Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study
Phase: PHASE4
Conditions: Hiv, Substance Use Disorders
Sponsor: University of Miami

IRB Study Number: 20210017
Page 1 of 8
Revised: 4/24/22
Mobile delivery of PrEP at a Syringe Services Program—A
Pilot Study
Protocol Version 1.1
Protocol Version Date 04/25/22
eProst ID Number 20210017
PI Hansel Tookes
NCT Number 04782180
-       Study #: 20210017        Effective Date: 5/5/2022

IRB Study Number: 20210017
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Revised: 4/24/22
1)
Protocol Title: Mobile delivery of PrEP at a Syringe Services Program—A
Pilot Study
2)
Objectives*
Aim 1: To develop a sustainable protocol for Rapid Mobile PrEP initiation at the IDEA 
Syringe Services Program (SSP). 
Aim 2: To assess the acceptability and feasibility of Rapid Mobile PrEP for People Who 
Inject Drugs (PWID) who utilize the Miami IDEA SSP.  
3)
Background*
PrEP is an understudied and underutilized HIV prevention strategy for PWID. PrEP has 
been widely studied in MSM. The evidence for daily oral PrEP is compelling; clinical trials have 
demonstrated risk reduction of 44-86% in HIV infections for those receiving PrEP with efficacy 
>90% for those taking the medication more than 4x/week (6-11). The Bangkok Tenofovir Study 
showed a 48.9% decrease in HIV incidence in PWID who took daily tenofovir compared to those 
who took placebo, as well as significant interest among PWID in continuing PrEP after the trial. 
However, there has been a large gap in the literature about PrEP in PWID since that trial. In 
Miami, our preliminary data from the National HIV Behavioral Surveillance (NHBS) IDU4 cycle 
showed that of 434 participants, 88.5% would take an HIV prevention pill if it were available to 
them at no cost.  Through our recent CFAR pilot award, we assessed knowledge and interest in 
PrEP at the IDEA SSP among HIV negative clients (n=159). Of PWID surveyed, 70% were not 
aware of PrEP. Of those with 
knowledge about PrEP, 75% were 
interested in linkage to PrEP and 
received a referral for PrEP services. 
However, only 6% made an 
appointment with a provider to be 
evaluated for PrEP, and ultimately no 
one surveyed received a prescription 
for PrEP.  These findings suggest 
willingness to use PrEP among PWID 
at the IDEA SSP, yet overwhelming 
barriers to PrEP use including low 
PrEP awareness and the same 
structural and economic barriers that 
we have documented in MSM 
populations (cost, transportation, language issues, stigma, and immigration status).  
4)
Inclusion and Exclusion Criteria*
Inclusion criteria for this study are: 1) over the age of 18, 2) speak either English or Spanish, 3) 
ability to provide informed consent, 4) currently enrolled in the SSP and have exchanged at least 
two times in the past three months, 5) have a negative HIV rapid test result, 6) estimated 
creatinine clearance > 30 ml/minute for Descovy and >60 for Truvada. Individuals will be 
excluded from this study if they 1) do not meet the above criteria of inclusion, 2) decline to 
participate, 3) test positive for HIV via rapid test, 4) are pregnant or plan on becoming pregnant 
5) have symptoms acute HIV. Any other comorbidities that at the discretion of the investigator 
would prevent the participant from participating in the study.
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5)
Study Design
To create a sustainable protocol for dissemination of our Rapid Mobile PrEP initiation at future 
Florida SSP expansion sites (Aim 1):
Firstly, we will develop a protocol for initiation of Rapid Mobile PrEP at the Miami IDEA SSP 
site. Throughout the grant period, we will continuously update our protocol through rapid 
feedback and implementation of new approaches to overcome encountered problems as they 
arise. In addition to academic dissemination of our work, we will produce an adaptable protocol 
for new SSPs as they expand throughout the state. We will enroll a prospective, open-label 
cohort, similar to the PrEP Demonstration Project at the Miami-Dade County Health Department, 
assessing uptake, adherence, and retention. 
Acceptability and feasibility of Rapid Mobile PrEP among SSP clients (Aim 2):
We will pilot test mobile PrEP at the IDEA SSP (N=100), conducting ongoing brief qualitative 
assessments and process improvement and developing sustainable protocol for adaptation at 
Florida’s SSP expansion sites in geographic hotspots. We will report the proportion of eligible 
PWID who elect to initiate Rapid Mobile PrEP to understand acceptability among at-risk PWID. 
Likewise, we will report correlates of initiation and retention. We hypothesize that coupling PrEP 
services with the provision of syringes and harm reduction equipment will increase retention in 
this Rapid Mobile PrEP initiation study. 
We will conduct detailed interviews including demographics, drug and sexual risk behaviors, and 
medical history. Labs will include: HIV via 4th generation test, HBsAg, gonorrhea/chlamydia 
(urine, rectal, pharyngeal), syphilis, creatinine, and HCV RNA. Participants will be offered 
immediate FTAF at the IDEA SSP on the first encounter and will meet with the peer navigator 
for a medication management and adherence plan that may include on-site storage of medications 
and deliveries of PrEP coupled with provision of injection supplies. 
If a participant becomes ineligible for PrEP during follow up based on renal function, other 
adverse events, or HIV infection, they will be contacted and discontinued from the study.  
Participants who test positive for HIV during study follow up will be linked to HIV care. 
Participants with chronic hepatitis B virus infection will be contacted immediately by the 
clinician for a discussion of the risks and benefits of FTAF in the context of chronic hepatitis B. 
Finally, PWID who decline study enrollment will be asked to participate in a brief survey that 
will include demographics, reason for declining, PrEP awareness and knowledge, and perceived 
HIV risk. Those who decline the study will receive $25 cash payment for this brief, 30 minute 
interview. 
The effectiveness of PrEP requires that it be taken every day minimizing missed doses as well as 
continuing PrEP over time during periods of potential HIV exposure. Follow up visits will occur 
at 1, 3, 6, 9 and 12 months. At each study visit participants will complete surveys about PrEP use 
since their last visit including semiqualitative/open-ended questions about reasons for use or non-
use. We will use this combination of quantitative and qualitative data to determine individual and 
structural contributors to non-adherence and discontinuation of PrEP among PWID.  For each 
study visit including baseline, participants will receive $50 cash payment. 
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6)
Arms and Interventions
This single arm pilot study will assess the effectiveness of on site initiation of PrEP and followup 
at an SSP (fixed site or mobile exchange on outreach). The study is 1 year duration, and study 
visits are conducted at at 0, 1, 3, 6, 9 and 12 months as outlined above. The intervention is 
delivery of PrEP outside of a traditional healthcare clinic. The principal medication offered will 
be FTAF 200/25mg tablet to be administered orally. In this study, we will offer Descovy to men 
and trans women due to decreased risk of side effects. If the participant is a assigned female at 
birth, Truvada will be prescribed instead of study drug per FDA approval. It is noted that 
signigicant risk for HIV among PWID is sexual. The intervention will include wraparound 
support by the peer navigator. Study visits will be conducted either at the IDEA Exchange fixed 
location, or on the mobile unit in the community (e.g. homeless encampments). The fixed site and 
mobile unit are equipped with private rooms for medical encounters. Medical visit with a 
provider and phlebotomy will be provided on site.
7)
Procedures Involved*
8)
Primary Endpoints
Patient-Level 
Outcomes
Definition
Implementation 
Construct 
Domain
Definition
PrEP levels at 6 
month follow 
up (primary)
Intracellular 
levels of tenofovir 
diphosphate 
(TFV-DP) by 
dried blood spot 
(DBS). 
Acceptability/feasi
bility of Rapid 
Initiation of PrEP
Number of PWID at risk for HIV that enter Rapid Mobile 
PrEP
Time to PrEP 
initiation post 
negative HIV 
Number of days 
between receiving 
negative HIV test 
Acceptability/feasi
bility of Rapid 
Initiation of PrEP
Mean time to PrEP initiation among PWID.
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9)
Data and Specimen Banking*
For clinical data, we will use the UHealth’s electronic health record, UChart, which is locked 
under dual authentication. 
All data collected will be housed in the REDCap database system, which is locked under dual 
authentication by University of Miami Information Technology and then extracted for 
analysis by the principal investigator. Only study staff will have access to survey results.
As for the in-depth interviews, sessions will be audio-recorded, transcribed by an external 
company, de-identified for analysis and stored on a password-protected computer in a secured 
office in the Don Soffer Clinical Research Center. Only study staff will have access to results.
10) Data Management*
Quantitative Data Analysis: Quantitative data will be analyzed using descriptive statistics and 
frequencies to examine the acceptability and feasibility characteristics of the PWID participants. 
Categorical data will be analyzed using frequency of responses and continuous variables will be 
analyzed using means and standard deviations. To assess barriers and facilitators to PrEP 
initiation (uptake), adherence, and retention, we will use Cox proportional hazard models to 
identify significant predictors for uptake, adherence, and retention on PrEP, and retention data 
will be presented as Kaplan-Meier survival plots. Multivariable models will be built to control for 
age, gender, race/ethnicity, insurance status, and income. Variables of association interest 
include: self-reported barriers to PrEP, sexual and injection risk behaviors, substance use, and 
social determinants of health (e.g., homelessness). 
All quantitative data will be stored and managed in REDCap and all analyses will be performed 
using SAS statistical software (Version 9.4; SAS Institute, Cary, NC). 
Qualitative Data Analysis: Qualitative data collected from the in-depth interviews will be 
analyzed using general inductive methodology, which allows for themes to be developed from the 
raw data based on a study objective/research question. A data codebook will be generated in an 
iterative process during transcript reading by the study team. All qualitative data analysis will be 
conducted using Dedoose (version 8.2.14, Sociocultural Research Consultants, Los Angeles, CA), 
a cross-platform software used for analyzing qualitative and mixed methods research.  
rapid test 
(secondary)
result and 
initiating PrEP, by 
self-report
PrEP 
Persistence
TFV-DP levels on 
DBS, pill counts, 
medication log, 
appointment 
attendance
 
Barriers to 
persistence
Exploration of challenges to PrEP persistence
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11) Risks to Subjects*
Study procedures: there is risk of discomfort to phlebotomy, but no risk above a routine sexual 
health visit
Study Drug: Serious risks of taking Truvada and Descovy includes serious drug reactions such as 
lactic acidosis, hepatomegaly with steatosis, hepatotoxicity, hepatitis B virus exacerbation, 
pancreatitis, nephrotoxicity, bone density loss, neutropenia, immune reconstitution syndrome, 
autoimmune disordersand angioedema. Common adverse reactions include diarrhea, headache, 
fatigue, elevated CK, abnormal dreams, dizziness, insomnia, hypercholesterolemia, 
hyperamylasemia, neutropenia, LFTs elevated, nausea/vomiting, depression, rash, dyspepsia, 
abdominal pain, asthenia, increased creatinine,  arthralgia/myalgia, cough, paresthesia, peripheral 
neuropathy, palmar-plantar hyperpigmentation, hypertriglyceridemia, hematuria, hyperglycemia, 
glycosuria, rhinitis and flatulence. 
Risk of HIV acquisition in PWID is extremely complex. This study is to assess the acceptability 
on on-site iniation of PrEP and persistence over 1 year. Importantly, Descovy is preferred for 
PrEP due to decreased nephrotoxicity and bone toxicity. However, the initial studies were only in 
men who have sex with men and transwomen. Therefore, we will prescribe Descovy, the 
preferred medication to those who meet eligibility i.e. MSM or transwomen. We will prescribe 
Truvada to cis women while explaining the increased risk of loss of bone mineral density and 
renal function. Importantly, HIV outbreaks in this country among PWID, including in Miami, and 
their resultant investigations have all indicated that sexual risk, especially from sex work, plays a 
major role in HIV acquisition. Therefore we will offer different PrEP medications only because 
the studies for Descovy have not yet been conducted in women. 
12) Adverse Events and Serious Adverse Events
AEs will be any of the common adverse reactions defined above. SAEs will include any 
hospitalization or death or disability that occurs with participants in the trial.  AEs will be 
reported to the IRB in continuing reviews. SAEs will be reported to the IRB within 24 hours. 
The following AEs of interest will be collected and reported: lactic acidosis, hepatomegaly with 
steatosis, hepatotoxicity, hepatitis B virus exacerbation, pancreatitis, nephrotoxicity, neutropenia, 
immune reconstitution syndrome, autoimmune disordersand angioedema.
13) Potential Benefits to Subjects*
The potential benefit to the PWID is that they will be able to access rapid on-site PrEP 
initiation with few barriers, improving their overall health in the short and long term. 
14) Vulnerable Populations*
This study will exclude children because the providers are board certified in Internal 
Medicine and only see adult patients. Children will be rapidly referred to University of Miami 
Department of Pediatrics.
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15) Setting
The IDEA Syringe Services Program of the University of Miami Miller School of Medicine 
is the study site. 
16) Resources Available
Dr. Hansel Tookes (Contact PI) is a board-certified internist. Dr. Tookes was the driving 
force behind the establishment of the IDEA SSP and serves as the PI of the UM Harm 
Reduction Research Group. Dr. Tookes has extensive knowledge regarding HIV prevention 
among PWID and has utilized community-based research approaches to improve health 
outcomes among this vulnerable population. 
Dr. David Serota (co-I) is a board-certified infectious disease specialist and internist. He 
specializes in the treatment of severe infections in PWID. He has extensive knowledge 
regarding HIV prevention in this high priority community, and a leader in harm reduction in 
our community.
Dr. David Forrest (co-I) is a medical anthropologist who brings expertise in advanced 
qualitative methods and research to inform HIV prevention among at-risk populations. Dr. 
Forrest is co-PI for the Miami-Dade site of the National HIV Behavioral Surveillance and has 
over 25 years of expertise conducting research among PWID. 
Dr. Tyler Bartholomew (co-I) has expertise conducting HIV and HCV implementation 
research among PWID, including the implementation and evaluation of HIV/HCV testing and 
linkage to care at the IDEA SSP. 
Dr. Katrina Ciraldo (co-I) is a board certified Family Medicine and Addiction Medicine 
specialist. She specializes in womens health with a focus on pregnant women with substance 
use disorders who are experiencing homelessness. Dr. Ciraldo has extensive knowledge in 
addiction medicine and innovator in the harm reduction community. 
Dr. Teresa Chueng (co-I) is finishing her Infections Disease clinical fellowship at Jackson 
Memorial Hosptial and will start her appointment as Assistant Professor of Clinical Medicine 
in the Division of Infectious Diseases at the University of Miami Miller School of Medicine 
in July 2022. Dr. Chueng provides expertise in clinicial infectious disease, including HIV, 
hepatitis C, and infections related to injection drug use. 
17) Prior Approvals
Funding agency approval: none
18) Recruitment Methods
Recruitment will be through the IDEA SSP participants with regular usage of SSP services 
(at least 1 visit per month). All PWID with a negative rapid HIV screen will be offered 
participation in this study. If they accept, SSP staff will refer to study research assistant for 
more information regarding this clinical trial. Study staff will be discrete from SSP staff to 
prevent possible undue influence. 
Local Number of Subjects
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The proposed study aims to pilot the Rapid Mobile PrEP protocol for 100 PWID at risk for HIV. 
We will ask 50 PWID who decline to participate in a brief qualitative assessment to explore 
reasons for declining treatment.  
19) Confidentiality
The REDCap surveys will be anonymous and do not solicit protected health information or 
any identifying information. If results of this survey are reported to any agency, or in journals 
or at scientific meetings, data will be de-identified and presented in aggregate. In addition to 
the research staff, the following entities may review information collected as part of this 
survey activity:  1) Office of Human Research Protections (OHRP), 2) University of Miami 
Human Subjects Research Office, and 3) professionals who may be evaluating this survey 
activity
The in-depth interviews audios and transcripts will be stored in a password-protected file that 
will be stored on University of Miami secure network.  Audio will be deleted immediately 
after transcription. 
In order to secure the data, all staff will be trained on confidentiality via the CITI program 
including Human Subjects Research and Good Clinical Practice
20) Provisions to Protect the Privacy Interests of Subjects 
All data will be stored on the PI’s password protected computer and data will only be shared 
via secured access Sharepoint with other members of the research team. The computer is 
secured by UM IT, kept in a locked office in the Soffer Clinical Research Center. Qualitative 
data will be transcribed and stored on the PI’s computer and shared only with the research 
team. Audio will be deleted immediately following transcription. Copies of the informed 
consent with patient signature will be stored in a locked filing cabinet within the PI’s keycard 
secured office. 
21) Consent Process
Written consent will be obtained at the IDEA SSP by study staff. 
(See attached consent documents for reference)
22) Process to Document Consent in Writing
Writtten consent (provided both in English and in Spanish) will be obtained using e-consent 
in REDCap. REDCap e-Consent Framework provides standardized tools to obtain consent 
and store consent documentation with a certification screen and a storage function which 
automatically generates a “hard-copy” PDF of the signed form. 
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