Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study
Phase: NA
Conditions: HIV/AIDS, PrEP
Sponsor: Icahn School of Medicine at Mount Sinai

Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): 
A Pilot Feasibility Study
PI: Ethan Cowan, MD
NCT04429971
Document Date: 4-20-2021

Pre-Exposure Prophylaxis Provision in the Emergency 
Department (PrEPPED): A Pilot Feasibility Study
Principal Investigator: Ethan Cowan, MD, MS
Effective Date: 4/20/2021
End Date: 3/18/2022

Study Staff
PRINCIPAL INVESTIGATOR
Ethan Cowan, MD, MS
CO-INVESTIGATOR
Yvette Calderon, MD, MS
Lauren Gordon, Project Manager
Clare O’Brien-Lambert, Research Assistant 
Lisa Casprowitz, Research Assistant
STUDY STAFF
Luisa Espinales, Research Assistant
Effective Date: 4/20/2021
End Date: 3/18/2022

Table of Contents
1.0 LIST OF ABBREVIATIONS.........................................................................................................................6
2.0 STUDY SYNOPSIS .........................................................................................................................................7
2.1 Study Design............................................................................................................................................7
3.0 INTRODUCTION ...........................................................................................................................................7
3.1 Background and Rationale.......................................................................................................................7
3.2 Innovation................................................................................................................................................7
3.3 Public Health Impact ...............................................................................................................................8
4.0 SPECIFIC AIMS AND HYPOTHESIS: .......................................................................................................8
5.0 STUDY DESIGN .............................................................................................................................................8
5.1 Study Timeline.........................................................................................................................................8
6.0 STUDY SETTING...........................................................................................................................................9
6.1 ED Characteristics ...................................................................................................................................9
6.2 Physical Space .........................................................................................................................................9
6.3 Clinical Services – Mount Sinai Beth Israel............................................................................................9
7.0 Randomized Controlled Trial.......................................................................................................................10
7.1 Primary Aim: .........................................................................................................................................10
7.2 Secondary/Exploratory Aims: ...............................................................................................................10
8.0 PATIENTS AND METHODS ......................................................................................................................10
8.1 Patient Population..................................................................................................................................10
8.2 Inclusion / Exclusion Criteria ................................................................................................................10
8.3 Number of Study Subjects.....................................................................................................................11
9.0 STUDY DESIGN AND PROCEDURES .....................................................................................................11
9.1 Screening and Recruitment....................................................................................................................11
9.2 Informed Consent Procedures................................................................................................................11
9.3 Study Procedures ...................................................................................................................................11
9. 4 Randomization......................................................................................................................................12
9.5 Follow-up...............................................................................................................................................12
9.6 Compensation ........................................................................................................................................13
9.7 Standard Intervention for all Participants: PrEP Counseling ................................................................13
9.8 PrEP starter packs..................................................................................................................................13
10. STUDY ASSESSMENTS..............................................................................................................................13
10.1 Overview: ............................................................................................................................................13
10.3 Pre-Enrollment (Screening) Assessment Phase...................................................................................13
10.3.1 ICAP PrEP Screening Questionnaire............................................................................................13
10.3.4 Patient Eligibility and Inclusion/Exclusion ..................................................................................14
10.3.5 Informed Consent and Research Authorization (HIPAA) Forms.................................................14
10.4 Enrollment Assessments......................................................................................................................14
10.4.1 Demographics...............................................................................................................................14
10.4.2 Locator Information Form ............................................................................................................14
10.4.13 Satisfaction Scale........................................................................................................................14
10.4.14 CDC Sexual Behavior Questions................................................................................................14
10.4.16 Attitudes toward Pre-Exposure Prophylaxis Scale (APS)..........................................................14
10.5 Follow-Up Assessments ......................................................................................................................14
10.5.1 Attitudes toward Pre-Exposure Prophylaxis Scale (APS)............................................................14
10.5.2 Section 4 of ICAP “Screening for Substantial Risk of HIV” .......................................................14
10.5.3 Satisfaction Scale..........................................................................................................................15
10.5.4 Visit specific satisfaction questionnaire (VSQ-9) ........................................................................15
10.5.6 Guidelines Regimen Information Program (GRIP) guide............................................................15
10.5 Outcome Data ......................................................................................................................................15
10.5.1 Engagement in Treatment Survey (Primary Outcome) ................................................................15
10.5.2 Treatment Facility Survey (Appendix 8)......................................................................................15
Effective Date: 4/20/2021
End Date: 3/18/2022

11.0 DATA MANAGEMENT AND STATISTICAL ANALYSES.................................................................15
11.1 Statistical Analysis...............................................................................................................................15
11.1.1 General approach..........................................................................................................................15
11.1.2 Analysis of Primary and Secondary Outcomes ............................................................................15
11.1.3 Sample Size ..................................................................................................................................16
12.0 REGULATORY COMPLIANCE, ETHICS, AND REPORTING.........................................................16
12.1 Protection of Human Subjects .............................................................................................................16
12.1.1 Risks to Human Subjects..............................................................................................................17
12.1.2Human Subjects Involvement, Characteristics, and Design..........................................................17
12.2. Study Procedures, Materials, and Potential Risks ..........................................................................18
12.3. Adequacy of Protection against Risks ................................................................................................18
12.3.1 Recruitment & Informed Consent ................................................................................................18
12.4 Protections against Risk.......................................................................................................................18
12.5. Vulnerable Subjects, if relevant to your study....................................................................................19
13.0. Potential Benefits of the Proposed Research to Research Participants and Others.............................20
14.0. Importance of the Knowledge to be Gained.............................................................................................20
15.0. INCLUSION OF WOMEN, MINORITIES AND CHILDREN.............................................................20
15.1 Women and Minorities ........................................................................................................................20
15.2. Children ..............................................................................................................................................20
16.0 Recruitment and Retention Plan................................................................................................................20
17.0 Data Safety Monitoring Plan ......................................................................................................................21
17.1 Roles and Responsibilities...................................................................................................................21
17.2 Trial Safety ..........................................................................................................................................21
18.0 ADVERSE EVENT REPORTING AND PROCEDURES......................................................................23
18.1 Definition of Adverse Events and Serious Adverse Events ................................................................23
18.2 Definition of Expectedness..................................................................................................................24
18.3 Medical and Psychiatric History..........................................................................................................24
18.4 Adverse Event Reporting.....................................................................................................................24
18.5 PIs Role in Assessing Severity and Causality of Adverse Events.......................................................24
18.6 Guidelines for Assessing Severity.......................................................................................................24
18.7 Guidelines for Determining Causality.................................................................................................25
18.8 Site’s Role in Monitoring Adverse Events ..........................................................................................25
18.9 Participant Withdrawal ........................................................................................................................25
19.0 Overall Structure of the Team....................................................................................................................25
20.0 Interventions ................................................................................................................................................26
21.0 Outcome measures.......................................................................................................................................26
22.0 FDA Regulated Intervention ......................................................................................................................27
23.0 Dissemination Plan ......................................................................................................................................27
23.1 Clinicaltrials.gov Requirements ..........................................................................................................27
23.2 Informed consent .................................................................................................................................27
23.3 Translation Plan...................................................................................................................................27
Bibliography.........................................................................................................................................................27
APPENDIX...........................................................................................................................................................32
Appendix 1: Locator Form ..........................................................................................................................32
Appendix 2: Satisfaction Measure...............................................................................................................33
Appendix 3: Attitudes Towards PrEP..........................................................................................................34
Appendix 4: CSBQ......................................................................................................................................35
Appendix 5: PrEP Screening for Substantial Risk and Eligibility (ICAP)..................................................42
Appendix 6: VSQ-9 .....................................................................................................................................45
Appendix 7: GRIP .......................................................................................................................................45
Appendix 8: Treatment Facility Survey ......................................................................................................45
Appendix 9: Authorized Release Form .......................................................................................................46
Effective Date: 4/20/2021
End Date: 3/18/2022

Appendix 10: Adverse Event Reports .........................................................................................................47
Effective Date: 4/20/2021
End Date: 3/18/2022

1.0 LIST OF ABBREVIATIONS
Abbreviation
Definition
Ab
Antibody
eCRCL
Estimated creatinine clearance rate
ED
Emergency Department
FDA
Food and Drug Administration
FTC/TDF
Emtricitabine and tenofovir disoproxil fumarate
GRIP
Guidelines Regime Information Program
HBsAg
Hepatitis B Surface Antigen
HCV
Hepatitis C Virus
HE
Health Educator
HIV
human immunodeficiency virus
iPrEP
Immediate PrEP initiation
PKC
Peter Kruger Clinic
PrEP
Pre-Exposure Prophylaxis
RCT
Randomized controlled trial
STI
Sexually Transmitted Infection
TAF/FTC
Emtricitabine and tenofovir alafenamide
VSQ-9
Visit specific satisfaction instrument
Effective Date: 4/20/2021
End Date: 3/18/2022

2.0 STUDY SYNOPSIS
This study will recruit and randomize 80 HIV Pre-Exposure Prophylaxis (PrEP) eligible Emergency Department 
(ED) patients to facilitated linkage to care for PrEP initiation versus immediate PrEP initiation in the ED (iPrEP) 
using a PrEP starter pack with facilitated linkage to care. The primary outcome is PrEP usage at 90 days post 
enrollment. Multiple secondary outcomes will also be measure including retention in care, STI diagnosis, risk 
behavior and PrEP adherence at 30, 60, and 90 days. 
2.1 Study Design
Overview
1) Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED) RCT 
We aim to assess the feasibility of initiating ED patients onto HIV PrEP. Specifically, among 80 PrEP eligible 
patients, this randomized controlled trial will compare the strategies of: a) ED screening with immediate PrEP 
(iPrEP) initiation, discharge with 14-day PrEP starter packs and facilitated linkage to outpatient care; vs. b) ED 
screening with facilitated linkage to an outpatient care for PrEP initiation. The primary outcome of interest is 
PrEP usage at 90 days with multiple exploratory secondary outcomes including PrEP adherence at 30, 60 and 
90 days, retention in care, STI diagnosis, risk factor modification and program satisfaction. The intent of the 
proposed study is to provide data on recruitment and attrition rates, as well as means and standard deviations 
for key measures that will be needed to plan a definitive multicenter trial of ED-initiated PrEP.
3.0 INTRODUCTION
3.1 Background and Rationale
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates 
of new infection have remained around 40,000 annually.1-6 The demonstrated efficacy and subsequent 
approval of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for pre-exposure prophylaxis (PrEP) for HIV 
by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new 
infections.7-10 Since approval, the promise of PrEP as a transformative intervention has yet to be realized.  
Despite the implementation of systems for clinical evaluation for and initiation of PrEP by primary care 
providers11-14, HIV specialists13, 15, 16, and STI clinics14, 17-21, numerous barriers to PrEP expansion have been 
identified including: 1) patient and provider lack of knowledge12, 13, 22-26, 2) lack of access to medical care 
among high-risk individuals27, 3) provider discomfort and inexperience with screening for risk behaviors13, 28, 29 
and 4) insurance and affordability.30, 31 This proposal seeks to expand access to and engagement in PrEP 
among high risk individuals though an innovative delivery approach in the non-traditional setting of the 
Emergency Department (ED) while addressing these four barriers enumerated above.
Traditionally, EDs have provided ‘safety net’ care for those who do not receive care elsewhere.32-34 These 
“hidden populations” consist of individuals who are not engaged in primary care, are underserved, uninsured, 
and belong to minority groups.34-36 It is these groups who are most at risk for acquiring HIV.1, 37 Expanding the 
HIV prevention continuum in the ED to include PrEP assessment, initiation and linkage could have a major 
contribution to population level prevention.31, 38-40 EDs already provide occupational and non-occupational post-
exposure prophylaxis and thus have demonstrated operational capacity and experience with the risk factors, 
pathways and medications relevant to PrEP implementation.41-43 For ED based PrEP to be broadly effective 
and implemented, however, it must be demonstrated that it is feasible in acceptable time frames. Experience 
with ED-based HIV testing interventions suggest this is likely; nonetheless data are needed.44-51
3.2 Innovation
This proposal seeks to use the techniques of dissemination and implementation research to translate PrEP 
screening, initiation and linkage into an ED setting. Efficacy data strongly supports the value and safety of 
PrEP.52-55 Multiple demonstration projects have focused on implementing what was learned from clinical 
trials into practice settings to determine real-world effectiveness.19, 56-63 The primary sites for these 
Effective Date: 4/20/2021
End Date: 3/18/2022

demonstration projects have been STI, HIV clinics, and primary care. This proposal seeks to generate new 
insights and generalizable knowledge regarding intervention dissemination, implementation dissemination, 
implementation processes, facilitators, barriers and strategies for improvement for ED-initiated PrEP, a 
setting in which, PrEP delivery strategies can be disseminated to reach at-risk populations. Many of the 
proposed process and outcome measures fit within the RE-AIM model (Reach, Effectiveness, Adoption, 
Implementation, and Maintenance).64 The three most applicable domains are reach, effectiveness and 
implementation and the RE-AIM checklist for those domains has been used to develop the research 
approach.65 While the proposed implementation methodology has been used in other settings, the use of 
PrEP in the ED represents a novel approach to improve PrEP awareness and delivery.
The expansion of emergency medicine’s (EM) mission beyond responding to emergencies into primary and 
secondary prevention has not been without controversy.66, 67 Yet, lack of access to primary care and the 
urgent need to provide out-patient medication assisted treatment and other prevention services is forcing 
the mandate of the specialty to expand. Given that there is likely to be little change in healthcare structure 
to reverse this trend, EDs will continue to address primary and secondary prevention head-on. This 
proposal is another step toward pushing the specialty to expand its traditional role to include primary 
prevention for HIV. Trained health educators, embedded in the ED will be in an optimal position to target 
PrEP to at risk-individuals and have a real impact on primary prevention for HIV. This proposal is the first 
step toward demonstrating the effectiveness of an ED-based PrEP program to the profession at large.      
3.3 Public Health Impact
Expanding access to Pre-Exposure Prophylaxis (PrEP) could have significant public health impact. It is 
estimated that even moderate increases in PrEP use could reduce new HIV infections by as much as 48,000 
over the next five years. The goal of this project is to investigate the effect of an intervention to expand access 
by screening patients and initiating PrEP in the non-traditional setting of the Emergency Department.
4.0 SPECIFIC AIMS AND HYPOTHESIS: 
 Aim 1: Pre-Exposure Prophylaxis Provision in the ED (PrEPPED) Trial: The target is to identify 80 PrEP 
eligible patients over a 12 month period who are interested in initiating PrEP. These patients will randomized to 
either immediate PrEP (iPrEP) initiation in the ED, a 14-day PrEP starter pack at ED discharge and facilitated 
linkage to comprehensive outpatient care or facilitated linkage to care for PrEP initiation only. 
1a. Evaluate the impact of iPrEP and the PrEP “starter pack” on patients agreeing to PrEP initiation. The 
primary outcome is PrEP usage at 90-days post enrollment. Secondary outcomes include retention in care, STI 
diagnosis, risk behavior and PrEP adherence at 30, 60 and 90 days. 
1b. Collect data on recruitment and attrition rates, as well as means and standard deviations for key 
measures that will be needed to plan a definitive trial of ED-initiated PrEP.
5.0 STUDY DESIGN
5.1 Study Timeline
RCTTimeline
Year 1
Year 2
Month
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
IRB 
Submission/Ap
proval
Develop SOPs 
for Aim 2: 
PrEPPED RCT 
(admin, clinical, 
lab, pharmacy, 
Effective Date: 4/20/2021
End Date: 3/18/2022

data 
management, 
quality 
assurance)
Aim 2: 
PrEPPED RCT 
Recruitment, 
Enrollment and 
Follow-up
Aim 3: Data 
analysis
Draft abstract 
and manuscript
Present data 
6.0 STUDY SETTING 
6.1 ED Characteristics
 
This is a single site study taking place in the Emergency Department of Mount Sinai Beth Israel Medical 
Center. 
The Beth Israel Department of Emergency Medicine was established as an independent academic ED in 1989. 
After the merger with the Mount Sinai Health System in 2013 the ED was integrated into the larger Mount Sinai 
Health System and is today known as the Mount Sinai Beth Israel (MSBI) Department of Emergency Medicine.  
There are 29 full-time core faculty actively engaged at the local, state, national and international levels as 
clinical, educational, administrative, and research experts in emergency medicine. MSBI is the second most 
active Emergency Department in respect to research activities in the health system after Mount Sinai Hospital.
6.2 Physical Space
The Emergency Department at MSBI is comprised of 3 main divisions: Pediatric Emergency Service, Adult 
Acute Care, FastTrack for lower acuity patients; all located in adjacent areas on the first floor of the Dazian 
Pavilion at the corner of 1st Avenue and 16th Street in Manhattan, New York. The Department also runs a 
separate Urgent Care Facility at 10 Union Square, part of the Mount Sinai Downtown out-patient clinic system. 
With more than 30 medical practices this center is a “hospital without beds” where patients care receive both 
primary and specialty care. The academic offices of the Department of Emergency Medicine are located in the 
adjacent Silver building. The Research division also has dedicated space in the Emergency Department for the 
research coordinators. All members of the research team who are housed in this area are outfitted with a 
workstation or laptop with network access to all MSBI computing services. 
6.3 Clinical Services – Mount Sinai Beth Israel 
An 856-bed teaching hospital founded in 1889 on Manhattan’s East Side, Mount Sinai Beth Israel (MSBI) is 
notable for its unique approach to combining medical excellence with clinical innovation. The hospital also has 
significantly advanced its commitment to community-based ambulatory care and expanding patient access to 
primary and specialty care. Built in 2010, the MSBI ED has approximately 90,000 annual patient visits. ED 
demographics are as follows: 51% male, 26% white, 18% African American, 20% Latino, 5% Asian, and 31% 
more than one race. The payer mix is 36% Medicaid, 11% uninsured, 26% Medicare and the remainder with 
private or other governmental plans.
Effective Date: 4/20/2021
End Date: 3/18/2022

7.0 Randomized Controlled Trial
7.1 Primary Aim:
Among 80 PrEP eligible patients compare in a pilot 1:1 RCT design, the strategies of a) facilitated linkage for 
PrEP initiation within 14-days of ED visit and b) immediate PrEP (iPrEP) initiation in the ED, a 14-day PrEP 
starter pack at discharge and facilitated linkage.
The primary outcome is PrEP usage at 90 days post PrEP initiation visit. Secondary outcomes include 
retention in care, STI diagnosis, risk behavior and PrEP adherence at 30, 60, and 90 days.
7.2 Secondary/Exploratory Aims:
(1) Retention in care at 30 and 60 and 90 days post PrEP initiation 
(2) PrEP usage at 30 and 60 days post PrEP initiation 
(3) PrEP adherence at 30, 60, and 90 days post PrEP initiation 
(4) Risk behavior at 30, 60, and 90 days post PrEP initiation 
(5) STI diagnoses at 30, 60 and 90 day follow-up visits 
(6) HIV infection 
(7) Program satisfaction
8.0 PATIENTS AND METHODS
8.1 Patient Population 
The target population will be the lower Manhattan community that Mount Sinai Beth Israel (MSBI) services.  
This community is predominantly made up of the Lower East Side, East Village, Two Bridges, Chinatown and 
Stuyvesant Town/Peter Cooper Village.68 The collective population of these neighborhoods is over 185,000.  
Within this geographic area, the community living between Bowery and the East river to the west and east 
respectively and 14th street and the Brooklyn Bridge to the north and south, has some of the oldest and 
poorest residents in New York City.69 Based on census data almost 35% of the population is foreign born with 
65% of those emigrating from Asia, 26% emigrating from Latin America, and 11% from Europe.69 Median 
household incomes in these neighborhoods remain substantially lower than the rest of NYC with some 
communities, such as Two Bridges, where the median household income is more than 60% below the NYC 
median.69 
8.2 Inclusion / Exclusion Criteria
INCLUSION CRITERIA
(1) Patients 13 years of age and above weighing at least 65 lbs., triaged to the adult or pediatric areas of the 
ED 
(2) Medically stable as determined by their provider 
(3) Able to speak English 
(4) Willing and able to consent to study participation
(5) Patient is either treated and released or placed in extended observation 
(6) Patient has at least two points of contact (can include phone, email, address, social media platform, etc.)
EXCLUSION CRITERIA
(1) Patient is younger than 13 years of age or weighing less than 65lbs.
(2) Medically or psychiatrically unstable as determined by the ED provider
(3) Unable to speak or understand English 
(4) Unable to provide consent for study participation
(5) Patient requires in-patient hospital stay
(6) Patient is receiving a sexual assault forensics exam (SAFE)
(7) Patient is suspected of having COVID-19 
(8) Patient is suicidal, homicidal, or on security watch or in police custody 
Effective Date: 4/20/2021
End Date: 3/18/2022

8.3 Number of Study Subjects
A single research assistant (RA), working 8-hour shifts, 5-days a week will be able to screen 10-15 patients a 
day. This is approximately 2.5-5% of the daily adult ED volume.
9.0 STUDY DESIGN AND PROCEDURES
9.1 Screening and Recruitment
The study team will use both targeted and non-targeted recruitment methods. 
Patients will only be recruited while they are in the ED. Research Assistants (RAs) assigned to the study will 
work various shifts including, days, evenings and weekends to ensure success with enrollment. The RA will 
identify patients seen in the ED by reviewing the EHR track boards and by provider referral. 
Study personnel will review the ED tracking board to identify patients with chief complaints that might indicate 
PrEP eligibility. This would include patients presenting to the ED for complaints related to sexually transmitted 
infections, non-occupational post-exposure prophylaxis (nPEP) or injection related complications. Study 
personnel will have to view the following identifiable information for recruitment screening purposes:
•
Date of Birth
•
Age
•
Chief Complaint
A HIPAA waiver request will be submitted to review this limited information for screening purposes only. This 
information will not be recorded. 
The RA will keep a log of all patients screening and excluded and the reasons for exclusion.  
If a patient is deemed potentially eligible based on tracking board review, study staff will approach the patient's 
ED provider to ascertain if the patient is medically and psychiatrically stable to be approached for potential 
study participation. Only after obtaining permission from the patient's ED provider will the patient be 
approached for study participation. If the patient is an adolescent under the age of 18, the following additional 
recruitment steps will be taken.  In addition to asking the provider for permission to speak with the patient the 
study staff will approach the patient and ask them if they are interested in participating in a study about sexual 
health.  If the patient is interested, but is with their adult caretaker the study staff will politely ask as the patient 
and caretaker if the patient can complete the screening instrument in private.  If the patient and caretaker 
agree the caretaker will be asked to leave the room at which point the study stuff will explain the study in more 
detail and ask the patient if they are willing to participate. If the patient would rather have the caretaker present 
for the screening and enrollment the study staff will ask to speak with the patient briefly in private to explain 
that the questions being asked are sensitive and include questions pertaining to sexual activity and drug use.  
If the patient still would like the caretaker present they will be invited back into the room. If the patient does not 
want the caretaker to be present they will be asked to wait outside the room until screening and enrollment are 
complete. 
Study staff will approach the patient, introduce themselves, and ask for verbal consent to complete the 
behavioral screening questionnaire (ICAP screening instrument).  If patients are eligible based on their 
behavioral screening they will be invited to participate in the RCT. 
9.2 Informed Consent Procedures
We will use the Icahn School of Medicine PPHS as the IRB of record for this study and will comply with all 
necessary informed consent requirements. Only IRB-approved Informed Consent documents and HIPAA 
disclosure allowing study access to protected health information in the patient’s ED medical record will be 
used. 
Effective Date: 4/20/2021
End Date: 3/18/2022

In addition, potential participants will be instructed concerning the importance of full and accurate disclosure. 
Initial screening questions will be asked with verbal consent however, all eligible study patients will be asked 
for written consent to participate using the IRB-approved forms.  
Adolescents age 13-17 will also be informed that while parental consent is not required for study participation, 
follow-up clinical visits and PrEP medications will be billed to their insurance which will be visible to their 
caretakers or legal guardian. The additional risk of the parents becoming aware of the patient’s PrEP use 
through insurance billing will be explained and noted in the informed consent document.
9.3 Study Procedures
After signing written informed consent study participants will undergo phlebotomy to assess the medical 
eligibility criteria for PrEP. This includes 1) Urine pregnancy for patients’ assigned female at birth of child 
bearing age and capable of giving birth (2) 4th generation rapid HIV Ag/Ab test (3) Basic Metabolic Panel to 
obtain estimated creatinine clearance rate (eCrCl) (4) Hepatitis B Surface Antigen (HBsAg) (5) Hepatitis C 
antibody (HCV Ab) (6) Sexually Transmitted Infection (STI) testing when clinically indicated (Gonorrhea, 
Chlamydia and Syphilis). All patients will be assessed for symptoms of acute HIV infection. If these labs have 
already been performed for clinical purposes as part of the patient’s Emergency Department clinical evaluation 
they do not need to be repeated.
After phlebotomy patients will complete the enrollment visit assessments as described below and be 
randomized to facilitated linkage to care for PrEP initiation versus immediate PrEP initiation in the ED (iPrEP) 
with a PrEP 14-day starter pack and facilitated linkage to care. Subjects started and discharged on PrEP from 
the ED will be provided with a medication guide that outlines how they should take their PrEP, common side-
effects and reasons to call their doctor. This will same information will also be provided to them as part of the 
PrEP counselling session that they have with the health educator. 
For patient randomized to iPrEP they will receive their first dose of oral PrEP in the ED. Patients’ assigned 
male gender at birth (males and transgender females) will receive emtricitabine and tenofovir alafenamide. 
Patients’ assigned female gender at birth (females and transgender males) will receive emtricitabine/tenofovir 
disoproxil fumarate. So long as patients do not have a known history of hepatitis B or renal disease, same day 
PrEP initiation, prior to confirmatory lab results, is safe and is supported by both NYC DOH guidelines and 
current literature.70-72 
If patient’s are found to have a clinical/laboratory contraindication for PrEP after ED discharge they will be 
informed of their ineligibility to continue PrEP by the PI and told to stop taking PrEP if they had already started 
(iPrEP group) or not start PrEP (standard referral group). Based on the implementation phase of the study we 
expect all laboratory results to be available within 48 hours of ED discharge. 
Laboratory abnormalities will be addressed using standard ED clinical protocols. Patient with critical values will 
be asked to return to the ED for repeat evaluation and laboratory testing. Patients with abnormal values (HBV+ 
or elevated eCRCL) will be referred for out-patient evaluation. If a patient is found to have a clinical 
contraindication for PrEP their study participation will end.
Enrolled participants will also be asked to complete a number of validated and study team developed 
measures including: 
1) Locator form with additional demographics (Appendix 1)
2) Satisfaction questionnaire and qualitative assessment (Appendix 2).
3) Attitudes towards PrEP Scale (Appendix 3)
4) CDC Sexual Behavior Questions (CSBQ) (Appendix 4)
Prior to ED discharge all patients will receive a referral to an out-patient PrEP provider. Referrals are made 
through the Institute of Advanced Medicine (IAM) PrEP Warm Line, the IAM REDCap referral system, or via 
email at Prevention@montsinai.org. Patients will also be asked to sign an Authorization for Release of Medical 
Effective Date: 4/20/2021
End Date: 3/18/2022

Information. The medical release form is needed to confirm clinic follow-up for patients not receiving their 
follow-up care within the Mount Sinai Health System.  
Patients will be instructed at the time of discharge that they will be contacted by a member of the PrEP Warm 
Line to schedule follow-up with a PrEP provider.  The decision to start PrEP for those not randomized to the 
iPrEP arm or to stop or continue PrEP for those randomized to the iPrEP arm will be a decision made by the 
patient in conjunction with their PrEP provider.  The ED clinical team will be available to assist patients should 
have they have any concerns or problems before that linkage occurs.  For those randomized to the iPrEP arm 
if they have any side-effects within the first 14-days of starter pack use they will contact the study team and a 
decision to continue or stop PrEP will be made after a discussion between the patient and the PI.  All patients 
enrolled in the study will receive standard PrEP counseling which includes information about the need for 
frequent HIV testing and risk reduction strategies.  The importance of follow-up with the PrEP provider will be 
stressed.  We do not anticipate the need for any re-testing (HIV, LFTs, eCrCL) by the study team after ED 
discharge.  These tests are not typically recommended until the patient has been on PrEP for at least 30 days 
and sometimes not until 90-days. All recommended follow-up testing will be the responsibility of the clinical 
PrEP provider.
9. 4 Randomization 
Randomization will occur after the patient signs the informed consent document. The randomization sequence 
will be obtained by computer-generated random numbers and provided to research associates through a web 
portal.
9.5 Follow-up
All follow-up assessments will be performed over the phone. Follow-up assessments will occur at 30, 60, and 
90 days post enrollment. 
Follow-up assessments will include:
1) Attitudes toward Pre-Exposure Prophylaxis Scale (APS) (Appendix 3) 
2) Section 4 of ICAP “Screening for Substantial Risk of HIV” (Appendix 5)
3) Satisfaction questionnaire and qualitative assessment and visit specific satisfaction instrument (VSQ-9) 
(Appendix 6)
4) Adherence information measured by (1) self-report. Self-report will be assessed with the single 
measure Guidelines Regimen Information Program (GRIP) guide and questions on last dose and 
number of missed doses since prior follow-up. (Appendix 7)
5) CDC Sexual Behavior Questions (CSBQ) (Appendix 4)
6) STAR*D PRISE (Side-effect assessment) 
Assessment of engagement in PrEP care at 30, 60, and 90 days post enrollment will be verified by direct 
contact with the treatment provider/program provided or by EMR review if the patient is linked within the Mount 
Sinai Health System. If the patient is receiving their PrEP care outside of the Mount Sinai Health System, a 
signed release authorization form will be sent. 
9.6 Compensation
Because of the expected difficulty of maintaining high follow-up rates in the study population, adequate 
compensation for time and inconvenience is critical. Compensation of a $25 gift card will be distributed in-
person for completing the enrollment process at the initial ED visit and each follow-up assessment (30, 60, and 
90 days). 
If the participant completes the enrollment and all follow-up all daily assessments the total additional amount 
they could receive would be $100.   
Effective Date: 4/20/2021
End Date: 3/18/2022

9.7 Standard Intervention for all Participants: PrEP Counseling
All participants initiating PrEP will be provided with standard PrEP counseling by the Emergency Department 
Health Educator. PrEP counseling includes, (1) how PrEP works, (2) the benefits and risks of PrEP, (3) the 
need for adherence to the dosing schedule for PrEP to be protective and (4) how other safer sex and safer 
drug injection practices decrease the risk of acquiring drug-resistant HIV, other sexually transmitted infections 
(STIs), Hepatitis C virus, and pregnancy.
9.8 PrEP starter packs 
14-day starter packs of FTC/TDF and FTC/TAF will be stored in the ED medication dispensing system. 
Standard operating procedures will be created for storage and dispensing. It should take no more than 5-
minutes to retrieve the medication.
10. STUDY ASSESSMENTS
10.1 Overview:
The baseline and follow-up assessments for this study attempt to balance the benefits of comprehensive data 
collection against the feasibility of collecting data in often chaotic and pressured environment of the Emergency 
Department.73 A cumbersome assessment process is also likely to impede the successful completion of the 
study through an adverse effect on recruitment nor would it model real-world clinical practice. If this 
intervention is to be successful it must not only be shown to be effective but also feasible and pragmatic. 
Excluding collection of a study patient participant characteristics and locator information, the patient’s baseline 
data will include a brief assessment of HIV risk and attitudes toward PrEP. The total expected time burden for 
the screening assessments is 30-60 minutes. Assessments collected at 30, 60, and 90 days post study 
enrollment will be similar. 
10.3 Pre-Enrollment (Screening) Assessment Phase
10.3.1 ICAP PrEP Screening Questionnaire
Individuals will meet with an RA to be evaluated for study eligibility. This assessment will be conducted after 
verbal consent, and before enrollment into the study. It will include questions about PrEP behavioral eligibility 
criteria. 
10.3.4 Patient Eligibility and Inclusion/Exclusion
The Patient Eligibility and Inclusion/Exclusion form collects information regarding eligibility during the screening 
phase, before written informed consent is obtained. This includes an initial discussion about the availability of 
two alternate contacts in addition to the participant. Prior to signing consent patients will only be asked if they 
have two points of additional contact and not the specific information for those contacts. 
10.3.5 Informed Consent and Research Authorization (HIPAA) Forms
Only patients who continue to meet study eligibility criteria will be allowed to continue to the enrollment phase. 
10.4 Enrollment Assessments
10.4.1 Demographics
The demographics forms collect information about demographic characteristics of the study participant, 
including age, gender, cultural/ethnic group, education level, marital status, and type of insurance. This form is 
completed at enrollment only. 
Effective Date: 4/20/2021
End Date: 3/18/2022

10.4.2 Locator Information Form
A locator form is used to obtain information to assist in finding study participants during the 90 day assessment 
period. The form collects contact information including the participant’s current address, email address, and 
phone number. In an effort to facilitate locating participants if direct contact efforts are unsuccessful, address 
and phone number of family/friends who may know how to reach the participant are also collected. This 
information will be collected at enrollment. Locator information will not be used in data analysis.  
10.4.13 Satisfaction Scale
A short 3 question satisfaction scale will be used to measure satisfaction with the screening and linkage 
process. This will be asked at enrollment and the 30, 60, and 90-day follow-up assessments.
10.4.14 CDC Sexual Behavior Questions
A comprehensive sexual risk assessment for HIV and other STIs. This measure will be completed at 
enrollment.
10.4.16 Attitudes toward Pre-Exposure Prophylaxis Scale (APS)
A brief assessment of knowledge and attitudes regarding PrEP. This assessment will be completed at 
enrollment and each follow-up visit.
 10.5 Follow-Up Assessments
10.5.1 Attitudes toward Pre-Exposure Prophylaxis Scale (APS)
A brief assessment of knowledge and attitudes regarding PrEP. 
10.5.2 Section 4 of ICAP “Screening for Substantial Risk of HIV” 
Section 4 focuses on screening for substantial HIV risk.
10.5.3 Satisfaction Scale
A short 3 question satisfaction scale will be used to measure satisfaction with the screening and linkage 
process. This will be asked at enrollment, 30, 60, and 90 days post enrollment. 
10.5.4 Visit specific satisfaction questionnaire (VSQ-9)
The VSQ-9 is a visit-specific satisfaction instrument adapted by the American Medical Group Association from 
the Visit Rating Questionnaire.
10.5.6 Guidelines Regimen Information Program (GRIP) guide
The GRIP measure is a validated instrument to assess medication compliance. This will be asked at each 
follow-up visit.
10.5.7 STAR*D PRISE
Effective Date: 4/20/2021
End Date: 3/18/2022

The STAR*D PRISE measure is a validated instrument designed to measure side-effects of common 
antidepressant medications but has been used widely as a general measure of medication side-effects.  This 
will be administered at each follow-up assessment for those patients taking PrEP. 
10.5 Outcome Data
10.5.1 Engagement in Treatment Survey (Primary Outcome) 
At 30, 60, and 90 days post enrollment, participants will be asked to report PrEP use and engagement in PrEP 
care. The services reported by the patient will be confirmed with the treatment provider or by review of the 
patient’s medical record. 
10.5.2 Treatment Facility Survey (Appendix 8)
The treatment facility survey will be completed to confirm where the patient is receiving PrEP follow up care. If 
they are outside of Mount Sinai Health System, they will be sent a signed authorized release form (Appendix 
9).
11.0 DATA MANAGEMENT AND STATISTICAL ANALYSES
11.1 Statistical Analysis
11.1.1 General approach
Nominal and ordinal categorical variables will be summarized as frequencies and percentages. Continuous 
variables will be summarized with the following descriptive statistics: N, mean, standard deviation, median, 
minimum, maximum, interquartile range, and range.
No imputation of missing data will be performed for any of the analysis given the pilot nature of the study and 
small sample size.
11.1.2 Analysis of Primary and Secondary Outcomes
Analysis will be on an intention-to-treat basis. In statistical analyses, participants will be included to the date of 
their last active follow-up visit. Comparisons between control and experimental (iPrEP) arms. To assess the 
success of randomization, a summary of the baseline variables by treatment group will be tabulated and 
univariate comparisons performed. The primary outcome, retention in care and PrEP usage, will be compared 
with proportions and Fisher’s exact derived confidence intervals. Secondary outcomes: Secondary analysis will 
focus on determining how retention in care, risk behavior, adherence or STI diagnosis differ between the 
groups at any of the follow-up time points. PrEP adherence based on pill counts will be calculated by dividing 
the number of pills taken by the number of pills prescribed. Adherence will be calculated by study month for 
each participant. Group adherence comparisons will be compared using Wilcoxon rank sum test. Retention in 
care, STI diagnosis and risk behavior at each time point will be analyzed for each study visit. Retention in care 
and STI diagnosis will be treated as dichotomous variables for analysis. Measures of risk behavior will include 
consistency of condom use and number of sexual partners since prior study visit. Condom use will be treated 
as an ordinal variable and number of sexual partners as a continuous variable for analysis. 
11.1.3 Sample Size
This pilot RCT will be insufficiently powered to provide definitive efficacy data on retention and adherence for 
the two study arms at 90 days. Yet, the pilot data is needed to determine recruitment and attrition rates, as well 
as means and standard deviations for key measures that will be needed to plan a definitive trial of ED-initiated 
Effective Date: 4/20/2021
End Date: 3/18/2022

PrEP. For illustrative purposes we have included the following table of powers based on different retention in 
care rates in the control and experimental groups with the assumption that those retained in care will be using 
PrEP. This analysis assumes initial groups sizes of 40 and 40. The test statistic used is the two-sided Z test 
with pooled variance. The significance level of the test was targeted at 0.0500.
Power
Control Group
Retained in Care/PrEP
Experimental (iPrEP) Group
Retained in Care/PrEP
Difference in 
Proportions
0.0812
50%
55%
5%
0.1571
50%
60%
10%
0.2859
50%
65%
15%
0.4581
50%
70%
20%
0.6474
50%
75%
20%
0.8166
50%
80%
30%
0.9327
50%
85%
35%
The 50% follow-up rate for the control arm is based on and manuscript by Bogoch et als. entitled “Attrition 
Between the Emergency Department and Clinic Among Individuals Presenting for HIV Non-occupational Post 
exposure Prophylaxis published in Clinical Infectious Diseases in 2014.74 The authors found that only 54% of 
patients seen in the ED for non-occupational post-exposure prophylaxis attended their first follow-up post-
exposure clinic visit.  This study did use appointment reminders but not the degree of facilitated linkage that will 
be used for the described ED PrEP program. In Project BRIEF, the HIV testing program described in the 
preliminary studies, the follow-up rate for newly infected HIV patients was 85%. Given that this will be the first 
effort at PrEP screening, initiation and linkage in the Emergency Department we do not expect to achieve the 
same degree of retention in care as we did for follow-up in Project BRIEF.
12.0 REGULATORY COMPLIANCE, ETHICS, AND REPORTING
12.1 Protection of Human Subjects
12.1.1 Risks to Human Subjects
The proposed project involves human subject’s research that is not exempt and involves a randomized clinical 
trial of a greater than minimal risk intervention to prevent HIV infection. Below we provide sufficient assurance 
to reviewers that the proposed research meets: (1) the requirements of the DHHS regulations to protect human 
subjects from research risks (45 CFR Part 46), (2) NIH policy requirements for Data and Safety Monitoring for 
Clinical Trials, (3) the ClinicalTrials.gov requirements, (4) the requirements of NIH policies on inclusion of 
women, minorities, and children and (5) the requirements of NIH policy on reporting race and ethnicity data for 
human subjects in clinical research. 
12.1.2Human Subjects Involvement, Characteristics, and Design
Aim 1 includes examining the impact of iPrEP initiation in the ED by providing a 14-day PrEP “starter pack” and 
facilitating linkage with the primary outcome being PrEP usage at 90-days post index visit compared to the 
facilitate linkage only arm, as well as a number of exploratory secondary outcomes including PrEP initiation 
Effective Date: 4/20/2021
End Date: 3/18/2022

and use at 30 and 60 days. We also will collect data on recruitment and attrition rates, as well as means and 
standard deviations for key measures that will be needed to plan a definitive trial of ED-initiated PrEP.  
For Aim 1, we will perform a randomized controlled clinical trial to compare the impact of immediate PrEP 
initiation (iPrEP) in the ED by providing a PrEP “starter pack” with facilitated linkage alone. The primary 
outcome is PrEP usage at 90-days post PrEP initiation visit. Participants will provide written informed consent 
for study participation. The consent to participate will also include 1) consent for investigators to collect 
prospectively collect clinical and sociodemographic data via medical record review and electronic data capture 
from the electronic health record. We anticipate 80 patients participating in the study associated with Aim 1.
Study procedures:
Aim 1: 80 PrEP eligible patients will be randomized 1:1 to either the experimental (iPrEP) arm or standard (out-
patient PrEP) initiation arm. Patients in the iPrEP arm will receive a 14-day starter pack of PrEP and facilitated 
linkage.  Patient in the control arm will receive facilitated linkage only. Patients in both arms will be followed for 
90-days with telephone call follow-up visits scheduled for 30, 60 and 90 days post enrollment. Patients will be 
asked to complete satisfaction and medication adherence questionnaires at each scheduled follow-up 
The setting of the human subjects’ will be Mount Sinai Beth Israel Emergency Department.
Subject populations: The study population will include patients recruited in the Emergency Department at 
Mount Sinai Beth Israel Hospital
Mount Sinai Beth Israel Community Characteristics: The Mount Sinai Beth Israel (MSBI) ED draws patients 
form a large catchment area that in includes the Lower East Side, East Village, Two Bridges, Chinatown and 
Stuyvesant Town/Peter Cooper Village. The collective population of this geographic region is over 165,000.  
Included in this region are the following zip codes (10002, 10003, 10004, 10005, 10006, 10007, 10009, 
10038). Within this geographic area are some of poorest residents in New York City.  In one geographic region 
within this catchment area, median household incomes were 60% below the NYC mean based on year 2000 
census data. Almost 35% of the population were foreign born with 65% of those emigrating from Asia, 26% 
emigrating from Latin America and 11% from Europe. The catchment area is also home to more than 15 
shelters and supportive housing sites, among the highest concentration in NYC. While it is hard to provide 
exact numbers, there is a large proportion of homeless youth using these support services. It is estimated that 
40% of these youth identify as LGBTQ and experience significant exposure to HIV. In regard to access to 
primary care services, 1 in 4 residents report not having a regular doctor, were currently uninsured, or went 
without health insurance at some time in the past year.  The number of individuals previously tested for HIV is 
low with only about one fifth of Lower East Side residents having been tested for HIV in the past year. HIV risk 
factors are high with fewer than 4 in 10 (38%) adults who had more than 1 sex partner in the past year 
reported using a condom at their last sexual encounter. 
Mount Sinai Beth Israel Emergency Department: The MSBI ED has approximately 90,000 annual patient visits. 
ED demographics are as follows: 51% male, 26% white, 18% African American, 20% Latino, 5% Asian and 
31% more than one race.  The payer mix is 36% Medicaid, 11% uninsured, 26% Medicare and the remainder 
with private or other governmental plans. 
12.2. Study Procedures, Materials, and Potential Risks 
Aim 1
Study Procedures: Patients found to be eligible for PrEP will be randomized to immediate PrEP (iPrEP) 
initiation using a 14-day starter pack or PrEP initiation in the outpatient clinic. Both groups will have facilitated 
linkage to care. Follow-up study visits will occur at 30, 60 and 90days post PrEP initiation. The 30, 60 and 90 
day assessments will over the phone.  
Study Risks: Aim 1 involves randomization to one of two different PrEP initiation programs. PrEP initiation 
includes risks that would be considered more than minimal. Patients in both groups will be prescribed 
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) which will be used for women and transgender men or 
Effective Date: 4/20/2021
End Date: 3/18/2022

emtricitabine/tenofovir alafenamide (FTC/TAF) which will be used for men and transgender women. Both of 
these medications are FDA approved and is being used for its intended purpose in the population for whom it 
is indicated. Known physical risks of emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir 
alafenamide are impaired renal function, intolerable side effects including nausea, vomiting or diarrhea as well 
as hypersensitivity reaction and osteopenia with long term use. Patients will also be subject to the same 
psychological and privacy and confidentiality risks.
 
Sources of Data: Aim 1 data sources will come from the following
1) Socio-demographic questionnaires collected during screening and enrollment
2) Behavioral risk factor questionnaires collected at enrollment and 30, 60, and 90day follow-up
3) PrEP attitude and knowledge measures
4) Satisfaction questionnaires collected during enrollment and 30 , 60, and 90-day follow-up
5) Laboratory reports obtained from the patient’s electronic medical record at enrollment and 30 and 90-day 
follow-up
6) Locator forms collected to obtain correct contact information collected at enrollment and 30 and 60 day 
follow up 
7) VSQ-9 study visit questionnaires collected at 30 and 90-day follow-up
8) Adherence questionnaires collected at 30, 60, and 90-day follow-up
9) Facility follow-up questionnaire
Data for Aim 1 will be collected using a touch screen tablet and paper and pencil surveys administered by the 
RA. All data will be linked to the individual study participant but will be de-identified for analysis.
12.3. Adequacy of Protection against Risks
12.3.1 Recruitment & Informed Consent
Participants will be recruited from the MSBI Emergency Department during their ED visit. Participants will be 
recruited during a single 12-month period. The RA will screen all adult patients using the electronic medical 
record tracking board. The RA will obtain permission from the clinical team to approach the patient. Using a 
standardized script, the RA will give a brief description of the study and ask for consent to participate. Patients 
will be given a consent form that outlines the purpose of the study, length of time of the study, describe what is 
involved, their responsibilities if they take part in the research, information regarding compensation, potential 
benefits and foreseeable risks where applicable and study contact information. Potential participants will be 
asked if they would like time to think about the study and review the consent form.  If requested, they will be 
given as much time as needed to review prior to signing the consent form. In addition to consenting to the 
survey, patients will also give consent to allow investigators to collect clinical and sociodemographic data from 
the medical record via chart review and electronic data capture. 
The following additional steps will be taken for patient’s age 13 to 18. In addition to asking the provider for 
permission to speak with the patient the study staff will approach the patient and ask them if they are interested 
in participating in a study about sexual health.  If the patient is interested, but is with their adult caretaker the 
study staff will politely ask as the patient and caretaker if the patient can complete the screening instrument in 
private.  If the patient and caretaker agree the caretaker will be asked to leave the room at which point the 
study stuff will explain the study in more detail and ask the patient if they are willing to participate. If the patient 
would rather have the caretaker present for the screening and enrollment the study staff will ask to speak with 
the patient briefly in private to explain that the questions being asked are sensitive and include questions 
pertaining to sexual activity and drug use.  If the patient still would like the caretaker present they will be invited 
back into the room. If the patient does not want the caretaker to be present they will be asked to wait outside 
the room until screening and enrollment are complete.
12.4 Protections against Risk
The investigators will make all efforts to minimize the physical, psychological, privacy and confidentiality risks 
to human subjects.  
Effective Date: 4/20/2021
End Date: 3/18/2022

Physical Risks: In regard to screening for study entry, patients’ discovered to have a clinical/laboratory 
contraindication for PrEP will be informed and educated by the PI regarding the reason for their ineligibility.  
Clinical/laboratory abnormalities will be addressed using standard ED protocols. Patients with a primary care 
provider will be referred back to their doctor for further management. For patients without a primary care 
provider follow-up will depend on the specific exclusion criteria. Patients with decreased eCrCL will be referred 
to out-patient nephrology. Patients found to have HBsAg+ will be referred to out-patient Hepatology. Patients 
found to be HIV+ will be immediately linked to care at Peter Krueger Clinic as per standard ED protocols.  
Patients found to be pregnant will be referred to out-patient Obstetrics and Gynecology. 
All patients initiated on PrEP in the ED will be monitored by the study team for the first 14-days (the duration of 
the starter pack) or until linked to their outpatient PrEP provider. While we will not be dictating out-patient 
clinical care we expect that patients will be managed as recommended in the US Public Health Service Pre-
Exposure Prophylaxis Clinical Practice Guidelines. This includes repeat HIV testing every 3-months, repeat 
pregnancy testing for women who may become pregnant, STI testing for sexually active persons with signs or 
symptoms of infection and eCrCL monitoring (every 6-months).  
Psychological Risks:  Patients may suffer from anxiety and discomfort at any point during the study. This could 
be the result of learning that they have one of the medical exclusion criteria or PrEP initiation or a sexually 
transmitted infection. The RAs will undergo extensive training with the New York City Department of Health 
and Mental Hygiene (NYC DOHMH) to learn the appropriate counseling skills to address patients concerns. In 
the event that a RA needs additional assistance they will reach out to the Principle Investigator or social 
workers from the Emergency Department.
Privacy and Confidentiality Risks: The PI, the project manager (PM), and RAs will have access to identifiable 
study data. All hardcopy will be kept in a locked file cabinet in the PI’s locked office. All study data will be 
entered into a password protected REDCap database or local databases behind the Mount Sinai firewall. The 
participant’s anonymous study ID will be used on a linking sheet to connect survey data with medical chart 
review data. Otherwise, identifiable data will not be shared outside of Mount Sinai. All data shared outside of 
Mount Sinai (with biostatisticians) will be stripped of identifiers and transmitted via encrypted email message. 
All possible steps will be taken to protect the participants against the unlikely and minimal risks described 
above. In order to ensure patient confidentiality, the following measures are proposed. Electronic data will be 
stored in password-encrypted files and transmitted by the research coordinator via secure, encrypted email to 
the PI. All paper data forms (used only when internet access is not available in the ED to permit data entry 
directly into REDCap), will be housed in a locked file cabinet within the PI’s office until they are batched and 
brought in person to the RA for data entry. The RA will check the forms for completeness and enter all data 
into the REDCap database. The study database will be password-protected and encrypted and data files will 
be backed up routinely to guard against losses. Access to the study database will be limited to the study 
personnel. 
All additional protections of participant confidentiality mandated by the Health Insurance Portability and 
Accountability Act (HIPAA) will be strictly followed. Additionally, the following data safeguarding procedures will 
be observed: 1) training staff on data sensitivity and data safeguards being employed to assure confidentiality, 
2) storing and processing a hard copy in a centralized location, 3) securing a sensitive hard copy in a locked 
file, 4) destroying all identifiable linkages to data after data accuracy has been verified and final analyses have 
been computed, and 5) protecting the database by encrypted password.  An encrypted master list of name to 
participant ID number will be kept by the PI separately in a locked location.
If at any time, a subject expresses verbal or nonverbal unwillingness to participate in any of the components of 
this proposal, the subject will be withdrawn from the study. 
12.5. Vulnerable Subjects, if relevant to your study
Individuals who meet inclusion criteria may be asked to participate in research at times separate from clinical 
care, thus institutionalized individuals and prisoners will not be able to participate. Children less than age 13 (or 
13-17 but weighing less than 65lbs.) will be excluded from this research as these individuals are not eligible for 
Effective Date: 4/20/2021
End Date: 3/18/2022

PrEP as it is currently approved by the FDA. It is anticipated that individuals from economically or educationally 
disadvantaged backgrounds will be enrolled, however special care will be taken to ensure that such individuals 
understand all aspects of the study and all of their rights as research participants. Urine tests will be conducted 
to ascertain the pregnancy status of participants and women found to be pregnant will not be able to continue 
in the study. 
13.0. Potential Benefits of the Proposed Research to Research Participants and Others
Participants may directly benefit from the proposed research in several ways. Patients will be educated about 
PrEP and may discover they are eligible for PrEP based on ED screening. Initiating PrEP, either in the ED or in 
the out-patient clinic will reduce the likelihood of acquiring HIV. Patients randomized to the experimental arm 
will have a more rapid initiation of PrEP than those initiation PrEP in the out-patient clinic. If patients 
randomized to immediate PrEP initiation are adherent to the medication they may achieve earlier protection 
against HIV infection. If successful, the screening and initiation pathways created during this project could help 
reduce the HIV acquisition risk of future ED patients and have significant benefits to public health. 
14.0. Importance of the Knowledge to be Gained
The proposed research could have a direct impact on future HIV prevention research. Ultimately, the studies 
proposed may result in improved knowledge on how expand access to PrEP. The proposed RCT will also 
provide the first data on the impact of ED initiated PrEP. The proposed work will form the foundation for a 
future multicenter RCT of ED initiated PrEP that could change ED based practice toward incorporating early 
portions of the PrEP cascade into routine ED based care for high risk individuals. 
15.0. INCLUSION OF WOMEN, MINORITIES AND CHILDREN
15.1 Women and Minorities
Women and minorities will be included in the research without exception; no one will be excluded from 
participation based on sex/gender, race or ethnicity. 
15.2. Children
Exclusion of groups: Children will be excluded from this research if they are age less than 13 or age 13-17 but 
weighing less than 65 lbs. as they are not eligible for PrEP. 
16.0 Recruitment and Retention Plan
Participants will be recruited, enrolled and followed during one 12-month study period the MSBI emergency 
departments during their ED visit. The RA will screen all adult patients using the electronic medical record 
tracking board; to maximize the likelihood of identifying eligible patients, RAs will prioritize approaching 
patients with a chief complaint that that suggests PrEP eligibility (e.g. penile or vaginal discharge, drug 
overdose or withdrawal). A HIPAA waiver will be requested for these screening activities.  
The RA will obtain permission from the clinical team to approach the patient. At this point, the research 
coordinator will approach the patient to provide information about the study, and if the potential participant is 
interested, verbal consent will be sought for PrEP behavioral eligibility screening. Patients that meet behavioral 
criteria for PrEP and are interested in participating will sign written informed consent will be obtained. Patients 
will be given a consent form that outlines the purpose of the study, length of time of the study, describe what is 
involved, their responsibilities if they take part in the research, information regarding compensation, potential 
benefits and foreseeable risks where applicable and study contact information. Potential participants will be 
asked if they would like time to think about the study and review the consent form. If requested, they will be 
given as much time as needed to review prior to signing the consent form. Participants will be informed of the 
Effective Date: 4/20/2021
End Date: 3/18/2022

data sharing plan and the protections against identification of individuals associated with it. In addition to 
consenting to the survey, patients will also give consent to allow investigators to collect clinical and 
sociodemographic data from the medical record via chart review and electronic data capture.
To maximize retention we will use a Locator Form to collect the study participants current address, email 
address, phone numbers and, with consent, private social media information. In order to facilitate linkage and 
follow-up, we will also collect similar information for friends and family who know how to reach the patient. All 
follow-up assessments will be conducted at 30, 60, and 90 from PrEP initiation. All follow-up assessments will 
be conducted by telephone. Patients will be mailed an appointment reminder and receive a phone call a week 
and a day before their scheduled assessment. Patients who miss one or more than one follow-up assessment 
will continue in the study so long as it is within 90 days of their enrollment.
We will provide a $25 cash incentive for all participants to complete their enrollment, 30, 60 and 90-day follow-
up assessments.
17.0 Data Safety Monitoring Plan 
17.1 Roles and Responsibilities
To meet the study's ethical responsibility to its patients, results will be monitored during the trial by Dr. Cowan 
(PI). There will be no external data and safety monitoring committee for this study. Study outcomes will be 
tracked and monitored by the PI.
Study staff are required to disclose any financial conflict of interest to our institutional compliance office. Any 
identified conflicts of interest are indicated to the patient in the study consent form.  
17.2 Trial Safety  
Events that would preclude a participant from continuing the intervention: 
Safety concerns:  Guidelines published by the Centers for Disease Control and Prevention (CDC) provide clear 
guidance for clinicians prescribing emtricitabine/tenofovir disoproxil fumarate or emtricitabine/tenofovir 
alafenamide for pre-exposure prophylaxis (PrEP). Indications for not starting or stopping PrEP once started 
would include renal insufficiency (eCrCL of ≤60 ml/min), HIV infection, Hepatitis B, pregnancy, signs or 
symptoms of acute HIV infection, possible HIV exposure within the last 72 hours. Indications for stopping PrEP 
would be a new HIV or Hepatitis B infection, worsening renal function, intolerable side effects, hypersensitivity 
reaction, osteopenia or pregnancy. In the group of patients randomized to iPrEP if any these safety concerns 
arise during the 14 days the patient is taking the PrEP starter pack they will be addressed by the PI and the 
patient will be withdrawn from the study since they will no longer be considered PrEP eligible. 
Participants could also be removed from the study by the investigator if they do not complete any follow-up 
assessments within 90-days of enrollment.  
Managing any medication related issues: In the group of patients randomized to iPrEP medication related side-
effects that occur while the patient is taking the 14-day starter pack will be addressed by the PI. After 14-days 
or linkage to care (whichever occurs first) the treating PrEP provider will manage the patient as clinically 
indicated. For any medication related emergency we will provide a “study card” with a number to call to speak 
with a physician and inform patients if they need immediate treatment to go to the closest emergency room.  
There is no wash-out period.  Patients will told to inform their treating provider of any other medications they 
are taking including any over-the-counter medicines. For those patients who wish to discontinue PrEP, we will 
recommend a test to determine HIV status at the time of discontinuation. We will also enquire about the reason 
for PrEP discontinuation, recent medication adherence and reported sexual risk behavior.
Effective Date: 4/20/2021
End Date: 3/18/2022

Protection against risks: Participants will be told that their involvement is voluntary. All data obtained during this 
study will be kept strictly confidential. All hard copy information will be kept in a separate private research 
room, in a cabinet, under lock and key. A password protected and secured database will hold all computer 
data. Access to the data will only be open to the co-PIs, co-investigators, and the research associates. All 
researchers will be required to take the CITI Human Subject web-based course or equivalent. 
The investigators will make all efforts to minimize the physical and psychological risks to human subjects. In 
regard to screening for study entry, patients’ discovered to have a clinical/laboratory contraindication for PrEP 
will be informed and educated by the RA regarding the reason for their ineligibility. Clinical/laboratory 
abnormalities will be addressed using standard ED protocols. Patients with a primary care provider will be 
referred back to their doctor for further management. For patients without a primary care provider follow-up will 
depend on the specific exclusion criteria. Patients with decreased eCrCL will be referred to out-patient 
nephrology. Patients found to have HBsAg+ will be referred to out-patient Hepatology.  Patients found to be 
HIV+ will be immediately linked to care at PKC as per standard ED protocols.  Patients found to be pregnant 
will be referred to out-patient Obstetrics and Gynecology. 
Data related risks are described below under privacy protections and data security and confidentiality. It is 
possible that patients may become anxious when responding to the risk factor questionnaires. RAs will receive 
extensive training on counseling patients for PrEP and addressing any patient concerns. If the RAs need 
additional assistance they will reach out to the PI.
Study protocol will be adhered to as indicated and approved by the Mount Sinai Institutional Review Board and 
compliance offices.  
Consent procedure: Consent procedures are described in Section 9.2. Informed consent procedures for all 
participants or informants, with attention to literacy level of participants.
Privacy protections: All data obtained during this study will be kept strictly confidential. All hard copy 
information will be kept in a separate private research room, in a cabinet, under lock and key. A password 
protected and secured database will hold all computer data. Access to the data will only be open to the co-PIs, 
co-investigators, and the research associates.
Stopping rules:  Given that this trial focuses on feasibility and acceptability of an FDA approved medication 
being used for its intended purpose in its indented population, no stopping rules are in place. 
Disclosure of incidental findings: As discussed in protection against risk, patients who screen out for a medical 
related reason will be informed of the reason for ineligibility by the PI and be provided with out-patient follow-up 
for further management. Standard mechanism are in place to address the laboratory abnormalities we expect 
to find during the screening process.
Data security and confidentiality protections: In order to capture the highest quality data, we will use a web-
based system with electronic validation. In addition, we will cross-validate the data for complex errors. Study 
data will be collected and managed using REDCap electronic data capture tools hosted at the Icahn School of 
Medicine at Mount Sinai.75 REDCap (Research Electronic Data Capture) is a secure, web-based application 
designed to support data capture for research studies, providing 1) an intuitive interface for validated data 
entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for 
seamless data downloads to common statistical packages; and 4) procedures for importing data from external 
sources.
All study data will be entered in the electronic data capture (EDC) system. Study personnel requiring access 
will have their own Login/Password. Access to clinical study information will be based on individuals' roles and 
responsibilities. All study data will be transmitted over an encrypted SSL (Secure Sockets Layer) connection 
that requires user authentication. This application is designed to be in full compliance with the International 
Conference on Harmonization and Good Clinical Practices (ICH-GCP), the FDA’s Code of Federal Regulations 
(CFR) 21 Part 11 Electronic Record and Electronic Signatures, the FDA's "Guidance: Computerized Systems 
Effective Date: 4/20/2021
End Date: 3/18/2022

Used in Clinical Trials,” and the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA). 
Reportable Events: 
HIV acquired while the patient is taking PrEP is considered a serious adverse event and reported to the IRB 
within 24 hours. Any pregnancy occurring while on PrEP will be considered a serious adverse event and 
reported to the IRB within 24 hours.
Data Management, Analysis, and Quality Assurance:
Sources of information will come from the socio-demographic questionnaires, behavioral risk factor 
questionnaires, PrEP attitude and knowledge measures, satisfaction questionnaires, laboratory test results, 
adherence questionnaires, electronic medical records and VSQ-9 study visit questionnaires. As noted above 
all study data will be entered in the electronic data capture (EDC) system that requires unique user 
Login/Password. 
The greatest threat to study validity is likely to be loss to follow-up. We have attempted to minimize this 
possibility by requiring detailed locator information and preforming facilitated linkage. The follow-up rate in our 
HCV screening program is 50% where there is no requirement for locator data or facilitated linkage.  We 
expect the rates of follow-up in this program to be closer to 85% as was seen in Project BRIEF where 
facilitated linkage mechanisms were used. We will also collect short term (30-day) and longer term follow-up 
(60 & 90-days) data to ensure that, even if there is drop-out at each time point, we will still have usable data for 
outcome analysis.
Given that the study will examine patients presenting to one urban academic emergency department, the 
results may not generalize to other EDs. We do not see this as problematic as more widespread dissemination 
first requires some data on the impact of a PrEP screening, initiation and linkage program in the ED setting.  
We anticipate that the results from this study will set the foundations for a future multicenter R01 that will 
specific address generalizability. 
18.0 ADVERSE EVENT REPORTING AND PROCEDURES
18.1 Definition of Adverse Events and Serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in humans, whether or not considered study 
medication related which occurs during the conduct of the clinical trial. Any change from baseline in clinical 
status, ECGs, lab results, x-rays, physical examination, etc., that is considered clinically significant by the PI 
are considered AEs. 
Suspected adverse reaction is any adverse event for which there is a reasonable possibility that the study 
medication caused the adverse event. A reasonable possibility implies that there is evidence that the study 
medication caused the event.
Adverse reaction is any adverse event caused by the study medication.
An adverse event, suspected adverse reaction, or adverse reaction is considered “serious” if, in the view 
of the PI it:
1) Results in a death
2) Is life-threatening
3) Requires inpatient hospitalization or prolongation of existing hospitalization
4) Results in persistent or significant incapacity of substantial disruption of the ability to conduct normal life 
functions
5) Is an important medical event that may not result in one of the above outcomes, but may jeopardize the 
health of the study participant or require medical or surgical intervention to prevent one of the outcomes 
listed in the above definition of serious event.
Effective Date: 4/20/2021
End Date: 3/18/2022

18.2 Definition of Expectedness
Any adverse event is considered “unexpected” if it is not listed in the package insert or is not listed at the 
specificity or severity that has been observed.
18.3 Medical and Psychiatric History
A thorough review of the participant’s medical and psychiatric history of any chronic, acute, or intermittent 
preexisting or current illness, diseases, symptoms, or laboratory signs should be undertaken to avoid reporting 
pre-existing conditions as new AEs and to assist in the assessment of worsening in intensity or severity of 
these conditions that would indicate an AE. Stable chronic conditions which are present prior to clinical trial 
entry and do not worsen are not considered AEs. 
18.4 Adverse Event Reporting
Appropriately qualified and trained personnel will elicit participant reporting of AEs and SAEs (Appendix 10) at 
each follow-up assessment. Study personnel will obtain as much information as possible about the reported 
AE/SAE to complete the AE/SAE forms and will consult with the PI as necessary.
Standard reporting, within 7 days of the site becoming aware of the event, will be required for all AEs.  
Expedited reporting (within 24 hours of their occurrence and/or site’s knowledge of the event) is required for 
reportable SAEs.  
Reportable adverse events will be followed until resolution, stabilization or study end.
18.5 PIs Role in Assessing Severity and Causality of Adverse Events
The PI will conduct an initial assessment of the serious, severity and causality when eliciting participant 
reporting of adverse events.  
18.6 Guidelines for Assessing Severity
The severity of an adverse event refers to the intensity of the event defined by CDISC SDTM Severity Intensity 
Scale for Adverse Event:
18.7 Guidelines for Determining Causality
The PI will use the following question when assessing causality of an adverse event to study medication where 
an affirmative answer designates the event as a suspected adverse reaction:
Effective Date: 4/20/2021
End Date: 3/18/2022

Is there a reasonable possibility that the study medication caused the event?
18.8 Site’s Role in Monitoring Adverse Events
Staff education, re-training, or appropriate corrective action plan will be implemented as needed in response to 
reported AEs and SAEs.
18.9 Participant Withdrawal
The PI will apply his/her judgement to determine whether or not an adverse event is of sufficient severity to 
require that the participant be withdrawn from further study medication. A participant may also voluntarily 
withdraw from treatment due to what he/she perceives as an intolerable adverse event or for any other reason. 
If voluntary withdrawal is requested within the first 14-day and the patient was assigned to the iPrEP arm, the 
participant will be asked to complete an end-of-study medication visit to return unused medication and 
document end-of-medication outcomes. 
19.0 Overall Structure of the Team
Research Team: The research team is comprised of experts in ED based public health program development 
and implementation. A project manager from the Mount Sinai Hospital Department of Emergency Medicine will 
provide administrative support. A TBN RA will undergo extensive training with the PI and the New York City 
Department of Health and Mental Hygiene (NYC DoHMH) to understand how to recruit, enroll and counsel the 
patients participating in this study. A TBN biostatistician will provide statistical support and analysis of the 
proposed studies.  
Research Associate Training: RAs will undergo two weeks of training that includes both didactic course work 
and shadowing. The didactic course work is offered by the New York City Department of Health and Mental 
Hygiene through the Training and Technical Assistance Program. Required courses for the RAs will include 
Understanding HIV infection, diagnosis and treatment (1-day), PEP, PrEP and Other Biomedical Interventions 
(1-day), Best Practices in PrEP/PEP Education & Counseling (1-day), Fundamentals of HIV Prevention 
Counseling (2-days) and Motivational Interviewing (2-day) and Improving linkage to care using the “ARTAS” 
model (2-days).76 Didactic training will occur in the first two months of the grant. RAs will shadow Dr. Salomon 
for 1 week prior to the start of the RCT to familiarize themselves with linkage pathways and mechanisms, PrEP 
counseling, adherence counseling and risk reduction counseling
20.0 Interventions
Intervention Type
Randomized Controlled Clinical Trial
Name
Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED 
Trial)
Description
Compare the impact of immediate PrEP initiation in the Emergency Department 
by providing a PrEP “starter pack” with facilitated linkage to care versus 
facilitated linkage to care for out-patient PrEP initiation within 14 days of the 
Emergency Department visit. 
21.0 Outcome measures
Secondary Outcome 1:
Retention in PrEP care at 30, 60, and 90 days post PrEP index visit
Type
Secondary
Time frame
30, 60 and 90 days
Brief description
# of patients retained in care at 30, 60 and 60-days post-PrEP initiation
Secondary Outcome 2: 
PrEP usage post PrEP index visit
Effective Date: 4/20/2021
End Date: 3/18/2022

Type
Secondary
Time frame
30, 60 and 90 days
Brief description
# of patients still using PrEP at 30 and 60-days post PrEP initiation
Secondary Outcome 3:
PrEP adherence at follow up post PrEP index visit
Type
Secondary
Time frame
30, 60, 90 days
Brief description
Level of adherence to PrEP at 30, 60, 90-days post PrEP initiation
Secondary Outcome 4: 
Risk behavior post PrEP index visit
Type
Secondary
Time frame
30, 60, 90 days
Brief description
HIV risk behaviors at 30, 60, 90-days post PrEP initiation
Secondary Outcome 5: 
STI diagnoses post PrEP index visit
Type
Secondary
Time frame
30, 60, 90 days
Brief description
# and type of STI diagnosed at 30 and 90-day post PrEP initiation visits
Secondary Outcome 6: 
HIV infection
Type
Secondary
Time frame
90-days
Brief description
# of new HIV infections, if any, at 90-days post PrEP initiation
Secondary Outcome 7: 
Program Satisfaction
Type
Secondary
Time frame
90-days
Brief description
Program satisfaction at 30, 60 and 90-day follow-up
22.0 FDA Regulated Intervention
For this intervention, we do not require an Investigational New Drug application to the FDA.  
Emtricitabine/tenofovir disoproxil fumarate and emtricitabine and tenofovir alafenamide are both FDA approved 
for Pre-Exposure Prophylaxis for HIV and meet all of the requirements for an IND exemption as described in 
21 CFR 312.2(b).  These include: 
1) The drug product is lawfully marketed in the United States.
2) The investigation is not intended to be reported to FDA as a well-controlled study in support of a new 
indication and there is no intent to use it to support any other significant change in the labeling of the drug.
3) In the case of a prescription drug, the investigation is not intended to support a significant change in the 
advertising for the drug.
4) The investigation does not involve a route of administration, dose, patient population, or other factor that 
significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug 
product (21 CFR 312.2(b) (1) (iii)).
5) The investigation is conducted in compliance with the requirements for review by an IRB (21 CFR part 56) 
and with the requirements for informed consent (21 CFR part 50). 
6) The investigation is conducted in compliance with the requirements of § 312.7 (i.e., the investigation is not 
intended to promote or commercialize the drug product).
Effective Date: 4/20/2021
End Date: 3/18/2022

23.0 Dissemination Plan
23.1 Clinicaltrials.gov Requirements
This project includes applicable clinical trials which require registration in ClinicalTrials.gov. In accordance with 
Public Law 110-85 the trials will be registered with clinicaltrials.gov prior to the enrollment of the first 
participant. Reporting of summary results will occur no later than 1 year after the completion date of the last 
enrolled participant. All grant and progress report forms shall include a certification that the responsible party 
has made all required submissions to ClinicalTrials.gov. The responsible party for all clinicaltrials.gov reporting 
will be the PI, Dr. Cowan.
23.2 Informed consent 
A description of this clinical trial will be available on the website, http://www.ClinicalTrials.gov, as required by 
U.S. Law. The National Institutes of Health (NIH) encourages all researchers to post their research. This Web 
site will not include information that can identify you. At most, the Web site will include a summary of the 
results. You can search the Web site at any time.
23.3 Translation Plan
We plan on publishing 3-5 manuscripts in peer-reviewed health science journals to disseminate the results of 
the proposed project and present our findings at professional conferences both regionally and nationally. Once 
this study is completed and data analyzed we will submit and R01 for a multicenter RCT to provide definitive 
evidence regarding the impact of an emergency department-based program for PrEP screening, initiation and 
linkage program in the ED setting.
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72. Mikati T, Jamison K, Daskalakis D. Immediate PrEP initiation at New York City sexual health clinics. 2019:
73. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: 
combining elements of clinical effectiveness and implementation research to enhance public health impact. 
Med Care. Mar 2012;50(3):217-26. doi:10.1097/MLR.0b013e3182408812
74. Bogoch II, Scully EP, Zachary KC, et al. Patient attrition between the emergency department and clinic 
among individuals presenting for HIV nonoccupational postexposure prophylaxis. Clin Infect Dis. Jun 
2014;58(11):1618-24. doi:10.1093/cid/ciu118
75. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture 
(REDCap)â€”a metadata-driven methodology and workflow process for providing translational research 
informatics support. Journal of biomedical informatics. 2009;42(2):377-381. 
76. M TATAP. 
https://static1.squarespace.com/static/57619bd2e32140ad3ec230fc/t/5a612ee3f9619a4f3c65e1d2/151631843
7322/T-TAP+Training+Descriptions%2C+November+2017.pdf. 
Effective Date: 4/20/2021
End Date: 3/18/2022

APPENDIX
Appendix 1: Locator Form
Name: _____________________________   ____
 __________________________
First
       MI
Last
Nick Name (s):
_______________________________________________
2. Age:  _____
Date of Birth:  ______/______/_______
3. MRN:_________________________
4. Where do you currently live?
Address
____________________________________________________
____________________________________________________
Apt No.: ___________
City
________________________________ State  ___________
Zip Code: __________
Type of dwelling: _______________________________________________________
Whose place is it?  ______________________________________________________
Name
Relationship
5. Is this the best address where we can send you information?
Address
_________________________________________
____________________________________________________
Apt No.: ___________
City
________________________________ State  ___________
Zip Code: __________
6. What is the best way we should contact you by?
   Regular mail
   Email
   Phone
   Text
7. Primary phone number:  (______)______________________
  Cell        Work        Home
Share phone?    No 
  Yes
 With whom?  ______________________________
If we leave a message for you, what can we say? OK to text?    Yes       No
Mount Sinai BI   
Hospital   
Navigator   
Other:     _________________________________________________________________
8. OK to text primary number?    Yes       No
9. Alternative phone number:  (______)______________________
  Cell        Work        Home
If we leave a message for you, what can we say?
Mount Sinai BI   
Hospital   
Navigator   
Other:     _________________________________________________________________
10.   OK to text alternative number?    Yes       No
11.
Email address:  ______________________________________________________________
Yes     (skip to Q6)
No      (complete address below)
Effective Date: 4/20/2021
End Date: 3/18/2022

12. Which of the above is the best way to reach you quickly, if necessary?
Specify:  _______________________________________________
13. May we contact you at work? 
  Yes
  No
  Not working
Name of employer:   ____________________________________________________
Work Address:  ________________________________________________________
City:  ___________________________  State:  ______   Zip:  _________
Phone:  ___________________________________
Can we leave a message at this number?
  Yes
  No
If yes, what can we say?
Mount Sinai BI   
Hospital   
Navigator   
Other:     ______________________________________________________________
14.     OK to text work number?    Yes       No
SECONDARY CONTACT INFORMATION: Parent, sister/brother, other relative, good friend, 
neighbor, case worker/social worker or counselor.  If not in contact with the person within the last 
month, ask for another contact. 
CONTACT #1
14.     Name:
___________________________________________  
Address:__________________________________________________________________
Phone: 
(______)__________________________
What is your relationship to this person?
____________________________
If we leave a message with them for you, what can we say?
Mount Sinai BI   
Hospital   
Navigator   
Other:     _________________________________________________________________
CONTACT #2
15.    Name:
___________________________________________   
Address:__________________________________________________________________
Phone: 
(______)__________________________
What is your relationship to this person?
____________________________
If we leave a message with them for you, what can we say?
Mount Sinai BI   
Hospital   
Navigator   
Other:   _____________________________________________________________
Appendix 2: Satisfaction Measure
Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED)
Satisfaction and Acceptability Measures
Overall satisfaction with the screening procedures
Effective Date: 4/20/2021
End Date: 3/18/2022

How inconvenient did you find today’s screening procedures?
Not 
Inconvenient
0
1
2
3
4
5
Very 
Inconvenient
6
Prefer not 
to answer
How difficulty did you find today’s screening procedures?
Not at all 
difficult
0
1
2
3
4
5
Very 
Difficult
6
Prefer not 
to answer
How satisfied were you with today’s screening process?
Very 
dissatisfied
0
1
2
3
4
5
Very 
satisfied
6
Prefer not 
to answer
Appendix 3: Attitudes Towards PrEP 
Attitudes toward future PrEP usage
What effect do you think being screened today in the Emergency Department will have on your future PrEP 
use?
Less 
likely to 
start 
PrEP
0
1
2
No effect 
on future 
PrEP use 
3
4
5
More 
Likely to 
start 
PrEP
6
Prefer not 
to answer
Would you be interested in starting PrEP today if we were able to give you the medications in the Emergency 
Department
Would 
not be 
interested 
in 
starting 
today
0
1
2
3
4
5
Would 
start 
medication 
today if 
available
6
Prefer not 
to answer
Effective Date: 4/20/2021
End Date: 3/18/2022

W hat d o y o u t hi n k a b o ut a n oral HI V pre ve nti o n met h o d?
W h at d o y o u t hi n k y o u mi g ht li k e a b o ut a n or al m et h o d ? C h ec k all t h at a p ply.
 N ot hi n g
 M a y pr ot ect a g ai nst HI V
 E asi er t o us e t h a n ot h er m et h o ds ( e. g., c o n d o ms)
 C a n b e us e d discr e etl y, wit h o ut a p art n er’s k n o wl e d g e
 D o es n ot i nt err u pt s ex
 E asil y r e v ersi bl e
 Ot h er, s p ecif y: _ _ _ _ _ _ _ _ _
 Pr ef er n ot t o a ns w er
W hat c o ncer ns d o y o u ha ve a b o ut a n oral HI V pre ve nti o n met h o d?
 N o n e
 M a y n ot pr ot ect a g ai nst HI V
 M a y c a us e h ar mf ul si d e eff ects
 R e q uir es t a ki n g a d ail y pill
 C a n n ot b e us e d discr e etl y, wit h o ut a p art n er’s k n o wl e d g e
 C ost m a y b e u n aff or d a bl e
 Ot h er, s p ecif y: _ _ _ _ _
 Pr ef er n ot t o a ns w er
A p p e n di x 4: C S B Q
C D C Se x ual Be ha vi or Q uesti o ns ( C S B Q) 
FI R S T TI E R Q U E S TI O N S 
T he ne xt q uesti o ns are a b o ut y o ur se x ual be ha vi or. B y se x we mea n oral, va gi nal, or a nal se x, b ut N O T 
mast ur bati o n. W he n we tal k a b o ut c o n d o ms, we mea n b ot h male as well as fe male c o n d o ms. 
 
1. D uri n g t he past 1 2 m o nt hs, ha ve y o u ha d se x? 
Yes [ 1] N o [ 2] S KI P t o E N D  Ref use d [ 9] S KI P t o E N D 
[ N H S D A] 
 
2. D uri n g t he past 1 2 m o nt hs, wit h h o w ma n y pe o ple ha ve y o u ha d se x? 
N u m ber [...] D o n’t k n o w / N ot s ure [e nter 7 7 7] Ref use d [e nter 9 9 9] 
[ B R F S S; N H S D A] 
 
3. D uri n g t he past 1 2 m o nt hs, ha ve y o u ha d se x wit h o nl y males, o nl y fe males, or wit h b ot h males a n d fe males? 
O nl y males [ 1]  O nl y fe males [ 2]  B ot h males a n d fe males [ 3] Ref use d [ 9] 
[ N H S D A] 
 
4. N o w, t hi n ki n g bac k a b o ut t he last ti me y o u ha d se x, di d y o u or y o ur part ner use a c o n d o m? Yes [ 1]  N o [ 2]  
Ref use d [ 9] 
Eff e cti v e D at e: 4/ 2 0/ 2 0 2 1
E n d D at e: 3/ 1 8/ 2 0 2 2

[NHSDA; BRFSS; YRBS] 
  
5. I’m going to read you a list. When I’m done, please tell me if any of the situations apply to you. You don’t 
need to tell me which one. 
 You have used intravenous drugs in the past year  You have been treated for a sexually transmitted disease or 
venereal disease in the past year  You tested positive for having HIV, the virus that causes AIDS  You have had 
more than one sex partner in the past year  During the past 12 months you have given or received money or 
drugs in exchange for sex 
  
Do any of these situations apply to you? 
 
Yes [1] No [2]  Refused [9] 
[BRFSS, adapted] 
 
END OF FIRST TIER QUESTIONS 
 
ALTERNATE FIRST TIER QUESTIONS 
 
The next questions are about your sexual behavior. By sex we mean oral, vaginal, or anal sex, but NOT 
masturbation. When we talk about condoms, we mean both male as well as female condoms. 
 
1. During the past 12 months, have you had sex? 
Yes [1] No [2] SKIP to END  Refused [9] SKIP to END 
[NHSDA] 
 
2. During the past 12 months, with how many people have you had sex? 
Number [...] Don’t know / Not sure [enter 777] Refused [enter 999] 
[BRFSS; NHSDA] 
 3. During the past 12 months, have you had sex with only males, only females, or with both males and 
females? 
Only males [1]  Only females [2]  Both males and females [3] Refused [9] 
[NHSDA] 
 
4. I’m going to read you a list. When I’m done, please tell me if any of the situations apply to you. You don’t 
need to tell me which one. 
 You have used intravenous drugs in the past year  You have been treated for a sexually transmitted disease or 
venereal disease in the past year  You tested positive for having HIV, the virus that causes AIDS  You have had 
more than one sex partner in the past year  During the past 12 months you have given or received money or 
drugs in exchange for sex 
Do any of these situations apply to you? 
 
Yes [1] No [2]  Refused [9] 
[BRFSS, adapted] 
 
The next questions are about sex with a main partner. 
 
5. In the past 12 months have you had sex with someone who you consider to be your main sex partner, that is a 
partner who you feel committed to above anyone else? 
Yes [1]  No [2] SKIP to QUESTION 8 Refused [9] SKIP to QUESTION 8 
[NHSDA- Adapted] 
 
Effective Date: 4/20/2021
End Date: 3/18/2022

If you had more than one main partner during the past 12 months, we would like you to think of the main 
partner you had last sex with.  
6. Is this person a man or a woman? 
Man [1]  Woman [2]  Refused [9] 
 
7. Now, thinking back about the last time you had sex, did you or your partner use a condom? 
Yes [1]  No [2]  Refused [9] 
[NHSDA; BRFSS; YRBS] 
 
8. In the past 12 months, have you had sex with someone who is not your main partner or whom you did not 
consider to be your main partner at the time? 
Yes [1]  No [2] SKIP to END Refused [9] SKIP to END 
For the next series of questions, think back to the last time you had sex with someone who is/was not your main 
partner. 
9. Is this person a man or a woman? 
Man [1]  Woman [2]  Refused [9] 
 
10. Now, thinking back about the last time you had sex, did you or your partner use a condom? 
Yes [1]  No [2]  Refused [9] 
[NHSDA; BRFSS; YRBS]  
END OF ALTERNATE FIRST TIER QUESTIONS 
 
 
SECOND TIER QUESTIONS 
 
The next questions are about your sexual behavior. By sex we mean oral, vaginal, or anal sex, but NOT 
masturbation. When we talk about condoms, we mean both male as well as female condoms. 
 
1. During the past 12 months, have you had sex? 
Yes [1] No [2] SKIP to END  Refused [9] SKIP to END 
[NHSDA] 
2. During the past 12 months, with how many people have you had sex? 
Number [...] Don’t know / Not sure [enter 777] Refused [enter 999] 
[BRFSS; NHSDA] 
 
3. During the past 12 months, have you had sex with only males, only females, or with both males and females? 
Only males [1]  Only females [2]  Both males and females [3] Refused [9] 
[NHSDA] 
 
4. During the past 12 months, has a doctor or other health professional told you that you had a sexually 
transmitted disease, or STD, for example, herpes, gonorrhea, chlamydia, genital warts? 
Yes [1] No [2] Don’t know / Not sure [7] Refused [9] 
[HITS] 
5. Have you ever been told by a doctor of other health professional that you were infected with HIV or that you 
have AIDS? 
Yes [1] No [2] Don’t know / Not sure [7] Refused [9] [RBA, adapted] 
 
6. During the past 12 months, have you given drugs in exchange for sex or received drugs in exchange for sex ? 
By sex we mean vaginal, oral, or anal sex. 
Yes [1] No [2] Refused [9] 
[NHSDA] 
 
Effective Date: 4/20/2021
End Date: 3/18/2022

7. During the past 12 months, have you given money in exchange for sex or received money in exchange for 
sex? By sex we mean vaginal, oral, or anal sex. 
Yes [1] No [2] Refused [9] 
[NHSDA; Some surveys have combined questions 6 and 7, for example: In the past 12 months, have you given 
or taken money or drugs in exchange for sex? (NHIS-Supplement)] 
**If respondent is female: SKIP to SECOND TIER QUESTION 26** 
[MALE RESPONDENTS ONLY] 
The next questions are about sex with a main partner. 
8. In the past 12 months have you had sex with someone who you consider to be your main sex partner, that is a 
partner who you feel committed to above anyone else? 
Yes [1]  No [2] SKIP to QUESTION 42 Refused [9] SKIP to QUESTION 42 
[NHSDA- Adapted] 
 
If you had more than one main partner during the past 12 months, we would like you to think of the main 
partner you had last sex with. 
 
 
9. When was the first time you had sex with your main partner? 
__ __/__ __ __ __ (month/year) 
 
10. When was the last time you had sex with your main partner? 
__ __/__ __ __ __ (month/year) 
11. Is this person a man or a woman? 
Man [1]  Woman [2]  Refused [9]  
**If partner is male (Question 11= 1), then SKIP to QUESTION 16 
12. The last time you had sex with your main partner, did you have vaginal sex, where your penis entered your 
partner’s vagina? 
Yes [1] No [2] SKIP to QUESTION 14 Refused [9] SKIP to QUESTION 14 
13. Was a condom used? 
Yes [1] No [2] Refused [9] 
 
14. The last time you had sex with your main partner, did you have oral sex, where your mouth touched your 
partner’s vagina? 
Yes [1] No [2] SKIP to QUESTION 16 Refused [9] SKIP to QUESTION 16 
15. Was a barrier (dental dam, plastic wrap, etc) used? 
Yes [1] No [2]  Refused [9]  
16. The last time you had sex with your main partner, did you have oral sex, where your penis entered your 
partner’s mouth? 
Yes [1] No [2] SKIP to QUESTION 18 Refused [9] SKIP to QUESTION 18  
17. Was a condom used? 
Yes [1] No [2] Refused [9] 
 
18. The last time you had sex with your main partner, did you have anal sex, where your penis entered your 
partner’s anus (butt)? 
Yes [1] No [2] SKIP to QUESTION 20 Refused [9] SKIP to QUESTION 20 
19. Was a condom used? 
Yes [1] No [2] Refused [9] 
**If main partner is female (Question 11 = 2) , then SKIP to QUESTION 24 ** 
20. The last time you had sex with your main partner did you have anal sex where your partner’s penis entered 
your anus (butt)? 
Yes [1] No [2] SKIP to QUESTION 22 Refused [9] SKIP to QUESTION 22 
21. Was a condom used? 
Effective Date: 4/20/2021
End Date: 3/18/2022

Yes [1] No [2] Refused [9] 
22. The last time you had sex with your main partner, did you have oral sex, where your partner’s penis entered 
your mouth? 
Yes [1] No [2] SKIP to QUESTION 24 Refused [9] SKIP to QUESTION 24 
23. Was a condom used? 
Yes [1]  No [2]  Refused [9]  
 
 
24. The last time you had sex with your main partner, were you under the influence of  alcohol? Yes [1]  No [2]  
Refused [9]  [modified from NHSLS] 
 
25. The last time you had sex with your main partner, had you been using drugs to get  high before or during 
sex? 
Yes [1] SKIP to QUESTION 42 No [2] SKIP to QUESTION 42 Refused [9] SKIP to QUESTION 42 
[modified from NHSLS] 
[FEMALE RESPONDENTS] 
The next questions are about sex with a main partner. 
26. In the past 12 months have you had sex with someone who you consider to be your main sex partner, that is 
a partner who you feel committed to above anyone else? 
Yes [1]  No [2] SKIP to QUESTION 60 Refused [9] SKIP to QUESTION 60 
[NHSDA- Adapted] 
 
27. When was the first time you had sex with your main partner? 
__ __/__ __ __ __ (month/year) 
 
28. When was the last time you had sex with your main partner? 
__ __/__ __ __ __ (month/year) 
29. Is this person a man or a woman? 
Man [1]  Woman [2]  Refused [9] 
**If partner is female (Question 29 = 2), then SKIP to QUESTION 36** 
 
 
30. The last time you had sex with your main partner, did you have vaginal sex, where your partner’s penis 
entered your vagina? 
Yes [1] No [2] SKIP to QUESTION 32  Refused [9] SKIP to QUESTION 32 
  
31. Was a condom used? 
Yes [1] No [2] Refused [9] 
32. The last time you had sex with your main partner, did you have oral sex, where your partner’s penis entered 
your mouth? 
Yes [1] No [2] SKIP to QUESTION 34 Refused [9] SKIP to QUESTION 34 
33. Was a condom used? 
Yes [1] No [2] Refused [9] 
34. The last time you had sex with your main partner, did you have anal sex, where your partner’s penis entered 
your anus (butt)? 
Yes [1] No [2] SKIP to QUESTION 36 Refused [9] SKIP to QUESTION 36 
 
35. Was a condom used? 
Yes [1] No [2] Refused [9] 
36. The last time you had sex with your main partner, did you have oral sex, where your partner’s mouth 
touched your vagina? 
Yes [1] No [2] SKIP to QUESTION 38 Refused [9] SKIP to QUESTION 38 
Effective Date: 4/20/2021
End Date: 3/18/2022

 
 
37. Was a barrier (dental dam, plastic wrap, etc) used? 
Yes [1] No [2] Refused [9]  
If partner is male (Question 29 = 1), then SKIP to QUESTION 40 
 
38. The last time you had sex with your main partner, did you have oral sex, where your mouth touched your 
partner’s vagina? 
Yes [1] No [2] SKIP to QUESTION 60 Refused [9] SKIP to QUESTION 60 
 
39. Was a barrier (dental dam, plastic wrap, etc) used? 
Yes [1] No [2] Refused [9] 
 
40. The last time you had sex with your main partner, were you under the influence of  alcohol? Yes [1]  No [2]  
Refused [9]  [modified from NHSLS] 
41. The last time you had sex with your main partner, had you been using drugs to get  high before or during 
sex? 
Yes [1] SKIP to QUESTION 60 No [2] SKIP to QUESTION 60 Refused [9] SKIP to QUESTION 60 
[modified from NHSLS] 
[MALE RESPONDENTS ONLY] 
The next series of questions are about sex with someone who is/was not your main partner. 
42. In the past 12 months, have you had sex with someone who is not your main partner or whom you did not 
consider to be your main partner at the time? 
Yes [1]  No [2] SKIP to END Refused [9] SKIP to END 
 For the next series of questions, think back to the last time you had sex with someone who is/was not your 
main partner. 
 
43. When was the first time you had sex with this partner? 
__ __/__ __ __ __ (month/year) 
 
44. When was the last time you had sex with this partner? 
__ __/__ __ __ __ (month/year) 
 
45. Is this person a man or a woman? 
Man [1]  Woman [2]  Refused [9] 
 
**If partner is male (Question 45 = 1), then SKIP to QUESTION 50** 
46. The last time you had sex with this partner, did you have vaginal sex, where your penis entered your 
partner’s vagina? 
Yes [1] No [2] SKIP to QUESTION 48  Refused [9] SKIP to QUESTION 48 
47. Was a condom used? 
Yes [1] No [2] Refused [9] 
 
48. The last time you had sex with this partner, did you have oral sex, where your mouth touched your partner’s 
vagina? 
Yes [1] No [2] SKIP to QUESTION 50 Refused [9] SKIP to QUESTION 50 
 
49. Was a barrier (dental dam, plastic wrap, etc) used? 
Yes [1] No [2] Refused [9] 
50. The last time you had sex with this partner, did you have oral sex, where your penis entered your partner’s 
mouth?  Yes [1] No [2] SKIP to QUESTION 52 Refused [9] SKIP to QUESTION 52  
Effective Date: 4/20/2021
End Date: 3/18/2022

51. Was a condom used? 
Yes [1] No [2] Refused [9] 
 
52. The last time you had sex with this partner, did you have anal sex, where your penis entered your partner’s 
anus (butt)? 
Yes [1] No [2] SKIP to QUESTION 54 Refused [9] SKIP to QUESTION 54 
53. Was a condom used? 
Yes [1] No [2] Refused [9] 
**If partner is female (Question 45 = 2), then SKIP to QUESTION 58.** 
 
54. The last time you had sex with this partner did you have anal sex where your partner’s penis entered your 
anus (butt)? 
Yes [1] No [2] SKIP to QUESTION 56 Refused [9] SKIP to QUESTION 56 
 
55. Was a condom used? 
Yes [1] No [2] Refused [9] 
 
56. The last time you had sex with this partner, did you have oral sex, where your partner’s penis entered your 
mouth? 
Yes [1] No [2] SKIP to END Refused [9] SKIP to END 
 57. Was a condom used? 
Yes [1] SKIP to END No [2] SKIP to END Refused [9] SKIP to END 
 
58. The last time you had sex with this partner, were you under the influence of alcohol? Yes [1]  No [2]  
Refused [9]  [modified from NHSLS] 
59. The last time you had sex with this partner, had you been using drugs to get high  before or during sex? 
Yes [1] SKIP to END No [2] SKIP to END Refused [9] SKIP to END 
[modified from NHSLS] 
[FEMALE RESPONDENTS] 
The next series of questions are about sex with someone who is/was not your main partner. 
60. In the past 12 months, have you had sex with someone who is not your main partner or whom you did not 
consider to be your main partner at the time? 
Yes [1]  No [2] SKIP to END Refused [9] SKIP to END 
61. When was the first time you had sex with your main partner? 
__ __/__ __ __ __ (month/year) 
 
62. When was the last time you had sex with your main partner? 
__ __/__ __ __ __ (month/year) 
 
63. Is this person a man or a woman? 
Man [1]  Woman [2]  Refused [9] 
 **If partner is female (Question 63 = 2), then SKIP to QUESTION 70.** 
64. The last time you had sex with this partner, did you have vaginal sex, where your partner’s penis entered 
your vagina? 
Yes [1]  No [2] SKIP to QUESTION 66 Refused [9] SKIP to QUESTION 66 
 
65. Was a condom used? 
Yes [1] No [2] Refused [9] 
 
Effective Date: 4/20/2021
End Date: 3/18/2022

66. The last time you had sex with this partner, did you have oral sex, where your partner’s penis entered your 
mouth? 
Yes [1] No [2] SKIP to QUESTION 68 Refused [9] SKIP to QUESTION 68 
 
67. Was a condom used? 
Yes [1] No [2] Refused [9] 
 
68. The last time you had sex with this partner, did you have anal sex, where your partner’s penis entered your 
anus (butt)? 
Yes [1] No [2] SKIP to QUESTION 70 Refused [9] SKIP to QUESTION 70  
69. Was a condom used? 
Yes [1] No [2] Refused [9]  
70. The last time you had sex with this partner, did you have oral sex, where your partner’s mouth touched your 
vagina? 
Yes [1] No [2] SKIP to QUESTION 72 Refused [9] SKIP to QUESTION 72 
 71. Was a barrier (dental dam, plastic wrap, etc) used? 
Yes [1] No [2] Refused [9] 
 
**If partner is male (Question 63 =1), then SKIP to QUESTION 74.** 
 
72. The last time you had sex with this partner, did you have oral sex, where your mouth touched your partner’s 
vagina? 
Yes [1] No [2] SKIP to QUESTION 74 Refused [9] SKIP to QUESTION 74 
73. Was a barrier (dental dam, plastic wrap, etc) used? 
Yes [1] No [2] Refused [9] 
 
74. The last time you had sex with this partner, were you under the influence of alcohol? 
Yes [1]  No [2]  Refused [9] 
[modified from NHSLS] 
75. The last time you had sex with this partner, had you been using drugs to get high before or during sex? 
Yes [1]  No [2]  Refused [9] 
[modified from NHSLS] 
Appendix 5: PrEP Screening for Substantial Risk and Eligibility (ICAP)
Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and 
Eligibility
1.  Facility Information
Facility Name
Date of Initial Client Visit (dd/mm/yyyy)   __ __ /__ __ 
/__ __ __ __ 
Person Completing Form 
2. Client Information 
First Name 
Middle Name
Surname
Address 
Telephone #
Effective Date: 4/20/2021
End Date: 3/18/2022

Client ID Number
3.  Client Demographics
What was your sex at birth?
  Male             
  Female               
  Other (specify): 
___________
  No response
What is your current gender?
  Male             
  Female        
  Transgender (male to female)             
  Transgender 
(female to male) 
  Other (specify): ___________
  No response
What is your age? (Specify 
number of years.)
_______ 
4.  Screening for Substantial Risk for HIV Infection
Client is at substantial risk if he/she belongs 
to categories , ,  or  below
Question Prompts for Providers
If client is sexually active in a high HIV 
prevalence population PLUS reports ANY 
one of the below in the last 6 months
Have you been sexually active in the last 6 
months?
Reports vaginal or anal intercourse 
without condoms with more than one 
partner
In the last 6 months, how many people did you have 
vaginal or anal sex with?
In the last 6 months, did you use condoms 
consistently during sex? 
Has a sex partner with one or more 
HIV risk: 
In the last 6 months, have you had a sex partner 
who:
Is living with HIV?   
Injects drugs?
Has sex with men?
Is a transgender person?
Is a sex worker?
Has sex with multiple partners without 
condoms?
Effective Date: 4/20/2021
End Date: 3/18/2022

History of a sexually transmitted 
infection (STI)  
based on self-report, lab test, syndromic 
STI treatment
In the last 6 months, have you had an STI?
History of use of post-exposure 
prophylaxis (PEP) 
In the last 6 months, have you taken post-
exposure prophylaxis (PEP) following a potential 
exposure to HIV?
If client reports history of sharing 
injection material or equipment in the 
last 6 months
History of sharing injection material 
or equipment
In the last 6 months, have you shared injecting 
material 
with other people?
 If client reports having a sexual partner 
in the last 6 months who is HIV positive 
AND who has not been on effective* HIV 
treatment  (i.e., the partner has been on 
ART for fewer than 6 months or has 
inconsistent or unknown adherence)
History of HIV-positive sex partner 
not on effective treatment
Is your partner HIV positive? 
Is he/she on ART? 
What was the last viral load result?
5.  PrEP Eligibility 
Client is eligible if 
he/she fulfills ALL the 
criteria below:
HIV negative
Date client tested: (dd/mm/yyyy): 
__ __ /__ __ /__ __ __ __
Date client received test results: (dd/mm/yyyy): 
__ __ /__ __ /__ __ __ 
__ 
Test result:  
  Negative     
                      
  Positive (Refer to HIV medical care.)     
                      
  Inconclusive  (Re-test in 14 days.)     
Effective Date: 4/20/2021
End Date: 3/18/2022

Type of test used:  
 Determine    
 Unigold     
 ELISA    
 
Other (specify):
At substantial 
risk of HIV
At least one item/risk in Section #4 above is ticked
Has no 
signs/symptoms of 
acute HIV infection
See Section #6 below to confirm no recent exposure to HIV
Has creatinine 
clearance (eGFR) 
>60 ml/min
Result: _____________ Date of creatinine test (dd/mm/yyyy):    __ __ /__ 
__ /__ __ __ __
If all boxes in Section 5 are ticked, offer PrEP.
7. Services Received by Client
 PrEP offered.  

 PrEP accepted. 

 PrEP declined.  (If declined, see Reasons for Declining PrEP, below).
6.  Recent Exposure to HIV
Ask the client:
In the past 72 hours, have you had sex without a condom with 
someone whose HIV status is positive or not known to you, or 
have you shared injection equipment with someone whose 
HIV status is positive or unknown to you?
 Yes*
 No
 Don’t 
know
In the past 28 days, have you had symptoms of a cold or flu, 
including fever, fatigue, sore throat, headache, or muscle pain 
or soreness?
Yes*
*
 No
 Don’t 
know
* If the client reports potential exposure to HIV within past 72 hours, do NOT offer PrEP.  
Follow facility procedures to evaluate further or refer for evaluation for post-exposure 
prophylaxis (PEP). 
** If the client reports flu-like symptoms or other signs of acute HIV infection, do NOT offer 
PrEP and evaluate further, following facility procedures to diagnosis acute HIV infection. 
Effective Date: 4/20/2021
End Date: 3/18/2022

Date eligible (dd/mm/yyyy):    __ __ /__ __ /__ __ __ __
Date initiated (dd/mm/yyyy):  __ __ /__ __ /__ __ __ __  Same-day initiation recommended.
Reasons for Declining PrEP 
(Check all that apply.)
 No need for PrEP 
 Does not wish to take a daily medication
 Concerns about side effects
 Concerns about what others might think
 Concerns about time required for clinic follow-up
 Concerns about safety of medication
 Concerns about effectiveness of medication
 Other (specify): 
 Referred for PEP evaluation
 Referred for PCR/HIV Ag test or follow-up HIV re-testing (if suspicion of acute HIV 
infection) 
Appendix 6: VSQ-9
Effective Date: 4/20/2021
End Date: 3/18/2022

Appendix 7: GRIP
Appendix 8: Treatment Facility Survey
Treatment Facility Survey (ETF)
Date of assessment:
1. What type of provider/program is this?
a.
Office based provider
b. Substance use treatment program
c.
Inpatient facility
d. Other:
Effective Date: 4/20/2021
End Date: 3/18/2022

2. Was this patient engaged in a program at your facility or being treated at your office for their alcohol use 
disorder?
If “Yes”, please review and answer the following questions.
3. What was the date of their admission into your program, or if office-based, when did their care begin? 
4. Indicate the type(s) of treatment they are receiving for their alcohol use disorder:
a.
Naltrexone treatment:
i. Oral:
ii. Injectable:
b. Short-term detoxification
c.
Inpatient
d. Other: 
5. How would you categorize the level of treatment received by this patient?
a.
No care received
b. Level 1: Outpatient treatment
c.
Level 2: Intensive outpatient treatment (including partial hospitalization) 
d. Level 3: Clinically managed residential/inpatient treatment
e.
Level 4: Medically managed intensive inpatient treatment
f.
Other: 
Appendix 9: Authorized Release Form
Effective Date: 4/20/2021
End Date: 3/18/2022

Appendix 10: Adverse Event Reports
Adverse Event Report (AD1)
Adverse Event Onset Date:
Sequence number: 
Effective Date: 4/20/2021
End Date: 3/18/2022

1. Adverse event name:
2. Date site became aware of the event:
3. Severity of event (pick one):
a.
Grade 1 – Mild
b. Grade 2 – Moderate
c.
Grade 3 – Severe
4. Is there a reasonable possibility that study medication caused the event?  ☐ Yes   ☐ No
a.
If “Yes”, action taken with study medication (select one):
i. None
ii. Decreased drug
iii. Increased drug
iv. Temporarily stopped drug
v. Permanently stopped drug
vi. Participant terminated from study
5. If not caused by the study medication, alternative etiology (select one):
a.
None apparent
b. Study disease
c.
Concomitant medication
d. Other pre-existing disease or condition
e.
Accident, trauma, or external factors
f.
Concurrent illness/condition (not pre-existing)
g. Study procedures
h. Other: 
6. Outcome of event (select one):
a.
Recovering/resolving (skip question 7)
b. Recovered/resolved
c.
Recovered/resolved with sequelae
d. Not recovered/not resolved (skip question 7)
e.
Fatal (skip question 7)
f.
Unknown (skip question 7)
7. Date of resolution or medically stable:
A response of “Yes” to any of the following will designate this as a Serious Adverse Event (SAE). The 
Serious Adverse Event Summary (AD2) form should be completed for all Serious Adverse Events 
reported.
8. Was this event associated with: 
If more than one option applies, select the most serious. 
a.
Is the adverse event associated with a congenital anomaly or birth defect? 
b. Did the adverse event result in persistent or significant disability or incapacity?
c.
Did the adverse event result in death?
i. If “Yes”, date of death:
d. Did the adverse event result in initial or prolonged hospitalization for the participant?
i. If “Yes”, 
1. Date of hospital admission:
2. Date of hospital discharge:
e.
Is the adverse event life threatening?
f.
Is the adverse event an “Other serious” event (important medical event)?
Effective Date: 4/20/2021
End Date: 3/18/2022

Comments:
Study staff completing form: 
Date completed: 
Serious Adverse Event Summary (AD2)
Adverse event onset date: 
Initial narrative description of serious adverse event: 
1. Relevant past medical history:   ☐ Yes   ☐ No  ☐  Unknown 
Allergies, pregnancy, smoking and alcohol use, hypertension, diabetes, epilepsy, depression, etc.
Expand on relevant past medical history:
2. Medications at the time of event:   ☐ Yes   ☐ No  ☐  Unknown
Be sure to assess for dosage and date of last dose for the study medication, and any prior/concomitant 
medications as needed. 
Medication (Generic Name)
Indication
3. Treatments for the event:  ☐ Yes   ☐ No  ☐  Unknown
Treatment
Indication
Date Treated (mm/dd/yyyy)
4. Labs/tests performed in conjunction with this event: ☐ Yes   ☐ No  ☐  Unknown
Lab/Test
Findings
Date of Test (mm/dd/yyyy)
5. Follow-up: 
Include labs/test results as they became available, clinical changes, consultant diagnosis, etc. 
Comments:
Study staff completing form:
Date completed: 
Effective Date: 4/20/2021
End Date: 3/18/2022

Effective Date: 4/20/2021
End Date: 3/18/2022

Effective Date: 4/20/2021
End Date: 3/18/2022