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 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 2 The Respiratory Protection Effectiveness Clinical Trial-NA_00031266 Trish Perl, PI, 214-648-9022, Lew Radonovich, PI, 412-386-6478 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. 3 The Respiratory Protection Effectiveness Clinical Trial-NA_00031266 Trish Perl, PI, 214-648-9022, Lew Radonovich, PI, 412-386-6478 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 4 The Respiratory Protection Effectiveness Clinical Trial-NA_00031266 Trish Perl, PI, 214-648-9022, Lew Radonovich, PI, 412-386-6478 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....................................................................