Incidence of Respiratory Illness in Outpatient Healthcare Workers Who Wear Respirators or Medical Masks While Caring for Patients
Phase: NA
Conditions: Influenza, Respiratory Syncytial Viruses, Paramyxoviridae Infections, Coronavirus, Rhinovirus
Sponsor: Johns Hopkins University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Respiratory Protection Effectiveness Clinical Trial 
 
NCT01249625 
 
May, 17, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

The Respiratory Protection Effectiveness Clinical Trial-NA_00031266 Trish 
Perl, PI, 214-648-9022, Lew Radonovich, PI, 412-386-6478  
  
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The Respiratory Protection Effectiveness Clinical Trial 
Trish Perl, PI, 214-648-9022, Lew Radonovich, PI,  
  
  
Incidence of Respiratory Illness in Outpatient Healthcare Workers Who 
Wear Respirators or Medical Masks while Caring for Patients  
The Respiratory Protection Effectiveness Clinical Trial: The 
ResPECT Study  
Principal Investigators  
 
Lew Radonovich, MD  
Trish M. Perl, MD, MSc  
 
Senior Physician Scientist  
Jay P Sanford Professor of Medicine  
 
National Personal Protective Technology  
Departments of Medicine  
 
Laboratory  
UT Southwestern Medical Center  
 
National Institute for Occupational Safety and  
Dallas, TX  
 
Health  
Adjunct Professor of Medicine  
 
Centers for Disease Control and Prevention  
Johns Hopkins School of Medicine and Bloomberg   
 
626 Cochrans Mill Road   
School of Public Health  
 
Building 40, Room 109  
Baltimore, Maryland  
Pittsburgh, PA 15236   
    
Sponsors:  
CDC (DHQP), NIOSH, BARDA and VHA  
Revision:  May 17, 2018  

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Disclaimer: The opinions and concepts expressed in this document are those of the investigators and do 
not necessarily represent the official position of the Department of Veterans Affairs, the Centers for 
Disease Control and Prevention, the National Institute of Occupational Safety and Health, Johns Hopkins 
Health System, UT Southwestern Medical Center, or any other employers or affiliates of the study team.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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TABLE OF CONTENTS  
A 
INTRODUCTION ............................................................................................................................... 7  
 
A1  
STUDY ABSTRACT ............................................................................................................................... 7  
 
A2  
PRIMARY HYPOTHESIS ......................................................................................................................... 7  
B 
BACKGROUND ................................................................................................................................. 8  
 
B1  
PRIOR LITERATURE AND STUDIES ........................................................................................................... 8  
 
B2  
RATIONALE FOR THIS STUDY: THE 2009-10 H1N1 INFLUENZA PANDEMIC ......................................... 14  
C 
STUDY OBJECTIVES ........................................................................................................................ 17  
 
C1  
PROTECTIVE EFFECTS ........................................................................................................................ 17  
1.a 
Primary.................................................................................................................................... 17  
1.b 
Secondary: .............................................................................................................................. 17  
 
C2  
INCIDENCE DETERMINATION ............................................................................................................... 17  
2.a 
Primary.................................................................................................................................... 17  
2.b 
Secondary: .............................................................................................................................. 18  
D 
STUDY DESIGN AND METHODS ...................................................................................................... 18  
 
D1  
OVERVIEW ...................................................................................................................................... 18  
 
D2  
STUDY SITE SELECTION AND RANDOMIZATION SCHEME ........................................................................... 19  
 
2.a  
Cluster Randomization Scheme: Clinical Unit of Analysis and Eligibility ................................. 19  
 
D3  
STUDY SUBJECT SELECTION: ............................................................................................................... 20  
3.a 
Inclusion Criteria ..................................................................................................................... 21  
3.b 
Exclusion Criteria ..................................................................................................................... 21  
 
D4  
SUBJECT RECRUITMENT PLAN AND CONSENT PROCESS ............................................................................ 21  
 
D5  
RESPIRATORY/FACIAL PROTECTIVE DEVICES .......................................................................................... 23  
5.a 
Data on respirators and mask ................................................................................................. 23  
5.b 
Fit testing ................................................................................................................................ 24  
 
D6  
ATTITUDES AND OPINIONS ................................................................................................................. 24  
 
D7  
ADHERENCE TO RESPIRATOR OR MASK USE AND HAND HYGIENE ................................................................. 24  
 
D8  
RISKS AND BENEFITS ......................................................................................................................... 25  
 
D9  
EARLY WITHDRAWAL OF SUBJECTS/DATA/FOLLOW-UP FOR WITHDRAWN SUBJECTS .................................... 26  
 
D10  
STUDY DATA COLLECTION TOOLS ......................................................................................................... 26  
10.a 
Pre-study Inclusion/Exclusion screening ................................................................................. 27  
10.b 
Baseline Survey ....................................................................................................................... 27  
10.c 
Preliminary Survey .................................................................................................................. 27  
10.d 
Amended Fit-Testing Medical Questionnaire .......................................................................... 28  
10.e 
HSE Fit-Test Evaluation Form .................................................................................................. 28  
10.f 
Enrollment Checklist ............................................................................................................... 28  
10.g 
Weekly Diary ........................................................................................................................... 28  
10.h 
Daily Exposure Form ............................................................................................................... 28  
10.i 
Symptomatic Event Report Form ............................................................................................ 28  
10.j 
Subject Compliance Monitoring Forms ................................................................................... 29 
10.k 
Post-Study survey .................................................................................................................... 29 
10.l 
Adverse Event Submission Form ............................................................................................. 29 
 
D11  
STUDY SPECIMENS COLLECTION, TEST METHODS, STORAGE AND SHIPPING .................................................... 29 
11.a 
Blood Specimen Collection ...................................................................................................... 30 

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11.b 
Respiratory Specimen collection ............................................................................................. 30  
11.c 
Study Specimen Storage and Shipping .................................................................................... 31  
E 
STUDY PROCEDURES ..................................................................................................................... 31  
E1 CERTIFICATION AND REGISTRATION OF THE CLINICAL SITES/CLUSTERS: ........................................................ 31 E2 
SCREENING FOR ELIGIBILITY ................................................................................................................ 31  
E3 SCHEDULE OF STUDY ASSESSMENTS ..................................................................................................... 32 1) 
Pre-study Period assessments ..................................................................................................... 32 2) 
Intervention Period Assessments: ............................................................................................... 33  
 
3)  
Post-Study Period Assessments ................................................................................................... 34  
E4 SUBJECT STIPENDS OR PAYMENTS........................................................................................................ 35 E5 
STUDY TIMETABLE ............................................................................................................................ 35  
 
E6  
SAFETY AND ADVERSE EVENTS ............................................................................................................ 35  
6.a 
Definitions and Classification of Adverse Events..................................................................... 35 
i Relationship ............................................................................................................................................ 
36 
ii 
Severity 
and 
Expectedness 
..................................................................................................................... 36  
6.b 
Data Collection and Reporting Procedures for Adverse Events .............................................. 36  
6.c 
Data and Safety Monitoring Board (DSMB) ............................................................................ 37  
F 
STATISTICAL PLAN ......................................................................................................................... 38  
 
F1  STUDY OUTCOME DEFINITIONS ............................................................................................................... 38  
 
F2  STUDY OUTCOME MEASUREMENTS: ........................................................................................................ 39  
2.a 
Measurement of the Protective Effects: ................................................................................. 39  
2.b 
Incidence Determination ......................................................................................................... 39  
 
F3  EFFECT SIZE ......................................................................................................................................... 39  
 
F4  SAMPLE SIZE DETERMINATION AND POWER ............................................................................................... 39  
 
F5  STATISTICAL METHODS AND ANALYSIS PLAN .............................................................................................. 41  
 
F6  MISSING OUTCOME DATA...................................................................................................................... 42  
 
F7  PLANNED SENSITIVITY ANALYSES .............................................................................................................. 43  
7.a 
Potential outcome analysis for laboratory-confirmed influenza ............................................ 43  
7.b 
Analysis of differential withdrawal ......................................................................................... 43  
G 
DATA HANDLING AND RECORD KEEPING ....................................................................................... 43  
 
G1  
CONFIDENTIALITY AND SECURITY ......................................................................................................... 43  
 
G2  
CASE REPORT FORMS AND SOURCE DOCUMENTS ................................................................................... 44  
 
G3  
DATA MANAGEMENT ........................................................................................................................ 44  
H 
LIMITATIONS ................................................................................................................................. 45  
I 
ANTICIPATED PRODUCTS AND IMPACT ......................................................................................... 46  
 
I1  
NEW KNOWLEDGE ................................................................................................................................ 47  

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I2  
PUBLICATIONS AND REPORTS .................................................................................................................. 47  
 
I3  
SIGNIFICANCE ...................................................................................................................................... 47  
J 
STUDY ADMINISTRATION .............................................................................................................. 47  
 
J1  ORGANIZATION AND PARTICIPATING CENTERS ............................................................................................ 48 
1.a 
Study Site and the Data Coordinating Center (DCC): Johns Hopkins Health System ............... 48 
1.b 
Study Administration: the National Center for Occupational Health and Infection Control ... 50 
1.c Study Administration: North Florida Foundation for Research and Education (NFFRE): ........ 
50 
1.d 
Study Administration: Veterans Health Administration Network of Medical Facilities: ......... 50 
1.e 
Study Site: VA New York Harbor Healthcare System............................................................... 51  
1.f 
Study Site: VA Eastern Colorado Healthcare System ................................................................... 
53  
1.g 
Study Site: VA Michael E. DeBakey Medical Center ................................................................ 53  
1.h 
Study Site: VA Washington DC Medical Center ....................................................................... 55  
1.i 
Study Site: Denver Health & Hospital Authority .......................................................................... 
56  
1.j 
Study Site: Children’s Hospital Colorado ..................................................................................... 
57  
 
J2  
FUNDING SOURCE AND CONFLICTS OF INTEREST ......................................................................................... 62  
 
J3  COMMITTEES/SCIENCE BOARD ................................................................................................................ 62  
K 
PUBLICATION PLAN ....................................................................................................................... 63  
L 
REFERENCES .................................................................................................................................. 64  
M 
ATTACHMENTS .............................................................................................................................. 72  
M1 TABLES ........................................................................................................................................... 72 
Table1 Protocol Activities by Week .................................................... Error! Bookmark not defined. 
Table2 Case Definition* of Acute Respiratory Illness ..................................................................... 73 
Table3 List of potential ILI pathogens ............................................................................................ 74  
 
Table4  
Power analysis of the sensitivity to the 4-year attack rate: ............................................... 75  
M2 APPENDICES .................................................................................................................................... 78 
Appendix  A Cluster Randomization Scheme ................................................................................. 78 
Appendix  B Recruitment Flyer ....................................................................................................... 79 
Appendix  C  Inclusion/Exclusion Screening ................................................................................... 81  
Inclusion/Exclusion Screening .............................................................................................................. 81  
 
Appendix  D  
Baseline Survey .......................................................................................................... 82  
 
Appendix  E  
Pre-Study Survey ........................................................................................................ 85  
 
Appendix  F  
Daily Exposure Form (Monday, Tues, etc.)................................................................. 89  
 
Appendix  G  
Weekly Diary   ............................................................................................................ 92  
 
Appendix  H  
Post-Study Survey ...................................................................................................... 95  
 
Appendix  I  
Hand Hygiene and FPE Observation Form ................................................................. 99  
 
Appendix  J  
Explanation of exclusion from study ........................................................................ 100  
 
Appendix  K  
Certification Criteria for Study Sites ......................................................................... 101  
 
Appendix  L  
Study Timeline.......................................................................................................... 102  

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Appendix  M  
Amended Fit Testing Medical Questionnaire ........................................................... 103  
 
Appendix  N  
Symptomatic Event Report Form ............................................................................. 107  
 
Appendix  O  
Adverse Event Submission Form .............................................................................. 109  
 
Appendix  P  
Participant File Checklist .......................................................................................... 110  
 
Appendix  Q  
HSE Qualitative Fit Test Evaluation Form ................................................................ 112  
 
Appendix  R  
Supplies for Take-Home Kits .................................................................................... 114  
 
Appendix  S  
Shipping Dangerous Goods and Hazardous Materials ............................................ 115  
 
Appendix  T  
At-Home Symptomatic Upper Respiratory Swab Directions .................................... 116  
 
Appendix  U  
Take-Home Kit Packaging Information .................................................................... 120  
 
Appendix  V  
Participant Correspondence Email Templates ......................................................... 122  
 
Appendix  W  
Payment Schedule .................................................................................................... 131  
 
Appendix  X  
Swab Delivery Form ................................................................................................. 132  
 
Appendix  Y  
Patient-Based Observation Form ............................................................................. 133 
Appendix Z HandyAudit Compliance Monitoring ............................................................................... 134 
Appendix  AA Respect Study Facebook Page.................................................................................. 135 
Appendix  BB Mask Up Sample Poster ........................................................................................... 136 
 
Appendix  CC  
Supplemental Vaccination Questions ...................................................................... 137 
  
    
 

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A  Introduction  
  
A1 Study Abstract  
  
Prevention strategies are key in limiting the transmission of respiratory pathogens such as 
influenza.  Among non-pharmacologic interventions, there is intense interest in the use of 
facial protective equipment (FPE) – medical masks (MMs) or N95 respirators (N95s) - as a 
key component of personal protective equipment (PPE) when faced with seasonal influenza, 
epidemic or pandemic respiratory illness. Patient isolation, cohorting, and healthcare 
personnel (HCP) use of PPE, including FPE, have been found important. However, their 
relative protective effect is unknown, especially in the outpatient setting.  In 2003, the 
Severe Acute Respiratory Syndrome (SARS) outbreak and the role of healthcare-associated 
transmission stimulated a series of evaluations examining which interventions were critical 
in decreasing spread of this respiratory virus among HCPs. While data emerged supporting 
the use of respirators for procedures with a risk of extensive exposure to respiratory 
secretions, the need for such respiratory protection outside of these settings was not 
adequately studied. Studies from epidemic respiratory illness season in the healthcare 
setting are missing and recommendations for respiratory protection among HCPs are 
controversial and not evidence-based. Public health groups and healthcare delivery 
organizations are uncertain about appropriate respiratory protection for HCPs in the event 
of an influenza pandemic or other infectious diseases epidemic. To plan for such an 
eventuality and to best manage limited supplies of FPE, evidence is needed to guide 
planning activities and policy makers. This project aims to answer a key question about FPE 
use: How do respirators (N95s) protect HCPs in the outpatient setting against influenza, 
influenza-like illness, acute respiratory illness, and other respiratory infections and illnesses, 
as compared to medical masks (MM)? This study will have the following outcomes:  
  
• An analysis to determine the more effective facial protective equipment, N95s or MM, to 
prevent disease transmission in the outpatient setting during a seasonal influenza outbreak, 
epidemic or pandemic event.  
• An analysis of the incidence of organism-specific rates of respiratory pathogen infections 
and illnesses in the outpatient setting during influenza season.  
• Occasional secondary analysis that use de-identified or limited data sets from the 
ResPECT database to support the central objectives of the study and to extend the scope of 
the project.  
  
  
A2 Primary Hypothesis  
Null Hypotheses: The incidence of (1) laboratory confirmed influenza (LCI) or (2) influenza-like 
illness (ILI), acute respiratory illness (ARI), laboratory confirmed respiratory illness (LCRI) and 
laboratory detected respiratory infection (LDRI) will not be different between HCPs who practice 
2007 guidelines (medical masks) or 2009 guidelines (N95 respirators).    

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Alternative Hypothesis: The incidence of (1) laboratory confirmed influenza (LCI) or (2) 
influenza-like illness (ILI), acute respiratory illness (ARI), laboratory confirmed respiratory illness 
(LCRI), and laboratory detected respiratory infection (LDRI) will be different between HCPs who 
practice 2007 guidelines (medical masks) or 2009 guidelines (N95 respirators).    
  
B  Background  
  
B1 Prior Literature and Studies  
Introduction: Despite widespread use of respiratory protective equipment in the U.S. healthcare 
workplace, there is limited and inconclusive clinical evidence that respirators prevent HCP from 
airborne infectious diseases.   Scientific investigation of this issue has been quite complicated, 
primarily because the use of respirators has become "the standard of care" for protection 
against airborne diseases in some instances, even without sufficient evidence to support their 
use. The key question remains: How well do respirators prevent airborne infectious diseases?  
The answer to this important question has medical, public health, political and economic 
implications.  
  
Key challenges posed by this gap in knowledge include an uncertainty among public health 
groups and healthcare delivery organizations about appropriate respiratory protection for HCPs 
who care for patients with confirmed or suspected respiratory infections.  This lack of 
knowledge posed pragmatic challenges and became source of controversy during the 2009 
H1N1 influenza pandemic and stands to hold equal or greater significance in the event of a 
future pandemic.     
  
This study aims to determine the relative effectiveness of two interventions, medical masks and 
N95 respirators, to protect HCPs against influenza and other respiratory infections.  This will be 
among the first studies to compare respirators to medical masks in high-risk outpatient settings.  
HCPs in outpatient settings are more likely to come into contact with more patients with 
influenza, are more likely to experience higher numbers of sick HCPs, and are more likely to 
show an epidemic curve of influenza infections that is representative of the community at large.   
The primary study goal is to determine whether there are differences in the incidence of 
laboratory-confirmed influenza when healthcare workers wear respirators or medical masks 
while caring for patients in the outpatient setting.  As secondary outcomes, we will also 
determine whether there are differences in the incidence of ILI, ARI, LCRI, and LDRI Indirectly, 
this project may also help gain understanding about modes of viral transmission, because 
respirators presumably prevent airborne transmission while medical masks do not.   
  

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Bacterial superinfection is a common, morbid, and potentially mortal complication of influenza 
(Chertow, 2013). Autopsy studies demonstrated bacterial infection in nearly all deaths resulting 
from the 1918 influenza pandemic.  During the 2009 H1N1 influenza pandemic, bacterial 
superinfection complicated 55% of fatal cases. Palacios et al found that presence of  
 S. pneumoniae in a nasopharyngeal swab specimen correlated with severe disease in previously 
healthy, low risk patients with 2009 pandemic strain influenza (Palacios 2009). There is clinical 
concern for bacterial superinfection after other respiratory virus infections, but the supporting 
evidence is limited (Randolph 2004). As noted, the data on bacterial superinfection is gleaned 
largely from autopsy series and cases of severe disease. Less is known about the events 
occurring early in bacterial colonization and infection of humans with influenza.   
  
Colonization of the nares or pharynx with Streptococcus pneumoniae, Staphylococcus aureus, 
Hemophilus influenzae, Streptococcus pyogenes, and other bacterial pathogens is presumed to 
be the antecedent to infection (Wertheim 2005; Simell 2012). Changes in the resident 
microbiota following viral infection may present an opportunity for more pathogenic bacteria to 
invade. To date, studies of bacterial superinfection have focused on the epidemiology of 
multiple pathogens, or on the pathophysiology of single pathogens. We propose to characterize 
the bacterial communities of the nares and oropharynx in healthy subjects prior to, during, and 
after natural infection with influenza and other respiratory viruses. We will use culture 
independent methods to comprehensively profile bacterial diversity in all specimens.  
  
The Veterans Health Administration (VHA) and the Centers for Disease Control and Prevention 
(CDC) have a vested interest in the results of this clinical trial, with both providing funding and 
sharing resources for its implementation.  The CDC is charged with providing guidelines to 
protect HCPs from infectious diseases while the VHA employs a large population of HCPs.  The 
results stand to have broad health policy implications that will reach well beyond the funding 
organizations on a global scale. The Johns Hopkins University (JHU) (Baltimore, MD) served as 
the initial Data Coordinating Center (DCC) for this clinical trial. We will transfer the DCC to the 
University of Texas Southwestern Medical Center (Dallas, TX) where the co-Principal Investigator 
(TMP) is now on staff.  
  
Historical Context:  Influenza, respiratory syncytial (RSV), coronavirus and other respiratory 
pathogens lead to serious complications resulting in substantial morbidity and mortality, 
especially among the frail and chronically ill.  Human-to-human spread of respiratory diseases 
can be explosive for several reasons, including the transmission characteristics of these viruses, 
the population density of ill patients in healthcare settings, the types of exposures within 
healthcare settings, and the administrative and physical structure of healthcare facilities.  These 
influences on transmission were evident during the 1918 influenza pandemic and became 
increasingly evident during the 2009 H1N1 influenza epidemics and the 2003 SARS outbreak 
(caused by a coronavirus). Additionally, patients in healthcare facilities who acquire influenza, 
RSV and other respiratory viruses, suffer increased morbidity and mortality. During the 
pandemic of 1957, influenza A impacted a Chicago hospital, causing one-third of the patients 
and staff-members on affected units to become ill with influenza. Leclair et al. found that the 
incidence of nosocomial RSV increased with the intensity of hospital exposure.  Sartor and 
colleagues describe a small outbreak on a 23-bed internal medicine unit where 41% of the 
patients and 23% of the HCPs developed influenza.  The authors noted that 14 person-days of 

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sick leave occurred, 8 scheduled admissions were canceled and all emergency admissions were 
canceled for 11 days.  Keech and colleagues found that people with influenza and ILI were 
confined to bed an average of 2.4 days, missed 2.8 days of work, and took a mean of 3.5 days 
after the onset of symptoms to resume normal activity.  Costs of outbreaks are difficult to truly 
estimate, but the outbreak reported by Sartor et al. cost $34,179, approximately $3,798 per 
patient.  Estimates also suggest that students miss about 22 to 189 million school days annually 
due to upper respiratory illnesses, commonly called "colds”.   Accordingly, parents miss about 
126 million workdays annually to stay home and care for their ill children. Together, the total 
economic impact of cold-related work loss exceeds $20 billion per year.  
  
While most clinical studies suggest influenza is transmitted from person-to-person via large 
respiratory droplets, several recent exhaustive reviews of the world’s literature suggest routes 
of transmission are variable, depending on virus characteristics, host-virus interactions, and 
environmental conditions.  Many studies indicate that that the predominant mode of 
transmission is via large droplets that are generally greater than 10 microns in diameter, remain 
suspended in the air for short periods of time, and are not typically inhaled into the trachea or 
lower into the pulmonary tree.  Still, other modes of transmission may also occur, including 
contact and small droplets (sometimes called aerosols) that are generally less than 10 microns in 
diameter, typically remain airborne for longer periods of time as “droplet nuclei,” and may be 
inhaled deep into pulmonary tree.  In addition, this later form of transmission may be more 
likely in the setting of procedures which potentially aerosolize secretions.   
  
It is generally agreed that the predominant mode of transmission for most other contagious 
respiratory pathogens, such as RSV and corona virus, is via large droplets, with small droplets 
(aerosols) playing a much smaller but clinically significant role.   Indirect contamination from the 
environment (e.g., fomites) or direct contact contamination (e.g., hand-to-hand or hand to 
conjunctiva) may also be important with many respiratory pathogens.     
  
Prevention Strategies: Healthcare facilities face challenges in preventing transmission to HCPs 
who are exposed to infectious patients, colleagues and family members.  Unfortunately, some 
pathogens, including influenza, can be transmitted when the infectious person is asymptomatic, 
although symptomatic transmission is believed to be the more common route.  The timing of 
when transmission is most likely to occur has not been defined for many respiratory pathogens.  
  
For many of these pathogens, vaccines or chemoprophylaxis may not be available, requiring 
institutions to use other infection prevention techniques.  Recommended prevention and 
control methods for the pathogens in this study include both primary strategies (e.g., 
vaccination, chemoprophylaxis, use of barriers), when available, and secondary strategies (e.g., 
hand hygiene, isolation, environmental disinfection, screening and cohorting). 
Nonpharmacologic interventions are promoted by many public health organizations and 
guidelines include the use of hand hygiene, patient isolation, and respiratory etiquette. The 

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challenge for infection prevention and control and public health emergency experts is in making 
data-driven and cost-effective recommendations to prevent transmission in a variety of 
healthcare settings. Hence, key areas of interest for healthcare epidemiologists and policy 
makers include (1) determining the most appropriate types of PPE for HCPs, (2) delivering data 
to HCPs that will help convince them to comply with infection control recommendations, and (3) 
actually implementing FPE usage, taking economic, logistical, and occupational factors into 
consideration.  The first issue is central to determining policy recommendations at institutional, 
national and international levels.  At a local level, these decisions determine planning and supply 
chain needs for healthcare facilities for both seasonal and pandemic respiratory viral outbreaks.  
  
Among non-pharmacologic interventions, there is continued interest in the use of "facemasks" 
as a key component of personal protective equipment (PPE).   While masks were used in the 
Middle Ages (between the approximate years of 400 and 1500 A.D.) to prevent transmission of 
plague, it was not until the mid-1980’s that Hall et al. demonstrated that the use of masks and 
goggles decreased healthcare-associated transmission of RSV.  Control measures for influenza in 
long term care settings have focused primarily on two methods: immunoprophylaxis for 
generally healthy HCPs and chemoprophylaxis for patients.  Still, the importance of patient 
isolation, cohorting, and use of FPE by HCP including eye goggles or faceshields and masks is 
widely recognized and practiced.    
  
Gaps in Knowledge: The relative importance of facemasks (medical masks), respirators and 
contact precautions (without masks or respirators) has not been definitively proven, prompting 
disagreement and controversy in the scientific and health policy communities.  In 2003, SARS 
and the role of healthcare-associated transmission stimulated a series of evaluations to identify 
which interventions had been critical in decreasing spread of the SARS coronavirus among HCPs.  
Jefferson et al. summarized studies that evaluated the utility of non-pharmacologic 
interventions used during the SARS epidemic. Transmission was reduced 55% by frequent hand 
hygiene, 78% by wearing masks, 57% by wearing gloves and 77% by wearing gowns.  Still, with 
only one exception, these studies did not determine the protective effect of N95 respirators 
relative to other types of prevention; the word "masks" were either undefined or represented 
by multiple types of medical masks and respirators.  One study that is often cited as showing a 
statistically significant decrease in infections with N95 respirators had such small subject 
numbers and so few measured events that drawing definitive conclusions is not warranted.   
  
In 2007, the World Health Organization (WHO) proposed draft guidance recommending a 
complement of strategies that included the use of medical masks for many respiratory 
pathogens, including novel influenza strains and the SARS coronavirus.  These recommendations 
were based on the experiences of several countries to prevent and control SARS infections and 
the lack of data showing superiority of respirators compared to medical masks. Data emerged 
from the SARS events supporting the use of respirators for certain procedures, such as 
intubations, which are known to produce aerosols of respiratory secretions.  While these data 
were valuable, they focused narrowly on infection control measures for SARS.  Similar studies 
are needed in the setting of other pathogens, such as influenza.    
  
MacIntyre and colleagues recently published a prospective cluster-randomized trial that 
compared medical masks and non–fit-tested respirators to standard practice (no masks) in 

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preventing ILI in households (MacIntyre et al. 2009). Among 286 adults, from 143 households, 
who were exposed to children with clinical respiratory illness, self-reported adherence to mask 
or respirator use significantly reduced the risk for ILI-associated infection, but only in the subset 
of the population reporting adherence to mask or respirator use.  However, adherence with 
mask or respirator use was poor; <50% of participants wore masks or respirators most of the 
time as instructed.  Across the entire study population, including those who were not adherent, 
the authors reported that household use of face-masks or respirators was low and ineffective 
for controlling seasonal respiratory disease.   What is not known, however, is whether the 
observed ineffectiveness was due to non-compliance or insufficient respiratory protection from 
medical masks.  Unfortunately, new knowledge gained from completion of this Australian study 
was limited.  This study lacked the power to compare any effects of masks with those of 
respirators.  Thus, it was not informative on this issue.    
  
MacIntyre et al. also conducted a study among 1936 front-line hospital HCPs in Beijing, initially 
reporting that use of N95 respirators was significantly more effective than use of masks in 
preventing clinical respiratory illness (MacIntyre et al. 2011).  However, due to low outcome 
incidence, the study lacked the power to address influenza, either from the standpoint of 
laboratory-confirmed respiratory viral infection, clinical respiratory illness, and influenza-like 
illness.  It was also initially reported that fit-testing did not improve N95 effectiveness, perhaps 
because a large proportion of the population was documented to have a good fit with the 
initially-chosen respirator. However, the authors later retracted their findings, citing 
methodological, analytic, and sample size limitations.   
  
The most recent research continues to fuel the debate over appropriate prevention against 
influenza and respiratory pathogens.  Loeb et al. (2009) conducted a trial comparing influenza 
rates among 446 Canadian nurses individually randomized to wear either an N95 respirator or a 
surgical/medical mask, finding that masks were no less effective at preventing 
laboratoryconfirmed influenza than N95 respirators.  However, nurses randomized to the use of 
masks did experience a strong trend (p = 0.06) towards higher level of influenza-like-illness and a 
statistically significantly higher level of fever (p = 0.007) compared to those wearing N95s.    
  
Although the Loeb study found no significant differences in the prevention of 
laboratoryconfirmed influenza, many of the cases were identified by serology and the majority 
of serologically detected cases were asymptomatic.  A main goal of proper FPE usage is the 
prevention of symptomatic influenza, resulting in the current study’s emphasis on obtaining 
data quickly on symptomatic individuals.  Loeb et al. acknowledged frequent non-occupational 
(e.g., home and community) exposures to influenza-like illness in both arms, but no analysis was 
done to assess the levels of risk associated with these home exposures.  Additionally, Loeb et al. 
conducted their study in a cohort of HCPs with relatively low influenza vaccination rates, did not 
directly assess exposure risks by quantifying nursing contacts with patients with febrile 
respiratory illness, and was unfortunately terminated prematurely (April 23, 2009) when, in 

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response to growing concern about the H1N1 outbreak, the Ontario Ministry of Health and Long 
Term Care recommended N95 respirators for all HCPs caring for patients with febrile respiratory 
illness.   
  
Perl & Srinivasan’s (2009) simultaneously published editorial in JAMA stressed that the lack of 
clinical trials on the transmission of influenza hampers the appropriate authorities from making 
definitive recommendations for PPE.   Two cluster randomized trials of medical masks versus 
N95 respirators in healthcare settings have been performed in Beijing, China. The first trial 
(McIntyre 2011) was conducted from December 2008 to January 2009 and enrolled 1441 
healthcare workers. The second trial (McIntyre 2013), conducted from December 28, 2009 to 
February 7, 2010 enrolled 1669 healthcare workers. These trials found no significant difference 
between groups assigned to medical masks or N95 respirators for ILI or laboratory confirmed 
influenza. The incidence of influenza during the study periods was low, limiting the power of the 
trials to identify significant differences. A meta-analysis (Smith 2013) of the three available RCTs 
also identified no significant difference in influenza like illness or laboratory confirmed influenza.  
  
Importantly, based upon numerous laboratory studies, most scientists believe that N95 
respirators provide superior prevention because of their tight facial fit design and generally 
higher filtration efficiencies.  After all, respirators are designed to reduce exposure to small, 
inhalable particulates while medical masks are not.  However, considering all published studies 
to date, the clinical data produced thus far by the public health and medical communities from 
across the world have been inconclusive.  One possibility that may help explain this gap between 
expectations and contemporary clinical evidence is pragmatic in nature: HCPs, in general, may 
not tolerate respirators as well as medical masks, prompting them to remove respirators for 
longer periods and/or more frequently, possibly increasing the likelihood of exposure and 
infections.  Of note, removing respiratory protective equipment in this fashion is often in 
violation of public health and institutional guidelines (non-compliance).   Importantly, in the 
context of this limitation with respirators, it is conceivable that medical masks could provide the 
same or higher levels of protection than N95 respirators.    
  
Unfortunately, clinical trials conducted in real patient-care environments during a respiratory 
virus epidemic (“flu season”) are lacking.  Accordingly, the public health recommendations for 
respiratory protection among HCPs are, in part, based on expert opinion, sometimes leading to 
controversy.  A key challenge posed by this gap in knowledge includes uncertainty about 
appropriate respiratory protection for HCPs in the event of seasonal or pandemic influenza.  To 
plan for such an eventuality and to be able to best manage limited supplies of respirators, 
evidence is needed to guide policy developers and decision-makers.  One of the most important 
lessons learned from the SARS crisis was the importance of protecting HCPs with appropriate 
personal protective equipment.  It is important to recognize that in Toronto, a SARS commission 
convened by the Canadian government found that 72% of SARS cases occurred in a hospital 
setting, 43% of cases involved HCPs, and of the 100 healthcare providers who became infected 
with SARS, three died.  Since this time, Suwantarat et al. found that another coronavirus causing 
Middle Eastern Respiratory Syndrome (MERS) has been associated with significant transmission 
to HCPs, further supporting the importance of solving this issue. Transmission in several settings 
in Middle East settings has resulted from conflicting recommendations issued by Public Health 

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authorities including the CDC and WHO. What remains to be answered for the vast majority of 
pathogens is what type of protection is most appropriate.  
  
B2 Rationale for this Study: THE 2009-10 H1N1 INFLUENZA PANDEMIC  
During the 2009-10 H1N1 influenza pandemic, the use of respiratory protection became one of 
the most frequently discussed and debated topics.  Many healthcare organizations found 
themselves without sufficient N95 respirators to meet national and/or local guidelines for use. 
Perhaps worse was a highly variable difference in the number of N95 respirators stockpiled by 
organizations; some hospitals had many and others had few.  The uncertainty and lack of 
evidence-based respiratory protection policies, in part, caused organizations to prepare 
differently, resulting in disparate levels of access to N95 respirators and, in some cases, 
interference with healthcare operations.    
  
In in midst of the 2009-10 H1N1 influenza pandemic, the WHO recommended in most instances 
the use of medical masks for HCPs exposed to H1N1-infected patients (except during 
aerosolgenerating procedures), while the CDC took a somewhat contradictory stance, 
recommending instead that HCPs wear N95 respirators in most instances.  The notoriety of this 
contradiction increased when many state and local health departments in the U.S. sided with 
the WHO.  In an open letter published on November 5, 2009, the Society for Healthcare 
Epidemiology of America (SHEA), IDSA, and the Association for Professionals in Infection Control 
and Epidemiology (APIC) jointly expressed their dissatisfaction with the CDC position.  Increasing 
the controversy, the National Academy of Sciences Institute of Medicine (IOM) issued findings 
from a consensus meeting that called for (a) HCPs to favor N95 respirators over medical masks 
for novel H1N1 influenza and (b) intensive research without delay to determine which is more 
effective. Although the CDC initially recommended and later reiterated its position that medical 
facilities should favor the use of N95 respirators, on a practical level, large sectors of the US 
healthcare workforce continued to essentially ignore these guidelines, wearing medical masks, 
and in some instances no protection.    
  
In October 2009, The CDC issued Interim Guidelines that addressed the insufficient supplies of 
N95 respirators in many settings.  This updated guidance recommended that supply shortages 
should prompt prioritization of FPE usage at the institutional level, calling for HCPs to wear 
devices at least as protective as N95 respirators in high-risk settings such as when performing 
aerosol-generating procedures.  In lower risk settings when there were clear shortages or 
impending shortages of respirators, facilities were permitted to use medical masks as a primary 
means of HCP protection against influenza. Facilities were advised to make a “good faith” effort 
to procure an adequate supply of respirators, and continue to implement a hierarchy of 
controls, including source control, engineering, and administrative measures, encourage 
vaccination, and continue other work practices recommended by the CDC.    
  

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In July 2010, CDC guidance was modified to call for U.S. HCPs to wear an N95 respirator when 
coming into close contact with patients who were, or may have been, infected with 2009 H1N1 
influenza.  This modification occurred after CDC posted in the Federal Register a notice that 
proposed a change such that (a) medical masks would be the primary means of respiratory 
protection worn by HCPs against influenza while (b) devices at least as protective as N95 
respirators would be worn by HCPs who perform (or help perform) procedures that produce 
bioaerosols (e.g., intubation, suction).  The 2009 H1N1 pandemic was officially declared over on 
August 10, 2010 by the CDC, rescinding the previous recommendations that were applicable 
only during the 2009 pandemic.  As a result, N95 respirators are no longer required as the 
primary means of protection against influenza, per CDC recommendations.  All HCPs are no 
longer required to wear N95 respirators when interacting with patients with 
confirmed/suspected influenza, allowing the current study to proceed.  Subsequently, the CDC 
guidelines have remained largely unchanged. Patients with respiratory pathogen symptoms 
should be provided with medical masks as soon as they enter a healthcare setting, HCPs should 
don a medical mask when entering the room of a patient with suspected or confirmed influenza, 
and HCPs performing aerosol-generating procedures should wear an N95 or equivalent.  If 
facilities or organizations wish to provide a different type of FPE (e.g. to meet evolving CDC 
guidance and local policies) than the standard medical mask, it should at least provide the same 
protection of the nose and mouth as a facemask (e.g., N95, PAPR, etc.).   
  
Despite the controversies, most who opined in 2009-10 about HCP respiratory protection 
against influenza acknowledged that the best course forward would be one that bases 
respiratory protection guidelines on scientific data.  The National Academy of Medicine 
(formerly the Institute of Medicine or IOM) articulated its position in multiple documents, 
including its 2009 Letter Report, Respiratory Protection for Healthcare Workers in the Workplace 
against Novel H1N1 Influenza A, where it clearly states the importance of research, noting that 
continued research asking the most important and pressing questions should be a top priority. 
Our protocol is designed to determine the most appropriate respiratory protection for US 
healthcare workers.  This approach is strongly endorsed by Dr. John Howard, Director of the 
National Institute of Occupational Safety and Health (NIOSH), and Dr. Ken Shine, Chair of the  
IOM Committee on Respiratory Protection for Health Care Workers in the Workplace against  
H1N1 Influenza, who both wrote letters in support of this clinical trial. Although the H1N1 
20092010 influenza pandemic has ended the need for this research remains essential.  This 
study will focus on the relative protective effects of the CDC’s 2007 seasonal influenza guidelines 
versus the CDC’s 2009 H1N1 pandemic influenza guidelines.    
  
Since this time, further controversy has developed around the appropriate prevention practices 
for Middle Eastern Respiratory Syndrome (MERS) caused by a novel coronavirus with differences 
between the CDC and the WHO guidelines (CDC 2015; Chung 2014; Hsu 2014; WHO 2015).  The 
emergence of another pathogenic respiratory virus that impacts HCP health has further pushed 
the scientific community to strive to answer the question of respiratory protection for HCP for 
influenza and other respiratory viral infections.  
  
 Non-Compliance with Respiratory Protective Measures:  The CDC and other influential public 
health organizations recommend in most scenarios that HCPs utilize droplet precautions when 
caring for patients who are ill with respiratory diseases.  Only a few diseases require airborne 

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precautions.  Droplet precautions consist of a gown, gloves, eye protection (glasses or goggles) 
and a medical mask.  Exceptions include tuberculosis, measles and a small set of diseases known 
to be capable of airborne spread, in which case a respirator (N95 respirator or equivalent) is 
recommended.  On a practical level, this means HCPs should wear a medical mask whenever 
they enter a room of a patient with respiratory symptoms, unless the worker is certain the 
patient is not infected (no mask needed) or the patient is suspected or known to have 
tuberculosis or one of the less common airborne diseases (respirator needed).  However, it is 
widely acknowledged that HCPs often do not fully adhere to these recommendations; 
compliance rates with personal protective equipment recommendations are near 30%.  
Interestingly, lower rates of FPE compliance are often observed among senior staff and longtime 
employees, possibly due to a feeling of increased invulnerability.  This trend is also reflected in 
lower hand hygiene and vaccination rates among more senior HCPs.  Limited tolerability may 
also play a role.    
  
Attitudes/Opinions/Beliefs: There is minimal data on the impact of attitudes and opinions 
among HCP about respiratory protective measures in an outpatient setting. An IOM report 
concluded that “Experience with… efforts to improve infection control… have demonstrated 
that the efficacy of an intervention alone does not guarantee its success. The best respirator or 
medical mask will do little to protect the individual who refuses, or who misunderstands how… 
to use it correctly.”   
  
Despite the crucial role that FPE plays in limiting nosocomial spread of respiratory pathogens, 
few studies have examined seasonal respiratory pathogen protection compliance rates, 
individual HCP attitudes and beliefs about FPE use, or the specific impact of safety climate in this 
setting. In a recent comprehensive review of the infection control literature regarding protecting 
workers from respiratory pathogens, The British Columbia Interdisciplinary Respiratory 
Protection Study Group found that “organizational and individual factors can explain much of 
the variations in self-protective behavior in health care settings, especially with respect to 
applying universal [standard] precautions. It seems likely that these factors were also important 
safety determinants during the SARS outbreaks but they have not been extensively studied”. 
This group also noted that “safety climate is being increasingly recognized as one of the most 
important determinants of safe work practice in terms of preventing exposures to [blood and 
body fluids] but has been little studied in other types of nosocomial transmitted diseases. 
Respiratory tract diseases, in particular, have not been well studied in this regard.” Thus, it 
would be interesting to collect data on HCPs attitudes and opinions concerning FPE use and the 
relationship of these beliefs on the incidence of respiratory infection. This data could possibly 
lead to policies that improve knowledge about FPE use among HCPs, especially in an outpatient 
setting.  
  
Number of Study Arms: The consequences of widespread non-compliance among HCPs and the 
impact on the efficacy of measures remain controversial.  On the surface, therefore, it would 

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follow that infection control researchers would want to assess the impact of non-compliance. To 
make an unbiased assessment of FPE effectiveness, a randomized clinical trial would ideally 
include three arms: a respirator arm, a medical mask arm and a negative control (no respiratory 
protection) arm.  However, there is often a dearth of evidence, in part, because the ideally 
designed clinical studies (e.g., randomized, double-blind trials) are challenging to conduct in a 
clinical (operational) context.    Ethical considerations often preclude designs that randomize 
individuals to “no protection” when the standard of care (or operational policy) calls for some 
level of protection.  This challenge has been discussed elsewhere in detail.  With this ethical 
limitation in mind, the protocol that follows is designed with two arms, not three.  
  
HCP Exposure Risk Assessment: This study will also investigate the relationship between HCP 
infection rates and their reported exposure to patients with suspected or confirmed respiratory 
illness, aerosol-generating procedures, or household members with respiratory pathogen 
symptoms.  Loeb et al. (2009) bears several important parallels to the current study but did not 
directly assess exposure risk by quantifying contact with individuals or procedures that may 
introduce a higher risk for infection.   Studying this relationship may reveal important 
information concerning transmission, prevention, and absolute and relative risks of respiratory 
viral infection. The proposed study aims to assess and account for the frequency and level of risk 
associated with non-occupational exposures.   
  
C  Study Objectives  
This study aims to determine the relative effectiveness of two interventions to protect HCPs 
against infections and illnesses caused by influenza and other respiratory pathogens.    
  
C1  
Protective Effects  
1.a  
Primary  
To determine and analyze the magnitude of the change, if any, in incidences of laboratory 
confirmed influenza in HCPs wearing N95 respirators (2009 guidelines) compared to medical 
masks (2007 guidelines).    
1.b  
Secondary:   
• 
To determine and analyze the magnitude of the change, if any, in incidence of ARI, ILI, 
LCRI and LDRI in HCPs wearing N95 respirators compared to medical masks.    
• 
To examine the relationship between incidence and possible risk factors, including 
compliance, attitudes and opinions of HCPs and workplace exposures.  
C2  
Incidence Determination  
2.a  
Primary  
• 
To improve understanding about the burden of infections and illnesses caused by 
influenza and other respiratory pathogen among HCPs working in outpatient settings.  
2.b  
Secondary:   

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• 
To measure the incidence of ARI, ILI, LCRI, and LDRI in selected outpatient settings.  
• 
To measure the changes in the participant’s nasal/oropharyngeal microbiome over the 
course of the study.  
  
D  Study Design and Methods   
  
D1 Overview   
This study will assess and compare the effectiveness of respiratory protective equipment among 
HCPs in the outpatient setting in a variety of geographic/climatic conditions.    
We propose a study with a prospective timeline (Appendix L), non-blinded, cluster randomized 
interventions (with the unit/clinic as the unit of randomization), a two-arm, “head-to-head” 
comparison, multiple sites and multiple geographic locations, with longitudinal cohorts recruited 
for multiple years.    
  
This study will be conducted in outpatient clinics, emergency departments and/or urgent care 
settings in multiple geographic locations.  The outpatient setting has been chosen because it is 
the front line in the event of an influenza epidemic.  Patients typically report to either their 
primary care physician, urgent care facility or the emergency department for respiratory 
infections.  It has been shown that the highest rate of infection in healthcare workers is in this 
outpatient setting. The Study Team aims to balance the sites to include medical, pediatric and 
VA study sites.  We will employ stratified randomization for FPE assignment, to assure 
generalizability of results across clinic types.  The types of clinics/clusters included will be 
dependent on the clinics that meet the requirements and agree to participate in the study, but 
we will attempt to recruit a variety of outpatient clinics to ensure a generalizable study group.   
Each study site will utilize a Master Study Protocol with synonymous text to produce a local IRB 
application.  
  
Subjects will be recruited and randomized to one of two study arms, medical masks (2007 and 
2010 CDC seasonal influenza guidelines) or N95 Respirators (2009 N95 pandemic influenza 
guidelines).  Sites will be randomized each flu season such that sites may use different types of 
FPE each flu season.  The duration of the intervention (mask wearing) period of the study is 
dependent on surveillance and incidence of viral respiratory illness at each site.  The 
intervention period may potentially be shortened due to site-specific/regional incidence and 
surveillance, but it is not anticipated to extend longer than 16 weeks.  The duration of viral 
respiratory season varies widely from year-to-year, so flexibility in the duration of the study 
intervention period is vital in allowing us to capture the height of viral respiratory season.  The 
duration of the intervention period may therefore be lengthened or shortened based on 
incidence and surveillance data available at each site.   Each subject will agree to participate in 

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the study for up to 16 weeks per flu season, in which the “pre-study period” is a screening and 
educational period.  During the pre-study period, participant demographic information will be 
collected (baseline survey), a survey on knowledge, attitudes, and beliefs regarding FPE will be 
administered (pre-study survey), a blood sample will be collected for baseline serology testing, 
and subjects will be educated about the study, including the fit testing process.  Weeks 1-16 are 
the “intervention period.”  A cluster-randomized design will be utilized such that a group 
(“cluster”) of approximately 16 people will be assigned (randomized) to wear the same device 
(Medical Mask or N95) for up to 16 weeks (potentially shorter) while working in the study site 
location (Appendix A).  Participants will also be asked to provide upper respiratory specimen 
during the intervention period.  During this time, the research team will also observe 
participants’ adherence to mask use and hand hygiene.   Two weeks after the final week of 
wearing FPE (hereafter referred to as “post-study period”), subjects will be asked to provide a 
final serological sample and to complete a post-study survey.   Participants may participate in 
successive flu seasons until the study is completed.  
  
Being able to wear OSHA-compliant and NIOSH-approved respiratory protective equipment 
when in contact with patients is considered a pre-employment condition for all study sites under 
consideration.  Therefore, the potential participants should have experience wearing medical 
masks and respirators and should be capable of safely wearing the respiratory equipment for 
the study period.  It is expected that a small percentage of subjects will be excluded because 
they have facial hair that precludes OSHA-accepted fit testing (likely < 5% of eligible subjects), or 
they will have been advised by an occupational or other qualified healthcare provider to avoid 
wearing certain types of respirators for medical or other reasons (likely < 1% of eligible 
subjects).    
  
D2 Study Site Selection and Randomization Scheme  
2.a  
Cluster Randomization Scheme: Clinical Unit of Analysis and Eligibility  
Previous studies utilized a traditional individually randomized design (in a healthcare setting) or 
cluster, randomized design (in a home setting), a methodological tool that may be utilized in 
suitable circumstances.  For this study, a “cluster design” will be used.    
  
A group of people (a “cluster”) will serve as one unit of randomization as described in the 
General Methods section of this protocol (Appendix A).  Ideally, most or all staff working in 
selected clinic locations will agree to participate via informed consent.  All HCPs (subjects) within 
that cluster will wear the same type of device (Medical Mask or N95) for the intervention 
period.    
  
This study focuses on illness and infection in the healthcare workplace, a setting known for 
propagating influenza outbreaks.  The principal and co-investigators believe a clusterrandomized 
design is essential to optimize the validity, reliability and generalizability of the results.  Others 
have proposed individual randomization schemes in which each person (not each clinical unit) is 
randomized to one of the intervention arms.  Justification has often centered on an individually 
randomized study often requiring fewer subjects to achieve statistical significance.  In this 
setting, staff working alongside each other in the same clinic would routinely wear different 

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respiratory protective devices for long periods.  While possible to design as a research study, this 
approach is unlikely to resemble the events in a real clinic during an infectious disease outbreak.  
Some have also expressed concern that different devices being worn in the same location could 
negatively influence compliance with assigned study arms.   
Individual randomization may increase the likelihood of bias toward the null hypothesis.  
Because transmission may occur from patient-to-worker and from worker-to-worker, identifying 
the contribution of each exposure type to the risk of acquiring infection would be exceedingly 
difficult.  Compared to cluster randomization, an individual randomization scheme may be more 
likely to cause patients and other HCP to raise questions or objections.  Patient requests or other 
staff requests for modification of respiratory protection among the staff would be expected to 
cause cross-over and bias toward the null hypothesis.    
  
Overall, to maximize compliance and ensure generalizability, the investigators have selected a 
cluster randomization, in collaboration with CDC partners, members of the Study Advisory Board 
and the Study Science Board, in which all subjects on the same clinical unit are outfitted with the 
same type of protective devices.   Although the model of N95 may vary at each study site and 
within each cluster, the type of respirator (NIOSH-certified, negative pressure, N95 filtering face 
pieces) will not change.  
  
Selection of clinic sites will be based on the size of the clinic.  Each cluster/clinic will have a 
median of approximately 20 HCPs.  Selection of clinic sites will also be based, in part, on the 
interest-level and enthusiasm of the HCP-subjects and the numbers of patients who present for 
healthcare with a diagnosable respiratory illness.  For purposes of this study, “primary care” will 
be defined as “a healthcare delivery site at which family practice, internal medicine, emergency 
medicine, or general practice clinicians (or nurse practitioners and physician assistants with 
similar training) evaluate and treat patients who typically arrive on their own accord (not via 
referral) and from which referrals to subspecialty services are typically requested” (See 
Appendix K).  While most clusters will naturally consist of consented HCP-subjects who work in a 
particular clinic location, some large clinics may be designed in functional partitions that are 
amenable to this study’s analysis scheme.  When deemed appropriate by the study team, large 
clinics may be further sub-divided into more than one cluster for study purposes.     
  
The participating center would register their clinical sites/clusters with DCC who meets the 
eligibility criteria for the cluster as described above. The clusters would be assigned to one of 
the two arms using a system established by the DCC).  
  
D3 Study Subject Selection:  
  
Seven institutions have been identified as participating centers: the Johns Hopkins Health  
System (JHHS) in Baltimore, MD; Denver Health Medical Center, and Children’s Hospital  

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Colorado in Denver, CO; and the Department of Veterans Affairs (VA) sites in Denver, CO;  
Washington, DC; NY, NY; and Houston, TX. Additional sites need to be added.   Additional sites 
will be assessed by certification criteria (Appendix K) and must have an adequate number of 
outpatient visits/clinics (at least 25 that employ 20 or more HCPs), history of collaboration with 
other sites on large clinical trials, and research infrastructure experience with clinical studies.  
We aim to recruit at least 500 participants per study site per influenza season, based on a 2530% 
dropout rate.  Depending on the capability of selected study sites to accrue subjects, up to 10 
(ten) sites may be included altogether.    
3.a  
Inclusion Criteria  
  
(1) Clinical site leadership has agreed to have one or more staff participate in the trial   
(2) Subject meets the definition of “healthcare personnel”  
(a) Provides healthcare to patients and/or  
(b) Typically positions themselves within 6 feet of patients (“close contact”) and (c) Is a full-
time employee (average of ≥ 24 hrs/week) working 75% of the time at a study site (and not 
employed at another location where the study is being conducted).  
(3) Subject able to read and sign informed consent  
(4) Subject agrees to all requirements of the protocol, including fit testing and diary keeping  
(5) Subject’s age 18 or greater  
(6) Subject passes fit testing for one of the study supplied respirator models and agrees to use 
that model for the entire intervention period of the study (if in the respirator arm).  
3.b  
Exclusion Criteria  
  
(1) Subject self-identified as having severe heart, lung, neurological or other systemic disease 
that one or more Investigator believes could preclude safe participation.  
(2) Known to not tolerate wearing respiratory protective equipment for any period.  
(3) Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit 
testing or proper mask fit during the study period  
(4) Advised by Occupational Health (or other qualified clinician) to not wear the same or similar 
respirator or medical mask models used in this study.  
(5) In the opinion of the Investigator, may not be able to reasonably participate in the trial for 
any reason (e.g. anatomic changes to nose).   
(6) Self-identified as in, or will be in the third trimester of pregnancy, during the study period.  
(7) Subject rotating in 2 different ResPECT study clinic sites /clusters during the study period.   
(8) Subject works less than 24 hours/week in the cluster/clinic in which they are recruited.    
(9) Subject work less than 75% of the intervention period in that clinic.   
(10) Subject is a previous participant of the ResPECT Study, but does not consent for data from 
previous flu season(s) to be linked.   
  
Subject Recruitment Plan and Consent Process  
HCP-subjects in each clinic will be made aware of the study through emails (Appendix V), 
telephone calls (emails and telephone calls will be used to contact HCP who express interest in 

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the study and those HCP who have previously participated in study), posters (“flyers”) 
distributed at each potential study location, the primary referral hospitals associated with the 
clinics, and other locations HCPs frequent (Appendix B).  Participants will receive emails and 
telephone calls throughout the study to alert them of study updates, planned times for 
specimen collection, and to address issues that the participants have. Another social medium we 
may use to optimize recruitment and retention is a ResPECT Study Facebook page occasionally 
posting information such as survey reminders, blood draws, or swab timing for clinics (example 
post: “We are nearing the half-way point! Please make sure you complete your Weekly Diary 
and Days Worked Surveys by <date>!! If you have questions, contact the ResPECT Study staff at 
respect@jhmi.edu or (410) 614-6206.)” The point is to leverage our social media contacts and 
widen the scope of information systems with which to communicate updates and important 
events to participants (see Appendix AA). The Facebook page will protect privacy by being a 
unidirectional information source – staff will post notifications, but participants will be unable to 
post messages on the page. The caveat being participants “liking” the page will show up in their 
news feed depending on their own privacy settings. We will have the following disclaimer on the 
page informing participants of the privacy policy:  The Johns Hopkins Health System and Johns 
Hopkins University School of Medicine do not edit or control the content of posted comments 
by third parties on this web site. However, Johns Hopkins reserves the right to remove any such 
postings that contain objectionable or inappropriate content.  The Facebook page and email 
addresses will be deactivated at the end of the study.  
  
The protocol, forms, and all written materials about the study will be approved by the local 
Institutional Review Board(s). The definition of eligible “healthcare personnel” for the purposes 
of the study will be any person who is a full-time employee (average of ≥ 24 hours/week), at 
least 18 years old, and who is employed by or works at the study site and interacts with patients.  
Interaction in this context will mean the provision of clinical care, typically positioning oneself 
within 6 feet of patients, or entering into a small-enclosed airspace shared with patients, such as 
a typical patient treatment room (e.g., “close contact”).  We will cover all operating hours of 
participating clinics.  Covering clinics such as emergency departments may require staffing 
outside of standard operating hours.  
  
Subjects will be recruited by the Study Coordinator or his/her designee or self-referred to the 
Study Coordinator in a response to emails, telephone calls, or flyers.  Initial recruitment will 
mainly occur through educational meetings.  Consent forms will be distributed to clinic directors 
prior to these meetings for dissemination among interested individuals.  Research staff will 
present the project during staff meetings, change-of-shift meetings, and other meetings/visits at 
the participating clinics.  The research staff will go over the consent forms to ensure participants 
fully understand the meaning of the forms, answer any questions, and ensure that each 
potential participant has adequate time to review the forms.  If any potential participants would 
like additional time to review the forms or consider enrolling, research staff will arrange to 
follow up with them later.  During these educational meetings, the research staff will explain to 

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each potential subject the risks of wearing a respirator for prolonged periods. Visual 
demonstrations of study requirements (e.g. how to properly put on, wear, and take off a 
respirator/mask; nasal and throat swab procedures) will also be presented to ensure that 
potential participants understand all study requirements before they agree to consent.  Study 
staff may also provide paper copies of the surveys and emails during the enrollment process 
and/or bring computers to show participants what the e-mails they’ll receive from the study will 
look like, as well as how to access and complete the weekly and daily surveys.  
  
D4 Respiratory/Facial Protective Devices  
4.a  
Data on respirators and mask  
The following models will be used in this study.  They were selected because these models:  
(a) Are commonly used by the VA medical centers and  
(b) Are commonly used by JHHS, Denver Health and the Children’s Hospital Colorado medical 
facilities and  
(c) Are commonly used in many settings from across the U.S.  
  
N95 Respirators:  
1. 
3M Corporation 1860, 1860S, and 1870 models  
2. 
Kimberly Clark Technol Fluidshield PFR95-270, PFR95-274  Medical 
Masks:  
1. Precept 15320   
2. Kimberly Clark Technol Fluidshield 47107 (preferred)  
  
(a) Data provided by the National Personal Protective Technology Laboratory at NIOSH 
indicate:3M 1860: 0.72% avg. penetration  
(b) 3M 1870: 0.32% avg. penetration  
(d) (c) Kimberly Clark PFR95-170: 1.38% avg. penetration Precept model 15320: 12.9% avg. 
penetration  
(e) Kimberly Clark Technol Fluidshield 47107: 10.3% penetration.  
  
NIOSH N95 approval criterion is ≤ 5% penetration (i.e., ≥ 95% efficiency), suggesting the practical 
difference between 0.32% and 1.38% penetration is negligible.    
  
The filter airflow resistance for the medical mask was 4.1 (Precept) and 4.5 mmH2O (Kimberly  
Clark), while the filter airflow resistances for the N95 filtering face piece respirators ranged from 
8.9 to 11.7 mmH2O.  The practical significance of these numbers is limited because human test 
subjects typically have difficulty detecting differences between these low levels of airflow 
resistance.  Each study site will purchase the appropriate FPE each flu season to ensure 
availability of the FPE models in the study at the participating clinics/clusters.    
  
FIGURE 1   
    Basic* Elements of Recommended Personal Protective Equipment   
  

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2007 CDC Influenza Guidance  
  
  
2009 CDC H1N1 Influenza Guidance   
Types of Precautions   
  
  
  
Types of Precautions  
   Standard Precautions   
  
  
   Standard Precautions  
   Droplet Precautions  
  
  
  
   Airborne Precautions   
   Medical Mask   
  
  
     
   N95 Respirator   
   Gloves  
  
  
  
  
   Gloves  
   Gown   
  
  
  
  
   Gown   
  
*This figure is for quick comparisons; for further details, see the original sources: references 47 and 
48.    
4.b  
Fit testing   
NIOSH defines a respirator fit test as the use of a protocol to qualitatively or quantitatively 
evaluate the fit of a respirator on an individual.  In compliance with JHH/OSHA regulations, 
subjects will be required to fill out an amended version of the 1910.134 OSHA Respirator 
Medical Evaluation Questionnaire (Appendix M). Subjects randomized to the N-95 arm will be 
fit-tested prior to the intervention period using the study supplied respirator and an 
OSHAaccepted fit-test kit (i.e., 3M™ FT-10 Saccharin Fit Test Kit, 3M, St Paul, MN, USA) that 
meets the manufacturers’ instructions for fit-testing.  The fit-tests used at each facility may vary 
but all will be OSHA-accepted.  As participants will change masks frequently during the course of 
a work shift, subjects will be educated about how to properly perform seal checks on their 
masks to ensure a proper fit.  Participants will be asked to refrain from eating or drinking for 15 
minutes before the test; males will be asked to be freshly shaven, and to remain without facial 
hair for the duration of the study (Appendix Q).  Instructions will be given as to how to properly 
don, doff, and adjust FPE, and manufacturer-recommended fit checks will be explained.  
Participants will be given specific instructions regarding when to reuse and replace their FPE.  
Participants will be instructed to don new respirators or masks before each close-contact with a 
patient with suspected or confirmed respiratory pathogen infection. Subjects will be allowed to 
choose which N95 respirator they will use – either 3M 1860 (regular or small), 3M 1870, or 
PFR95270/PFR95-274 Kimberly Clark N95 (regular or small). In instances in which subjects who 
are fittested using either qualitative or quantitative methods cannot detect the Saccharin 
solution, Bitrex will be used instead.  Subjects who fail all N95 respirator fit-tests or cannot 
detect either Bitrex or Saccharin will be considered screening failures and will be excluded from 
the study.  Alternative respirators will not be provided as part of this protocol.   
D5 Attitudes and Opinions  
Participants will be asked to complete surveys about their attitudes and opinions concerning FPE 
both before and after the study.  A standardized form will be used (Appendices E & H).  
  

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D6 Adherence to Respirator or mask use and hand hygiene  
Trained research assistants will observe clinics to determine adherence to correct FPE use and 
number of respirator/mask changes required.  Participants will be instructed to don a new 
respirator/mask each time they come into close contact (within 6 feet) of a patient with 
suspected or confirmed respiratory pathogen infection.  Hand hygiene frequency will also be 
observed.  Unannounced observations will occur in each clinic throughout the intervention 
period of the study; these visits will take place during all operating hours of each participating 
clinic.  A standardized system will be used to measure FPE and hand hygiene compliance 
(Appendices I and Z) using HandyAudit compliance measurement iPad application.  These 
observations may be made using paper or electronic methods but must ultimately be submitted 
via HandyAudit.  
  
As discussed, a patient-based observation system (see Appendix Y) may also serve as an 
additional method for assessing HCP compliance with FPE and HH, especially when these 
observations are difficult or impossible to attain by study staff (i.e. behind closed doors or in 
areas with limited visibility).  
  
To encourage and remind participants of mask wearing, study sites may hang posters with a 
“Mask Up” slogan (see Appendix BB) in clinics and high traffic areas of the hospital.  These 
posters reiterate CDC mask wearing guidelines for HCPs in close contact with patients presenting 
with signs and symptoms of respiratory infection. The intent of this campaign is to maximize 
mask-wearing compliance among study participants.  
    
D7 Risks and Benefits  
Respirator or medical mask wear is completely voluntary; therefore, any subject may remove 
his/her respiratory protective equipment at any time for any reason for any duration.  While 
CDC guidance specifies (and OSHA regulation enforces) the settings and conditions in which 
these protective devices are to be worn, employees are afforded the right to remove the 
equipment.  Still, it is the subjects’ best interest to remove these devices at appropriate times, 
such as during break periods or when not interacting with patients.  
  
POSSIBLE RISKS: The problems posed by N95 respirators and medical masks in this study are 
primarily related to discomfort and annoyance.  The risks of wearing a respirator are minimal.  
Subjects wearing respirators or medical masks who engage in low-level exertion, the type typical 
for HCPs, should not experience limits of endurance or exertion capacity.  Subjects who exert 
themselves at a moderate or high-level workload for a prolonged period (highly unusual for 
HCPs) may need to remove their protective equipment for all or some of the remaining study 
session.  While the risks of ischemic events, such as a myocardial infarction or cerebrovascular 
accident, cannot be completely excluded, the risks of these events have been conventionally 
understood to be extremely low.  Studies quantifying the risks of such rare events while wearing 
respirator protection in the healthcare sector have not been conducted.  However, HCPs who 
can perform the occupational duties required to care for patients are believed to be capable of 
wearing a respirator without adverse incident.  
  

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While there are no known data that support exclusion of pregnant women from this study, the 
investigators raised concerns about the possibility of a change in respirator fit caused by the 
typical facial changes during pregnancy.  The primary concern is that the fit may become 
inadequate during the latter stages of pregnancy.  Because of a theoretical risk posed by illfitting 
respirators during pregnancy, HCPs who will be in the 3rd trimester of pregnancy during the 
study period are excluded from the study.  
  
Mild discomfort is the primary risk associated with upper respiratory specimen swabs (throat 
and nasal swabs).  Gagging or aspiration may theoretically occur, although the investigators are 
not aware of well-documented cases in the public domain.  Other rare occurrences may include 
bleeding or emesis.   
  
There is a risk associated with the collection and handling of PHI. All PHI data will be coded at 
the earliest opportunity, transmitted and stored according to institutional guidelines, and the 
code key will be destroyed at the end of the study.  
  
Risks associated with having blood drawn are slight but may include excessive bleeding, fainting 
or feeling light-headed, hematoma, and rarely, infection. Trained personnel will collect blood for 
serological testing.  
  
POSSIBLE BENEFITS: The study is designed to help answer an important question regarding the 
safety of all HCPs.  All participants will meet fit-testing criteria (as determined by the  
“Inclusion/Exclusion” protocol).  They will also be fit-tested for the N95 respirator specifically for 
the study.   The fit-testing documentation provided by ResPECT Study staff may also be 
submitted to each participating site to fulfill a clinic’s mandatory fit-testing renewal 
requirement.  Because OSHA-designed fit-testing provides a means for education about 
respiratory protection and fit-testing can help equip HCPs with a safe work environment, the 
study could offer the benefit of enhanced workplace safety.  Otherwise, there is no known 
direct, immediate benefit to subjects.  
  
D8 Early Withdrawal of Subjects/Data/Follow-up for Withdrawn Subjects   
If a participant is unable to complete the study, due to illness (other than a respiratory pathogen 
illness) or non-compliance with the data collection and sampling required for this study, they 
will be removed from the study. If participants fail to submit more than three entire weeks of 
surveys (i.e. no weekly survey and no daily surveys) and/or fail to comply with three warnings 
from study personnel during observations (i.e. improper use of FPE, failure to correct HH) they 
will be subject to an administrative withdrawal at the discretion of the site PI.  
In the event a participant becomes ineligible but is still willing to participate (i.e. – changes 
location but still willing to be involved with the study) AND has completed at least eight weeks 
of the study intervention period, the final blood collection and post-study survey will be 

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completed before removal from the study. All post-study collections will be reviewed and 
completed at the discretion of the site PI.    
  
D9 Study Data Collection tools  
The data will be collected on electronic data capture forms (HandyAudit and REDCap). Findings 
may be validated with a telephone call, email, or a face-to-face contact by study personnel.    
  
  
Forms  
Study time 
point  
Appendix  
Filled by  
a)  Pre-study Inclusion/Exclusion  
Screening   
Pre-study  
C  
Research 
team/participant  
b) Baseline Survey  
Pre-study  
D  
Participant  
c)  Preliminary Survey  
Pre-study  
E  
Participant  
d) Amended Fit-testing Medical  
Questionnaire  
Pre-study  
M  
Participant  
e)  HSE Fit Test Evaluation Form  
Intervention  Q  
Research Team  
f)  Enrollment Checklist  
Pre-study  
P  
Research Team  
g)  Weekly Diary  
Intervention  G  
Research Team  
h) Daily Exposure Form  
Intervention  F  
Participant  
i)  Symptomatic Event Report  
Form  
Intervention  N  
Participant/Research  
Team  
j)  
Subject Compliance Monitoring 
Forms:   
FPE Observation Form          
Intervention  I, Y, Z  
Research Team  
k)  
Subject Compliance Monitoring 
Forms:  
Hand Hygiene Observation  
Form  
Intervention  I, Y, Z  
Research Team  
l)  Post Study Survey  
Post-study  
H  
Participant  
m) Supplemental Vaccination  
Questions  
Post-study  
CC  
Participant   
9.a  
 Pre-study Inclusion/Exclusion screening  
All potential participants will be required to complete a pre-study screening form to determine 
their eligibility to participate in the study (Appendix C). If HCPs are determined to not be eligible 
to participate in the study due to a potentially complicating health condition, they will be 
provided information about proper respiratory protection (Appendix J).  
9.b  
Baseline Survey  
The baseline survey (Appendix D) will collect contact information, demographic information, 
recent exposure (risk factor) history, vaccination status, smoking status, history of systemic 

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disease (respiratory/heart/neurological) and information about medication use.  Participants 
will be required to complete this survey prior to the study intervention period.   
9.c  
Preliminary Survey  
The pre-study attitudes, beliefs, and opinions survey (Appendix E) will collect participants’ 
knowledge, attitudes, beliefs, and opinions about FPE.   Participants will be required to complete 
this survey prior to the study intervention period.      
9.d  
 Amended Fit-Testing Medical Questionnaire  
In compliance with OSHA regulations, subjects will be required to complete an amended version 
of the 1910.134 OSHA Respirator Medical Evaluation Questionnaire (Appendix M) prior to being 
fit tested.  
9.e  
HSE Fit-Test Evaluation Form  
This form will be completed by the research team to evaluate the participants for fit testing. 
(Appendix Q)  
9.f  
Enrollment Checklist  
This will be a checklist (Appendix P) to ensure that the participants enrolled in the study 
intervention period meet the study entry criteria. The data collected during the pre-study 
assessments including; Inclusion/Exclusion criteria, Fit-testing, and Baseline survey will 
determine if a participant can be enrolled into the study or is a screen failure.  
9.g  
Weekly Diary   
During the intervention period (Table 2), the information will be collected once weekly  
(Appendix G) updating their influenza vaccination status, symptoms, treatment and exposure.    
  
9.h  
Daily Exposure Form   
  
A daily exposure form (title “Monday Exposure Form, Tuesday Exposure Form, etc; Appendix F) 
will be used to help participants recall and record exposure risks, signs and symptoms of 
respiratory illness and periods of daily FPE wear. The daily exposure form will ask about 
respiratory illness among household members, work colleagues and other contacts.  Participants 
will complete the daily exposure form every day to track the existence or absence of respiratory 
or influenza-like symptoms on each date worked at the study site.    
  
While data from this study will be kept confidential and will not be reported to managers and 
will not be used to enforce furloughs for ill participants, we will encourage participants who 

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become ill to consult with their local occupational/employee health departments concerning 
their illness.  
  
9.i  
Symptomatic Event Report Form  
Subjects who self-identify as having any sign(s) or symptom(s) of influenza (as defined in Table 3) 
will be asked to complete a Symptomatic Event Report Form (Appendix N).  Trained study staff 
will then determine if the subject should undergo an upper respiratory specimen collection 
using nasal/throat swabs for data collection purposes.    
  
Participants reporting signs or symptoms of respiratory disease (including influenza) in their 
weekly symptom diary/daily exposure diary will be contacted by study personnel to schedule an 
upper respiratory specimen swab (throat and nasal swabs). Those participants who are not 
working or are unable to come to work will be instructed to use their take-home kit (Appendices 
R, S, T, and U).  
  
9.j  
Subject Compliance Monitoring Forms   
  
Data will also be gathered on FPE compliance and hand hygiene (HH) compliance.  Data will be 
collected by trained study staff using the electronic HandyAudit compliance monitoring system 
(https://www.handyaudit.com/) or using standardized forms if the HandyAudit system is 
unavailable (Appendix I, Appendix Z).  FPE and HH compliance data collection will occur during 
unannounced observation visits within clinic operating hours. This information will be used to 
analyze the relationship between levels of compliance with FPE and HH and incidence of 
respiratory disease.  Participants will be asked to wear FPE whenever they have close contact 
(within 6 feet or sharing a small enclosed airspace) with an individual with suspected or 
confirmed ILI.  They will also be asked to don new FPE before each new close-contact patient 
interaction.   The study team will aim to achieve five FPE and five HH observations per site, per 
week. These data were collected using HandyAudit (Handimetrics, Toronto, 
CAhttps://www.handyaudit.com/handyaudittechnology.html).  
9.k  
Post-Study survey  
After the intervention period, there will be a post-study period when the participants will 
complete a post-study survey regarding attitudes, beliefs, and opinions about FPE and the study. 
(Appendix H).  
9.l  
Adverse Event Submission Form  
An adverse event (AE) is any adverse change from the patient’s baseline (pre-study) condition, 
which occur during the course of the study and, after the consent form has been signed, 
whether the event is considered to be related to the study intervention or not. The research 
team will complete an AE submission form (Appendix O) upon reporting of such events.  

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D10 Study specimen collection, test methods, storage and shipping  
The high cost of this study requires prioritization of achievable endpoints and target data.    In an 
effort to optimize the use of available funds, a subset of lab tests for identification of respiratory 
pathogens through serologic testing will be performed while the remainder will be stored for 
future completion when additional funding becomes available (more information is available in 
the section on funding source). The lead study team (principal and lead site investigators) 
determined that all sites will send remaining samples to UT Southwestern (UTSW) and the VA 
North Texas for storage. Future sample testing will be determined by the lead study team.  
Samples from VA sites will be stored in space leased by the VA North Texas at UTSW. All storage 
facilities are in compliance with VA North Texas requirements.   
  
Excess samples remaining after study tests have been completed may be released to ResPECT 
investigators for analyses of other respiratory organisms, after approval by the lead study team 
and local IRBs. As new respiratory pathogens are identified, specimens may be used for 
additional testing as dictated by changing epidemiology. According to record retention policies, 
the VA requires that records are retained until six years after the end of the calendar year in 
which the study closed. The lead study team will comply with the record retention policies at the 
VA, as well as the policies at each individual site.  
  
10.a Blood Specimen Collection  
Blood samples will be collected by trained personnel at two time points; one at the beginning of 
the intervention period and second at the end of the intervention period. The samples collected 
were originally stored for serology testing and sent to Dr. Geoffrey Gorse at Saint Louis  
University at agreed upon intervals for analysis. Dr. Gorse’s lab operates in a VA-leased space at 
Saint Louis University and complies with all VA St. Louis Healthcare System regulations. To 
maintain data integrity and ensure study longevity, the lead study team determined that all sites 
will send remaining blood samples to UTSW and the North Dallas VA for storage. VA samples will 
be stored in space leased by the North Texas VA at UTSW. As new respiratory pathogens are 
identified, specimens may be used for additional testing as dictated by changing epidemiology.   
10.b Respiratory Specimen collection  
The specimen will be taken from the upper respiratory passages that will be collected and stored 
using the standard methods.  The respiratory specimens will be collected from throat and nasal 
passages. No nasopharyngeal aspirates will be performed for the purposes of this study.  If it is 
determined that subjects are unable to come to work and participate in specimen collection 
when they experience respiratory pathogen symptoms, participants will use “take-home” 
specimen collection kits, which will be provided to them upon enrollment, (Appendix R) and 
procure a respiratory specimen themselves.  The kits will include instructions on dangerous 
goods shipping (Appendix S), self-specimen collection (Appendix T), and shipment packaging 
(Appendix U) so that the specimens can be sent to the research lab.   

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Laboratory Specimens and Test Methods   
  
Respiratory Pathogen Identification  
Swab specimens (secretions/swabs in viral transport medium) will be processed and stored 
within 48 hours at each study site. Frozen samples will stored at Johns Hopkins University and 
the Denver VA/the University of Colorado at agreed upon intervals. Storage and laboratory 
testing will occur at both Johns Hopkins and the Denver VA/the University of Colorado. Samples 
will then be sent to UTSW for storage, where they will be stored for future use.   
  
Nucleic Acid Extraction, PCR   
Samples will be processed for nucleic acid extraction using multiplex PCR assay(s) at JHU to 
identify human respiratory pathogens (Table 4). St. Louis testing is done using assays to 
determine serum hemagglutination inhibition (HAI) antibodies to multiple strains of Influenza A 
and B viruses.  Excess samples were stored for further analysis by ResPECT investigators at their 
respective institutions. These will be transferred to UTSW where they will be used for additional 
studies based on the determination of ResPECT investigators. Samples may be destroyed at the 
discretion of the lead study team.  
    
10.c Study Specimen Storage and Shipping  
  
Because Dr. Perl, study co-PI and original lead site investigator at the lead clinical site, has left 
JHU for UTSW, the study lead team has determined that all respiratory and blood samples will 
be transferred from the other ResPECT sites to UTSW for storage. UTSW will house and 
catalogue the samples according to good laboratory practices in a freezer farm in the 
institution’s ID Division and space leased by the North Texas VA. Samples will be stored in one of 
several -80°C upright freezers. Protocols for specimen cataloguing and storage will be developed 
with the Johns Hopkins University under the direction of Charlotte Gaydos, who also now serves 
as the lead site investigator at JHU. A laboratory based, inventory database and tracking system 
will be put in place and will be used to track samples. Freezer temperatures will be monitored 
daily for temperature deviations. A materials transfer agreement (MTA) has been signed by JHU, 
UTSW and the New York VA. The study team will check with individual site IRBs to ensure this 
MTA suffices for all sites.   
  
  
E  Study Procedures   
E1 Certification and Registration of the clinical Sites/Clusters:  
  
The participating sites will certify (Appendix K) and then register these clusters with DCC. DCC 
will then randomize the clusters to one of the two arms and send the randomization scheme to 
the participating site.  

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E2 Screening for Eligibility  
The anticipated duration of this study is four respiratory virus seasons.  Enrollment of subjects 
will commence as soon as possible after IRB approval, with the intention that the study will 
cover four respiratory virus seasons.  The start of the actual intervention period will be 
determined by year and site based upon influenza surveillance at the participating site, as well 
as state and regional health departments. The clusters would be assigned by one of the two 
arms using a system established by the DCC.  
  
HCPs who agree to participate will be asked to provide written informed consent and agree to 
participate for up to 16 weeks with the option to voluntarily withdraw at any time, for any 
reason.   
  
Once consented, participants will be screened for exclusion (Appendix C), and to ensure that 
they are healthy enough to participate in the study. Non-English speakers and those with a 
language or hearing impairment will be excluded from the study.  Once participants are 
consented, they will be asked to fill out the baseline survey and preliminary 
attitudes/opinions/beliefs survey, will provide their initial blood draw, and will be fit-tested if 
they are being recruited at a site that has been designated as an N95-wearing clinic.  Ideally, all 
these (pre-study assessments) initial procedures will occur during their initial enrollment but 
may have to be performed later date in the study. During the pre-study period, fit testing will be 
done to confirm eligibility of participants at the site randomized to wear N95 respirators. There 
will not be a pre-participation physical examination. However, during the informed consent 
process, the Study Coordinator will explain to each potential subject the risks of wearing a 
respirator for prolonged periods and the procedure of collecting upper respiratory specimen.  
  
Contacting participants may include (but is not limited to) following up with participants about 
form compliance, fielding questions, ensuring payment and scheduling, and contacting 
participants who alert us that they have become symptomatic.   The list of participating HCPs 
and the intervention schedule will be kept confidential to protect HCPs from repercussions for 
either declining or accepting participation in the study.    
  
E3 Schedule of Study Assessments  
1) Pre-study Period assessments  
Prior to the initiation of the intervention period, participants will be expected to provide an 
initial serological sample for comparison with their final serological sample for influenza titers.  
Study preparation/screening and education will also take place during this time.  Participants 
will also be required to complete a baseline survey and preliminary attitudes, beliefs, and 
opinions survey.  

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i. 
Consent form: After explaining the study to the potential participant as discussed in the 
previous section, consent from the agreeing participant would be obtained. The study 
participant will sign two copies of the consent form, one for the study use and other 
would be given to the study participant for their record.  
ii. 
Pre-study Inclusion/Exclusion screening   
iii. 
Enrollment checklist iv.       Baseline survey  
v. 
Preliminary survey  
vi. 
Fit-testing: Fit testing will include education on how to properly don and doff FPE, 
perform user seal checks, and when masks should be reused or replaced.  Education on 
donning and doffing respirators and medical masks will be through handouts at 
fittesting and one-on-one discussion during the fit-testing process. In compliance with 
JHH/OSHA regulations, subjects will be required to fill out an amended version of the 
1910.134 OSHA Respirator Medical Evaluation Questionnaire (Appendix M).   We will 
only include clinics whose managers/leaders have agreed to the inclusion of their 
clinical site(s) in the study.  The researcher will complete a fit test evaluation form 
(Appendix Q) to assess if the participant passes the fit testing requirement.  
vii. 
Initial blood draw: approximately 15-20cc of blood will be drawn from the subject for 
baseline (at enrollment) influenza titers. Blood for serum titers will be drawn, 
processed and stored per laboratory protocol.  
viii. 
Educational component: All subjects will be counseled on influenza vaccination per 
their local policy if they have not received it for the current season. Subjects wishing to 
be vaccinated will be encouraged to do so at the earliest possible time, so that 
seroconversion occurs by the study start.  All subjects will be counseled on influenza 
vaccination in accordance with local policies and procedures (e.g., no change in 
recommendations despite study participation). All subjects will be educated about 
standard precautions.    
2) Intervention Period Assessments:  
The intervention period will consist of 12-16 weeks of participants wearing their assigned FPE.  
Depending on the observed incidence of viral respiratory disease, the intervention period may 
be extended (or otherwise modified) if the incidence of influenza remains significantly elevated.   
  
As discussed in the methods section, the duration of the intervention (mask wearing) period 
may be shortened or lengthened based on incidence and surveillance data available from each 
site.  Flexibility in adjusting the duration of the intervention period is vital to allow for the 
maximum capture of data during viral respiratory season, which may be different at each site, 
each year. Consenting HCPs in each of the included clinics will be enrolled for the duration of the 
intervention period and will be asked to follow the cluster randomization scheme.    
  
i. 
Daily Exposure Form:  All participants will be asked to complete the daily exposure 
diary for each day during the intervention period regardless of whether the participant 
worked that day.  This diary will collect participant symptom information, participant 
exposure to symptomatic patients/co-workers, hand hygiene frequency, and frequency 
of wearing N95s/medical masks.  

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ii. 
Weekly Diary: All participants will be asked to complete the weekly diary.  This diary 
will capture participant symptom information, participant exposure to symptomatic 
household members, and flu vaccination status  
iii. 
Symptomatic Event Report Form:  If a participant develops respiratory/flu-like 
symptoms, a symptomatic event report form will be completed by either the 
participant/research staff.  
iv. 
Respiratory Specimen:  All subjects will be asked to consent to respiratory specimen 
collection, regardless of respiratory symptoms. Specimens from the upper respiratory 
passages, that may include a nasal and throat swab, will be collected from participants 
during this time.  No nasopharyngeal aspirates will be performed.  Randomized upper 
respiratory specimens will be collected 2-6 times during the study period: 2-3 times on 
a random basis, while 1-4 triggered respiratory specimens will be collected when 
symptoms are reported by participants. Participants may have two upper respiratory 
specimens collected in a single week, should they report symptoms, but will also be 
scheduled for a randomized swab.   All swabs will be processed and stored for analysis 
at a later date.  Should funding be made available, we plan to perform PCR testing on all 
respiratory specimen secretions, including the randomly collected specimens from 
asymptomatic subjects.  First, we will be performing PCR testing on the samples from 
subjects having signs or symptoms of a respiratory infection including influenza.  
Respiratory specimens obtained from asymptomatic randomized participants will be 
stored for later PCR testing and analysis.  While serology may detect up to 75% of 
asymptomatic cases, serology cannot identify infection with organisms other than 
influenza.  PCR testing of samples from participants with signs or symptoms of influenza 
will allow us to accurately determine the organism that is causing the symptoms.  
v. 
FPE/Hand Hygiene Compliance Monitoring:  During unannounced visits to study clinics, 
research assistants will complete the subject compliance forms and may verbally 
correct participants who are observed donning/doffing/wearing FPE incorrectly or who 
are not following proper hand hygiene procedures to maximize compliance and 
protection of healthcare workers and patients. We may also be employing an additional 
patient-based hand hygiene and FPE monitoring system to assess practices on a clinic-
wide basis (see Appendix Y). Forms may be distributed to participating sites asking their 
patients to record the HH and FPE practices of HCP during interactions. This information 
will be collected anonymously with respect to HCP and the patients.  
  
Subjects with signs or symptoms of respiratory infection will be advised to consult with the local 
occupational/employee health department as per institutional guidelines. In many cases the 
Occupational Health Clinic would be expected to recommend employee sick leave for a short 
period (1 or more days).  When absent from duty, subjects will be asked to continue completing 
their exposure and symptom forms.  However, we plan to have an online survey/form system 
that will be integrated into the data collection scheme within the first flu season. When the 
subject-employees return to work (e.g., the Occupational/Employee health Department permits 

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the employee to return to duty), s/he will resume donning of the assigned protective devices 
and will resume their testing.     
  
3) Post-Study Period Assessments  
Two weeks after the conclusion of the intervention period, a post-season serological sample will 
be collected and a post-study survey will be completed.  Although participants will only be 
required to wear FPE, provide upper respiratory specimen, and be observed for the initial 
intervention period, the entire course of the study will continue for two weeks after the 
intervention period to allow for the final visit for final serology and the post-study survey.  It is 
anticipated that study participants will enroll for subsequent respiratory virus seasons. However, 
if participants withdraw prior to the completion of 4 respiratory virus seasons, replacements can 
be recruited on a season-by-season basis.   
  
i. 
Post-Study Survey: All participants will be asked to complete a post-study survey.  This 
form will collect participants’ post-study attitudes, behaviors, and opinions on FPE 
usage and vaccination status at the end of the study period.     
ii. 
Final Blood draw: Approximately 15-20cc of blood will be drawn from the subject at the 
end of the study (before termination). Blood for serum titers will be drawn, processed 
and stored per laboratory protocol.    
iii. 
Supplemental Vaccine Questions: All participants will be asked to complete an 
additional survey about selected vaccinations for preventable diseases that can be 
acquired in the healthcare environment, in addition to the questions asked in the pre- 
and post-study surveys.   
iv. 
Sub-study consent: Participants who participated in the main portion of the study will 
be asked to take part in a study extension, in which any additional respiratory 
specimens collected elsewhere may be accessed and tested for respiratory pathogens.  
E4 Subject Stipends or Payments   
Subjects will be compensated for the time necessary to complete the entire study, resulting in a 
maximum possible compensation of $599 (Appendix W).  HCPs’ compensation will be prorated 
by duration of participation, contingent on the completion of the nasal and throat swabs, 
preliminary and post-study surveys, daily exposure diaries, weekly symptom diaries, and 
serological testing at the beginning and end of the study.  Subjects who voluntarily withdraw 
from the study or are removed from the study mid-week, because of illness or other 
investigator-identified issue will receive compensation prorated according to completed study 
requirements.  Subjects who do not meet eligibility requirements at screening will not receive 
compensation and will be withdrawn from the study. Receipt of the final $135 compensation at 
the end of the study will be prorated according to overall participant performance.   Subjects 
who have withdrawn from the study before the endpoint, voluntarily or at the direction of the 
investigator, will not receive the additional $135. The compensation will be issued to study 
participants via checks mailed to their home addresses and will be issued twice during the study 
period, once after the 6th week of intervention and again after all study activities are complete.  
  

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The research team may also implement incentives such as providing food or gift cards to 
participants to thank them for their participation and assistance, rewarding the clinic with the 
highest compliance, etc.  
  
E5  Study Timetable  
  
See Table 2  
  
E6 Safety and Adverse Events   
6.a  
Definitions and Classification of Adverse Events  
Definition of Adverse Event:  An adverse event (AE) is any adverse change from the patient’s 
baseline (pre-study) condition, which occurs during the trial, after the consent form has been 
signed, whether the event is considered related to study procedure or not.  
  
i 
Relationship  
At each site, the principal investigator will assess the relationship of each adverse event to the 
research procedure, based on available information, using the following as guidelines:  
a) Unrelated: No temporal association, or the cause of the event has been identified; or 
the study procedure cannot be implicated  
b) Probably not related: the cause of the event has been identified;   
c) Possibly related: Temporal association is present, but other etiologies are likely to be 
the cause; however, involvement of the study procedures cannot be excluded   
d) Probably related: Temporal association is present; other etiologies are possible, but 
unlikely  
e) Related: Temporal association is present  
f) Other: unknown  
  
ii 
Severity and Expectedness  
The following AE definitions will be used:  
Unanticipated/Unexpected Event: (Any untoward event that is not identified with the current 
investigator brochure or study protocol) Awareness of sign, symptom, or event, but discomforts 
enough to cause interference with usual activity and may warrant intervention.  
  
Serious Adverse Event: Any untoward medical occurrence that results in death, is life-threatening, 
requires patient hospitalization, prolongs existing hospitalization, results in persistent or 
significant disability/incapacity, or is a congenital abnormality.  

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6.b  
Data Collection and Reporting Procedures for Adverse Events  
  
Data collection procedures for adverse events   
Any event experienced by a participant in a given week will be documented in the weekly diary.  
Participants will complete the weekly symptom diary, and any event experienced during that 
week will be noted. The Research team will assess if the reported event meets the definition of 
adverse event. If the Study Coordinator or Principal Investigator learns of any hospitalizations or 
other adverse events or serious adverse event between study visits, an Adverse Event 
Submission Form will be completed (Appendix O). Information regarding the type of report will 
be collected initial and a follow-up, the date and description of the AE.  All adverse events and 
Serious Adverse Events between the time of study entry (consent) and the end of post-study 
period will be collected and reported.  Patients will be monitored for all ongoing unresolved 
adverse events until they are either resolved, or in the opinion of the Principal Investigator, the 
patient is medically stable.  
  
Reporting procedures: All serious adverse events and unexpected/unanticipated events(s), will 
be submitted to local IRB according to their reporting policy. In addition, a summary of the 
adverse and serious adverse events will be sent to the sponsors/agency/DCC annually.  
  
6.c  
Data and Safety Monitoring Board (DSMB)  
  
Three independent researchers will constitute a Data Safety Monitoring Board (DSMB).  The 
members of the board are expected to include the following members. The board composition 
could change at any time. Members with similar qualifications will be included to replace exiting 
members.   
• 
Dr. Tia Powell, MD is a psychiatrist and bioethicist. She is the Director of the Montefiore- 
Einstein Center for Bioethics.   Previously she has been the Executive Director of the  
New York State Task Force on Life and the Law, and the Director of Clinical Ethics at  
Columbia-Presbyterian Hospital in New York City.  She graduated from Harvard  
University and Yale Medical School.  She was a member of the Institute of Medicine 
Committee that reviewed a CDC and OSHA request to clarify the recommended 
guidelines for protection of HCPs exposed to novel H1N1 influenza.  
• 
Dr. Elizabeth Colantouni Johnson, PhD is an Assistant Professor with joint appointments 
at the Johns Hopkins School of Medicine in the Department of Anesthesiology and 
Critical Care Medicine (ACCM) and at the Johns Hopkins School of Public Health in the 
Department of Biostatistics.  She is a member of the Quality and Safety Research Group 
within ACCM.  She earned her PhD at the Johns Hopkins Bloomberg School of Public 
Health of the Johns Hopkins University, her MS in Statistics at North Carolina State 
University and her BS at Virginia Tech.    
• 
Daniel Morgan MD, MS is a physician and epidemiologist in Baltimore, Maryland. He is 
Associate Professor of Epidemiology and Medicine at the University of Maryland School 
of Medicine, Chief Hospital Epidemiologist at the Baltimore VAMC and a fellow at the 
Center for Disease Dynamics, Economics and Policy (CDDEP). His work is funded through 
the Department of Veterans Affairs, the Centers for Disease Control and Prevention 
(CDC), the National Institutes of Health (NIH), and the Agency for Healthcare Quality and 
Research (AHRQ).   

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DSMBs typically make recommendations about study cessation/modification to avoid exposing 
subjects to an inferior intervention.  This often occurs when the study results pass a statistical 
threshold demonstrating one arm to be inferior. In this context, the DSMB will be charged with 
identifying an appropriate time for protocol termination/modification based on available interim 
data about the incidence of influenza and respiratory infections.  If one respiratory protective 
device is found to change the incidence of disease in a clinically significant fashion (e.g., p=0.05), 
the DSMB will weigh the risks and benefits of continuing or prematurely terminating the study.  
The DSMB will meet approximately yearly for respiratory virus seasons 1 and 2, and on an as 
needed basis after that time (e.g., December, May).  One member of the team will be selected 
to be the primary liaison with the DSMB.  
  
  
  
F  Statistical Plan   
  
F1 Study Outcome Definitions   
    
The following definitions align with the definitions in the study’s analysis plan, posted on 
clinicaltrials.gov here:  
https://clinicaltrials.gov/ct2/show/study/NCT01249625?show_desc=Y#desc. The most recent 
analysis plan was uploaded and registered to ClinicalTrials.Gov in June of 2017.   
  
Laboratory-confirmed influenza illness (LCI): A laboratory-confirmed influenza illness is defined 
as laboratory confirmation of influenza infection by either: (A) detection of influenza virus by 
RTPCR in an upper respiratory specimen swab collected ideally within 48 hours of symptom 
onset but at least within seven days of symptom onset or (B) influenza seroconversion defined 
as a 4fold rise in hemagglutination inhibition antibody titers from the pre- to post-season 
serological samples.  
  
Acute Respiratory Illness (ARI): The first secondary outcome is the incidence of ARI as a clinical 
syndrome. ARI is defined as the occurrence of signs or symptoms of respiratory infection, as 
defined by Table 2 in the published protocol, with or without laboratory confirmation.   
  
Influenza-Like Illness (ILI): The second secondary outcome is the incidence of ILI as a clinical 
syndrome. ILI is defined as temperature of 100°F [37.8°C] or greater plus cough and/or a sore 
throat, with or without laboratory confirmation.  
  
Laboratory Confirmed Respiratory Illness (LCRI): The third secondary outcome is LCRI 
attributable to any of the pathogens listed in Table 4. LCRI is defined as ARI combined with 

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laboratory confirmation by RT-PCR of any of the pathogen listed in Table 4 in an upper 
respiratory specimen swab after symptoms were reported and within seven days of the original 
symptomatic report. Events with multiple viruses detected will count as a single event of LCRI.  If 
a swab that tested positive but was not associated with a symptomatic event (i.e. was not 
collected between symptom onset and seven days after symptom onset) then the incident does 
not count as a LCRI event. If an individual seroconverts to influenza, had symptoms at some time 
during the study, and does not have a PCR-confirmed pathogen event already, then we will 
assign them a single LCRI event.   
  
Laboratory Detected Respiratory Infection (LDRI): The fourth secondary outcome is LDRI 
attributable to any of the pathogens listed in Table 4. For a participant with or without 
symptoms, an LDRI is defined as: 1) detection of a respiratory pathogen by PCR or other 
laboratory methods, or 2) serological evidence of infection (e.g. seroconversion) with a 
respiratory pathogen during the study surveillance period(s). In a case where two or more 
pathogens are identified in the same specimen, each pathogen will be considered to represent a 
separate infection (e.g., 2 pathogens as 2 events, 3 pathogens as 3 events) for that study 
participant for that time-point.  Sequential detection of the same pathogens by PCR or other 
laboratory method in swabs collected at least 21 days apart will be considered separate 
infections.  
F2 Study Outcome Measurements:  
2.a  
Measurement of the Protective Effects:  
• 
Investigators will compare the incidence rates of LCI, ARI, ILI, LCRI, and LDRI among HCPs 
who were randomized to wear respirators versus medical masks as discussed in the 
following statistical section.  
  
• 
Investigators will examine the relationship between incidence and possible risk factors, 
including compliance, attitudes and opinions of HCPs and workplace exposures. The 
analysis plan will account for the frequency and level of risk associated with 
nonoccupational exposures.  
2.b  
Incidence Determination  
• 
Investigators will determine incidence rates of LCI among HCPs in outpatient setting.  
  
• 
Investigators will determine incidence rates of ARI, ILI, LCRI, and LDRI among HCPs in 
outpatient setting.  
  
F3 Effect Size  
This study is powered to detect a statistically significant difference between two randomized 
intervention arms, where the primary outcome is laboratory-confirmed influenza.  We aim to 
detect a 25% reduction (i.e., a relative risk of 0.75) in the incidence of laboratory confirmed 
influenza among subjects wearing an N95 respirator compared to subjects wearing a medical 
mask.  These figures were chosen by balancing the goals of the study that are sometimes in 

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competition with each other, including (a) the anticipated mean incidence of laboratory 
confirmed ILI virus infection in all study locations, (b) level(s) at which one intervention is 
considered superior to another from a scientific perspective, and (c) the level(s) at which one 
intervention is considered superior to another from an ethical perspective, such that study 
discontinuation becomes necessary.  Clinicians and clinical scientists in the Infectious Diseases 
and Occupational Medicine communities were informally surveyed for their opinions about the 
magnitude reduction necessary to sway policy, such that one device would be considered better 
than another.  Most clinicians reported 15-25% would be necessary to change practice.  
  
F4 Sample Size Determination and Power  
We chose the size of our sample based upon the expected attack rate of our primary outcome 
(lab-confirmed influenza) in our population.  We estimate that over a year, 20% of unvaccinated 
individuals in the medical mask group will experience laboratory confirmed influenza.  We 
assume that 65% of our population will be vaccinated. Among vaccinated individuals in the 
medical mask group we assume that vaccine is 65% effective in preventing influenza infection. 
Vaccine efficacies at the higher end of what has been seen (86% in health care workers) will lead 
to a reduction in the yearly attack rate to 8.8%, and efficacy on the lower end of what has been 
seen (51% in the general population) will lead to an increased yearly attack rate of 13.4%. This 
variation is smaller than what we might expect due to variations in the severity of influenza 
epidemics and vaccine uptake, and falls within the range of potential outcomes we consider in 
our sensitivity analysis (Table 5).  
  
Hence, we expect a yearly attack rate of 11.55% {11.55% = 0.35*0.2+0.65*(1-0.65)*0.2}. Based 
on this yearly attack rate, we expect a 4-year attack rate of 38.80% {38.80%=1-(1- 
(0.35*0.2+0.65*0.35*0.2))4}. We aim to detect a 25% reduction (i.e., a relative risk of 0.75 within 
each season) in the incidence of laboratory confirmed influenza among subjects wearing an N95 
respirator compared to subjects wearing a medical mask.   
  
We estimate the sample size needed to detect a significant difference in the incidence of 
laboratory confirmed influenza using the approach described by Ukoumunne. The sample size is 
given by   
  
2 
0(1
0)
1(1
1) 
 
pn 2*(z /2 z ) 
2(DEFF)  
(
0 
1) 
  
where p=the number of clusters (to be calculated)             n=number of people in each cluster 
(estimated from the units targeted for inclusion to be  

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16)             z /2=1.96 for an 
alpha=0.05              z =0.84 for 
beta=0.8  
            
0=cumulative proportion with lab confirmed influenza over four seasons in group 1   
(medical mask group) (assumed to be 0.388 for LCI)  
            
1=cumulative proportion with lab confirmed influenza in group 2 (   
N95 respirator group) (assumed to be 0.304 for LCI)  
DEFF=design effect (calculated to be 2.5)  
  
The Design effect is calculated as:  
  
1
(n 1)  
  
where  is the intra-class correlation coefficient (assumed to be 0.1) and n is the average 
number of people in each cluster.  The design effect provides an adjustment for the correlation 
of outcomes within clusters.   
  
Using the above assumptions, we estimate that we need 157 independent clusters (clinics) with 
a median size of 16 individuals each to detect a relative risk of 0.75 between N95 and medical 
masks at preventing laboratory-confirmed influenza infection.  Using this model, the total 
number of individuals participating each season would need to be 2506, with total 
personseasons accumulated over the course of the study of 10,024.  For our secondary outcome 
of laboratory confirmed respiratory illness (LCRI), the total number of individuals participating 
each season would need to be 1,276, with total person-seasons accumulated over the course of 
the study of 5,104. (See Table 6). We expect some loss to follow-up (20-25%) and thus would 
target clusters of 20 individuals each cluster. These main power calculations have been 
confirmed using the Cluster Power software package for R.   
  
We have performed an analysis of the sensitivity of our study design to variations in the fouryear 
attack rate of laboratory confirmed influenza, as well as our power to assess secondary 
outcomes under both high and low attack rate scenarios. These results are shown in Table 5.  
  
F5  Statistical Methods and Analysis Plan  
Descriptive statistics  
Standard descriptive statistics will be used to describe baseline characteristics and follow-up 
measures, both overall, and within each group. Summary statistics such as means, medians, and 
ranges will be produced for all measured continuous variables. Frequencies will be computed for 
all categorical and ordinal variables. Graphical methods including stem-and-leaf diagrams and 
box plots will be used to examine distributions, identify potential influential points, and guide 
the choice of transformations if warranted.   
  
Raw incidence calculations  
Using the outcome data discussed above, we will obtain estimates of the following quantities for 
all study participants and for each of the two study groups:  

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• 
the incidence of laboratory-confirmed influenza (rate across the whole season),  
• 
the incidence of acute respiratory illness (rate by person-weeks),  
• 
the incidence of influenza-like illness (rate by person-weeks),  
• 
the incidence of laboratory-confirmed respiratory illness (rate by person-weeks),  
• 
the incidence of laboratory-detected respiratory infection (rate by person-weeks).  
  
Incidence comparison between study groups  
To compare the above incidence rates among HCPs who were randomized to wear respirators 
versus medical masks, we will fit two different types of models.    
  
Logistic regression model  
A dichotomous variable will indicate whether or not a subject became infected with 
laboratoryconfirmed influenza during the entire influenza season. We will use logistic regression 
to model the difference in seasonal influenza infection between the N95 and medical mask 
groups, using generalized estimating equations (GEE) to account for cluster-specific correlation.  
If Yij is an indicator of whether subject i in group j developed laboratory-confirmed influenza, 
and  
MASKij is an indicator of which mask the individual wore, then we would fit a version of this 
model  
logit
Pr(Yij =1  MASKij)
0 
1MASKij   
with an exchangeable correlation structure within each unit to account for clustering. Additional 
covariates may be added to the model to adjust for possible confounding variables.  
  
Count variables will measure the number of ARIs, ILIs and LCRIs that a subject developed across 
the study period and corresponding variables will track person-time. We will use Poisson 
loglinear regression to model the difference in seasonal respiratory infection rates between the 
N95 and medical mask groups, using GEE to account for cluster-specific correlation.  Assuming 
that Dij is the number of illnesses experienced by subject i in group j, and Nij is the total person-
time contributed, we model the expected number of illnesses as follows:  
log
E
Dij  MASKij
 logNij 
0 
1MASKij  
e 
This model will be fit with an exchangeable correlation structure within each unit to account for 
clustering. Additional covariates may be added to the model to adjust for possible confounding 
variables.  
  

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F6 Missing Outcome Data    
Efforts will be made to keep missing data to a minimum, and participants who withdraw from 
treatment will be encouraged to continue on study in order to provide complete follow-up 
information. An intent-to-treat analysis, in which all available data on all randomized 
participants are included, will be used for the primary comparison of treatments.   
  
Information necessary to complete the intention-to-treat analysis will be collected. Methods 
with potential outcome framework will be used as a secondary analysis.  This data will be used 
to evaluate the effect of wearing respirators by accounting for the limited wear time or change 
in behavior during the course of the study that falls outside the study protocol.   
  
Since periodic changes in infection control guidance and practice may occur over the study 
years, participants will be expected to adhere to the most up-to-date guidance issued by the 
Centers for Disease Control and Prevention (CDC) and local policies at each study institution, at a 
minimum. This may result in cross-overs (e.g., wearing an N95 instead of a MM) which will be 
accounted for in an intention-to-treat analysis after study termination.  
  
The characteristics at the time of randomization for those participants without complete 
followup will be examined. To assess the potential biases introduced by differential withdrawal 
among different respirators, a comparison of withdrawal rates and time to withdrawal will be 
included as an ancillary analysis to the primary outcome comparison.  The processes are further 
explained in the analysis plan.  
  
F7 Planned sensitivity analyses  
7.a  
Potential outcome analysis for laboratory-confirmed influenza  
To account for the unavoidable additional uncertainty regarding the missing data from our 
primary outcome, we will conduct a sensitivity analysis that randomly assigns binary outcomes 
to participants who did not complete the study. Specifically, we will create a two-dimensional 
grid on which we vary the influenza attack rates in participants who dropped out of the study for 
both the MM and N95 arm, separately. We will fix the MM dropout attack rate between half 
and twice the observed MM attack rate, based on complete data. We will fix the N95 dropout 
attack rate between half and twice the observed N95 attack rate, based on complete data. By 
varying these two parameters across the grid, and for each combination, calculating the 
adjusted odds ratio (averaged across n=50 imputed datasets for each point on the grid), we will 
observe the sensitivity of our results to values of the missing data.  
  
7.b  
Analysis of differential withdrawal  
The characteristics at the time of randomization for those participants without complete 
followup will be examined. To assess the potential biases introduced by differential withdrawal 
among different respirators, a comparison of withdrawal rates and time to withdrawal will be 
included as an ancillary analysis to the primary outcome comparison.  
  
  

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G  Data Handling and Record Keeping   
  
G1 Confidentiality and Security  
  
Data Management and Privacy:    
Data will be entered into a password protected database with unique identifiers assigned to 
each study participant. Paper data collection instruments will be stored in a locked filing cabinet.  
The data will be entered into a secure database. The specific database/data collection system 
used may vary at each site due to site-specific privacy/database/IRB guidelines.  However, all 
data collected (i.e. surveys, specimen collection data) will be standardized.  JHU has been 
identified as the data collection center and will serve as a clearinghouse for data while the study 
active (i.e., recruiting participants). Once participant recruitment interaction is complete, 
REDCap and cluster data will be securely moved to and stored at the UTSW, which will become 
one of the data management centers along with UF. After all data are collected and all analyses 
completed, linkage between participants and their unique identifier will be destroyed. During 
the course of the study, protected health information that is collected will be disclosed only to 
study personnel, unless otherwise required by law. All personnel have taken (and will continue 
to maintain) required training for HIPAA protection and research ethics.   
  
A tracking system using coded identifiers will be implemented to facilitate tracking of sample 
compliance and sample movement between study sites, laboratories, and/or other pertinent 
locations. Coded identifiers will be matched year-to-year to link participants’ data. This 
information will be stored and accessed in compliance with federal and study site requirements.    
  
  
G2 Case Report Forms and Source Documents  
All subject-specific data recorded in diaries, forms or other record (including infection status) 
will be de-identified and kept confidential.    
G3 Data Management   
Study data will be collected and managed using an electronic database which is a secure, 
webbased application designed exclusively to support data capture for research studies. This 
application provides: 1) an intuitive interface for data entry (with data validation); 2) audit trails 
for tracking data cleaning and export procedures; 3) automated export procedures for seamless 
data downloads to common statistical packages (SPSS, SAS, Stata, R); 4) procedures for 
importing data from external sources; and 5) advanced features, such as branching logic and 
calculated fields.  

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Hosting and Security  
During the active recruitment period, the application was hosted on servers administered by 
Johns Hopkins University. The servers were protected by both a hardware firewall and a web 
application firewall. In addition, they had multi-level intrusion detection, network security 
audits, and secondary hardware on standby for immediate replacement. All data transmitted 
between the client browser and web servers were encrypted using an SSL connection. They also 
ensured that server updates were applied in a timely manner and that the data were regularly 
backed-up and stored securely off-site.   
  
UTSW and UF will become the data management centers, as was decided by the lead study 
team. The electronic database will be moved to a secure server hosted at UT Southwestern, and 
the study files will be transferred from JHU using an encrypted external hard drive. The study 
files will be securely stored on a password-protected, limited access network drive at UT 
Southwestern.   
  
Data storage facilities managed by the Information Resources (IR) Department at UTSW will 
house the ResPECT database. The facilities agreement with UTSW’s IR provides for an enterprise 
class data center equipped with uninterruptible power supplies (UPS) with automatic generator 
backup power in the event of a utility failure. In addition to state-of-the-art network security, 
the facility provides excellent physical security with 42 digitally recorded cameras monitoring 
every square inch of floor space, keycard access, and NACI federal background checked 
operations staff on-duty 24 hours a day, 365 days a year.  
  
UTSW has state-of-the-art environmental controls and safety monitoring systems including fire 
detection with various levels of suppression, and the perimeter of the building is protected by a 
two-hour firewall. Authorized personnel have 24x7 access to their systems housed in the data 
center. In addition, IR maintains backup data sets in a data vault, in the event of a catastrophic 
failure. The locations of the backup sets are logged, tracked, and audited using a media 
management system.   
  
A backup copy of the data will also be securely stored on an encrypted external hard drive at UF.    
  
Authentication and User Rights  
To access the ResPECT study website, all users of the web-capture system must have a valid 
username and password. Each user account has rights that can be granted or denied including: 
data import, data export, data comparison, data logging, file repository access, user rights 
assignment, data access groups assignment, lock/unlock records, and super user. In addition, 
they can be granted read, edit or no data entry rights for each data entry form.    
  
The standard REDCap audit trail cannot be disabled. REDCap records all data activity, including 
the access username, timestamp, and a detailed description of the action. In compliance with 
FDA 21 CFR Part 11, an additional level of audit information is available using e-signatures and 
required descriptions of reasons for change. Once a data collection instrument has been locked 
for a given record in the project, a user with e-signature privileges may then apply an esignature 
to that form. If a record has been e-signed, then it denotes that its data has been both locked (to 

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prevent further changes) and authorized (i.e. by a user with e-signature privileges). In addition 
to e-signatures, a required “reason for change” can be enabled which requires the user to enter 
a description of the reasons for the changes being made. The e-signature history and the 
required reasons for change descriptions are both stored in REDCap's data audit trail.  
H  Limitations  
  
There are several possible limitations for this study:   
(1) 
Available scientific literature supports a wide spectrum of respiratory illnesses involving 
HCPs.  Our screening tool may miss persons who are infected with influenza or other respiratory 
pathogens if they are asymptomatic or minimally symptomatic. However, the presence of 
asymptomatic HCPs with respiratory infections should not affect the comparison of the 
effectiveness of the interventions as they should be equally distributed among the arms.    We 
also hope to capture a significant portion of asymptomatic disease through serological testing 
for influenza titers, and by performing and storing respiratory swab specimens on all 
participants, with analysis of these stored samples carried out should funding be made available.  
However, currently only samples from participants who meet the criteria of being symptomatic 
with ILI will undergo analysis by PCR testing.  
  
Still, as some organisms may be less likely to cause signs and symptoms, infections from these 
specific organisms may be more difficult to document.    
  
(2) 
Self reporting of symptoms in the daily diary may under or overestimate illness especially 
among HCPs where there is a culture of “presenteeism.”   
  
(3) 
Compliance with not only respiratory personal protective measures, but with other 
behaviors such as hand hygiene and isolation, could all be important effect modifiers and could 
bias or confound results towards or away from the null.  However, we would expect that the use 
of these normal protective measures would not be impacted by this study.   
  
(4) 
We are including HCP populations that have a high rate of influenza vaccination that will 
require an increased sample size (accounted for in the calculations) using the conservative 
influenza incidence rates in this protocol.    
  
(5) 
We are limited by our diagnostic strategy.   We will attempt to obtain swabs from upper 
respiratory passages on all participants but will be limited by their willingness to have sampling 
done.   
  
(6) 
Because we are having subjects wear personal protective equipment while at work, but 
not at home or in the community, it is possible that non-occupational exposures could nullify 
("wash-out") any otherwise detectable differences in study arms.  The probability of a Type I 

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(false positive) epidemiologic error is greater than would be expected if HCPs were to wear their 
respiratory protective measures 24 hours per day for the study duration.  However, we will be 
assessing the level of risk exposure at home (Appendix D) that will allow us to account for to 
potential risk of infection outside of the workplace.  
  
(7) 
Some subjects will probably choose to be compliant with guidelines, while some of their 
colleagues are non-compliant.  All workers will be required to comply with the minimum 
requirements of the CDC guidelines and OSHA regulations.  Since those wearing medical masks 
may not be complying with existing federal and institutional guidelines, it stands to influence 
other workers to do the same.  Further, the presence of our study stands to raise awareness 
about the importance of wearing respiratory protective equipment, possibly introducing bias 
toward the null (Hawthorne effect).  Such a "minority of compliance" could introduce error into 
our analyses, including sample size under-estimation.  
  
(8) 
Only two medical mask models are used.  The models used in this study exhibit better 
capture efficiency than most medical masks.  Thus, other models of medical masks may not 
perform as well as this model and thus the data may not be generalizable to all hospital settings 
where poorer quality masks are used.  
  
I  Anticipated Products and Impact  
  
I1  
New Knowledge  
• 
An assessment of the incidence rate of organism specific respiratory viral infections 
during respiratory season in all study locations.  
• 
An analysis to determine the most effective respiratory protective equipment for use 
among HCPs to prevent transmission of respiratory viral illnesses during seasonal 
influenza season.  
• 
In the event of a large-scale respiratory epidemic or pandemic, an analysis to 
determine the more effective respiratory protective equipment for use among HCPs to 
prevent transmission of respiratory viral illnesses during periods of prolonged wear and 
national equipment shortages.  
I2  
Publications and Reports   
• 
A publication in peer-reviewed medical journal – submission fall ~ 2017 – describing the 
absolute and relative effectiveness of respiratory personal protective measures.  
• 
A publication in peer-reviewed medical journal – submission winter ~2017 describing 
the epidemiology of pathogens and the clinical impact of pathogens on HCPs in 
outpatient settings.  
• 
A publication in peer-reviewed medical journal – submission winter ~2017 describing 
the knowledge, attitudes and beliefs of HCPs in outpatient settings about respiratory 
pathogens and FPE use to prevent their transmission.  
• 
A report gauging national respiratory protective program changes, including resource 
and financial costs, that grow out of the study results  

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• 
A report that projects the development of evidence based guidelines that grow out of 
the study results for prevention of respiratory infection.    
Additional publications 
may follow.  
  
  
I3  
Significance  
  
This study will be among the first attempts to determine the best facial protective equipment to 
use in a seasonal influenza outbreak, epidemic or pandemic event.  This evidence-based 
information is needed to inform policy makers and administrators on how to prepare for these 
events.  
J  Study Administration  
  
At this time, nine institutions have been identified as participating centers: the Johns Hopkins  
Health System (JHHS) in Baltimore, MD; Denver Health Medical Center, in Denver, CO, and  
Children’s Hospital Colorado, in Aurora, CO; the Department of Veterans Affairs sites in Denver,  
CO, Washington, DC, New York, NY, and Houston, TX; the University of Massachusetts, Amherst,  
MA; and University of Texas Southwestern, Dallas, TX.  UTSW will serve as the study 
administrative site and house the samples and data for further analyses, and UF will also house a 
copy of the study data on an encrypted external hard drive. The transitions were made due to 
investigators moving to sites and are providing coordinating and supporting functions. 
Additional sites will be assessed by certification criteria (Appendix K) and must have an adequate 
number of outpatient visits/clinics (at least 25 that employ 20 or more HCPs), history of 
collaboration with other sites on large clinical trials, and research infrastructure experience with 
clinical studies.  We aim to recruit at least 500 participants per study site, per influenza season.  
Depending on the capability of selected study sites to accrue subjects, up to 10 (ten) sites may 
be included altogether.    
J1  
Organization and Participating Centers  
1.a  
Study Site: Johns Hopkins Health System, Baltimore-Washington Region  
  
JHHS includes 4 acute care hospitals:  (1) JHH, (2) Bayview Medical Center (BMC), (3) Howard 
County General Hospital, and (4) Suburban Hospital; and a network of urgent care facilities and a 
group of outpatient primary care clinics organized under the umbrella of the Johns Hopkins 
Community Physicians.  For this proposed study the primary sites will be the JHHS and BMC that 

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are located in the Baltimore area, the largest metropolitan area in Maryland (population of 
1,024,645).  Forty-seven percent of the population is African-American, and 52% is Caucasian.   
Only 9% of the population is over 65 years of age.  One fifth of the population qualifies for 
Medicaid.  We will also be approaching the network of 18 primary care facilities that constitute 
the Johns Hopkins Community Physicians.  These facilities are located in 11 counties, providing a 
variety of primary care services to communities in and around Baltimore, Washington DC, and 
across the state of Maryland.  
  
JHHS provides medical care to patients regardless of payer status and serves patients of both 
sexes and all races. Johns Hopkins Hospital is a 1026 bed hospital that includes a pediatric 
hospital (Johns Hopkins Children’s Center), a 63-bed oncology unit (The Johns Hopkins Weinberg 
Oncology Center) and 8 ICUs.  Johns Hopkins Bayview Medical Center (JHBMC), a 678-bed, 
fullservice medical center, includes a 331-bed community teaching hospital and 347 non-acute 
care beds, and the Baltimore Regional Burn Center.  Services for seniors are concentrated in a 
255bed Johns Hopkins Geriatrics Center. Clinics will be selected from this rich network of 
healthcare institutions and will be selected based on volume of cases of respiratory illness seen 
and willingness to participate.  The participating JHH sites include the Harriet Lane Clinic, and 
the Pediatric and Adult Emergency Departments.  Other proposed and participating sites include 
the Bayview and Howard County Emergency Departments, the Bayview Pediatric Department, 
JHHS clinics located in Green Spring, MD and White Marsh, MD, interested departments in JHH’s 
Outpatient Center, and the Patient First Clinics associated with the Johns Hopkins Health 
System.  
  
Resources at the Johns Hopkins Health System study site:   
  
JHHS’s Hospital Epidemiology and Infection Control (HEIC) is responsible for surveillance of 
healthcare-associated infections and epidemiologically- important organisms (MRSA, VRE, 
influenza, RSV, etc.), prevention and control of communicable disease exposures, investigation 
and control of outbreaks, development of hospital policies to prevent and control the spread of 
healthcare-associated infections and epidemiologically-important organisms. All are infectious 
diseases-trained hospital epidemiologists with expertise in surveillance, healthcare economics 
and healthcare-associated infections.   
  
Charlotte A. Gaydos, MS, MPH, DrPH will now serve as the site PI for the ResPECT Study, 
following Dr. Trish Perl’s departure to UTSW. Dr. Gaydos is a Professor and Director of the 
Infectious Diseases STD Lab at Johns Hopkins University School of Medicine. She advised the 
study team on the appropriate handling of specimens and continues to advise on aspects of 
virology pertinent to the project. She has been responsible for the virological testing performed 
at JHU and will be overseeing the transfer of samples to UTSW.  
  
Derek A. Cummings, PhD, who will supervise and conduct statistical and epidemiologic analyses, 
is an Adjunct Professor in the Department of Epidemiology at Johns Hopkins Bloomberg School 
of Public Health.  He is also a Preeminence Professor in the Department of Biology and in the 
Emerging Pathogens Institute, at the University of Florida.  Dr. Cummings' interests are in 
bridging theoretical work on infectious disease dynamics, field work on infectious diseases and 
public health responses to infectious disease outbreaks. He conducts research on spatial 

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temporal dynamics of dengue in Southeast Asia, influenza in the US and China, the impact of 
socioeconomic and demographic changes on disease transmission, dengue diagnostics and the 
dynamics of immune response as well as dengue vaccination strategies.  Dr. Cummings training 
is in systems research and has worked on theoretical simulations of dengue, measles, 
chikungunya and influenza transmission. His field-work includes a community based study of 
influenza in southern China, a study of dengue among non-human primates in Senegal and a 
study of dengue in Thailand.  Dr. Cummings conducts studies of influenza dynamics in southern 
China, health care workers in the US and in school-children in the US. Dr. Cummings has also 
worked to characterize transmission of multiple emerging pathogens including MERS-CoV, 
pandemic influenza, chikungunya and Ebola.  
  
DCC: Initially at JHHS, the DCC for the ResPECT study includes a strong research group led by our 
Research Program Manager, a research coordinator, and research assistants.  The group has a 
long history of implementing interventions within the healthcare setting.  They have 
collaborated with the CDC and VHA and completed many projects designed to reduce the risk of 
healthcare-associated infections including clinical trials. This research group would be 
responsible for distributing the study materials and training the various participating sites on the 
conduct of the ResPECT clinical trial.   
  
NOTE: The DCC will be moved to UTSW following the move of one of the co-PIs.    
  
Surveillance data including the status of respiratory viruses are collected from several local area 
networks. The system contains information on demographics, length of stay, DRG’s, ICD-9 codes 
and severity, reason for admission, previous admissions, number of preoperative days, and cost.  
Each system has limited access and significant security. In addition, surveillance for 
epidemiologically significant organisms including respiratory pathogens is performed and 
automated using several different surveillance/tracking/chart review systems in the JHHS.  This 
system of healthcare information tools allow for efficient research and clinical accuracy across 
the many sites within the Hopkins network.  These systems include (but are not limited to) 
Theradoc  software (Theradoc Corporation, Salt Lake City, Utah), the Johns Hopkins Hospital  
EPR (Electronic Patient Record), Eclipsys /Allscripts , the JHH POE (Provider Order Entry  
System), the Johns Hopkins Adjusted Clinical Groups Case Mix System, and the CDC Biosense 
System.  If necessary, data for this project will be collected based on the systems and software 
available at each research site.  
  
Occupational Health Services (OHS) is integrated across JHHS.  Each site is staffed by a CRNP 
manager and nurses. As part of the respiratory virus policy, these personnel test ill HCPs with 
nasopharyngeal (NP) swabs.  NP swabs are performed routinely on ill HCPs who present to work 
during the respiratory virus season.  NP swabs are available during the day at OHS and in the 
emergency department in the evenings and on weekends. Investigators may pursue access to 
both to the results of these NP swab studies, performed per JHHS usual procedures, and to the 

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results of the respiratory specimen collection performed as part of the experimental studies 
described in this protocol.  
  
1.b  Study Administration:  National Personal Protective Technology 
Laboratory, National Institute for Occupational Safety and Health, CDC  
Lewis Radonovich, MD, formerly the Director of the VA’s National Center for Occupational  
Health and Infection Control COHIC, a Senior Physician Scientist and Medical Officer at the 
National Personal Protective Technology Laboratory at NIOSH, who has served as Co-PI since 
study inception will continue in this role.    
1.c Study Administration: North Florida Foundation for Research and Education 
(NFFRE):   
  
A not-for- profit education foundation based in Gainesville, Florida, established in 1997 to 
administer and facilitate research funded from non-VA sources.  The Executive Director of 
NFFRE, will be responsible for managing and distributing the non-VA funds to their respective 
locations.    
  
1.c  
Study Administration: Veterans Health Administration Network of 
Medical Facilities:   
On a nationwide scale, VA’s health care system now includes 153 medical centers, with at least 
one in each state, Puerto Rico and the District of Columbia. The rich network of VA investigators 
is available for consultation and collaboration.  In the past, VA investigators played key roles in 
developing the cardiac pacemaker, the CT scan, radioimmunoassay, and improvements in 
artificial limbs.  Through VA's Cooperative Studies Program, researchers conduct multicenter 
clinical trials to investigate the best therapy for various diseases affecting large numbers of 
veterans.    
  
 The 1400 medical facilities in the national VA healthcare system are decentralized into 21 
Veterans Integrated Service Networks (VISNs), each representing a geographic portion of the 
nation.  Regional Network offices help integrate the activities of the medical facilities included in 
each VISN.  Local medical center leadership is primarily responsible for the activities at each 
hospital and its affiliated outpatient clinics.    
  
Almost 5.5 million people received care in VA health care facilities in 2008.  In 2008, VA facilities 
treated 773,600 inpatients and served over 60 million outpatient visits. VA manages the largest 
medical education and health professions training program in the United States.  VA facilities are 
affiliated with 107 medical schools, 55 dental schools and more than 1,200 other schools across 
the country.  Each year, about 90,000 health professionals are trained in VA medical centers.  
More than half of the physicians practicing in the United States had some of their professional 
education in the VA health care system.   
  

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1.d  
Study Site: VA New York Harbor Healthcare System, New York NY   
Setting:  VA New York Harbor Healthcare System (NYHHS) is the first Veterans Health  
Administration (VHA) site and overall the second site to join the Respiratory Protection 
Effectiveness Clinical Trial (ResPECT) Study.  It joins Johns Hopkins University (JHU) which served 
as the pilot site for this study and has been in operation for approximately 1 year.  
Organization:  VA NYHHS is a level 1A VHA facility.  It consists of two tertiary care medical 
centers located in Manhattan and Brooklyn and a Community Living Center located in St. Albans, 
Queens.  VA NYHHS also operates four Community Based Outpatient Clinics (CBOCs) located in 
Harlem, downtown Brooklyn, New York and Staten Island which serve New York, Kings, Queens 
and Richmond Counties. The Veteran population in this catchment of the New York-New Jersey 
Veterans Integrated Service Network #3 (VISN-3) is approximately 186, 869.   
VA NYHHS operates 318 acute hospital beds, 179 Community Living Center beds and 74 
Residential Treatment beds. The New York Campus is a tertiary care facility with bed services in 
acute medicine, surgery, acute psychiatry, neurology, rehabilitation medicine. It is also the 
interventional cardiology, cardiac surgery, and neurosurgery referral center for VISN-3. Its 
facility also includes an Emergency Room and an Ambulatory Care Center with Primary Care and 
all Specialty Care clinics.  The Brooklyn Campus provides bed services in acute medicine, surgery, 
psychiatry and residential substance abuse. Specialized programs exist in comprehensive cancer 
care and non-invasive cardiology.  The Cancer Program includes special expertise in palliative 
care and radiation oncology.  Brooklyn also has a busy Emergency Room, Primary Care, and all 
Specialty Care Clinics. The St. Albans Community Living Center serves the metropolitan area with 
specialized geriatric care. The Center provides extended care rehabilitation, psycho-geriatric 
care and general nursing home care. A separate domiciliary provides psychosocial and 
independent living skills rehabilitation. St. Albans provides Primary Care and a limited number of 
specialty care clinic services (Mental Health, Dermatology, Optometry, Cardiology, Urology, 
Podiatry, and Dental). The CBOC in Staten Island provides Primary Care, Mental Health, 
Optometry and Podiatry services.  The CBOCs in Harlem, lower Manhattan, and downtown 
Brooklyn provide Primary Care and Mental Health clinics.  
VA New York Harbor’s two major academic affiliations are New York University (NYU) Medical 
Center and SUNY Downstate Medical Center.  It provides funding for 270 medical residents, as 
well as other disciplines, including dental, optometry, podiatry, psychology, physician assistants, 
nursing, pharmacy, social work, Dietician, Respiratory Therapy and Pastoral Care.  In addition, 
approximately 850 medical students rotate through the Brooklyn and NY campuses annually.   
In fiscal year 2010, VA New York Harbor Healthcare System Research Program had 199 both 
human and animal research projects and a budget of ~$6.0 million.  Important areas of research 
include cardiovascular, hematology/oncology, cancer, infectious diseases including AIDS/HIV, 
mental health, substance abuse, rehabilitation engineering/ prosthetics, pulmonary, renal, 
geriatrics and optometry as well as clinical trials and co-operative studies.  

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In Fiscal Year 2010 VA NYHHS treated 50,705 unique patients and had 7115,382 outpatient 
visits.  It provided 72,374 hospital days of care in its acute facilities (Brooklyn and New York); 
50,047 days of care in the Community Living Center and 24,031 days of care in its Residential 
Rehabilitation programs.    
  
VA NYHHS employs approximately 3,450 full time employee equivalents (FTEE).  While some of 
the Medical Staff attending and all of its resident physicians are part-time and rotate at the 
affiliated hospitals, the vast majority of its primary care physicians and all of its nursing and 
support personnel are full-time employees.  
  
Resources Available:    
Michael S. Simberkoff, M.D. serves as the site PI for the ResPECT Study.  He retired from the 
position of Executive Chief of Staff, VA NYHHS on July 1, 2016.  He is now a volunteer member of 
the Infectious Diseases Section, Medical Staff of the New York Campus, VA NYHHS and Professor 
of Medicine, NYU School of Medicine.  Dr. Simberkoff is Board Certified in Internal Medicine and 
Infectious Diseases (ID).  He has extensive experience in infectious diseases research, VA 
Cooperative Studies (served as Study Chairman for 2 CSPs and as site PI as well as member of 
the Executive Committee of 2 others) as well as clinical infectious diseases.  He has been the 
facility PI for the Veterans Aging Cohort Study (VACS) since it was initiated in 1993.  Prior to his 
appointment as Chief of Staff, he served as Chief, Infectious Diseases, Chairman of the Infection 
Control Committee, and ACOS, R&D at VA NYHHS.   
  
VA NYHHS has Employees Health Services at its Brooklyn, NY, and St. Albans campuses.  It also 
has active Infection Control programs and practitioners at each of these sites. Infection Control 
reports through an Infection Control Nurse Manager to the Associate Director of Patient Care 
Services (Chief Nurse) and to the Chairman, Infection Control Committee.    
  
VA NYHHS has well equipped and staffed Microbiology Laboratories at its Brooklyn and NY 
campuses.  Both laboratories are equipped to perform some molecular testing for respiratory 
pathogens.  Both are prepared to expand molecular testing should funding become available.  
  
VA NYHHS has Employees Health Services at its Brooklyn, NY, and St. Albans campuses.  It also 
has active Infection Control programs and practitioners at each of these sites. Infection Control 
reports through an Infection Control Nurse Manager to the Associate Director of Patient Care 
Services (Chief Nurse) and to the Chairman, Infection Control Committee.    
  
VA NYHHS has well equipped and staffed Microbiology Laboratories at its Brooklyn and NY 
campuses.  Both laboratories are equipped to perform some molecular testing for respiratory 
pathogens.  Both are prepared to expand molecular testing should funding become available.  
  
1.e  
Study Site: VA Eastern Colorado Healthcare System, Denver CO   
  
Setting: VA-ECHCS is a tertiary care medical center serving veterans residing in Colorado, 
Wyoming, and Montana, and the second Veterans Affairs medical center to join the ResPECT 
study.  

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Organization: VA-ECHCS provides comprehensive care to 75,000 veterans, including community 
based primary care and a full range of referral services.  It includes an acute care medical center 
with a full range of inpatient tertiary care service, on site primary and specialty care clinics, an 
active Emergency Department, two nursing homes in Denver and Pueblo, and nine community 
based outpatient clinics (CBOCs). There are CBOCs located in the Denver metropolitan area, 
Colorado Springs, and Pueblo that well serve as study clinics. VA-ECHCS employs approximately 
1600 persons, of whom approximately 800 are direct care providers. There are two unions that 
are active at the campus, UNOS and AFGE. Both have been consulted and are supportive of the 
project. Dr. Bessesen has worked closely with the Nurse Executive, who also supports the 
participation of nurses in the study.  
  
Resources available: Mary Bessesen, M.D. will serve as the site principal investigator for VA- 
ECHCS. She is the hospital epidemiologist, Chief of the Infectious Diseases section and a VA  
Merit funded investigator at VA-ECHCS. She has served as site director for multicenter studies of 
Clostridium difficile epidemiology and natural history, C. difficile treatment and S. aureus 
bacteremia epidemiology and treatment. She supervises a staff of four infection control 
practitioners, as well as a full-time nurse study coordinator and 2 RAs to complete the necessary 
protocol activities.  
1.f  
Study Site: VA Michael E. DeBakey Medical Center, Houston TX  
Medical Care: The Michael E. DeBakey VA Medical Center (MEDVAMC) serves as the primary 
health care provider for more than 120,000 Veterans in southeast Texas. Veterans from around 
the country are referred to the MEDVAMC for specialized diagnostic care, radiation therapy, 
surgery, and medical treatment including cardiovascular surgery, gastrointestinal endoscopy, 
nuclear medicine, ophthalmology, and treatment of spinal cord injury and diseases. The 
MEDVAMC is home to a Post-Traumatic Stress Disorder Clinic; a Network Polytrauma Center; an 
award-winning Cardiac and General Surgery Program; a Liver Transplant Center; a VA Epilepsy 
Center of Excellence; a VA Rehabilitation Research of Excellence focusing on mild to moderate 
traumatic brain injury; and one of the VA’s six Parkinson’s Disease Research, Education, and 
Clinical Centers. Including the outpatient clinics in Beaumont, Conroe, Lufkin, and Galveston, 
MEDVAMC outpatient clinics logged almost one million outpatient visits in fiscal year 2009.  
Teaching Hospital: Nearly 3,500 health care professionals provide high-quality care to our 
Veterans. For more than 50 years, the MEDVAMC has provided clinical training for health care 
professionals through our major affiliate, Baylor College of Medicine *.  MEDVAMC now 
operates the largest VA residency program with more than 251 slots. Each academic year, more 
than 1,972 students are trained through 144 affiliation agreements with institutions of higher 
learning in 19 states. Health care students from fields such as nursing, dietetics, social work, 
physical therapy, and a wide variety of medical specialties receive training here each year. This 
responsibility serves to enhance the quality of care provided to our Veterans. As a member 
institution of the Texas Medical Center * (TMC) since 1985, the MEDVAMC staff serves on 

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various TMC oversight committees that contribute to improved patient care and hospital 
operations. The majority of MEDVAMC physicians are also faculty members of Baylor College of 
Medicine.  Many MEDVAMC programs have received national awards and honors including 
accreditation from Joint Commission for hospital, long-term care, behavioral health care, and 
substance abuse.  
Modern Facility: Located on a 118-acre campus and built in 1991, MEDVAMC is a state-of-theart 
facility with 386 hospital beds, a 40-bed Spinal Cord Injury Center, and a 120-bed transitional 
care unit for long-term care. An automated, computer-controlled transport system delivers 
food, laundry, and supplies throughout the building. The six-story granite building is designed 
with four exterior sections and four atriums that contain patio gardens, wheelchair basketball 
courts, and a rehabilitation pool.  
Research & Development: Supported with more than $16 million annually, research conducted 
by MEDVAMC staff ensures Veterans access to cutting-edge medical and health care technology. 
With 729 active research projects, the MEDVAMC Research & Development (R&D) Program is an 
integral part of the medical center’s mission and plays a very important role in the health care 
Veterans receive. The production of new knowledge, techniques, and products has led to 
improved prevention, diagnosis, treatment, and control of disease.   
  
Resources Available: Maria C. Rodriguez-Barradas, M.D. will serve as the site Principal  
Investigator (PI) for the ResPECT Study.  She is the Director for the HIV Program and Professor of 
Medicine, Baylor College of Medicine.  As Director for the HIV Program, she is responsible for all 
medical staff activities at the HIV-ID outpatient clinic at MEDVAMC, as well as in charge of the  
Infectious Diseases Fellows Program within the VA.  Dr. Rodriguez-Barradas is Board Certified in 
Internal Medicine and Infectious Diseases (ID).  She has extensive experience in infectious 
diseases research, including participation in VA Cooperative Studies (site PI for OPTIMA), in NIH 
funded clinical trial networks (CPCRA, INSIGHT) as well as PI for Merit Review Programs.   She 
has been the facility PI for the Veterans Aging Cohort Study (VACS) since it was initiated in 1993. 
MEDVAMC has an active Infection Control program and Dr. Rodriguez participates in Infection 
Control activities as required.  MEDVAMC has well equipped and staffed Microbiology 
Laboratories as well as an Infectious Diseases Research Laboratory. Both laboratories are 
equipped to perform molecular testing for respiratory virus pathogens.  Both are prepared to 
expand molecular testing should funding become available.  
  
1.g  
Study Site: VA Washington DC Medical Center, Washington, DC  
  
Setting: Washington DC VA Medical Center (DC VAMC) is one of the four Veterans Health 
Administration (VHA) sites for the Respiratory Protection Effectiveness Clinical Trial (ResPECT) 
Study.  The DC VAMC joined the ResPECT Study as a site in the fall of 2012.  
  
Organization:  DC VAMC is one of the most visible and dynamic facilities in the VA system. This 
tertiary care teaching facility provides acute general and specialized services in medicine, 
surgery, neurology and psychiatry, and also has a large long-term care facility on site. The 
Medical Center has a satellite Substance Abuse Clinic and three Vet Centers and a number of 
Community Based Outpatient Clinics.  
  

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The Medical Center's staff of 1,700 provides care to Veterans residing in the District of Columbia 
and portions of Virginia and Maryland. The DC VAMC cares for over 50,000 Veterans with more 
than 500,000 outpatient visits each year. The DC VAMC is the only VA medical center with three 
medical school affiliations – George Washington, Georgetown and Howard Universities. It is also 
affiliated with many other colleges and universities in such areas as pharmacy, rehabilitation 
medicine, biomedical engineering, dietetics, social work, nursing and medical center 
management.  
  
The DC VAMC has a multi-million dollar research program that supports more than 100 
investigators and 300 active research projects. Areas of research include mental health, 
substance abuse including alcoholism, hypertension, cardiovascular disease, 
hematology/oncology, infectious diseases including HIV/AIDS, pulmonary, nephrology, 
neurology, and war-related injuries.  
  
The DC VAMC is part of the VA Capitol Health Care Network (VISN 5), which was established in  
October 1995, and serves Veterans from economically and demographically diverse areas within 
Maryland, the District of Columbia, and portions of Virginia, West Virginia, and Pennsylvania.  
  
Resources Available:  Cynthia L. Gibert, MD, MSc will serve as the site PI for the Respect Study.   
Dr. Gibert is Professor of Medicine, George Washington University School of Medicine and  
Health Sciences.  At the Washington DC Veterans Affairs Medical Center, she is the Director of 
Special Projects in the Medical Service, an attending physician in the Infectious Diseases Section 
and a member of the IRB. For more than ten years she was the Assistant Chief of Infectious 
Diseases and the Director of the Infectious Diseases Clinic. Dr. Gibert is also a Senior Medical 
Adviser to the Veterans Affairs Office of Public Health. For 25 years, she has been involved in the 
conduct of NIH-funded clinical research in HIV/AIDS. Currently, she is the site PI for both the 
NIH-sponsored Veterans Aging Cohort Study. She served as the site PI for the OPTIMA trial a VA 
CSP-sponsored study. She is also a site investigator for the NIAID-funded DC Center for AIDS 
Research (D-CFAR) being overseen by the George Washington University HIV/AIDS Institute. Dr. 
Gibert is a member of the VA taskforce for multidrug resistant organisms – that has defined VA 
policy for both methicillin-resistant Staphylococcus aureus as well as Clostridium difficile. She is a 
fellow of both the American College of Physicians and the Infectious Diseases Society of 
America.  She is board certified in both Internal Medicine and Infectious Diseases.   
  
The Washington DC VAMC has an active Infection Control program and with four infection 
control practitioners.  The Infection Control staff reports through the Infection Control Nurse 
Manager to the Medical Center Director and to the Chairman, Infection Control Committee.  The 
Medical Center has a well-equipped and staffed Microbiology Laboratory.   The laboratory is 
equipped to perform some molecular testing for respiratory pathogens if necessary and is 
prepared to expand molecular testing should funding become available.  There is also a robust 
Occupational Health Service.   

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1.h  
Study Site: Denver Health & Hospital Authority, Denver CO   
Setting:  Denver Health and Hospital Authority (DHHA), is a regional, academic, level-one trauma 
center for the Rocky Mountain Region, and overall the third site to join the Respiratory 
Protection Effectiveness Clinical Trial (ResPECT) Study.  It joins Johns Hopkins University (JHU) 
which served as the pilot site for this study and has been in operation for approximately 1 year.  
  
Organization:  DHHA serves the city and county of Denver, CO, and the Rocky Mountain Region.  
DHHA integrates acute hospital and emergency care with public and community health to 
deliver preventive, primary, and acute care services.  DH employs approximately 5,000 people, 
approximately 2,500 of whom are direct care providers and serve special populations such as 
the poor, uninsured, mentally ill, pregnant teens, persons addicted to alcohol and other 
substances, victims of violence, the homeless, and those with AIDS and tuberculosis.    
  
DHHA operates 477 acute hospital beds, and is one of the state’s busiest hospitals with more 
than 25,000 admissions annually.  DHHA’s major academic affiliation is the University of 
Colorado Anschutz Medical Campus.  Denver Health’s Community Health Services manages 
more than 355,000 outpatient visits annually, from eight family health centers located 
throughout Denver neighborhoods, and 13 school-based health centers in Denver Public 
Schools, offering on-site medical care to elementary, middle and high school students, while 
DHHA’s Emergency Department (Adult and Pediatric) and Adult Urgent Care Center manages 
more than 106,000 visits annually.    
  
Resources Available:  Connie S. Price, MD will serve as the site PI for the ResPECT study.  She is 
the Chief Medical Officer at DHHA, and Assistant Professor of Medicine at the University of 
Colorado, School of Medicine.  Dr. Price is board-certified in infectious diseases and medical 
microbiology.  Her research and clinical interest focuses in healthcare epidemiology and 
methods to prevent nosocomial infections. She is an independently funded investigator who has 
served on numerous AHRQ task orders:  As a task order lead for PBRN Task Order #16:  Reducing 
Inappropriate Prescribing of Antibiotics by Primary Care Clinicians; as a Principle Investigator  
(with Dr. Savitz) on AHRQ (ACTION) Task Order 8- Improving the Measurement of Surgical Site  
Infection (SSI) Risk Stratification and Outcome Detection; as a Principle Investigator on AHRQ 
(ACTION) Task Order 7 - Reducing Hospital Associated Infections (HAI):  Improving Patient Safety 
through Implementing Multidisciplinary Interventions in the Safety Net; a Consultant on PBRN 
Task Order #4: Management by Primary Care Clinicians of Patients Suspected of Having 
Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections; a 
Coinvestigator on  Task Order #10  Model for Health Professionals Cross Training for Mass 
Casualty  
Respiratory Needs.  She chairs the Infection Control and Prevention Committee at Denver 
Health.  She has nationally-recognized expertise in prevention of healthcare associated 
infectious diseases and currently is lead faculty for the State of Colorado ARRA- funded 
collaborative to reduce surgical site infections and Clostridium difficile.  She is active in the 
Infectious Diseases Society of America and recently served in an elected position to the Board of  

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Directors of the Society of Healthcare Epidemiology of America.  She also serves on the Colorado 
Healthcare Associated Infections advisory committee for public reporting of healthcare 
associated infections for Colorado.  
  
DHHA Division of Infectious Diseases will also employ 3.25 FTEs for the duration of this study to 
complete necessary protocol activities.  DHHA also has an active Infection Control program and 
practitioners.  
1.i  
Study Site: Children’s Hospital Colorado, Denver, CO   
Organization: Children’s Hospital Colorado (Children’s Colorado) has defined and delivered 
pediatric health care excellence for more than 100 years. Founded in 1908, Children’s Colorado 
is a leading pediatric network entirely devoted to the health and well-being of children. 
Continually recognized as one of the nation’s outstanding pediatric hospitals by U.S. News &  
World Report and ranked 9th on its Best Children’s Hospitals 2016-17 Honor Roll, Children’s 
Colorado is known both for its nationally and internationally recognized medical, research and 
education programs, as well as the full spectrum of everyday care for kids throughout Colorado 
and surrounding states. Children’s Colorado is recognized for excellence in nursing from the  
American Nurses Credentialing Centers and has been designated a Magnet® hospital since 2005. 
With more than 1,000 health care professionals representing the full spectrum of pediatric 
specialties, the network for Children’s Colorado includes 16 regional locations including its main 
campus on the Anschutz Medical Campus, and more than 400 outreach clinics. For more 
information, visit www.childrenscolorado.org and connect with Children’s Colorado on 
Facebook and Twitter (@ChildrensColo).   
  
Resources Available: Ann-Christine Nyquist, MD, MSPH will serve as the site Principal  
Investigator (PI) for the ResPECT study. She is the Medical Director of Infection Prevention and  
Control Program and the Medical Director for Occupational Health at Children’s Hospital  
Colorado. Dr. Nyquist is board-certified in Pediatrics and Pediatric Infectious Diseases. She is a  
Professor in the Department of Pediatrics, Sections of Infectious Diseases and Epidemiology at 
the University of Colorado School of Medicine and holds a secondary appointment in the 
Colorado School of Public Health in the Department of Community and Behavioral Health.  Her 
research and clinical interest focuses in healthcare epidemiology, influenza, vaccinations and 
methods to prevent nosocomial infections. Dr. Nyquist served as Co-Principal Investigator for 
the CDC Emerging Infections study assessing pneumococcal vaccine efficacy which resulted in 
the Center for Disease Control and Prevention Charles C. Shepard Award for the Best Manuscript 
in 2006 in the Category of Prevention and Control-. From 2005-2009 she served as the site 
Principal investigator for the NIH Region VIII Regional Center of Excellence in Biodefense for two 
components of the grant: the Training Program for Clinical and Translational Research and 
Group Education. Nationally, Dr. Nyquist serves on American Academy of Pediatrics Committee 
on Infectious Diseases and the Society for Healthcare Epidemiology of America  
(SHEA) Pediatric Leadership Council Chair. She was an Invited Expert, representing Pediatric  

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Infectious Diseases Society, Department of Health and Human Services (HHS) Progress Toward  
Eliminating Healthcare-Associated Infections meeting. In 2007 she served on the Colorado State 
Health Department Pandemic Influenza Triage Working Group. Dr. Nyquist and her team 
recently received Children’s Hospital Colorado 2011 Annual Pillar Award for Quality and Patient 
Safety- Infection for special recognition to staff who display outstanding performances that 
positively affect hospital outcomes related to their outbreak investigation of Bacillus cereus 
contamination of alcohol prep pads.   
  
Children’s Hospital Colorado will utilize the Children’s Clinical Research Organization (CCRO) for 
the duration of the study to complete the necessary protocol activities. Children’s Hospital has 
an active Infection Control program with 1.5 Physician FTEs, 4.0 FTE Infection Preventionists, 1.0  
FTE Industrial Hygienist and 2.0 FTE Administrative Support. The Children’s Clinical Research 
Organization (CCRO) at the Children’s Hospital Colorado provides comprehensive research 
services, facilities and personnel to support the conduct and facilitation of clinical trials, 
including study start-up, execution and close-out. The mission of the CCRO is to improve the 
health of children by providing patients and health care professionals access to timely and 
reliable research resources to plan and execute clinical trials; as well as innovative opportunities 
to advance the diagnosis, treatment and prevention of pediatric diseases and their sequelae.   
  
The CCRO team is made up of a dedicated group of clinical research professionals, including 
clinical research coordinators, regulatory professionals, financial administrators and 
management team. Services include: Study coordination: start-up and initiation, patient 
screening and recruitment, consenting, patient management, identification and reporting of 
adverse events, phlebotomy and drug administration (as appropriate and according to 
licensure), monitoring of patient compliance, data entry and query response, coordination of 
preparation for sponsor monitor visits, specimen processing and shipment, collaboration and 
coordination of ancillary services, project management, budget development and negotiation, 
collaboration with Office of Research Services contracting team and IRB submission and 
continuing review.   
  
l.l   
Study Site: Statistical Support: University of Massachussetts, Amherst,  
MA  
UMass Amherst, the flagship campus of the University of Massachusetts system, sits on nearly  
1,450 acres in the scenic Pioneer Valley of Western Massachusetts, 90 miles from Boston and  
175 miles from New York City. The library system is the largest at a state-supported institution in  
New England with more than 5.8 million items. The University of Massachusetts Amherst Library 
System provides support for research through collections in the 28-story W.E.B. Du Bois Library 
and two science libraries. Numerous periodical indexes and full text databases may also be 
accessed electronically. The Five College online catalog provides electronic access to library 
catalog records at the University and the surrounding four colleges (Amherst, Hampshire, Mount 
Holyoke and Smith colleges). Reference librarians are available in person, online, and by 
telephone.  
The Reich Laboratory (http://reichlab.io) is the research lab of Dr. Nicholas Reich at U. Mass.  In 
addition to Dr. Reich, it also houses Dr. Alexandria C. Brown.  Dr. Reich is Dr. Brown's primary 
mentor, in the Department of Biostatistics and Epidemiology. Dr. Brown has her own desk space 

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and computer in a shared office space with 2 other postdoctoral researchers and 2 graduate 
students, all of whom are working on modelling infectious disease dynamics. Weekly lab 
meetings allow the opportunity to present ongoing work, confront issues, and brainstorm new 
ideas with the lab team. Dr. Brown has a 15.6 GiB Intel® Core™ i7-4790 CPU @ 3.60GHz × 8 
desktop computer with 3.9 TB of disk space. This machine is connected to the Department’s 
Local Area Network (LAN). The LAN enables secure hard disk space for research projects that is 
accessible by multiple users and backed-up daily.  
The School of Public Health and Health Sciences (SPHHS) is comprised of approximately 50 
fulltime faculty members, including six epidemiologists and six biostatisticians. SPHHS maintains 
micro computer research rooms for faculty, staff and students. Fourteen PC compatible 
microcomputers, a file server, a scanner and two laser printers are connected to the 
Department’s Local Area Network (LAN). The LAN enables secure hard disk space for research 
projects that is accessible by multiple users and backed-up daily. The following software 
packages have been installed on the LAN: SAS System 9.1 for Windows, Stata 9, SAS callable 
SUDAAN, Minitab 13.1 for Windows, SPSS 14, Microsoft Office XP, Dreamweaver MX, Endnote  
6.0, NCSS 2001, Nud*ist N6, and Adobe Acrobat.  
Resources Available: Nicholas Reich, PhD, is a biostatistician whose research operates at the 
interface of biostatistics and epidemiology. He has broad experience as a collaborating and 
independent biostatistician across many different biomedical and global health research settings. 
His areas of research focus have been on developing statistical methodology for analyzing and 
modeling disease surveillance data, and developing methods for analyzing clusterrandomized 
clinical trial data. He received doctoral training in Biostatistics and post-doctoral training in 
Infectious Disease Epidemiology at Johns Hopkins Bloomberg School of Public Health. He has 
served as the statistician for the ResPECT Study since its inception.  
  
l.m   Study Site Administration and DCC: University of Texas Southwestern 
Medical Center, Dallas TX  
  
UT Southwestern is a prominent medical education and biomedical research institution in the  
United States. It is located in the Southwestern Medical District, a 1,000 plus-acre campus in  
Dallas incorporating three degree-granting institutions - UT Southwestern Medical School, UT  
Southwestern Graduate School of Biomedical Sciences, UT Southwestern School of Health  
Professions – along with four affiliated hospitals: Parkland Hospital, Children’s Health℠, Zale 
Lipshy University Hospital, and William P. Clements Jr. University Hospital. One of the largest 
medical schools in the country, UT Southwestern annually trains about 3,700 medical, graduate, 
and health professions students, residents, and postdoctoral fellows each year. Ongoing support 
from federal agencies, such as the National Institutes of Health, along with foundations, 
individuals, and corporations, provides approximately $422.6 million per year to fund more than  
5,700 research projects. UT Southwestern faculty physicians provide patient care at UT  

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Southwestern University Hospitals & Clinics, Parkland Health & Hospital System, Children’s 
Medical Center, Texas Scottish Rite Hospital for Children, VA North Texas Health Care System, and 
other affiliated hospitals and community clinics. Faculty and residents care for more than 100,000 
hospitalized patients and oversee approximately 2.2 million outpatient visits a year, providing 
more than $106.7 million in unreimbursed clinical services annually.  
  
The Division of Infectious Diseases includes 24 full time faculty members, 9 of whom are faculty 
preceptors. There is ample administrative support for the training program within the division 
which includes: 1) Division Administrator, who manages and directs the administrative and 
business functions of the Division and also coordinates grant submissions, budget monitoring, 
and personnel; 2) Division Accountant, who monitors budgets and provides monthly reports to 
PIs in the division; 3) Grants and Contracts Specialist, who prepares grant applications and 
progress reports for all divisional grants; and 4) Fellowship Coordinator, who oversees 
administrative duties of both the fellowship and T32 grant trainees. The Division of 
Epidemiology, organized within the Department of Internal Medicine, was founded by Dr. 
Robert Haley in 1983 and since has served a leading role in organizing and managing large 
multidisciplinary studies spanning the range of research from basic mechanistic to clinical and 
population studies. The UT Southwestern Department of Clinical Sciences is a multidisciplinary 
department which encourages clinical research and provides an academic, educational, and 
cultural home for clinical investigators across all departments and disciplines of the University. 
The DCS has the following 5 divisions staffed by full-time faculty: Outcome's and Health Services 
Research, Biostatistics, Biomedical Informatics, Community Health Sciences, and Behavioral and 
Communication Sciences.  
    
Resources Available: Trish M. Perl, MD, MSc, serves as a co-PI for the ResPECT study.   
She supervised the Johns Hopkins University sites while a faculty member there and the DCC.   
She continues to supervise the overall conduct of the study. She is the Chief of Infectious  
Diseases at UT Southwestern Medical Center where she is the Jay P Sanford Professor of 
Medicine.   She has extensive experience in clinical trials and is an expert in in health 
careassociated infections, antimicrobial-resistant organisms, emerging pathogens, and infection 
prevention.  She is an Adjunct Professor of Medicine in the School of Medicine and recently left  
Johns Hopkins. Previously, she served for 20 years on the faculty of Johns Hopkins School of  
Medicine, which was one of the first Centers of Excellence for health care-associated infections.  
She earned her medical degree at the University of North Carolina School of Medicine, did her 
residency at Royal Victoria Hospital at McGill University in Montreal, and did her fellowship in 
clinical epidemiology and infectious diseases at the University of Iowa. Dr. Perl also did a 
twoyear stint with the Canadian equivalent of the Epidemic Intelligence Service, and her first 
outbreak investigation – an encephalopathy caused by eating mussels – was published in the 
New England Journal of Medicine.  
  
l.n   
Study Site: Statistical and Epidemiologic Support: University of Florida   
  
The University of Florida (UF) is an American public university that sits on a 2,000-acre campus in 
Gainesville, Florida. The University of Florida is divided into 16 colleges and more than 150 
research, service and education centers, bureaus and institutes, offering more than 100 
undergraduate majors and 200 graduate degrees. The University of Florida is one of the nation's 

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largest research universities. The University of Florida was awarded $678 million in research 
expenditures, more than all other Florida universities combined, in sponsored research in 2009- 
10.  
  
University of Florida Health has two campuses in Gainesville and Jacksonville. It includes two 
teaching hospitals and two specialty hospitals, as well as the colleges of Dentistry, Medicine, 
Nursing, Pharmacy, Public Health and Health Professions, and Veterinary Medicine, including a 
large animal hospital and a small animal hospital. The system also encompasses six UF research 
institutes: the Clinical and Translational Science Institute, the Evelyn F. and William L. McKnight 
Brain Institute, the Genetics Institute, the UF Health Cancer Center, the Institute on Aging and 
the Emerging Pathogens Institute. UF Health is the only academic health center in the United 
States with six health-related colleges on a single, contiguous campus.  
  
Resources Available: Derek Cummings, PhD, MHS, MS, is an infectious diseases epidemiologist 
under UF’s Preeminence Program, through which he serves as a full professor for the 
department of biology and the Emerging Pathogens Institute. Prior to his arrival at the 
University of Florida he worked for the school of public health at Johns Hopkins University, 
where he was an associate professor in the school’s department of epidemiology. Cummings’ 
research focuses on identifying the factors that influence the spread of infectious diseases in 
order to develop strategies to control and curb their proliferation. Cummings’ work with 
emerging pathogens spans several nations, including southern China, Thailand, Liberia, Senegal, 
and Saudi Arabia. Though he has examined a variety of diseases, the bulk of his research has 
focused on the dengue virus and influenza.  
  
In southern China he studied influenza A and patterns of transmission between rural and urban 
areas. In Saudi Arabia he studied Middle East Respiratory Syndrome (MERS). In Senegal he 
studied transmission of the dengue virus in non-human primate species – baboons, red 
monkeys, and green monkeys. Cummings has conducted extensive research on pathogens in the 
United States as well. He was the principal investigator in a study of seasonal shifts in 
transmission of influenza A, influenza B, and respiratory syncytial virus (RSV) in Pittsburgh, 
Pennsylvania.  
  
ADDITIONAL STUDY SITES  
Since it is not possible to predict the location of the future outbreaks, despite being “seasonal,” 
multiple sites from across the U.S. will be identified for participation.  In order to optimize the 
use of funding, several criteria will be used to guide the selection process (Appendix K).  
 Ideally, study sites would have the following characteristics:  
• 
Site has at least 25 clinics (EDs, outpatient clinics, etc.) that employ 16 people or more.  
Or, have fewer clinics that are easily divisible into 25 separate work environments, with 
16 or more people working in each work environment.    

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(This is based on 400 participants per site, per year.) 
  Site needs to have a track record of research.  
• 
Site needs to have an active research staff that can conduct the study without undue 
delay.    
• 
The site needs to show past ability to do collaborative research.  
• 
Site should have a track record of clinical trials.  
• 
Site should have a history of collaborative research efforts with one of the Principal 
Investigators  
• 
Site should have a pediatric component in their set of possible study locations (because 
the incidence of infectious diseases is highest in these settings).  This criterion would not 
apply to VA study sites.  
• 
Active respiratory protection program including training and annual fit testing in place  
  
J2  
Funding Source and Conflicts of Interest  
Two US Federal Government Agencies provided most of the funding for this project. Together, 
the Centers for Disease Control (National Institute of Occupational Health and Safety) and the 
Veterans Health Administration (Office of Public Health and Environmental Hazards) have 
expressed commitment to approximately $10M.  It is well-understood by representatives at 
both agencies that funds reaching beyond $10M could be required to reach the primary 
endpoint, especially if the incidence of measured outcomes happens to be relatively low in the 
study-site locations when data is collected.  However, in a setting with high-than-usual counts of 
influenza or ILI, the primary endpoint could be achieved in less than a 4-year period as 
described.   If accessible funding draws low, a group of key CDC decision-makers will determine 
whether to continue pursuing some or all of the study endpoints, and how. The Biomedical 
Advanced Research and Development Authority (BARDA) provided an additional $350,000 in 
funding in fiscal year 2017.  
  
There are no known conflicts of interest, financial or otherwise.  
  
J3  
Committees/Science Board  
While many of the key questions about the design and conduct of this clinical trial have been 
answered, a variety of questions and issues will be raised during the course of the study.  To 
ensure that each question or issue receives impartial and equitable attention from the  
Investigators, an independent Science Board (SB) will be developed.  The Members of this Board, 
each an eminent scholar and/or opinion leader, will offer their personal opinions about 
challenging and complicated questions or concerns about the study while it is being conducted.  
Any changes made by the SB on the protocol or the conduct of the study will be reviewed and 
approved by the coordinating center’s IRB, the IRB at NIOSH, and the local IRBs for each site 
before the changes are implemented in the conduct of the study.    
  
In contrast to the narrow focus of the Data Safety Monitoring Board (DSMB), topics addressed 
by the SB will be open and unrestricted and may involve a wide variety of scientific, sociological, 
economical or political topics. Members of the SB may change over the course of the Study.    

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Science Board Members:  
  
Michael Bell, MD – Centers for Disease Control  
Arnold Monto, MD – University of Michigan School of Public Health  
David Weissman, MD – Centers for Disease Control/ National Institute for Occupational Safety 
and Health  
Mark Loeb, MD – McMaster University  
  
Trish M. Perl, MD, MSc – University of Texas Southwestern  
Lew Radonovich, MD – Centers for Disease Control and Prevention  
  
K  Publication Plan   
As this is a large, multicenter study, authorship rules need to be defined in advance.  All 
publications of information or data related to this project will come under this rule.  Publications 
by an investigator of results from his or her institution's part of the study should involve 
collaboration with the other participating investigators and the ResPECT Study Consortium and 
should include input from the principal investigator(s), and his or her colleagues. Such input 
should be reflected in publication authorship, and agreement regarding order of authors’ names 
should be tentatively established before drafting the manuscript. Additionally, publications must 
comply with confidentiality obligations owed to the sponsor.  
  
The members of the ResPECT Study Consortium must have the opportunity to review and 
comment on all proposed abstracts, manuscripts, or presentations regarding this study ideally 
60 days prior to submission for publication/presentation. During this 60-day period, Consortium 
members may respond with any requested revisions. Any information identified by the 
members of the Consortium as confidential must be deleted prior to submission. If reasonably 
requested, members of the Consortium will take reasonable steps to expedite the review 
process to meet publication deadlines. Submission may be made upon notification by the 
Consortium that such review has been completed and after issues found in the review and/or 
information identified by the Consortium as confidential is deleted. The ResPECT Study 
Consortium also has the right to publish the results of this study.  
All manuscripts submitted for publication must have “The ResPECT Study Consortium” listed in 
the authorship section.  The members of the ResPECT Study Consortium will be identified under 
acknowledgements at the end of the manuscript.    
  
  
L  References  
  

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Askarian M, Mirzaei K, Honarvar B, Etminan M, Araujo MW. Knowledge, attitude and practice 
towards droplet and airborne isolation precautions among dental health care professionals in 
Shiraz, Iran. J Public Health Dent. Winter 2005;65(1):43-47.  
  
Blachere FM, Lindsley WG, Pearce TA, et al. Measurement of Airborne Influenza Virus in a 
Hospital Emergency Department. Clin Infect Dis. Jan 9 2009.  
  
Booth TF, Kournikakis B, Bastien N, et al. Detection of airborne severe acute respiratory 
syndrome (SARS) coronavirus and environmental contamination in SARS outbreak units. J Infect 
Dis. May 1 2005;191(9):1472-1477.  
  
Brankston G, Gitterman L, Hirji Z, Lemieux C, Gardam M. Transmission of influenza A in human 
beings. Lancet Infect Dis. Apr 2007;7(4):257-265.  
  
Bridges CB, Kuehnert MJ, Hall CB. Transmission of influenza: implications for control in health 
care settings. Clin Infect Dis. Oct 15 2003;37(8):1094-1101.  
  
Centers for Disease Control. 2009 H1N1 Flu. 2009; http://www.cdc.gov/H1N1FLU/. Accessed 
5/6/2009, 2009.  
  
CDC 2007. Centers for Disease Control and Prevention. 2007 guideline for isolation precautions:  
preventing transmission of infectious agents in healthcare settings, 2007.  Available at: 
http://www.CDC.gov/hicpac/2007IP/2007ip_appendA.html. Accessed 3/14/2018.  
  
Centers for Disease Control. CDC H1N1 Flu. Interim guidance on Infection Control Measures for  
2009 H1N1 Influenza in Health Care Workers: A Randomized Trial. 2009; 
http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm. Accessed October 21, 2009.  
  
CDC 2010. Centers for Disease Control and Prevention.  Updated Guidance: Prevention 
Strategies for Seasonal Influenza in Healthcare Setting, June 22, 2010.  Available at:  
https://www.gpo.gov/fdsys/pkg/FR-2010-06-22/html/2010-15015.htm.  Accessed 3/14/2018.  
  
Centers for Disease Control. MERS-CoV.  Interim Infection Prevention and Control  
Recommendations for Hospitalized Patients with Middle East Respiratory Syndrome Coronavirus 
(MERS-CoV). 
https://www.cdc.gov/coronavirus/mers/infection-prevention-control.html. 
Accessed May 9, 2017.   
  
Chia SE, Koh D, Fones C, et al. Appropriate use of personal protective equipment among 
healthcare workers in public sector hospitals and primary healthcare polyclinics during the SARS 
outbreak in Singapore. Occupational and Environmental Medicine. Jul 2005;62(7):473-477.  
  
Chor JS, Ngai KL, Goggins WB, et al. Willingness of Hong Kong healthcare workers to accept 
prepandemic influenza vaccination at different WHO alert levels: two questionnaire surveys. 
BMJ.  
2009;339:b3391.  

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Chung JS, Ling ML, Seto WH, et al. Debate on MERS-CoV respiratory precautions: surgical mask 
or N95 respirators? Singapore Med J 2014;55(6):294-297.   
  
  
Evans ME, Hall KL, Berry SE. Influenza control in acute care hospitals. Am J Infect Control. Aug 
1997;25(4):357-362.  
  
Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenzarelated 
viral respiratory tract infection in the United States. Arch Intern Med. Feb 24 2003;163(4):487-
494.  
  
Fine AD, Bridges CB, De Guzman AM, et al. Influenza A among patients with human 
immunodeficiency virus: an outbreak of infection at a residential facility in New York City. Clin 
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M Attachments   
M1  Tables  
  
  
  
  
 

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Table1  
Protocol Activities by Week  
  
Pre-Study Period  
Intervention Period (weeks)  
 
 
 
Post-Study 
Period  
Week  
≥5 weeks before study 
begins  
1  
2  
3  
4  
5  
6  
7  
8  
9  
10  
11  12-16  
≥2 weeks  
Event  
-Recruitment  
-Consenting  
-Lead-in Education  
-FPE Training  
I  
I  
I  
I  
I  
I  
I  
I  
I  
I  
I  
I  
  
Data Forms  
-Screening  
-Fit-testing Q  
-Baseline Survey  
-Pre-study survey  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
L  
  
O  
Post-study 
survey  
Specimen 
Collection  
B  
R  
R  
R  
R  
R  
R  
R  
R  
R  
R  
R  
R  
B  
Key:  
B = Blood Draw        
I = Randomized Intervention FPE  
R= Upper Respiratory specimen, randomized and triggered as indicated.     
L = Weekly diary and Daily Exposure forms, and Symptomatic Event Report form if needed.  
O =FPE and Hand Hygiene Observation Forms  
 
 
 
 
Study is projected to last 20 weeks during the height of viral respiratory season, as determined by 
surveillance/incidence of RPI, but may be modified according to incidence rates. Intervention Period 
could be shorter than 16 weeks, but will be at least a minimum of 12 weeks.  

-NA_00031266 412-386-
6478  
 
The Respiratory Protection Effectiveness Clinical Trial 
Trish Perl, PI, 214-648-9022, Lew Radonovich, PI,  
  
  
Table2 Case Definition* of Acute Respiratory Illness  
  
  
                
 Signs  
   
Fever (T > 37.8° C)  
   
Tachypnea (Respiratory Rate > 25)  
   
Coryza  
   
Lymphadenopathy             
   
Symptoms  
  
Vomiting/Nausea  
  
Diarrhea  
  
Cough  
   
Sputum Production   
   
Fatigue   
   
Malaise  
   
Headache  
   
Sore Throat  
   
Dyspnea  
   
Chills  
   
Sweats  
   
Arthralgias/Myalgias/Body Aches  
  
Other Gastrointestinal Symptoms  
*An acute respiratory illness is defined as:  
 The presence of any sign(s) OR two symptom(s) listed above.  
 Positives must represent a change from baseline  
  
  
  
  
  
  
  
  

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Table3 List of potential ILI pathogens  
  
□ Influenza A □ 
Influenza B  
□ Respiratory Syncytial Virus Type A □ 
Respiratory Syncytial Virus Type B  
□ Parainfluenza virus Type 1  
□ Parainfluenza virus Type 2  
□ Parainfluenza virus Type 3  
□ Parainfluenza virus Type 4(a)  
□ Parainfluenza virus Type 4 (b)  
□ Human Metapneumovirus  
□ Adenoviruses   
□ Coronavirus OC43  
□ Coronavirus NL63  
□ Coronavirus 229E  
□ Coronavirus HKU1  
□ Human Rhinovirus  
□ Cocksackie/echoviruses  
□ Bocavirus  
□ Bordetella pertussis  
□ Streptococcus pneumonia  
□ Steptococcus pyogenes   
□ Staphylococcus aureus  
□ Hemophilus influenza  
□ Other microbial respiratory organisms of interest in the future  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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Table4 Power analysis of the sensitivity to the 4-year attack rate:  
Power analysis of the sensitivity to the 4-year attack rate for the primary outcome (laboratory 
confirmed influenza) and secondary outcomes (ILI, ARI). The power to detect a relative-risk of 
0.75 between the N95 group and the medical mask group and the relative-risk that can be 
detected with 80% power are shown for scenarios representing the low and high end of 
reasonable attack rates in the medical mask (i.e., the control) group. For all calculations the 
twosided Type I error probability is 0.05.  
  
  
  
  
Low Attack Rate Scenario  
High Attack Rate Scenario  
Outcome  
S.M. Attack  
Rate  
Power  
Detectable RR  
(RR=0.75)  
(80% Power)  
S.M. Attack  
Rate  
Power  
Detectable RR   
(RR=0.75)  
(80% Power)  
Primary  
0.2  
43%  
0.62  
0.5  
93%  
0.80  
ILI  
0.15  
33%  
0.56  
0.4  
82%  
0.76  
ARI  
0.5  
93%  
0.80  
0.95  
100%  
0.94  
LCRI  
0.3  
91%  
0.79  
0.7  
100%  
0.90  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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Table5 Sample size and power calculations for primary and secondary outcome.  
  
This table shows the total person-seasons of observation required for the primary outcome (LCI) 
and a secondary outcome (LCRI), assuming a four-year study. The annual attack rate for the 
medical mask (MM) group is calculated for LCI based on assumed vaccination rates and efficacy.  
  
  
M.1.a.i.1.1.1.1.1  
LCI  M.1.a.i.1.1.1.1.2  
LC 
RI  
M.1.a.i.1.1.1.1.3  
Annual 
attack rate,  
SM group  
M.1.a.i.1.1.1.1.4  
0.1 
2  
M.1.a.i.1.1.1.1.5  
0. 
25  
M.1.a.i.1.1.1.1.6  
Cumula 
tive 4-year 
attack rate,  
SM group  
M.1.a.i.1.1.1.1.7  
0.3 
9  
M.1.a.i.1.1.1.1.8  
0. 
68  
M.1.a.i.1.1.1.1.9  
Detecta 
ble relative risk  
M.1.a.i.1.1.1.1.10  
0.7 
5  
M.1.a.i.1.1.1.1.11  
0. 
75  
M.1.a.i.1.1.1.1.12  Median 
cluster size  
M.1.a.i.1.1.1.1.13  
16  
M.1.a.i.1.1.1.1.14  
16 
M.1.a.i.1.1.1.1.15  
ICC  
M.1.a.i.1.1.1.1.16  
0.1  M.1.a.i.1.1.1.1.17  
0. 
1  
M.1.a.i.1.1.1.1.18  Total 
personseasons 
of observation  
M.1.a.i.1.1.1.1.19  
10, 
024  
M.1.a.i.1.1.1.1.20  
5, 
104  
  
  
  
M2  Appendices   
 
Appendix  A  
Cluster Randomization Scheme  
  
  
  
  
  
  

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M.2.a.i.1.1.1.1.1    
Cluster A FPE  
Cluster B FPE  
M.2.a.i.1.1.1.1.2 Week  
1  
M.2.a.i.1.1.1.1.3 Not yet 
randomized  
M.2.a.i.1.1.1.1.4 Not yet 
randomized  
M.2.a.i.1.1.1.1.5 Week  
2  
M.2.a.i.1.1.1.1.6 N95 
Respirator  
M.2.a.i.1.1.1.1.7 Medical  
Mask  
M.2.a.i.1.1.1.1.8 Week  
3  
M.2.a.i.1.1.1.1.9 N95 
Respirator  
M.2.a.i.1.1.1.1.10 Medical  
Mask  
M.2.a.i.1.1.1.1.11 Week  
4  
M.2.a.i.1.1.1.1.12 N95 
Respirator  
Medical Mask  
M.2.a.i.1.1.1.1.13 Week  
5  
M.2.a.i.1.1.1.1.14 N95 
Respirator  
M.2.a.i.1.1.1.1.15 Medical  
Mask  
M.2.a.i.1.1.1.1.16 Week  
6  
M.2.a.i.1.1.1.1.17 N95 
Respirator  
M.2.a.i.1.1.1.1.18 Medical  
Mask  
M.2.a.i.1.1.1.1.19 Week  
7  
M.2.a.i.1.1.1.1.20 N95 
Respirator  
M.2.a.i.1.1.1.1.21 Medical  
Mask  
M.2.a.i.1.1.1.1.22 Week  
8  
M.2.a.i.1.1.1.1.23 N95 
Respirator  
M.2.a.i.1.1.1.1.24 Medical  
Mask  
M.2.a.i.1.1.1.1.25 Week  
9  
M.2.a.i.1.1.1.1.26 N95 
Respirator  
M.2.a.i.1.1.1.1.27 Medical  
Mask  
M.2.a.i.1.1.1.1.28 Week  
10  
M.2.a.i.1.1.1.1.29 N95 
Respirator  
M.2.a.i.1.1.1.1.30 Medical  
Mask  
M.2.a.i.1.1.1.1.31 Week  
11  
M.2.a.i.1.1.1.1.32 N95 
Respirator  
M.2.a.i.1.1.1.1.33 Medical  
Mask  
M.2.a.i.1.1.1.1.34 Week  
12-16  
M.2.a.i.1.1.1.1.35 N95 
Respirator  
M.2.a.i.1.1.1.1.36 Medical  
Mask  
 
Appendix  B  
Recruitment Flyer  
  
The Respiratory Protection Effectiveness Clinical Trial (ResPECT)  
  

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In the face of a respiratory disease epidemic, what kind of respiratory protection works best? 
We are investigating what type of facial protective equipment is more effective in preventing flu 
and other respiratory pathogen transmission. Help us find the answer!  Earn up to $599 for your 
time and participation in our research study!  
  
Open to outpatient healthcare workers over the age of 18.  We will be visiting your clinic for 
enrollment soon.  
  
Questions?  
  
Please call the ResPECT Team at 410.614.6206/pager 410.434.0821  
OR  
email us at respect@jhmi.edu  
  
 
 
 
 
 
 
 
 
 
ResPECT Study 
 
 
10.614.6206, 410.434.0821 
 
0 
 
ResPECT Study 
 
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410.614.6206, 410.434.0821 
 
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ResPECT Study 
 
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410.614.6206, 410.434.0821 
 
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ResPECT Study 
 
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ResPECT Study 
 
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ResPECT Study 
 
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ResPECT Study 
 
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ResPECT Study 
 
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Name: _________________________  
 
Appendix  C  
 Inclusion/Exclusion Screening  
  
Inclusion/Exclusion Screening  
  
Inclusion/Exclusion Screening Form  
  
  
Yes        No                                      
1. Are you 18 years or older?  
□  
□  
2. Do you have daily face-to-face (within 6 feet) contact with patients during work 
shifts?  
□  
□  
3. Are you willing to wear either an N95 respirator or a medical/surgical mask 
when coming into contact with patients with suspected/confirmed respiratory 
infection for the duration of the study period?  
□  
□  
4. On average, do you work at least 24 hours per week in a clinic setting?  
□  
□  
  
a. If yes, on average, how many hours per week do you have patient 
contact (within 6 feet of patients) at this clinic?  
b. If no, on average, how many hours a week do you work in the clinic in 
which you were recruited for this study?       
  
  
_____________  
  
_____________  
5. During the intervention period (flu-season), will you be working at only one 
clinic or emergency department?  
              
            (If no, ask details, record in notes, and report to PI)  
   □           □  
  
  
_____________  
6. (N/A for women): If you have facial hair, are you willing to shave it off and keep 
it off, so that you can be fit tested for and wear a mask or respirator for the 
16-week study period?  
□  
□  
  
7. Can you wear a respirator or medical mask for an extended period of time?   
□  
□  
8. Are you able to walk (or minimally exert yourself) for 10 minutes without 
becoming short of breath or needing to rest?  
  
□  
□  
  
  
  
  
9. (N/A for men): Are you currently pregnant or attempting to become pregnant?    
□  
□  
  
  
  
Exclusion based on PI reasoning: __________________________________________________________  
  
Notes:  

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_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
__________________________________________________________  
Name: _________________________  
 
Appendix  D  
Baseline Survey  
  
  
This information will be kept confidential.  We are collecting this information for your participant 
payments and to contact you in regards to the study.  
  
Contact Information  
  
1. What is your first name?    ___________________________________________________________  
  
2. What is your last name?    __________________________________________________________  
  
3. What is your date of birth?  _________________________  
  
4. What is your address?  
_______________________________________________________________  
  
  
  
                   _________________________ ______________________________________  
  
5. What is your daytime phone number?  
_____________________________________________  
  
6. What is your evening phone number?  
_____________________________________________  
  
7. What is your email address?   
____________________________________________________  
(It is important that you use the same email for all documents related to the study)  
  
8. What is the best way to contact you (day/evening phone, pager, email, text, social media etc.)?         
______________________________________  
  
9. Have you been a participant in the ResPECT Study in the past?   
□Yes   □ No   
  
If yes, please choose the year(s) where you have participated:   
  
Johns Hopkins  
 
□ 2010-2011  
  
□ Other (site and year):_________________________________  
□ 2011-2012    
  
  
  
  
________________________________ 
□ 2012-2013   
  
  
  
  
________________________________  

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□ 2013-2014  
  
10. At which clinic or Emergency Department are you employed?  
 __________________________________________________________________________________  
  
Name: _________________________  
  
11. Has your name changed since you last participated?   
  
□Yes   □ No   
  
If yes, what was your name previously? _________________________________  
  
12. Do you anticipate any changes that could affect your eligibility for the ResPECT Study over the 
next year? (i.e. third trimester of pregnancy, change in work location, etc.)     
 □Yes  □ No  
If yes, explain (this information is completely confidential and will not be shared with your employer or other 
staff members):  
_____________________________________________________________________________________ 
_____________________________________________________________________________________  
  
Demographic Information 13.   
What is your gender?  
  
□ Female  
□ Male   
  
14. What is your ethnicity?  
  
□ Hispanic or Latino  
  
□ Non-Hispanic or non-Latino  
  
  
15. What is your race? (Check all that apply)                      
 
□ Black or African American     □ Caucasian/White   
□ American Indian/Alaskan Native     
□ Asian   
□Native Hawaiian or other Pacific Islander   
□ More than one race    □ 
Other (please list) ______________________  
  
16. What is your job/role at this institution?  
□ MD/DO – House Staff   
□ MD/DO - Fellow or Faculty  
□ Dentist  
  
  
□ Physician Assistant/Nurse Practitioner   
  
  
□ Nursing Staff    
  
□ Clinical Technician (ED, Dental, Dialysis, Radiology, etc.)  
□ Medical Student  
  
□ Clinical Support (CMA, CNA, Dental, etc.)  
□ Nursing Student    
  
□ Patient Support Assistant/Care Worker/Care Assistant   
□ Administrative/Clerical  
□ Environmental Services/Housekeeping   
□ Registration/Reception  
□ Respiratory/Physical/Occupational Therapist   
□ Social Worker/Pastoral Care   □ Paramedic  
□ Other________________________________  
  

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17. Not including yourself, please provide the following information about the members of your 
household. If none, please enter “0”.   
Age of household 
members  
# of household 
members  
# of immunocompromised 
household members  
# of household members 
who received seasonal  
# of household 
members  
 
(does not include 
you!)  
(chemotherapy, transplant, 
steroids, etc.)  
flu vaccine (since July  
2014)  
diagnosed with 
influenza A  
(since July 2014)  
0–5 years  
  
  
  
  
6-24 years  
  
  
  
  
25-64 years  
  
  
  
  
65+ years  
  
  
  
  
  
  
The following questions pertain to you.  
Yes  
No  
18. Do you smoke tobacco?  
  
  
a. If yes, how many times do you smoke tobacco (cigarettes, pipe, cigars) in a day?  
□ <5    □ 5-10     □ 11-20    □ >20  
 
 
19. Do you have any of the following conditions?  
 
 
a. COPD (Chronic obstructive pulmonary disease)  
  
  
b. Asthma  
  
  
c. Other respiratory disease   
  
  
i. If yes, please specify _________________________  
 
 
d. Heart disease (i.e. severe congestive heart failure, angina)  
  
  
ii. If yes, please specify _________________________  
 
 
e. Neurologic disease (i.e. stroke, MS)  
  
  
iii. If yes, please specify _________________________  
 
 
f. Other systemic disease (i.e. rheumatoid arthritis, lupus) iv. If yes, 
please specify _________________________  
  
  
  
  
20. Do you use any of the following medications regularly?  
 
 
a. Albuterol/ventolin  
  
  
b. Inhaled medication   
  
  
c. Antipyretics (i.e. Tylenol, Ibuprofen, Aspirin)   
  
  
d. Immunosuppressants (i.e. oral corticosteroids, antibodies)  
  
  

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e. Steroid nasal sprays  
  
  
21. Do you wear or use any of the following?   
  
  
a. Glasses (prescription or non-prescription)  
  
  
b.    Contacts   
  
  
22. (N/A for men) Are you currently pregnant or are you attempting to become pregnant ?   
  
  
a.    If currently pregnant, what trimester? _________________________   
 
 
  
  
 
Appendix  E  
Pre-Study Survey  
  
  
Vaccination  
  
1) Have you had a lab-confirmed or physician-diagnosed case of influenza between July 2014 
and today?  
a) If yes, approximately when?            
Date:  
2) Did you receive a vaccination for influenza between July 2014 and today?  
a) If yes, approximately when?           
Date:   
b) If yes, what type of vaccine did you receive?  
 □ Injectable (killed) vaccine   □ Inhaled/nasal (live, attenuated) vaccine 3) Did you 
receive a vaccination for pertussis (often included with vaccinations for diphtheria and 
tetanus, also known as the DTaP or Tdap) between July 2014 and today?   
 
a) If yes, approximately when?           
Date:   
  
Knowledge  
  
1. If a patient came in with the following symptoms, I would use the following personal protective 
equipment (PPE)… (Check all that apply)  
  
  
  
 
 
 
  
 
 
  
Today’s Date: ____/___/____ 
  
  
(MM/DD/YEAR)  
Study Subject ID: ____________  

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Symptoms  
Hand 
hygiene  
Gowns  
Gloves  
Eye protection/ 
face shield  
Medical/ 
surgical 
masks  
N95  
respirator  
Don’t know  
Fever, cough, sore 
throat  
□  
□  
□  
□  
□  
□  
□  
Bloody/ productive 
cough, chest pain, 
fever, weight loss  
□  
□  
□  
□  
□  
□  
□  
Itchy rash and blisters  □  
□  
□  
□  
□  
□  
□  
Sore throat, runny 
nose, sneezing, mild 
cough   
□  
□  
□  
□  
□  
□  
□  
Diarrhea, vomiting, 
stomachache    
□  
□  
□  
□  
□  
□  
□  
Dry, uncontrollable 
cough   
□  
□  
□  
□  
□  
□  
□  
Immuno- 
compromised patient 
(chemotherapy, 
transplant patient, 
steroid therapy)   
□  
□  
□  
□  
□  
□  
□  
2. If I needed to perform a nebulizer treatment on a patient with respiratory or influenza-like 
symptoms, I would use the following PPE… (Check all that apply)  
Hand 
hygiene  
Gowns  
Gloves  
Eye protection/ face 
shield  
Medical/ surgical masks  
N95 respirator  
Don’t 
know  
□  
□  
□  
□  
□  
□  
□  
  
  
Behaviors  
  
  
  
Medical/surgical mask  
  
3. I wear a medical/surgical mask during my work shift…  
 (If never, skip to question 6)  
      □ All patients  
  
  
  
  
        □ Immunocompromised patients   

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      □ Patients with respiratory or influenza-like illness   □ Other? ________________________       
□ Patients with confirmed influenza A  
□ I never plan to wear medical/surgical       
 
mask  
  
4. I wear a surgical/medical mask when required by policy…  
 (i.e. when in contact with a patient on droplet isolation)  
 
□ Never   
□ With some patient contacts  
□ With every patient contact    
  
5. When I do wear a medical mask, I do so…  
 Please rank the following reasons in order of importance:  
 (1 = most important, 2 = important, 3 = less important, 4 = least important):  
____ To avoid getting a respiratory infection  
____ To keep from spreading respiratory pathogens among patients  
____ To keep from spreading respiratory pathogens to my family or those I live with  
____ Because I am required to wear mask by supervisor, Occupational Health, or clinic policy  
  
6. The following reasons may deter me from wearing a surgical/medical mask…  
(Check all that apply)  
□ Uncomfortable    
  
  
  
□ Difficulty breathing     
□ Interferes with communication  
  
□ Masks are unavailable     
  
□ Masks don’t protect from infection      
□ No need to wear a mask   
   
  
 
□ Wear N95 instead  
  
  
  
□ Other ______________  
  
  
  
N95 Respirator  
7. I wear an N95 respirator during my work shift…  
(If  never, skip to question 10)  
      □ All patients  
  
  
  
  
        □ Immunocompromised patients   
      □ Patients with respiratory or influenza-like illness   □ Other? ________________________  
      □ Patients with confirmed influenza A  
□ I never plan to wear medical/surgical      
mask  
8. I wear an N95 respirator when required by policy…   
(i.e. when in contact with a patient on droplet isolation)   

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□ Never       □ With some patient contacts  □ With every patient contact   
  
  
9. When I do wear an N95 respirator, I do so…  
Please rank the following reasons in order of importance   
(1 = most important, 2 = important, 3 = less important, 4 = least important):  
____ To avoid getting a respiratory infection  
____ To keep from spreading respiratory pathogens among patients  
____ To keep from spreading respiratory pathogens to my family or those I live with  
____ Because I am required to wear respirator by supervisor, Occupational Health, or clinic policy        
  
10. The following reasons may deter me from wearing an N95 respirator…  
 (Check all that apply)  
 
□ Uncomfortable    
  
  
  
□ Difficulty breathing     
 
□ Interferes with communication  
  
□ Respirators are unavailable      
 
□ Respirators don’t protect from infection     
  
□ No need to wear a respirator     
   
 
□ Wear masks instead   
  
  
□ Other ______________________  
  
11. When were you last fit-tested to wear an N95 respirator in a healthcare setting?  
□ Within 1 year (12 months)        □ Within 2-5 years        □ Greater than 5 years        □ Never               
 
□ Don’t know  
  
Attitudes/Beliefs  
  
12. Do you think medical/surgical masks or N95 respirators are effective and necessary for 
preventing the transmission of influenza? (Check all that apply)  
  
  
      Mask  
N95  
Effective  
□  
□  
Necessary  
□  
□  
Not effective or 
necessary  
□  
□  
Other measures (hand 
hygiene, cough 
etiquette) are more 
important  
□  
□  
  
  
13. Wearing a medical/surgical mask or an N95 respirator has the following effect(s) on 
patient interaction:  (Check all that apply)  

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               Mask  
 N95  
Makes communicating difficult  
□  
□  
Increases patients’ fear of infection  
□  
□  
Increases patients’ concern/confusion 
about lack of FPE consistency  
□  
□  
Decreases patients’ fear of infection  
□  
□  
Has little or no effect on patient 
interaction  
□  
□  
  
Appendix  F  
Daily Exposure Form (Monday, Tues, etc.)  
  
If you have developed respiratory/flu-like symptoms today, please contact the ResPECT Study Staff as 
soon as possible:  
  
Phone: xxx-xxx-xxxx  
Email: email@domain.edu  
  
Pager: xxx-xxx-xxxx   
  
Please complete the Daily Form each day regardless of whether you work.  
  
REMINDER: Individuals with facial hair must continue to shave any facial hair during the study period.  
  
FPE = facial protective equipment (medical/surgical mask or N95 respirator)  
Please refer to the Symptomatic Event Report Form, Weekly Diary, or ResPECT business card for list of 
respiratory/flu-like symptoms.  
  
1. This form is for XXX (date range) – did you work today or have a shift that started on this date?   
 
     □ Yes  
  
□ No   
2. What shift is this in your work week starting Monday? (Please select one.)   
        □ First Work Day  
    □ Second Work Day       
□ Third Work Day    
□ Fourth Work Day  
□ Fifth Work Day  
□ Sixth Work Day  
□ Seventh Work Day  
3. Did you feel sick or have any respiratory or influenza-like symptoms on this work date?   
 
□ Yes    
□ No  

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a. 
If yes, did you contact the ResPECT Study Staff?  
  
  
□ Yes    
□ No  
b. If yes, did you remember to fill out a Symptomatic Event Form?  
□ Yes    
□ No      
                                                                                    
4. Were you in contact with any patients or coworkers with confirmed influenza or who appeared to have a 
respiratory or influenza-like illness on this work date?                                                  
 
□ Yes    
□ No  
a. 
If yes, what was the estimated duration ( in minutes) of contact over the whole work shift?  
 
□ <15 minutes    
□ 15-29 minutes   
□ 30-44 minutes   
  
 
□ 45-59 minutes         
□ 1-2 hours                    □ >2 hours  
  
b. If yes, the contact(s) occurred: (select all that apply)  
 
□ Within 6 feet    
□ Further than 6 feet    □ In direct contact (e.g., touching)   
  
c. 
If yes, I wore Facial Protective Equipment (FPE):  
 
□ None of the time  
□ Part of the time       
□ All of the time    □ Don’t know  
  
  
d. If yes, what type of FPE?  
  
 
□ N95   
  
□Medical/surgical mask  
4.  Estimate how often you performed hand hygiene before and after seeing each patient on this date:  
 
□ Never       
□ Some patient encounters      □ Most patient encounters       
 
□ All patient encounters  
□ Don’t remember            
□ No patient encounters                          
  
5:  Estimate how often you wore a medical/surgical mask on this date:  
□ Never       
  
  
□ Some patient contacts       
□ Most patient contacts      □ 
All patient contacts   
  
□ Don’t remember  
  
6:   Estimate approximately how many total hours you wore a medical/surgical mask on this date:                                         
□ Never   
  
□ <15 minutes      
□ 15-29 minutes       
□ 30-44 minutes       
 □ 
45-59 minutes      
□ 1-2 hours        □ >2hours      
  
7:  Estimate how often you wore an N95 respirator on this date:  
□ Never       
  
  
□ Some patient contacts       
□ Most patient contacts      □ 
All patient contacts   
  
□ Don’t remember  
  
8:  Estimate approximately how many total hours you wore an N95 respirator on this date:                                                       
□ Never   
  
□ <15 minutes      
□ 15-29 minutes       
□ 30-44 minutes       
 □ 
45-59 minutes      
□ 1-2 hours        □ >2hours      
  
9:  On this work date, did you perform any of the following procedures?  If yes, write in the number of times 
performed and mark the type of protection worn during the procedure.  
  

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# of times     
N95  
Surgical  
Mask  
Other  
PPE  
None  
   
Intubation*  
   
   
  
  
   
Respiratory/airway suctioning**  
   
   
  
  
   
Nebulizer treatments***  
   
   
  
  
   
Nasopharyngeal aspiration****  
   
   
  
  
  
*placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway or to serve as 
a conduit through which to administer certain drugs  
  
**removal of airway secretions by inserting a suction catheter into the patient’s oral airway and/or trachea  
  
***a drug delivery device used to administer medication in the form of a mist inhaled into the lungs  
  
****insertion of catheter or tube to suction mucus from patient’s nasal cavity, sometimes in addition to 
saline wash  
  
  
 

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Today’s Date: _____/__/_____ 
  
             (MM/DD/YEAR)  
Study Subject ID: ____________  
  
 
Appendix  G  
Weekly Diary  
  
  
Phone: 410-614-6206  
Email: respect@jhmi.edu  
  
Pager: 410-434-0821   
  
  
1. 
In the week from Monday, DATE to Sunday, DATE, have you experienced any of the following 
symptoms? (Please check all that apply.)  
 
  
  
  
Date of Onset  
  
Yes  
No  
Unsure  
(MM/DD/YEAR)  
Fever (greater than 37.8oC or 100.1oF)  
□  
 
□  
□  
 
__/__/____  
Nasal congestion/runny nose(Coryza)  
□  
 
□  
□  
 
__/__/___  
Headache  
□  
 
□  
□  
 
__/__/____  
Sneezing   
□  
 
□  
□  
 
__/__/____  
Fatigue  
□  
 
□  
□  
 
__/__/____  
Dry cough  
□  
 
□  
□  
 
__/__/____  
Body aches (myalgias or arthralgias)  
□  
 
□  
□  
 
__/__/____  
General feeling of being sick (malaise)  
□  
 
□  
□  
 
__/__/____  
Sore throat  
□  
 
□  
□  
 
__/__/____  
Sputum  production  
□  
 
□  
□  
 
__/__/____  
Diarrhea  
□  
 
□  
□  
 
__/__/____  
Bloody sputum  
□  
 
□  
□  
 
__/__/____  
Chills  
□  
 
□  
□  
 
__/__/____  
Nausea/vomiting  
□  
 
□  
□  
 
__/__/____  

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Abnormal sweating  
□  
 
□  
□  
 
__/__/____  
Rapid breathing/shortness of breath 
(tachypnea >25)  
□  
 
□  
□  
 
__/__/____  
Swollen lymph nodes  
(lymphadenopathy)  
□  
 
□  
□  
 
__/__/____  
Other Gastrointestinal symptoms 
(please specify)  
□  
 
□  
□  
 
__/__/____  
Other (please specify)  
□  
 
□  
□  
 
__/__/____  
  
2. 
If you developed any of the above symptoms:  
Did you call the study coordinator?                       
□ Yes    
□ No  
 
If NO, please contact the ResPECT Study Staff as soon as possible.  
 
Did you receive an upper respiratory swab?              
□ Yes    
□ No  
  
3. 
In the last week, have you: (Please check all that apply)  
  
Yes  No  
Don’t 
remember  
  Had any problems with seasonal or chronic allergies?  
□  
□  
□  
  Used any nasal sprays?    
               If yes, please specify:_________________  
□  
□  
□  
  Taken any antihistamines or decongestants?  
               If yes, please specify:_________________  
□  
□  
□  
  Taken any fever-reducing medication (Tylenol, Ibuprofen, Aleve, aspirin)?       
If yes, please specify:_________________  
□  
□  
□  
  Taken any immune-suppressing drugs?  
               If yes, please specify:_________________  
□  
□  
□  
Been exposed to anyone with symptoms of a respiratory illness (please 
refer to list of symptoms above)  
□  
□  
□  
  
4:  Were you in contact with any household members with respiratory or influenza-like illness this 
week?  
 
□ Yes  
  
□ No  
  
a.  If yes, how many? __________           
a. If yes, what was the total duration of contact with all household members with 
respiratory or influenza- like illness?  
 
□ Never       
  
□ <15 minutes       
□ 15-29 minutes              
□ 30-44 minutes       
□ 45-59 minutes        
□ 1-2 hours          □ 
>2 hours  
  

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Perl, PI, 410.955.8384, Lew Radonovich, PI, 352.376.1611  
  
  
95  
b. If yes, the contact (or most of the contacts) were (select all that apply):  
 
   
□ Within 6 feet    
□ Further than 6 feet away  
 
    □ In direct contact (i.e. touched) the family member  
  
c. 
If yes, I wore FPE    
 
□ None of the time  
□ Part of the time     □All of the time  
□Don’t know  
 
□ If yes, what type of FPE?  
□ N95   
□Medical/surgical mask  
  
5. Do you remember a significant exposure to a person with respiratory or influenza-like symptoms on 
any day of this week?  
  
Monday 
(M/DD)  
Tuesday 
(M/DD)  
Wednesday 
(M/DD)  
Thursday 
(M/DD)  
Friday 
(M/DD)  
Saturday 
(M/DD)  
Sunday 
(M/DD)  
  
  
  
  
  
  
  

 
  
  
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6. Did you receive a vaccination for influenza this week?   
  
 
□ Yes    
□No  
  
a) If yes, approximately when?                                 Date: ____/____ /_____  
 
       (MM/DD/YEAR)  
  
  
b) If yes, which type of vaccine did you receive?  
  
 
□ Injectable (killed) vaccine  
  
□ Inhaled/nasal (live, attenuated) vaccine   
  
7. Did you receive a vaccination for pertussis (DTaP or Tdap) this week?  
  
 
□ Yes    
□No  
a) If yes, approximately when?                                 Date: ____/____ /_____  
        (MM/DD/YEAR)  
  
8. If you were absent from work this week as a result of any of the symptoms you experienced, 
how many days were you absent?  
  
 
□ 1   
□ 2   
□ 3   
□ 4   
□ 5   
□ 6   
□ 7  
  
  
  
  
 
Appendix  H  
Post-Study Survey  
  
  
Medical/surgical mask  
  
1:  In the future, I plan to use a medical/surgical mask when 
delivering healthcare to the following patients: (Check all that apply)  
□ All patients    
  
  
  
  
□ Immunocompromised patients   
□ Patients with respiratory or influenza-like illness  
□ Other? _________________________  
□ Patients with confirmed influenza A    
  
□ I never plan to wear a medical/surgical mask  
  
Today’s Date: ____/___/____ 
  
  
(MM/DD/YEAR)  
Study Subject ID: ____________  

 
  
  
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2:  If you plan on wearing a medical/surgical mask in the future, please rank the following reasons in 
order of importance (1 = most important, 2 = important, 3 = less important, 4 = least important):  
  
____ To avoid getting a respiratory infection  
____ To keep from spreading respiratory pathogens among patients  
____ To keep from spreading respiratory pathogens to my family or those I live with  
____ Required to wear mask by supervisor, Occupational Health, or clinic policy  
  
3:  Which of the following statements most reflects your future plans for medical/surgical mask use?   
□ I will wear a mask more often than before        
 
□ I will wear a mask as often as before   
  
 
□ I will wear a mask less often than before    
  
□ Don’t know  
  
4:  If you will not use a medical/surgical mask in the future, check all the reasons that apply  
  
□ Uncomfortable      
  
  
□ Difficulty breathing     
□ Interferes with communication  
  
□ Masks are unavailable     
  
□ Masks don’t protect from infection     
□ No need to wear a mask   
   
  
□ Wear N95 instead   
  
  
□ Other ______________________  
  
5:  How often during the course of the study were you unable to wear the medical/surgical mask due 
to discomfort?  
 
□ Always  
□ Often   
□ Rarely  
  
□ Never  
 

 
  
  
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N95 respirator  
  
6:  In the future, I plan to use an N95 respirator when delivering healthcare to the following patients:  
  
□ All patients   
  
  
  
  
□ Immunocompromised patients   
□ Patients with respiratory or influenza-like illness  
□ Other ____________________ □  
Patients with confirmed influenza A   
  
□ I never wear a respirator  
  
7:  If you plan on wearing an N95 respirator in the future, please rank the following reasons in order of  
importance (1 = most important, 2 = important, 3 = less important, 4 = least important):  
  
____ To avoid getting a respiratory infection  
____ To keep from spreading respiratory pathogens among patients  
____ To keep from spreading respiratory pathogens to my family or those I live with  
____ Required to wear mask by supervisor, Occupational Health, or clinic policy  
  
8:  Which of the following statements most reflects your future plans for N95 respirator use?  
□ I will wear a respirator more often than before        
□ I will wear a respirator as often as before    
□ I will wear a respirator less often than before  
  
 □ 
Don’t know  
  
9:  If you will not use an N95 respirator in the future, check all the reasons that apply.  
  
 
□ Uncomfortable      
  
□ Difficulty breathing     
 
□ Interferes with communication  
□ Respirators are unavailable      
 
□ No need to wear a mask    
□ Respirators don’t protect from infection  
 
 □ Wear mask instead  
  
□ Other   ___________________________  
  
10:  How often were you unable to wear the N95 respirator due to discomfort?  

 
  
  
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□ Always  
□ Often   
□ Rarely  
□ Never  
  
11: Did you receive a vaccination for influenza between July 2012 and today?  
 
□ Yes    
□No  
  
a. If yes, approximately when?                 Date: ____/____ /____  
(month)  (day)   (year)  
  
b. If yes, which type of vaccine did you receive?  
  
 
□ Injectable (killed) vaccine  
  
□ Inhaled/nasal (live, attenuated) vaccine  
  
12: Did you receive a vaccination for pertussis (often included with vaccinations for diphtheria and 
tetanus, also known as the DTaP or Tdap) between July 2014 and today?   
 
□ Yes    
□No  
  
 
a) If yes, approximately when?           
Date: _____________________________  
  
  
  
  
 

 
  
  
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Appendix  I Hand Hygiene and FPE Observation Form  
  
  
  
  

 
  
  
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Appendix  J Explanation of exclusion from study  
  
The Respiratory Protection Clinical Effectiveness Trial - NA_00031266  
  
Exclusion Explanation  
   
Thank you for your interest in the Respiratory Protection Clinical Effectiveness Trial.   
Unfortunately, you have been excluded from the study based on your answers to an exclusion/inclusion 
survey.  You may have been disqualified for one or more of the following reasons:  You are a part-time 
worker; an N95 respirator was unable to properly fit to your face based on a qualitative fit test; you are 
unable to wear an N95 respirator or surgical mask due to an intolerance to the masks or as suggested by 
occupational health or a trained clinician; you have facial hair which interferes with the efficacy of the 
N95 respirator; you are in your third trimester of pregnancy (due to possible changes in the shape of 
your face); you have a medical condition that makes you more susceptible to influenza-related 
complications or unable to wear a mask;  a member of the study staff has deemed you unfit for the 
study.  
Regardless of why you were excluded from the study, there are a number of precautions 
you  
can take, as a healthcare worker, to greatly reduce the risk of infection.     
  
• 
Wash your hands frequently, especially before and after having contact 
with a patient.  If soap and water are not immediately available, use an 
alcohol-based hand rub such as Purell.  
  
  
  
• 
Get the flu vaccine, as well as the H1N1 vaccine, if possible.  Both vaccines 
come in an inactivated shot form and a live, attenuated nasal mist.    
  
• 
Cover your mouth and nose when sneezing or coughing.  This should 
ideally be done into a tissue, but if one is not available, use the bend in 
your arm.  
  
• 
Use personal protective equipment such as gloves and appropriate facial or 
respiratory protection.   
  
• 
Consult the Occupational Health department for any additional 
information about how to protect yourself from influenza and respiratory 
infections  
  
If you become infected with influenza, it is important that, if possible, you wear appropriate 
facial or respiratory protection because you are susceptible to complications.  An N95 respirator is 
recommended.  If you are unable to wear an N95 respirator, you should consult the Occupational Health 

 
  
  
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department; you may be able to use a medical mask or other form of FPE.  It is extremely important that 
you are vaccinated with the seasonal vaccine, which includes the pandemic H1N1 strain.  If you are 
concerned about the risks of being vaccinated, please call Johns Hopkins Infection Control at 410-
9558384.  The risks due to vaccination are minimal compared to the risks of complications should you 
become infected with H1N1 or seasonal influenza.  You should also conduct a thorough hand hygiene 
regimen to minimize your exposure to influenza.  If you feel feverish and have a sore throat or cough, it 
is recommended that you see a clinician immediately.       
Those with chronic respiratory or systemic disease were excluded from the study due to a 
higher risk for influenza-related complications, such as pneumonia.  For this reason, protecting yourself 
from seasonal influenza and H1N1 is important.  You should follow the standard procedures listed 
above, and if you have a fever with a cough or a sore throat, you should immediately see a clinician.  If 
you have a respiratory or systemic illness, and you are in frequent patient contact, it is recommended 
that you receive the seasonal vaccine.    
  
  
  
  
 
Appendix  K  
Certification Criteria for Study Sites  
  
• 
Minimum of 24 clinics/clusters employing a median of at least 16 full-
time HCPs. May also have fewer clinics that are easily divisible into 24 
separate work environments, with 16 or more people working in each 
environment  
• 
History of collaboration with other sites on large clinical trials  
• 
Research infrastructure experience with clinical studies  
• 
Active research staff to conduct the study  
• 
High interest level and enthusiasm of HCP participants  
• 
High number of patients who present for healthcare with a diagnosable 
respiratory illness  
• 
Outpatient/primary care facilities  
• 
Track record of collaborative research  
• 
Site is preferred to have a track record of clinical trials  
• 
Site is preferred to have a pediatric component in their set of possible 
study locations (because the incidence of infectious diseases is highest 
in these settings).  This criterion would not apply to VA study sites.  
• 
Active respiratory protection program including training and annual fit 
testing in place  

 
 
Appendix  L Study Timeline  
  
 
  
  
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Today’s Date:     ____/___/____   
  
  
  
  
  
(MM/DD/YEAR)  
Study Subject ID: ____________ Study Site: ______________   
  
 
Appendix  M  
Amended Fit Testing Medical Questionnaire    
Reference: Appendix C to Sec. 1910.134: OSHA Respirator Medical Evaluation Questionnaire (Mandatory)   
  
ResPECT Study Questionnaire   
  
  
Please answer the following questions.  
  
1. Have you been fit tested within the past 6 months?     Yes ________    No ________  
2. If you have been fit tested within the past 6 months, have you either lost or gained 10% or more of your 
total body weight after the fit test?     Yes ________   No _________  
  
To the employer: Answers to questions in Section 1, and to question 9 in Section 2 of Part A, do not require a 
medical examination.   
  
To the employee:   
  
Can you read (circle one): Yes/No   
  
Your employer must allow you to answer this questionnaire during normal working hours, or at a time and 
place that is convenient to you. To maintain your confidentiality, your employer or supervisor must not look at 
or review your answers, and your employer must tell you how to deliver or send this questionnaire to the 
health care professional who will review it.   
  
Part A. Section 1. (Mandatory) The following information must be provided by every employee who has been 
selected to use any type of respirator (please print).   
  
1. Today's date: _______________________________________________________   
  
2. Your name: __________________________________________________________   
  
3. Your age (to nearest year):_________________________________________   
  
4. Sex (circle one): Male/Female   
  
5. Your height: __________ ft. __________ in.   

 
  
  
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6. Your weight: ____________ lbs.   
  
7. Your job title: _____________________________________________________   
  
8. A phone number where you can be reached by the health care professional who reviews this questionnaire 
(include the Area Code): ____________________   
  
  
  
  
9. The best time to phone you at this number: ________________   
  
10. Has your employer told you how to contact the health care professional who will review   
this questionnaire (circle one):   
  
  
  
Yes  
No   
  
11. Have you worn a respirator (circle one):    
  
Yes  
No   
  
If "yes," what type(s):___________________________________________________________ 
_____________________________________________________________   
  
Part A. Section 2. (Mandatory) Questions 1 through 9 below must be answered by every employee who has 
been selected to use any type of respirator (please circle "yes" or "no").   
  
1. Do you currently smoke tobacco,   
or have you smoked tobacco in the last month:   
  
  
Yes  
No   
  
2. Have you ever had any of the following conditions?  
a. 
Seizures (fits):     
  
  
  
  
Yes  
No  
b. 
Diabetes (sugar disease):     
  
  
  
Yes  
No  
c. 
Allergic reactions that interfere with your breathing:     
Yes  
No  
d. 
Claustrophobia (fear of closed-in places):   
  
  
Yes  
No  
e. 
Trouble smelling odors:     
  
  
  
Yes  
No  
3. Have you ever had any of the following pulmonary or lung problems?  
a. 
Asbestosis:   
  
  
  
  
  
Yes  
No  
b. 
Asthma:    
  
  
  
  
  
Yes  
No  
c. 
Chronic bronchitis:   
  
  
  
  
Yes  
No  
d. 
Emphysema:   
  
  
  
  
  
Yes  
No  
e. 
Pneumonia:   
  
  
  
  
  
Yes  
No  
f. 
Tuberculosis:   
  
  
  
  
  
Yes  
No  

 
  
  
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g. 
Silicosis:    
  
  
  
  
  
Yes  
No  
h. 
Pneumothorax (collapsed lung):   
  
  
  
Yes  
No  
i. 
Lung cancer:   
  
  
  
  
  
Yes  
No  
j. 
Broken ribs:   
  
  
  
  
  
Yes  
No  
k. 
Any chest injuries or surgeries:   
  
  
  
Yes  
No  
l. 
Any other lung problem that you've been told about:     
Yes  
No  
4. Do you currently have any of the following symptoms of pulmonary or lung illness?  
a. 
Shortness of breath:   
  
  
  
  
Yes  
No  
b. 
Shortness of breath when walking fast on level   
 
ground or walking up a slight hill or incline:   
  
  
Yes  
No  
c. 
Shortness of breath when walking with other   
 
people at an ordinary pace on level ground:     
  
Yes  
No  
d. 
Have to stop for breath when walking   
at your own pace on level ground:     
  
  
Yes  
No e. 
 
Shortness of breath when washing or dressing yourself:   
Yes  
No  
f. 
Shortness of breath that interferes with your job:   
  
Yes  
No  
g. 
Coughing that produces phlegm (thick sputum):   
  
Yes  
No  
h. 
Coughing that wakes you early in the morning:   
  
Yes  
No  
i. 
Coughing that occurs mostly when you are lying down:    
Yes  
No  
j. 
Coughing up blood in the last month:   
  
  
Yes  
No  
k. 
Wheezing:   
  
  
  
  
  
Yes  
No  
l. 
Wheezing that interferes with your job:   
  
  
Yes  
No  
m. Chest pain when you breathe deeply:   
  
  
Yes  
No  
n. 
Any other symptoms that you think may be   
 
related to lung problems:    
  
  
  
Yes  
No  
5. Have you ever had any of the following cardiovascular or heart problems?  
a. 
Heart attack:   
  
  
  
  
  
Yes  
No  
b. 
Stroke:    
  
  
  
  
  
Yes  
No  
c. 
Angina:    
  
  
  
  
  
Yes  
No  
d. 
Heart failure:   
  
  
  
  
  
Yes  
No  
e. 
Swelling in your legs or feet (not caused by walking):     
Yes  
No  
f. 
Heart arrhythmia (heart beating irregularly):    
  
Yes  
No  
g. 
High blood pressure:   
  
  
  
  
Yes  
No  
h. 
Any other heart problem that you've been told about:    
Yes  
No  
6. Have you ever had any of the following cardiovascular or heart symptoms?  
a. 
Frequent pain or tightness in your chest:   
  
  
Yes  
No  
b. 
Pain or tightness in your chest during physical activity:    
Yes  
No  
c. 
Pain or tightness in your chest   
 
that interferes with your job:   
  
  
  
Yes  
No  
d. 
In the past two years, have you noticed your   

 
  
  
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heart skipping or missing a beat:   
  
  
  
Yes  
No e. 
 
Heartburn or indigestion that is not related to eating:    Yes  
No  
f. 
Any other symptoms that you think may be related   
g. 
to heart or circulation problems:     
  
  
Yes  
No  
  
7. Do you currently take medication for any of the following problems?  
a. 
Breathing or lung problems:   
  
  
  
Yes  
No  
b. 
Heart trouble:     
  
  
  
  
Yes  
No  
c. 
Blood pressure:     
  
  
  
  
Yes  
No  
d. 
Seizures (fits):     
  
  
  
  
Yes  
No  
8. If you've used a respirator, have you ever had any of the following problems? (If you've never used a 
respirator, check the following space and go to question 9:)  
a. 
Eye irritation:   
  
  
  
  
  
Yes  
No  
b. 
Skin allergies or rashes:     
  
  
  
Yes  
No  
c. 
Anxiety:    
  
  
  
  
  
Yes  
No  
d. 
General weakness or fatigue:   
  
  
  
Yes  
No  
e. 
Any other problem that interferes   
 
with your use of a respirator:   
  
  
  
Yes  
No  
  
9. Would you like to talk to the health care professional  who will review this questionnaire about your   
answers to this questionnaire:   
  
  
  
  
Yes  
No   
  
  
 

 
  
  
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Appendix  N  
Symptomatic Event Report Form  
If you have developed any respiratory or influenza-like symptoms today, please contact the 
ResPECT Study Staff as soon as possible.  
  
Phone: 410-614-6206  
  
  
  
  
Study Subject ID: ______________  
Email: respect@jhmi.edu  
  
  
  
Study Site: ___________________  
Pager: 410-434-0821    
  
Today’s date: _____/___/____   
  
  
(MM/DD/YEAR)  
Complete the Symptomatic Event Report Form and Remember to contact the ResPECT Study 
Staff if you develop one of the following symptoms:    
  
1. Please complete the following table if you have experienced anyone of the following 
symptoms? (Please check all that apply.)  
 
  
  
  
Date of Onset  
   
Yes  
No  
Unsure  
(MM/DD/YEAR)  
Fever (greater than 37.8oC or 
100.1oF)  
□  
□  
□  
__/__/____  
  
Nasal congestion/runny 
nose(Coryza)  
□  
□  
□  
__/__/___  
Headache  
□  
□  
□  
__/__/____  
Sneezing   
□  
□  
□  
__/__/____  
Fatigue  
□  
□  
□  
__/__/____  
Dry cough  
□  
□  
□  
__/__/____  
Body aches (myalgias or arthralgias)  □  
□  
□  
__/__/____  
General feeling of being sick 
(malaise)  
□  
□  
□  
__/__/____  
Sore throat  
□  
□  
□  
__/__/____  
Sputum  production  
□  
□  
□  
__/__/____  
Diarrhea  
□  
□  
□  
__/__/____  
Bloody sputum  
□  
□  
□  
__/__/____  
Chills  
□  
□  
□  
__/__/____  

 
  
  
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Nausea/vomiting  
□  
□  
□  
__/__/____  
Abnormal sweating  
□  
□  
□  
__/__/____  
Rapid Breathing/shortness of breath 
(tachypnea>25)  
□  
□  
□  
__/__/____  
Swollen lymph nodes 
(lymphadenopathy)  
□  
□  
□  
__/__/____  
Other Gastrointestinal symptoms 
(please specify)  
□  
□  
□  
__/__/____  
Other (please specify)  
□  
□  
□  
__/__/____  
  
  
  
  
2.) If you answered yes to any one of the above symptoms, did you take any of the following 
actions?  
  
a)  Seek medical help from a   
  
MD/Provider    
  
□ Yes  
 
□No 
Emergency Department   
□ Yes  
 
□No 
Occupational Health Services  
  
b)  Take medication  
 
□ Yes  
 
□No 
Tylenol   
 □ Yes   
□No  
Ibuprofen   
□ Yes    
□No  
Aleve    
□ Yes    
□No  
Aspirin   
□ Yes    
□No  
Oseltamivir   
□ Yes    
  
□No  
3.) If you answered YES to any of the above symptoms, are your symptoms still present?   
  
 
□ Yes    
□No  
  
If no, when did your symptoms end? __/__/____  
  
  
  
  

 
  
  
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Appendix  O  
  
Adverse Event Submission Form  
The Principal Investigator must promptly report to the IRB, in writing, any unanticipated side 
effects, hazards, or other problems involving risks to subjects or others.   Promptly report all 
adverse events considered to be related to research procedures to the Steering Committee.  Please 
fax to Jenna Los at 410-614-6207.  
  
M.2.a.i.1.1.1.1.61 Date:   
M.2.a.i.1.1.1.1.62 Principal Investigator:  Perl, Trish  
M.2.a.i.1.1.1.1.63 Protocol#:  NA_00031266  
M.2.a.i.1.1.1.1.64 Protocol Title:  The Respiratory Protection Clinical Effectiveness Trial  
 M.2.a.i.1.1.1.1.65 Research Coordinator(s):  M.2.a.i.1.1.1.1.66 Phone:  
M.2.a.i.1.1.1.1.67 Fax:  
 
Jenna Los  
410-614- 
410- 
   
6206  
614- 
 
  
6207  
  
  
Report Type:  
 Initial    
 Follow-up  
Subject Identifier # (study ID number, do not list medical record number or other personal identifier): AE 
Date:    
AE Description (brief):    
  
  
  
  
  
Is the adverse event a previously described complication that is listed in the “Risk” section of 
the Investigator’s Brochure    Yes      No  

 
  
  
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This is a (an):   
  
M.2.a.i.1.1.1.1.68 
  
Unanticipated/Unexpected 
Event   
M.2.a.i.1.1.1.1.69  
(Any untoward event 
that is not identified with 
the current  
The opinion of the Principal Investigator is that the 
relationship of the research procedure is:  
  
M.2.a.i.1.1.1.1.72 
 
Unrelated  
M.2.a.i.1.1.1.1.73 
not related 
Possibly 
 
Probably 
related  
M.2.a.i.1.1.1.1.74  Probably related  
 
  
 
Appendix  P  
Participant File Checklist  
   
Study ID: __________________  
  
Study Site: ____________________  
 Consent obtained:   
 Yes      No Date of consent: ____/_____/________  
             
  
  
  
  
  
  
  
            (MM/DD/YEAR)      
 Reviewed & entered in RedCap:    
  
• 
Baseline survey:    Yes     No  
  
• 
Inclusion/exclusion criteria:   
 Yes     No   
investigator brochure or  
study protocol)  
 
M.2.a.i.1.1.1.1.70  
 Serious Adverse Event   
M.2.a.i.1.1.1.1.71  
Any untoward  
( 
medical occurrence that  
results in death, is life - 
threatening, requires  
patient hospitalization,  
prolongs existing  
hospitalization, results in  
persistent or significant  
disability/incapacity, or is  
a  congenital abnormality)  
 
M.2.a.i.1.1.1.1.75  Related  
M.2.a.i.1.1.1.1.76  Other:        
 
 
________________________________________          _________________  
I NVESTIGATOR SIGNATURE  
       
 
 
DATE  
( Sub - investigator may sign if the investigator is unavailable (i.e. out of the country )  

 
  
  
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o Eligible?   
 Yes     No  
 o   
 If eligible, date enrolled (date emailed by RedCap): _____/______/_______  
  
• 
Site assignment:   
 N95    
 Medical Mask  
• 
If N95, complete Amended Fit Test Questionnaire.   
  
o Fit test qx reviewed (signed & dated) by licensed MD or RN: Yes  No o Fit 
testing:   
  
 
Qualitative  
 Quantitative  
       
 
Pass   
 Fail      Date of testing: ____/_____/________  
             
  
  
  
  
  
  
                                              (MM/DD/YEAR)      
o Successfully fit-tested for the following respirator: _____________  
  
• 
Vendor form reviewed and submitted:   
 Yes     No    
 On file from prior year   
  
o Initial payment: $______.00 & Date Submitted: ____/_____/________  
                                             
 [If only submitting final payment] Emailed participant earning status: ____/_____/______  
 o Final 
payment: $______.00 & Date submitted: ____/_____/________  Withdrawn?     
  
• 
If yes, date withdrawn: _____/______/_______   
 
                                          
  
(MM/DD/YEAR)           
  
• 
If yes, reason withdrawn (list option #): _______  
  
  
Option 1: No longer eligible due to change in work location  
Option 6: Does not believe seeing enough flu to be helpful  
Option 2: Lack of time/schedule conflicts  
  
  
Option 7: No reason given  
Option 3: Swab discomfort  
  
  
  
Option 8: Other (please describe):   
Option 4: Can't Keep up with Surveys  
  
  
Option 9: Administrative Withdrawal - Team removed  
Option 5: Mask Discomfort  
  
  
  
due to lack of completion  
  

 
  
  
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Appendix  Q  
HSE Qualitative Fit Test Evaluation Form   
  
NAME_________________________________________ DATE________________  
             (PLEASE PRINT CLEARLY)  
  
CLINIC NAME___________________________________   
  
HAS SUBJECT EATEN WITHIN THE LAST 15 MINUTES? (CIRCLE ONE)      
YES   NO  
COULD THE SUBJECT TASTE SACCHARIN?  (CIRCLE ONE)     
  
  
YES   NO*  
* IF NO, REFER FOR QUANTITATIVE TESTING  
  
RESPIRATOR ASSESSMENT  
RESPIRATOR TYPE:    
⁬ N95       
⁬ ELASTOMERIC   ⁬ (OTHER SPECIFY)_________  
MANUFACTURER         
⁬ 3M  
  
⁬ KIMBERLY CLARK⁬        (OTHER SPECIFY)_________  
STYLE:      
⁬ 1870    
⁬ 1860         
⁬             (OTHER SPECIFY)_________  
SIZE:    
  
    
⁬ SMALL      
⁬ MEDIUM    
  
⁬ LARGE    
                N/A  
  
ADEQUACY OF RESPIRATOR FIT                                                              NOTES  
ROOM FOR EYE PROTECTION?        (CIRCLE ONE)  
YES   NO MASK 
POSITIONED PROPERLY?       
  -FIT ACROSS NOSE BRIDGE?         (CIRCLE ONE) YES   NO    -CHIN 
PROPERLY PLACED?            (CIRCLE ONE) YES   NO STRAPS 
POSITIONED PROPERLY?  
  -LOWER AROUND NECK?         (CIRCLE ONE) YES   NO  
  -UPPER AT CROWN OF HEAD?      (CIRCLE ONE)  
YES   NO  
  
  
  
  
  
  
CHALLENGE 
EXERCISES               
PASS    FAIL   /                 
2ND MODEL: PASS    FAIL  
NORMAL BREATHING                ⁬ 
⁬  
  
DEEP BREATHING  
         
 
  
       
  
  
TURNING HEAD (SIDE TO SIDE)       
 
  
 
 
       
MOVING HEAD (UP & DOWN)   
 
  
  
TALKING  
  
         
 
  
       
  
  
BENDING (AT WAIST/KNEE 
BENDS)   
 
 
       
NORMAL BREATHING  
  
 ⁬       
  
  
       
  
  
  
FIT TEST RESULTS:  
(CIRCLE ONE)    PASS    FAIL  
        
 
      
 
      
  
 
      
  
        
 
      
 
      
  
       
 
 
        
  
      
      
      
⁬
      ⁬
 
      
 
     
 
      ⁬
      ⁬
 
      ⁬
 

 
  
  
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NOTES:  _______________________________________________________  
  
  
HSE STAFF: ____________________________DATE___________________  
  
  
 

 
  
  
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Appendix  R  
Supplies for Take-Home Kits  
  
In order to comply with Dangerous Goods and Hazardous Materials Shipping Regulations, the 
kits will include materials for specimen collection, triple packaging and proper labeling, and 
instructions to complete collection and shipping:  
  
  
1. 
Specimen Tubes (Primary Packaging)  
a. UTM Tube and 2 regular flocked swabs  
2. 
Biohazard Bags (for Secondary Packaging)  
3. 
Absorbent Sheets (for Secondary Packaging)  
4. 
FedEx Padded Envelope (for Outer Packaging)  
a. FedEx Small Pak  
b. Inside Dimensions: 12-3/4” x 10-1/4”  
5. 
FedEx Box (for Outer Packaging)  
a. FedEx Small Box  
b. Inside Dimensions: 12-1/4” x 10-7/8” x 1-1/2”  
6. 
FedEx UN3373 Pak (for Outer-Outer Packaging)  
a. UN 3373 Pak  
b. Inside Dimensions: 18” x 13-1/2”  
7. 
Barcode identifier labels (tracking purposes)  
8. 
‘Shipping Dangerous Goods and Hazardous Materials’ instructions (Appendix S)  
9. 
‘At-Home Symptomatic Upper Respiratory Swab Directions’ (Appendix T)  
10. ‘Take-Home Kit Packaging Information’ (Appendix U)  
11. ‘For Any Questions Regarding This Package Or Its Contents’ contact information insert  
12. 12. Swab Delivery Form and separate envelope with line indicated “For Personnel Use Only” 
for lab to indicate date and time of receipt (Appendix X).  
  
  
  
 
Appendix  S  
Shipping Dangerous Goods and Hazardous Materials           
  
  
What are dangerous goods? Articles or substances which are capable of posing a significant 
risk to health, safety or to property when transported by air.  
What are hazardous materials? A substance or material that has been determined by the 
Secretary of DOT to be capable of posing an unreasonable risk to health, safety, and property.  
• 
Hazardous materials are organized into nine primary hazard classes, however, this 
study will be dealing solely with Class 6.2 (Infectious Substances.) o Class 6.2 
includes two sub-categories: Category A are the most virulent agents and Category 

 
  
  
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B are potentially pathogenic substances.  Take-home kits will be shipped under a 
Category B classification with the label UN3373.  
There are steep penalties for non-compliance with hazardous materials regulations.  
Packaging:  
• 
Triple Packaging is used in sending any biological substance. Triple packaging 
contains: primary receptacle leak-proof (liquids), leak-proof secondary packaging 
and durable outer packaging. Triple packaging must always be used whether 
shipping Category A, B, or Exempt substances.  
• 
Marking and labeling for Category B biological substances requires a diamond-on-
point label with UN3373 with the words “Biological substance, category B” 
adjacent. It must also include the name, address, and phone number of a 
responsible person, either on the package or the waybill.  
Category B Infectious Substances:   
• 
Can never be taken aboard an aircraft in carry-on or checked baggage, nor on your 
person.  
• 
May be transported in your private vehicle or in any other private motor vehicle, 
provided they meet the appropriate packaging requirements.  
Specific Security Procedures:  
• 
All packages of hazardous materials intended for shipment should be kept in a 
secure area until collection by the shipper.  
• 
Do not leave a package unattended in an unlocked area.  
• 
If left in a locked area where others have access, sure they are known to you and 
reliable.   
  
Appendix  T  At-Home Symptomatic Upper Respiratory Swab 
Directions  
  
Be sure to complete both the nasal and throat swab procedures.  
  
At-Home Symptomatic NASAL Swab Directions  
 Considerations:   
   
When possible, do your swab before starting antibiotic therapy or use of antihistamines. Antibiotics may 
suppress growth of infecting agent, causing a false negative culture.  
  
Swab Directions:   

 
  
  
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1. Blow your nose to remove excess mucous.   
2. Remove cap from the tube & place cap upside down on a clean surface.  
a. Open plastic swab package at the end nearest to the handle (Photo 
Companion 1, Figure 1).  
  
3. Take swab by the handle (be sure not to touch any part of the swab below the 
breakpoint). Tilt head back slightly & insert swab approximately 2 cm (¾ inches) 
into one naris, rotate against the anterior nasal mucosa.   
a. Rotate for 3 seconds to ensure swab contains both cells, as well as 
mucosa (Photo companion 1, Figure 2, & 3).   
  
4. Place the swab inside the tube until the end touches the bottom.  
a. Bend the swab shaft against the side of the tube to remove the 
handle at the breaking point (Photo companion 1, Figure 4).  
  
5. Cap specimen swab collection tube and continue to Throat Swab          Directions.  
  
Photo Companion 1: At-Home Symptomatic Nasal Swab  
Directions  
 
 
Figure 1 :  
 
 
 

 
  
  
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At-Home Symptomatic THROAT Swab Directions  
Swab Directions:  
   
1. 
Position yourself in front of a well-light mirror so that your oral cavity (mouth & 
throat) is well defined.   
  
2. 
Remove cap from the tube & place cap upside down on a clean surface.   
  
3. 
Open plastic swab package at the end nearest to the handle (Photo companion 1, 
Figure 1).  
   
4. 
Take one (unused) swab by the handle (be sure not to touch any part of the swab 
below the breakpoint).  
  
Figure 2 :    
Figure 3 : 
 
 
Figure 4 :  
 

 
  
  
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5. 
Breathe deeply and flex tongue towards the bottom of your mouth (to avoid 
contact with the swab).   
  
a. Guide the swab to the posterior pharynx (back of throat), taking care not to 
touch tongue, cheeks, and uvula (Photo companion 2, Figures 1 & 2).   
  
b. Swab vigorously while saying “Ah.” (This lifts the uvula and decreases the 
gag reflex.) Swab area from right tonsillar area across posterior pharynx 
(back of throat) to left tonsillar area and across to right tonsillar area.  
  
c. In addition, areas of inflammation, ulceration, exudation, or with white 
patches should be touched. Rub vigorously, not gently, to remove 
organisms adhering to the mucosal membrane.  
  
6. 
Do not touch swab tip after removal.  
  
7. 
Place the swab inside the same tube until the end touches the bottom   
a. Bend the swab shaft against the side of the tube to remove the handle at 
the breaking point (Photo companion 1, Figure 4)   
  
8. 
Cap the specimen swab collection tube tightly.  
  
9. 
Peel off one barcode and place it on tube.  
  
10. Read “Shipping Dangerous Goods and Hazardous Materials” handout.  
  
  
Photo Companion 2: At-Home Symptomatic Throat Swab 
Directions  

 
  
  
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Great job taking your own throat swab!  
  
  
  
  
  
 
Appendix  U  Take-Home Kit Packaging Information  
Please follow the instructions below to ship your collected nose and throat 
swabs.  
  

 
  
  
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1.) 
Insert swabs into specimen tube.  
Specimen tube with screw-top containing  nose and 
throat swabs, labeled with your barcode ID, is  your 
“primary packaging”.  Proper labeling of swab tube:  
 
 
2 
.  
3.  
1  
Return THESE  unused labels to us  
in the biohazard bag along with  
the specimen swab collection  
tube  
See Step 4  

 
  
  
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Remaining labels should be included in bag with tube, but not peeled off backing.  
  
Swab Delivery Form should be completed from the link in your weekly email.   
  
2.) 
Place the specimen tube inside the biohazard bag with absorbent sheet.  
  
Biohazard bag with absorbent sheet is your “secondary packaging  
  
3.) 
Place the remaining 4 (not peeled off the backing) 
specimen barcode ID labels in biohazard bag with specimen 
tube.  
  
4.) 
Place biohazard bag (“secondary packaging”) into FedEx padded envelope. 
Then place this envelope into FedEx box.   
  
The FedEx box will be your “outer packaging”.   
5.) 
Insert the ‘For Any Questions’ contact information sheet between the FedEx 
box and the padded envelope.  
  
6.) 
Seal the FedEx® corrugated cardboard box with its contents.  
  
7.) 
Seal the orange FedEx UN 3373 Pak.   
FedEx® UN 3373 Pak [intended for Biological Substance, 
Category B (UN 3373) specimens] is an extra layer, an 
“outer-outer packaging,” used because it already comes 
with the required hazardous materials labels.  
  
8.) 
Keep your prepared FedEx® package in a secure area until collection by 
shipper.  
 
 
The padded  envelope provides protection.  
 
 
 

 
  
  
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9.) 
Call 1.800.463.3339 to schedule a FedEx Express pick up from your home. In 
case needed by FedEx agent, the account number is xxx-xxx-x (located on the 
pre-printed waybill).   
  
10.) 
Complete online your “Swab Delivery Form.”  
  
Biological samples cannot be put into a FedEx Drop Box.  
 
Appendix  V  
Participant Correspondence Email Templates  
  
Mass ResPECT Recruitment Email  
  
Greetings from the ResPECT study!   
  
We are recruiting healthcare workers from your place of work for a 19 week study researching 
the effectiveness of surgical masks vs. N95 respirators in preventing the transmission of flu and 
other respiratory pathogen illnesses (RPI). If you choose to participate in this study, you will be 
randomly assigned to wear either a surgical mask or an N95 respirator during all close contact 
with patients with suspected RPI. Your experiences will be shared with us via weekly surveys as 
well as randomized anonymous compliance observations made by our research assistants.   
  
Participants will:  
  
• 
complete a baseline and pre-study survey  
• 
submit to 2 blood draws (at the beginning and end of study) as well as 2 combined nasal and 
throat swabs  
• 
be fit-tested if necessary (if working at an N95-assigned site)  
• 
be expected to wear their assigned facial protective equipment (FPE) when in close contact 
with patients with suspected RPI  
• 
Surveys:  
o Weekly Diary for each week of the study o Daily (Monday, 
Tuesday, etc.) Forms for each day of the week  o Symptomatic 
Event Report Form if you become ill   
• 
be randomly observed by study staff to assess adherence to FPE use as well as hand hygiene  
• 
be asked to inform study staff if you are on vacation, are sick, or are otherwise unavailable 
during a week of the study  
• 
be asked to complete a post-study survey after the end of the study  

 
  
  
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Participation in the study is open to any healthcare worker with regular close patient contact 
who works a minimum of 24 hours per week at the assigned study site and is willing and able to 
comply with the study requirements, as outlined above.  
  
Participants can receive a maximum of $599.00 compensation for partaking in the study.  The 
rate of compensation is based directly on the participant’s completion of study requirements 
(surveys, diaries, blood draws and specimen collections.)  
  
Please call or e-mail us if you are interested in participating in our study, or if you have any 
questions.  Also, be sure not to miss our first recruitment/information session at your site on 
[date for that site]!  
  
For more information, please see our Facebook page at www.facebook.com/RespectStudy  
  
Sincerely,  
[see signature line information at end of templates]  
  
ResPECT Ineligible Email Template:  
  
Dear [First Name of Participant; automatically generated by secure RedCAP],  
  
Thank you for your interest in the ResPECT Study!  Unfortunately, you are ineligible to join our 
study so we won’t be able to include you at this time.  If you have any questions, please feel 
free to contact your local ResPECT Team.  
  
Thank you,  
[See Signature Info]  
  
  
ResPECT Initial Welcome E-mail  
  
  
Dear [First Name of Participant; automatically generated by secure RedCAP],  
  
Thank you for agreeing to participate in the ResPECT Study! You will fill out a series of surveys 
throughout the intervention period.  Links for the new surveys will be emailed to you each 
week, as well as any surveys that were left incomplete from the previous week.  
  
Please click the link below to access your Pre-Study Survey so that we can get some 
information about you before the intervention period of the study begins:  
  
LINK HERE  

 
  
  
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Thank you,  
[Signature Line Info]  
  
Respect Week [week number] Survey Email Template  
  
Dear ____,  
  
Welcome to Week 2 of ResPECT!  
  
Please use the links below to complete the appropriate forms for this week.    
These links are unique to YOU and should not be forwarded to others.    
If you are unable to open these links or have questions, please notify the ResPECT team in your 
area.  
  
Week 2 Forms:  
  
Monday (Week 2) [Required regardless of days worked ]  
Tuesday (Week 2) [Required regardless of days worked]  
Wednesday (Week 2) [Required regardless of days worked]  
Thursday (Week 2) [Required regardless of days worked]  
Friday (Week 2) [Required regardless of days worked]  
Saturday (Week 2) [Required regardless of days worked]  
Sunday (Week 2) [Required regardless of days worked]  
  
Weekly Diary (Week 2) [Required regardless of days worked]  
  
Symptomatic Event Report Form 1 (Week 2) [only if you have symptoms] 
Symptomatic Event Report Form 2 (Week 2) [only if you have symptoms]  
  
Swab Delivery Form – Take-Home Kit [only if instructed to use your take-home kit]  
  
**********************************************************  
In this section, you will find your INCOMPLETE forms from last week (Week 1); they will not be 
available again, so please complete them as soon as possible:  
  
Monday  (Week 1) [Required regardless of days worked]   
Tuesday (Week 1) [Required regardless of days worked]   
Wednesday  (Week 1) [Required regardless of days worked]   
Thursday  (Week 1) [Required regardless of days worked]   
Friday  (Week 1) [Required regardless of days worked]   

 
  
  
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Saturday  (Week 1) [Required regardless of days worked]   
Sunday  (Week 1) [Required regardless of days worked]   
  
Weekly Diary (Week 1) [required]  
  
Symptomatic Event Report Form 1 (Week 1) [only if you have symptoms] Symptomatic 
Event Report Form 2 (Week 1) [only if you have symptoms]  
  
Swab Delivery Form – Take-Home Kit [only if instructed to use your take-home kit]  
  
********************************************************** 
Thank you for your continued participation!  
[Signature Line Info]  
  
Survey and Week Info to Participants   
  
Hello ResPECT Study Participants!   
  
Now that we have started our study, we realize there is some confusion about filling out the 
surveys and what a “survey week” consists of.  Please note that you will be emailed survey links 
late Sunday/early Monday that will be for the week beginning on that Monday.  For example, 
the links sent late last night are for the work week starting today through Sunday (Week 1 = 
Date – Date).  
  
There are 3 categories of Forms sent in each weekly email:  
• 
You should fill out your Daily Exposure Form at the end of every day whether or not you 
work..    
• 
A Symptomatic Event Form should be filled out whenever you feel sick and may need to 
be swabbed, as soon as possible after feeling sick (so if you feel sick today, please do 
not wait until Friday to fill out this form or contact us directly).    
• 
The Weekly Diary should only be filled out after you have finished all your work shifts 
for that week.  It will cover the time period from when you receive the email until your 
last work shift that week or Sunday evening, whichever comes first.  We are working on 
resetting the surveys that were submitted today in error.  
  
For your convenience, here are all the time periods (Mon-Sun) covered by Study Week:  
• 
Week 1:  date - date  
[…..]   
• 
Week 16:  date - date  
• 
FINAL STUDY ITEMS (after intervention period ends): post-study survey, blood draw #2  
  

 
  
  
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[Signature Line Info]  
  
Study Activation to Champions   
  
  
Hello ResPECT Study Site Champions!   
  
The ResPECT Study is activating on <day, date> and you can expect to see more staff than 
usual wearing masks. We are asking that all participants wear masks anytime they are within 6 
feet of patients with respiratory symptoms, so please feel free to remind staff you know to be 
participating (or any of your staff as it is good infection control practice!) to wear their masks 
at the appropriate time.   
  
You can also expect to see us periodically during the 16 weeks – we will be there doing 
compliance checks, swabs, and replenishing masks. On the week when your site is chosen for 
swabs, we will let you know in advance when you expect us.   
  
Thank you again for agreeing to assist the study this flu season!!!   
  
[Signature Line Info]  
  
Study Activation to Participants   
  
Hello ResPECT Study Participants!   
  
It is time to start wearing masks – we are activating the study on <day, date>!!! Please 
remember to wear your masks when within 6 feet of patients with respiratory symptoms and 
make sure to do your daily and weekly surveys! You will receive a weekly email with a link to 
that week’s surveys.   
  
A couple reminders about the take-home swab kits:   
  
• 
Please call us if you plan to use a take-home kit and/or submit a symptomatic event form. 
We will then determine if we would like you to take a sample at home.  
• 
There are 2 swabs required for each sample: 1 nasal and 1 throat; instructions are provided 
in the take-home kit and you can always call us for clarification  
• 
For the nasal swab, please make sure you insert the swab 2 -3 centimeters inside your 
nostrils! We realize it will be uncomfortable, but we need you to do your best to get us 
good samples.   
• 
If you are sick on the weekend (Friday through Sunday) please wait until Monday to do 
your swab. FedEx doesn’t pick up Sunday and the lab is closed through the weekend.   

 
  
  
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[Signature Line Info]  
  
Symptomatic and Incompletes Info to Participants   
  
Hello ResPECT Study Participants!   
  
Now that we are in Week 2, we have noticed some additional confusion over the surveys.   
Please recall from previous email that you will be emailed survey links late Sunday/early 
Monday that will be for the week beginning on that Monday.  You should not complete your 
Weekly Diary until you have stopped working for that week.  
  
In addition, the Symptomatic Event Forms are only if you feel sick and may need to be 
swabbed.  If you don’t feel sick, you don’t need to fill it out.  We gave you 2 each week in case 
you feel sick more than once that week.  You may also call the office or email us if you feel sick 
and want to know if you should swab yourself (or have a Research Assistant come take one).  
  
You will now notice some “Incompletes” at the bottom of your list of Weekly Surveys.  These 
will only appear for the previous week (you get 2 weeks to complete your surveys and then 
they disappear).  Also make sure to complete 7 Daily Exposure Forms each week – this year 
you’re required to do all 7!!  
  
Thank you so much for your continued help,  
  
[Signature Line Info]  
  
Question #2 Clarification to Participants   
  
Hello ResPECT Study Participants!   
  
The flu season has arrived and we have been following up on everyone’s submissions! Many of 
you have seen us recently for a swab because you’re ill, and many more of you have been 
confused when we ask about your symptoms.   
  
The problem across the board is on the Daily Exposure form, Question #2 – which asks if you 
feel sick. Please be careful here; the question is not about the patients you were exposed to – it 
only wants to know about you.  Question #3 is about your patients and coworkers.  
  
We love hearing from everyone, but whenever you say “Yes you’re having symptoms” (of any 
sort, including a headache) we get an automated notification. And then we worry that you’re 

 
  
  
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sick! So please be extra careful on this form – it’ll save you the hassle of explaining yourself to 
us every week.  
  
Thanks so much!   
[Signature Line Info]  
  
Swab Week to Champions   
  
Hello <CHAMPION NAME>!   
  
Your site has been selected to have nose-throat swabs done the week of <DATE to DATE>. We 
would like your assistance to make this process as efficient as possible. If you could please send 
us schedules for the below participants and let us know of any schedule conflicts with site 
events we would greatly appreciate it! We have emailed the participants for their schedules, 
but your input is very valuable to us.   
  
We appreciate your help!!   
  
[Signature Line Info]  
  
Swab Week to Participants  
  
Hello XXXXX Site Participants!   
  
Congratulations! Your site has been selected to have nose-throat swabs done the week of 
<DATE to DATE>. We would like to visit your site <DATE> at <TIME>. If you will not be on site 
during this time, please send us your schedule as soon as possible so we can visit when you are 
working. It is very important that we see you this week, so please consider dropping by if you 
are not working so we don’t miss you.   
  
We look forward to seeing you <DATE>!!!  
  
[Signature Line Info]  
  
Week 6 Survey Reminder   
  
Hello Respect Study Participants!   
  
We are nearing the half-way point for the study – which means your first payment is being 
tallied (YAY!). However – your payment is dependent on completion of surveys so in order 

 
  
  
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to maximize your payment, the following forms need to be submitted to us by <INSERT 
DATE>.   Please go through your email and make sure you’ve submitted:  
  
1) Pre-Study Survey  
2) Weekly Diary – for each week, total of 6 (even if you did not work)  
3) Daily Exposure Survey – for each day of the week (even if you do not work)  
  
We are re-sending the Pre-Study Survey to all participants – if you have not filled this out, 
please submit this as soon as possible!! You can check whether the survey is complete by 
simply clicking on the link – if you’ve submitted it, the link will not work.   
  
Remember: If you don’t submit all the surveys, you won’t get all your money! If you can’t find 
the emails, please let us know so we can resend them!!!   
  
Thanks and we look forward to your participation in the second half!   
  
[Signature Line Info]  
  
Final Blood Draw to Participants  
  
Hello XXXXX Site Participants!   
  
You’re almost finished!! Starting <date>, we will be visiting <CLINIC OR ED NAME> to collect the 
last blood draw from everyone. We would like to visit on <DATE> at <TIME>. If you will not be 
on site during this time, please send us your schedule as soon as possible so we can visit when 
you are working. It is very important that we see you sometime between April 30th and May 
18th so you can get full participation credit for being in the study!!   
  
Please also remember to do the Post-Study Survey by April 30th. We look forward to seeing you 
in the upcoming weeks!!!   
  
[Signature Line Info]  
  
End of Study to Participants   
  
Hello XXXXX Site Participants!   
  
You’re almost finished!! Starting April 30th, we will be visiting <CLINIC OR ED NAME> to collect 
the last blood draw from everyone. We would like to visit on <DATE> at <TIME>. If you will not 
be on site during this time, please send us your schedule as soon as possible so we can visit 

 
  
  
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when you are working. It is very important that we see you sometime between April 30th and 
May 18th so you can get full participation credit for being in the study!!   
  
Please also remember to do the Post-Study Survey by April 30th. We look forward to seeing you 
in the upcoming weeks!!!   
  
[Signature Line Info]  
  
ResPECT Post-Study Email Template  
  
Dear ____,  
  
We would like to thank you so much for your participation in the ResPECT Study.  We would 
not have been successful or made any meaningful results without the participation of you and 
other healthcare workers like you.  
  
In order to receive your final study payment, you need to complete a final blood draw (if you 
haven’t already), as well as your final survey, the Post-Study Survey.  Please click below to 
access it:  
  
LINK HERE  
  
Thank you,  
[Signature Line Info]  
  
ResPECT Final Email Template  
  
Dear ___,  
  
This email signifies that you have completed the ResPECT Study for this season!  Once again, 
we would like to thank you for all of your help in this research.  
  
We have submitted everyone’s final study payments to be processed. You should receive this 
check (pro-rated based upon your amount of participation) in the next 2-3 weeks; if you do not 
receive it in 1 month, please contact your local ResPECT Team who can assist you in tracking 
down the problem.  
  
Thank you again!  
[Signature Line Info]  
  
  
  
ResPECT Supplemental Vaccination Questions Email Template  

 
  
  
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Dear [Participant Name],  
  
Thank you again so much for your participation in the ResPECT Study.  As we wind down this 
multi-year study, we realize that there were a couple additional questions we should have 
asked about other vaccinations you may have previously received.  
  
Please use the link below to access and answer these final couple questions (at the most, 
depending on responses, you could have 5 questions total):  
  
[Participant’s Link here]  
  
Thank you once again for your continued support and participation in this very important study.  
  
Sincerely,  
  
The ResPECT Study Team  
  
[site specific info]  
  
  
  
Signature Line Information (will be tailored to which arm the participant is recruited under: Baltimore, 
Denver, Houston, New York, or Washington DC)  
  
The ResPECT Study Team  
Children’s Hospital Colorado: 720-777-8864; respectstudy@childrenscolorado.org  
Denver Health: 303-436-4843; Amy.Irwin@dhha.org (Amy)  
Denver VA: 303-399-8020 x6862; vhaechrespect@va.gov  
Houston VA: 713-794-7224 or 713-791-1414 x5458; VHAHOUMCLRespectStudy@va.gov  
Johns Hopkins: 410-614-6206; respect@jhmi.edu  
New York: 212-686-7500 x4469 and 718-836-6600 x6588; ResPECTStudy@va.gov  
Washington DV VA: 202-745-8457 DC.ResPECT@va.gov  
  
[this part only for Weekly Emails]  
Reminder: Please contact your study team if you develop any flu-like symptoms and please  
wear your study-assigned masks when interacting with patients with suspected influenza-like 
illness.    
  
  

 
  
  
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Appendix  W  
Payment Schedule  
Study Requirement  
Frequency  
Payment 
Amount  
Total  
Possible  
Payment  
Pre-study package:  
1. Pre-study attitudes, beliefs, and opinions 
survey (Preliminary survey)  
2. Baseline survey (participant demographic 
information)  
3. Blood draw #1  
1x (subject 
to being 
eligible to 
participate)  
$ 55.00  
$ 55.00  
Randomized nasal and throat swab set  
2-3x   
$60.00 (1st &  
2nd set)  
$59.00 (3rd 
set)  
$120.00- 
$179.00  
Weekly symptom diary  
12-16x  
$ 5.00 (each)  
$ 60.00- 
$80.00  
Daily Exposure Form  
Every day 
during 
study 
period  
$ 5.00  
(weekly)  
$ 60.00- 
$80.00  
Post-study package:  
1. Blood draw # 2  
2. Post-study attitudes, beliefs, and 
opinions survey  
  
1x  
$ 70.00  
$ 70.00  
*Study Bonus:  Prorated according to participant 
completion of weekly symptom diaries and daily 
exposure forms.  
1x  
Up to $135.00  Up to 
$135.00  
  
  
  
  
  
  
Maximum  
Total Study  
Payment  
$500.00  
(12 wks) or  
$599.00  
(16 wks)  
  
Payment Schedule:  There are two payment dates- the first payment will be distributed 
midway through the study period, and the second payment will be distributed at the end of the 
study period.  The first payment has a maximum of $175 and the second payment, which will 
include the bonus, has a maximum of $325 if the study ends after 12 weeks and $424 if 
extended to 16 weeks. Payment amounts will reflect each participant’s completion of study 
requirements. Payment is capped at $599 for tax purposes. Please contact the ResPECT 
Research Office with any payment questions.  

 
  
  
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Reminder:  Please contact the ResPECT Research Office at 410-614-6206 or respect@jhmi.edu 
if you experience ANY of the respiratory/flu-like symptoms listed on the Symptomatic Event 
Form (symptoms also listed on weekly symptom diary and back of ResPECT Study business 
card).    
 
Appendix  X  
Swab Delivery Form  
  
Swab Delivery Form                                       
  
Participant ID: ________  
  
1.) When did symptoms begin? (date and time)  
  
2.) When is pick-up scheduled? (date and time)  
  
a. What is the FedEx tracking number? (16-digit field)  
  
Please remember to complete your Symptomatic Event Form online! Please contact us at 
XXXXX@domain.com or XXX-XXX-XXXX with any questions or concerns.  
  
  
  
  
 

 
  
  
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Appendix  Y  
Patient-Based Observation Form  
  
Please let us know…  
  
Were you given a face mask to wear today?    Yes______  
No______  
  
Did you see your doctor, nurse, or other healthcare professional wear a face mask 
during your visit today?  If yes, please circle the mask that most closely resembles what 
they wore.  
  
 
  
  
  
 
  
  
  
 
 
Mask unlike those 
above.   
Please describe mask:  
  
  
  
N95 Masks 
 
Medical Masks 
 
Other 
 

 
  
  
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Did you see your doctor, nurse, or other healthcare professional 
clean their hands during your visit today?   
  
Yes _____      No _____  
  
If yes, what did they use? Please indicate when they used this method.  
  
BEFORE your exam  
AFTER your exam  
Sanitizing Gel  
  
  
Sanitizing Foam  
  
  
Soap and Water  
  
  
Thank you for answering our survey!  
  
  
Appendix Z HandyAudit Compliance Monitoring  
  
  
  

 
  
  
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Appendix  AA  Respect Study Facebook Page  

 
  
  
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Appendix  BB Mask Up Sample Poster  
  
 
  
WE WANT YOU TO MASK UP!  
  
  

 
  
  
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Today’s Date:  ____/___/____  
  
  
(MM/DD/YEAR)  
Study Subject ID: ____________  
  
Appendix  CC Supplemental Vaccination Questions   
  
1) Have you ever had measles?   
a) If yes, approximately when?   
Date:   
  
2) 
Have you ever had varicella (aka chicken pox)?  a) If yes, 
approximately when?   Date:   
  
3) 
If you have not had measles or varicella (chicken pox) or you 
are unsure, have you ever received a vaccination for measles (often 
included with vaccinations for mumps, rubella, and sometimes 
varicella/chicken pox, known as MMR or MMRV)?   
a) If yes, what type of vaccine did you receive?   
□ 2 doses as a child  
 
□ 2 doses as an adult  
□ 1 dose as a child  
 
□ 1 dose as an adult  
□ 0 doses as a child  
 
□ 0 doses as an adult  
  
b) If yes, approximately when did you receive your dose(s)?    
Year of 1st dose:   
Year of 2nd dose:  
  
4) 
Have you ever received a pneumococcal vaccination (pneumonia)?  a) 
If yes, approximately when?   Date:   
  
5) 
Have you ever received a tuberculosis vaccination (this is not the same 
as the “TB skin test”)?   
a) If yes, approximately when?   
Date:   
  
  
  
  
  
  
  
  

 
  
  
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