ATN 113 Version 2.0 02/03/2014 ATN 113 Version 2.0 February 3, 2014 PROJECT PrEPare – AN OPEN LABEL DEMONSTRATION PROJECT AND PHASE II SAFETY STUDY OF PRE-EXPOSURE PROPHYLAXIS USE AMONG 15 TO 17 YEAR OLD YOUNG MEN WHO HAVE SEX WITH MEN (YMSM) IN THE UNITED STATES A Multi-Center Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Sponsored by: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 6100 Executive Boulevard Bethesda, MD 20892-7510 Telephone: (301) 402-0698 With co-funding from: The National Institute on Drug Abuse (NIDA) The National Institute of Mental Health (NIMH) IND # 113,920 Protocol Chair: Sybil Hosek, Ph.D. NICHD Medical Monitor and Program Director: Bill G. Kapogiannis, M.D. NICHD Health Science Administrator: Sonia S. Lee, Ph.D. NICHD Program Scientist: George K. Siberry, M.D., M.P.H. Protocol Specialist: Nancy Liu, M.P.H. Page 1 of 188 Downloaded From: https://jamanetwork.com/ on 09/28/2021 ATN 113 Version 2.0 02/03/2014 TABLE OF CONTENTS SUMMARY OF CHANGES FOR ATN 113, VERSION 2.0 (02/03/2014) ................... ERROR! BOOKMARK NOT DEFINED. ATN 113 PROTOCOL TEAM ROSTER .................................................................................... 6 SIGNATURE PAGE ...................................................................................................................... 9 REQUIREMENTS FOR SITE PARTICIPATION IN PROTOCOL ..................................... 10 STUDY MANAGEMENT ........................................................................................................... 11 LIST OF ABBREVIATIONS ...................................................................................................... 12 STUDY ABSTRACT .................................................................................................................... 15 STUDY SCHEMA ........................................................................................................................ 20 SCHEMATIC OF STUDY FOLLOWUP .................................................................................. 21 1.0 INTRODUCTION........................................................................................................ 22 1.1 Background and Significance .................................................................................................. 2 3 1.2 Rationale .................................................................................................................................... 29 1.3 Research Design Considerations ............................................................................................. 29 2.0 STUDY OBJECTIVES ................................................................................................ 33 2.1 Primary Objectives ................................................................................................................... 33 2.2 Secondary Objectives ............................................................................................................... 33 3.0 STUDY DESIGN .......................................................................................................... 34 3.1 Study Population ....................................................................................................................... 34 3.2 Sample Size ................................................................................................................................ 34 3.3 Behavioral Intervention and Wisepill Device Assignments .................................................. 34 4.0 SITE AND PROTOCOL REGISTRATION ............................................................. 34 5.0 SELECTION AND ENROLLMENT OF STUDY SUBJECTS .............................. 35 5.1 Inclusion Criteria ...................................................................................................................... 35 5.2 Exclusion Criteria ..................................................................................................................... 35 5.3 Disallowed Medications ............................................................................................................ 36 5.4 Recruitment and Screening ..................................................................................................... 37 5.5 Informed Consent ..................................................................................................................... 38 5.6 Contact Information ................................................................................................................. 39 5.7 Subject Registration and Enrollment ..................................................................................... 39 5.8 Co-enrollment Guidelines ........................................................................................................ 39 6.0 STUDY AGENT MANAGEMENT............................................................................ 40 Page 2 of 188 Downloaded From: https://jamanetwork.com/ on 09/28/2021 ATN 113 Version 2.0 02/03/2014 6.1 Study Agent Administration .................................................................................................... 40 6.2 Study Agent Supply and Distribution ..................................................................................... 40 6.3 Study Agent Formulation and Storage ................................................................................... 40 6.4 Study Agent Labeling ............................................................................................................... 40 6.5 Study Agent Dispensing ........................................................................................................... 41 6.6 Study Agent Accountability ..................................................................................................... 41 7.0 BEHAVIORAL EVALUATIONS .............................................................................. 41 7.1 Many Men, Many Voices Intervention ................................................................................... 41 7.2 Personalized Cognitive Counseling ......................................................................................... 42 7.3 Audio Computer-Assisted Self-Interview (ACASI) ............................................................... 42 7.4 Youth Who Decline Participation ........................................................................................... 42 7.5 Implementation Process Evaluation ....................................................................................... 42 7.6 Description of Measures ........................................................................................................... 43 7.7 Training and Supervision of Behavioral Intervention .......................................................... 44 7.8 Intervention Monitoring/Quality Control .............................................................................. 45 8.0 STUDY EVALUATIONS ............................................................................................ 45 8.1 Screening Visit .......................................................................................................................... 45 8.2 Baseline Visit ............................................................................................................................. 46 8.3 3MV/PCC Behavioral Intervention ........................................................................................ 48 8.4 Re-Screening Visit .................................................................................................................... 48 8.5 Week 0 Visit .............................................................................................................................. 49 8.6 Follow-up Study Visits ............................................................................................................. 50 8.7 Premature Discontinuation Evaluations ................................................................................. 52 8.8 HIV Seroconversion Visits ....................................................................................................... 53 8.9 Extension Phase Visits .............................................................................................................. 55 9.0 DATA COLLECTION AND SITE MONITORING ................................................ 56 9.1 Development of Protocol and Case Report Forms ................................................................ 56 9.2 Data Records ............................................................................................................................. 57 9.3 Data Collection .......................................................................................................................... 57 9.4 Data Submission ....................................................................................................................... 58 9.5 Data Quality Assurance ........................................................................................................... 59 9.6 Role of Data Management........................................................................................................ 59 9.7 Clinical Site Monitoring and Record Availability ................................................................. 59 9.8 Retention of Clinical Research Records ................................................................................. 59 Page 3 of 188 Downloaded