern for complicated STI (i.e., PID) will be offered 
prolonged treatment (single dose IM ceftriaxone and 2-week course of doxycycline and 
metronidazole) and referred for prompt follow up in SHE Clinic, another primary care clinic, or 
urgent care as indicated. Participants will be encouraged to tell partners to also be treated and 
made aware that these are reported by the lab to public health department. Should patients 
develop signs or symptoms of an STI at any point in the study they may come to the study clinic 
for additional laboratory-based testing (including for BV or candida infections) and treatment if 
needed.  
 
Management of HIV 
Patients who test positive for HIV on rapid or follow-up laboratory-based testing will be counseled 
on strategies to prevent transmission and referred to SHE Clinic for urgent evaluation and 
initiation of antiretroviral therapy, per clinical guidelines.  
 
Management of pregnancy 
Participants found to be pregnant will be counseled on referral options and supported as 
needed with rapid referral for OB care at the UW Northgate Family Medicine Clinic, as well as 
follow up at SHE Clinic. Participants will be counseled on PrEP and MOUD safety and efficacy 
during pregnancy.  
 
Management of viral hepatitis 
Participants diagnosed with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) will be 
counseled on strategies to prevent transmission and referred to SHE Clinic for further evaluation 
and management.   
 
Management of acute opioid overdose or severe intoxication 
In the event that participant presents to the research clinic and is found to be severely 
intoxicated or experiencing an acute opioid overdose, emergency medical personnel will be 
called for transport to a local emergency department. In the case of an opioid overdose, the 
individual will be given intranasal Narcan by research clinic staff. 
 
Research Reimbursement and Incentives 
Participants will receive up to a total of $75 in reimbursement for participating in this study. They 
will be reimbursed $25 for the baseline study visit, $25 for the 3-month study visit, and $25 for 
the 6-month study visit. Reimbursement will be provided in the form of a Visa gift card, that will 
be giving to the participant at each study visit. Participants who return to the venue-based clinic 
between study visits for clinical care will not be reimbursed for interim visits. Participants who 
return to the research clinic to receive results of laboratory tests will receive an additional $15 
incentive for follow-up. Persons who are not participants in this study but access the venue-
based clinic for standard of care will not receive any reimbursement or financial incentive. Study 
team members will retain a log of each reimbursement provided, and participants will be asked 
to sign their initials on the log to confirm receipt of each $15 Visa gift card.   
 
 
Protection of Human Subjects  
Involvement of Human Subjects  
This is a prospective observational cohort study, which aims to enroll 50 women who inject 
drugs in a venue-based clinic. Study participants will be offered HIV PrEP and buprenorphine 
for treatment of opioid use disorder, as indicated by national guidelines. The main objective is to 

 
16 
assess the impact of venue-based care on uptake and sustained use of PrEP and 
buprenorphine for the prevention of HIV and treatment of opioid use disorder, respectively.  
 
Research Material Obtained from Participants  
Individuals who are eligible and enroll in venue-based care will complete a baseline, 3-month 
and 6-month study visit. Data to be collected at those visits include information on 
demographics, risk factors for HIV, PrEP eligibility, prior use of PrEP, history of substance use, 
prior use of medications for opioid use disorder (MOUD), current use of MOUD, and self-
reported adherence to PrEP and/or MOUD, as indicated. Participants will also provide 
information on their experience accessing venue-based care, including acceptability and 
perceived stigma associated with accessing venue-based care. POC HIV testing, POC STI 
testing, and standard of care labs for PrEP will be obtained at baseline, 3-months and 6-months. 
Hair samples and DBS samples to test for tenofovir and buprenorphine will be obtained at 3-
month and 6-month visits. A review of the participants medical and pharmacy records will be 
conducted. 
 
Assessment data will be collected directly onto iPads used by research team members. We will 
utilize the Research Electronic Data Capture (REDCap) system through the University of 
Washington’s Institute of Translational Health Services (ITHS) to log and store data.  
 
Women who are started on buprenorphine therapy will also return for monthly refill visits, during 
which time no additional study data will be collected.  
 
Risks to Human Subjects  
There are limited physical risks to study subjects beyond what is incurred during standard 
primary care. Participants may experience mild bruising or pain at the site of point of care finger 
prick testing (e.g., POC HIV and syphilis testing, DBS sampling), or at the site of phlebotomy 
draws. Participants who choose to initiate on oral PrEP and/or buprenorphine will be at risk of 
experiencing established side effects, as outlined in each drugs’ prescribing materials.  
 
Participants may experience psychological distress associated with discussing confidential 
topics such as sexual and drug use practices. Research medical team staff will be trained in 
trauma-informed care and to address psychological distress with a calm, non-judgmental 
attitude. We will take steps to minimize any psychological discomfort by ensuring confidentiality 
as described below. We will only enroll patients who understand the study procedures and are 
willing to participate.  
 
Participants may also experience loss of confidentiality related to study visits, which is likely the 
most serious risk of the study. We take this risk seriously, and we will take steps to protect 
participants’ confidential data and anonymity. All subjects will be informed of risks and provide 
their consent prior to enrollment.   
 
Adequacy of Protection Against Risks  
Risks of psychological distress from the research assessments will be minimized by using 
research medical staff that are trained in how to provide trauma-informed care. Participants may 
choose to leave the study visit at any time. If consequences arise due to research procedures 
(e.g., distress, anxiety, suicidal thoughts), then the physician investigators will be available to 
assess subjects in real time and make appropriate interventions or referrals based on the 
clinical circumstances.  

 
17 
Loss of confidentiality is very unlikely given the structures that will be put in place to avoid 
inadvertent disclosure. These structures to assure confidentiality include the following: each 
subject will receive a unique identification number, and research data collection and data entry 
forms will be electronic and identified only with this number. Only the master enrollment list and 
electronic informed consent forms will have identifying information on them. These documents 
will be kept on secure University of Washington servers / in REDCap, accessible only to 
principal investigators, the research assistant and research coordinator. Tracking information 
will be kept similarly. Computer data will be password protected and accessible only to research 
staff needing the information for follow-up and monitoring purposes. Files stored on UW servers 
will be protected by electronic firewalls that restrict access to designated users.  
 
Another possible threat to confidentiality could arise if a participant indicates an imminent 
danger to self or others or if a participant discloses abuse of vulnerable persons such as 
children, the elderly, or the disabled. Ethical and legal requirements may force us to disclose 
this type of information to relevant authorities. We will attempt to minimize this threat to 
confidentiality by clearly informing participants of the risks involved during the informed consent 
process.  
 
Potential Benefits  
Participants may benefit from access to research POC STI testing, which is not generally 
commercially available. Participants may similarly benefit from the reimbursement provided for 
attending study visits and returning for lab results.  
 
Importance of Knowledge to be Gained  
The study will inform us about the ability of venue-based care to improve and support uptake 
and sustained use of critical HIV prevention interventions, including PrEP and buprenorphine, 
for women who inject drugs, many of whom also engage in exchange sex. It will also inform us 
about the acceptability and feasibility of providing venue-based care for women who inject 
drugs. If the study demonstrates benefit of venue-based care, this would provide evidence that 
this type of intervention should be studied at scale.  
 
Electronic Health information  
This novel venue-based clinic will be integrated within the larger University of Washington (UW) 
healthcare system, and necessary referrals will be made to UW facilities, including a large UW 
medical campus located two miles north of Aurora Commons. Participants not already 
registered in UW system will receive a medical record number and clinical portion of study visits 
will be included in electronic medical records to improve overall continuity of care. Participants 
will consent to a review of their health information in the UW Epic EHR system and review of 
local pharmacy records.   
 
Incarcerated Participants  
As per NIH guidance, research participants who become incarcerated during the study will be 
temporarily withdrawn from the study until OHRP guidelines are met. When subjects are 
incarcerated their buprenorphine and PrEP treatment may not be continued, and they do not 
have access to cell phones, so they cannot continue participation for these reasons. When 
subjects become released from incarceration, we will resume study procedures. If research staff 
members are unable to contact a participant who has missed an appointment or cannot be 
reached to remind them of an upcoming research visit, research staff should check the local law 
enforcement databases to determine if the study participant is incarcerated. 
 
 

 
18 
Important Definitions  
Adverse Event (AE)  
Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or 
disease temporally associated with the use of a medical treatment or procedure, regardless of 
whether it is considered related to the medical treatment or procedure.  
 
Serious Adverse Event (SAE)  
Any adverse event that results in any of the following outcomes:  
• Death  
• Life-threatening  
• Event requiring inpatient hospitalization or prolongation of existing hospitalization  
• Persistent or significant disability/incapacity  
• Results in birth defect  
 
Unanticipated problems/events  
They must meet all of the following criteria (per UW definition):  
1) Unexpected-- The harm (or potential harm) is inconsistent with risk information previously 
reviewed and approved by the Institutional Review Board (IRB) in terms of nature, severity, or 
frequency as well as the characteristics of the study population  
2) Related or probably related to participation in the research. Probably related: there is 
reasonable (more likely than not) that the incident, experience or outcome may have been 
caused by the procedures involved in the research, or that it is associated with the use of any 
drug, biologic, or medical device that is part of the research.  
3) Suggests that the research placed (or did place) one or more subjects or other a greater risk 
of harm than was previously know or recognized. This includes physical, psychological, 
economic, educational advancement, or social harm.  
 
Classifying adverse events  
Adequate review, assessment, and monitoring of adverse events require that they be classified 
as to severity, expectedness, and potential relatedness to the study intervention. Study 
protocols will include a description of how adverse events will be classified in these terms and 
the appropriate course of action. 
 
Severity 
Classifications often include the following:  
• Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type 
causing no loss of time from normal activities. Symptoms do not require therapy or a medical 
evaluation; signs and symptoms are transient.  
• Moderate: Events introduce a low level of inconvenience or concern to the participant and 
may interfere with daily activities, but are usually improved by simple therapeutic measures; 
moderate experiences may cause some interference with functioning  
• Severe: Events interrupt the participant’s normal daily activities and generally require systemic 
drug therapy or other treatment; they are usually incapacitating  
 
Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE.  
Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result 
in a day’s hospitalization and thus is an SAE.  
 
Expectedness  

 
19 
AEs must be assessed as to whether they were expected to occur or unexpected, meaning not 
anticipated based on current knowledge found in the protocol, investigator brochure, product 
insert, or label. Categories are:  
 
• Unexpected - nature or severity of the event is not consistent with information about the 
condition under study or intervention in the protocol, consent form, product brochure, or 
investigator brochure.  
 
• Expected - event is known to be associated with the intervention or condition under study.  
 
Relatedness  
The site investigator assesses the potential event relationship to the study intervention and/or 
participation. A comprehensive scale in common use to categorize an event is:  
• Definitely Related: The adverse event is clearly related to the investigational agent/procedure 
– i.e. an event that follows a reasonable temporal sequence from administration of the study 
intervention, follows a known or expected response pattern to the suspected intervention, that is 
confirmed by improvement on stopping and reappearance of the event on repeated exposure 
and that could not be reasonably explained by the known characteristics of the subject’s clinical 
state.  
• Possibly Related: An adverse event that follows a reasonable temporal sequence from 
administration of the study intervention follows a known or expected response pattern to the 
suspected intervention, but that could readily have been produced by a number of other factors.  
• Not Related: The adverse event is clearly not related to the investigational agent/procedure. - 
i.e. another cause of the event is most plausible; and/or a clinically plausible temporal sequence 
is inconsistent with the onset of the event and the study intervention and/or a causal relationship 
is considered biologically implausible.  
 
 
Data Safety Monitoring Plan 
The principal investigators (MPIs) will be responsible for ensuring participant safety on a day-to-
day basis. The MPIs (Dr. Maria Corcorran and Dr. Jenell Stewart) along with the Data Safety 
Monitoring Board (DSMB) will oversee the safety of participants and the validity and integrity of 
the data. Drs. Corcorran and Stewart will be responsible for selecting the DSMB members and 
ensuring they have no conflicts of interest with the current study or principal investigators.  
 
DSMB Responsibilities 
The DSMB will be responsible for reviewing and evaluating the study protocols, plans for 
participant safety, and data monitoring plan prior to study enrollment. The DSMB will also 
evaluate the study progress, including participant recruitment, enrollment, and retention, data 
collection, and general operations of the venue-based clinic. The DSMB will evaluate for 
treatment harm or benefit, including individual AEs and SAEs, and make decisions regarding 
the continuation, modification or termination of the study based on these data. The DSMB will 
also review external information, if relevant to the study, that might affect the ethics of study 
continuation (e.g., new therapeutic advances that impact standard of care).  
 
Cadence of DSMB meetings 
The DSMB will meet remotely with study MPIs: 
1. Prior to enrollment 
2. Once the study has reached 50% enrollment (n=25) 
3. At least every 6 months thereafter while the study is active. 

 
20 
Following each meeting, the DSMB will make recommendations on continuation, modification, 
or termination of the study. Aside from these regular meetings, an unanticipated AE may prompt 
an ad hoc report to be distributed and may result in an ad hoc teleconference for the entire 
DSMB. Upon study completion no additional meetings will be required of the DSMB. 
 
DSM Reporting 
Following each meeting the DSMB will produce a report that will be sent to the UW IRB within 
10 days and to NIDA within 30 days of the DSMB meeting. The report will include a meeting 
summary, DSMB recommendations regarding the continuation, modification, or termination of 
the research project, and any other specific recommendations put forth by the DSMB.  
 
 
Analysis Plan 
1. Evaluate uptake of PrEP:  
a. Defined as the proportion of participants who accept a prescription for PrEP from 
the study team at any point (i.e., baseline, Month 3, and/or Month 6 visit) during 
study participation. The denominator will be all participants (N=50) enrolled in the 
study. 
b. Participants who accept prescriptions for PrEP at multiple points throughout the 
study will only be counted once when calculating uptake. 
c. Final analysis will present uptake as a percentage (proportion). 
2. Evaluate uptake of MOUD 
a. Defined as the proportion of participants who accept a prescription for MOUD 
from the study team at any point (i.e., baseline, Month 3, and/or Month 6 visit) 
during study participation. The denominator will be all participants (N=50) 
enrolled in the study. 
b. Participants who accept prescriptions for MOUD at multiple points throughout the 
study will only be counted once when calculating uptake. 
c. Final analysis will present uptake as a percentage (proportion). 
3. Evaluate sustained use of PrEP  
a. PrEP: Dried blood spot (DBS) samples were obtained at each visit to assess 
PrEP adherence via tenofovir-diphosphate (TFV-DP) concentrations. Sustained 
use was defined as >4 doses/week, resulting in a DBS TFV-DP concentration of 
>700 fmol/sample at 3 and/or 6 months post-enrollment among those prescribed 
PrEP at a preceding study visit. 
b. Final analysis will present sustained use for both PrEP as a percentage 
(proportion). 
4. Evaluate sustained use of MOUD 
a. MOUD: DBS samples were obtained at each visit to assess MOUD adherence 
via buprenorphine and norbuprenophrine concentrations, both measured in 
ng/mL. Sustained use was defined as any buprenorphine and/or 
norbuprenophrine detected, resulting in a DBS >0 ng/mL concentration of 
buprenorphine and/or norbuprenophrine at 3 and/or 6 months post-enrollment 
among those prescribed MOUD at a preceding study visit. 
b. Final analysis will present sustained use for MOUD as a percentage (proportion). 
5. Evaluate STI treatment completion rate and time to completion after POC STI testing 
a. Treatment completion will be defined as documented treatment following a 
reactive POC STI test (chlamydia, gonorrhea, syphilis, and/or trichomonas). 
Treatment will either be indicated in the Visit Clinical Summary from the study 
visit or noted during medical record chart review by a study provider. If treatment 

 
21 
was not provided on the same day as the visit, the date of treatment will be 
documented in the study database. 
b. Final analysis will present the treatment completion rate as the proportion of STIs 
where treatment was documented, by all STIs and by type. 
c. Final analysis will present the time to treatment completion as the proportion of 
STIs treated same-day. Of the STIs not treated same-day, time to treatment will 
be presented as median number of days with an interquartile range. 
6. Assess acceptability of pilot community-based care model 
a. Participants completed an acceptability survey following each study visit. 
Acceptability will be presented by study visit (i.e., enrollment, Month 3, and 
Month 6) as a proportion of all enrolled participants (N=50) who responded to the 
following questions: 
i. “I feel confident that my health is improved by getting care in a mobile 
clinic.” (Agree, Somewhat agree) 
ii. “I feel safe getting care in a mobile clinic.” (Agree, Somewhat agree) 
iii. “I am worried about how people will react if they see me getting care at a 
mobile clinic.” (Disagree, Somewhat disagree) 
7. Assess acceptability of POC STI testing at community-based site. 
a. Participants completed an acceptability survey following each study visit. 
Acceptability will be presented by study visit (i.e., enrollment, Month 3, and 
Month 6) as a proportion of all enrolled participants (N=50) who responded to the 
following questions: 
i. “I felt comfortable getting rapid STI testing in the mobile clinic.” (Agree, 
Somewhat agree) 
ii. “I prefer getting rapid tests for sexually transmitted infections (STI) more 
than getting traditional STI tests.” (Agree, Somewhat agree)