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Study Protocol ____________________________________________________ The Botswana Combination Prevention Project (BCPP) Evaluation Protocol (Protocol #1) ____________________________________________________ Research Design and Impact Evaluation Version 7.0 January 16, 2019 Collaborating Institutions: Botswana–Harvard AIDS Institute Partnership (BHP) Botswana Ministry of Health (MOH) Harvard T.H. Chan School of Public Health U.S. Centers for Disease Control and Prevention (CDC) Funded by: The United States President’s Emergency Plan for AIDS Relief (PEPFAR) through the Centers for Disease Control and Prevention (CDC) i. PRINCIPAL INVESTIGATORS Myron Essex, DVM, PhD Lasker Professor of Health Sciences Harvard T.H. Chan School of Public Health FXB 402, 651 Huntington Avenue Boston, MA 02115-6017 Email: [email protected] Phone: +1-617-432-0975 Fax: +1-617-739-8348 Joseph Makhema, MBChB, FRCP Chief Executive Officer Botswana Harvard AIDS Institute Private Bag BO320 Gaborone, Botswana Email: [email protected] Phone: +267-390-2671 Fax: +267-390-1284 Shahin Lockman, MD, MS Associate Professor of Medicine; Associate Professor in the Department of Immunology and Infectious Diseases Harvard T.H. Chan School of Public Health FXB 406a, 651 Huntington Avenue Boston, MA 02115 Email: [email protected] Phone: +1-617-771-8780 Fax: +1-617-739-8348 Eric Tchetgen Tchetgen, PhD Professor of Biostatistics and Epidemiologic Methods Departments of Biostatistics and Epidemiology Kresge, Room 822 677 Huntington Avenue Boston, MA 02115 Email: [email protected] Phone: 617-432-5970 Fax: 617-432-1884 Molly Pretorius Holme, MS Senior Research Manager Department of Immunology and Infectious Diseases Harvard T.H. Chan School of Public Health BCPP Evaluation Protocol Version 7.0 | January 16, 2019 2 FXB 406a, 651 Huntington Avenue Boston, MA 02115 Email: [email protected] Phone: +1-617-432-4377 Fax: +1-617-739-8348 ii. ROLES OF INSTITUTIONS AND PRINCIPAL INVESTIGATORS • Institutions: Close coordination between MOH, Harvard Chan School, CDC, and BHP is needed to ensure seamless implementation of research and program activities. However, MOH and CDC will lead, and ultimately be responsible for, program implementation and monitoring and evaluation, while Harvard Chan School/BHP will lead, and ultimately be responsible for, the evaluation of HIV incidence and viral genetic linkage analyses. • Principal Investigators: Myron Essex: Harvard Principal Investigator (PI) responsible for preparation of the study protocol, design and evaluation of research, monitoring of research progress, creation and monitoring of research budgets, and preparation of research progress reports; responsible for design of initial proposal, including virological analyses, and supervision of Harvard and BHP investigators. Joseph Makhema: BHP Co-Principal Investigator (Co-PI) responsible for preparation of study protocol, preparation of progress reports, and overseeing field research staff in Botswana. Shahin Lockman: Harvard Co-Principal Investigator (Co-PI) responsible for preparation of the study protocol, and monitoring of research progress / revisions of research protocol and procedures as needed; and assisting with monitoring/revision of research budgets and preparation and review of research progress reports. Eric Tchetgen Tchetgen: Harvard Co-Principal Investigator (Co-PI) responsible for monitoring of research progress, facilitation of internal and external study monitoring, and preparation of research progress reports; responsible for overseeing statistical design and analyses as well as their interpretation. Molly Pretorius Holme: Harvard Co-Principal Investigator (Co-PI) responsible for preparation of the study protocol, and monitoring of research progress / revisions of research protocol and procedures as needed; and assisting with monitoring/revision of research budgets and preparation and review of research progress reports. BCPP Evaluation Protocol Version 7.0 | January 16, 2019 3 iii. INVESTIGATOR LISTS BY INSTITUTION Botswana Ministry of Health (MOH), Gaborone, Botswana (Alphabetical Order) Name Role Contact Email Marina Anderson, MD, MPH Surveillance [email protected] Shenaaz El-Halabi (DPS), MPH In-country oversight [email protected] Ernest B. Fetogang, PhD M&E [email protected] Refeletswe Lebelonyane, MD In-country oversight [email protected] Madisa Mine, PhD Laboratory [email protected] Harvard T.H. Chan School of Public Health, Boston, MA, USA (Alphabetical Order) Name Role Contact Email Ingrid Bassett, MD Cost-effectiveness [email protected] Kara Bennett, MS Statistical Consultant [email protected] Victor DeGruttola, DSc Senior Statistical Scientist [email protected] Scott Dryden-Peterson, MD Treatment and PMTCT [email protected] Kenneth Freedberg, MD Cost-effectiveness [email protected] Vladimir Novitsky, MD, PhD Lab [email protected] Research Operations, Treatment Kathleen Powis, MD, MPH [email protected] and PMTCT Roger Shapiro, MD, MPH Treatment and PMTCT [email protected] Rochelle Walensky, MD Cost-effectiveness [email protected] Rui Wang, PhD Statistics [email protected] Kathleen Wirth, ScD Statistics [email protected] Botswana–Harvard AIDS Institute Partnership (BHP), Gaborone, Botswana (Alphabetical Order) Name Role Contact Email Treatment and PMTCT, Tendani Gaolathe, MD [email protected] Field research operations Simani Gaseitsiwe, PhD Lab [email protected] Poloko Kebaabetswe, PhD, MPH Qualitative research consultant [email protected] BHP oversight and research Mompati Mmalane, MD, FRCS-Ed, MSc [email protected] operations Mosepele Mosepele, MBBS, MSc Clinical outcomes [email protected] Sikhulile Moyo, MSc, MPH, PhD Lab [email protected] Rosemary Musonda, MSc, PhD Lab [email protected]. bw Erik van Widenfelt, BA Research data systems [email protected] BCPP Evaluation Protocol Version 7.0 | January 16, 2019 4 Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA, and Gaborone, Botswana (Alphabetical Order) Name Role Contact Email Pam Bachanas, PhD, MS HTC [email protected] Ebi Bile, BSc, MA In-country lab oversight [email protected] Arielle Lasry, PhD HTC Costing [email protected] Tafireyi Marukutira, MD Clinical [email protected] Lisa A. Mills, MD Co-Investigator [email protected] Janet Moore, PhD Co-investigator [email protected] Sherri Pals, PhD Statistics [email protected] Elliot Raizes, MD Clinical Consultant [email protected] Chunfu Yang, PhD Laboratory [email protected] BCPP Evaluation Protocol Version 7.0 | January 16, 2019 5 iv. TABLE OF CONTENTS I. PRINCIPAL INVESTIGATORS ........................................................................................................................... 2 II. ROLES OF INSTITUTIONS AND PRINCIPAL INVESTIGATORS ............................................................................ 3 III. INVESTIGATOR LISTS BY INSTITUTION ........................................................................................................... 4 IV. TABLE OF CONTENTS ..................................................................................................................................... 6 V. LIST OF TABLES AND FIGURES ........................................................................................................................ 9 VI. ACRONYMS AND ABBREVIATIONS .............................................................................................................. 11 VII. BOTSWANA COMBINATION PREVENTION PROJECT SCHEMA ...................................................................... 13 VIII. EVALUATION PROTOCOL SYNOPSIS............................................................................................................. 20 1. INTRODUCTION AND BACKGROUND ........................................................................................................... 22 1.1. EPIDEMIC IN BOTSWANA .................................................................................................................................. 22 1.2. COMBINATION PREVENTION ............................................................................................................................. 22 1.3. THE PROPOSED COMBINATION PREVENTION (CP) PACKAGE ................................................................................... 23 2. STUDY OBJECTIVES ...................................................................................................................................... 24 2.1. PRIMARY STUDY HYPOTHESIS ............................................................................................................................ 24 2.2. PRIMARY OBJECTIVES ...................................................................................................................................... 24 2.3. EVALUATING THE IMPACT OF COMBINATION PREVENTION: DESIGN AND RATIONALE TO ADDRESS PRIMARY OBJECTIVES ..... 25 2.4. SECONDARY OBJECTIVES .................................................................................................................................. 27 2.5. DESIGN AND RATIONALE TO ADDRESS SECONDARY OBJECTIVES ............................................................................... 28 3. OVERVIEW OF STUDY METHODS ................................................................................................................. 31 4. STUDY POPULATIONS .................................................................................................................................. 32 4.1. SELECTION OF STUDY
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