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Study Protocol and Statistical Analysis Plan

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Study Protocol and Statistical Analysis Plan THIS DOCUMENT IS CONFIDENTIAL Clinical Study Protocol - VIllage-based refill of ART after same-day ART start vs clinic-based ART refill for HIV-positive individuals not on ART during home-based HIV testing – a cluster randomized controlled trial in rural Lesotho abbreviated title: VIBRA study („VIllage-Based Refill of ART”) PART B of GET ON research project This study is embedded in the overall research project called GET ON (“GETing tOwards Ninety”) project Protocol Version Number 7 Document Date 25.09.2018 Niklaus Daniel Labhardt Principal Investigator Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002 Basel, Switzerland Protocol authors (so far) AA, FT, FV, JM, NDL, TIL, TRG The information contained in this document is confidential. It is intended solely for the Investigators, potential Investigators, consultants, or applicable independent ethics committees. It is understood that this information will not be disclosed to others without prior written authorisation from the sponsor, except where required by applicable local laws. Signature PI: ______________________ Date: 25.09.2018 1 of 49 VIBRA study / study protocol version nr 7 25.09.2018 I. List of investigators Status in the study Name Institutional/organizational affiliations Principal Investigator Niklaus Daniel Labhardt, Swiss Tropical and Public Health Institute; MD, MIH [email protected]; +41 79 870 18 59 Co-Investigators - Coordinator of Josephine Muhairwe, MD, SolidarMed Lesotho; Country Coordinator; study implemen- MPH [email protected], +26628325172 tation - Study physician Bienvenu Lengo Nsakala, SolidarMed Lesotho; [email protected]; MD +266 59355461 - Local Principal Alain Amstutz, MSc Swiss Tropical and Public Health Institute; Investigator; [email protected]; +41 79 489 94 48 / +266 Study physician 58604300 - Local Deputy Thabo Ishmael Lejone, RN, SolidarMed Lesotho; Research Manager; Principal Investi- MIH [email protected]; +266 62000584 gator; Commu- nity ART Nurse - Statistician Tracy Renée Glass, PhD Swiss Tropical and Public Health Institute; [email protected] - Community ART Lefu Khesa, PN SolidarMed Lesotho; [email protected]; Nurse +266 56425205 - Laboratory Thomas Klimkait, PhD Department of Biomedicine – Haus Petersplatz, Uni- expertise Prof. versity of Basel, Switzerland; [email protected] - Study Chair Manuel Battegay, MD Infectious Diseases & Hospital Epidemiology, Univer- Prof. sity Hospital Basel, University of Basel, Switzerland; [email protected] - Laboratory tech- Katleho Tlali, MLS District Laboratory Services Butha-Buthe, Lesotho; nologist [email protected] II. List of other persons/institutions involved and acknowledged Name Institutional/organizational affiliations Lebohang Sao, MD District Health Management Team Butha-Buthe, [email protected]; +266 58847542 Kyaw Thin, MD, DCH, MSc Research Coordination Unit, Ministry of Health of Lesotho; dr.kyaw- [email protected]; +266 22226317 Fiona Vanobberghen, PhD Swiss Tropical and Public Health Institute; [email protected] Fabrizio Tediosi, MSc, PHD Health Systems Research & Dynamical Modelling Unit, Department of Epidemiol- ogy and Public Health, Swiss Tropical and Public Health Institute; [email protected] Monitoring Institution Clinical Operations Unit (COU), Swiss TPH, Basel, Switzerland III. Remarks 1) A list of all other involved staff (lay counsellors, campaign organizers, village health workers) will only be availa- ble at the start of the study and is not feasible to include at this stage, because it is more than 100 people. They will all receive a specific training and the study personnel who enrols patients will get an introduction into GCP (without certificates). 2) This is an investigator-initiated trial. The Principal Investigator, the Swiss TPH respectively, acts as Sponsor. 3) This study protocol will be registered on clinicaltrials.gov, the registration number will be provided at a later stage 4) According to Swiss lab (ClinO, Art. 19, 20, App 3, 1.1) this is a Category A trial 5) Conflict of Interest: All authors declare that they have no competing interests. 2 of 49 VIBRA study / study protocol version nr 7 25.09.2018 IV. The “Towards 90-90-90” research consortium This research protocol has been developed in collaboration with the “Towards 90-90-90 in Butha-Buthe” research consortium. The project with the full title Improving the HIV care cascade in rural Lesotho – Towards 90-90-90: A research collaboration with the Ministry of Health entails operational and clinical research aiming at achieving the 90- 90-90 targets in Butha-Buthe and generating evidence on innovative approaches for Lesotho and similar settings. The five institutions that are part of this consortium are introduced below: 1. District Health Management Team (DHMT) of Butha-Buthe and Mokhotlong, Lesotho: DHMT has the responsibility for the practical implementation of all activities. It ensures the coordination of the pro- posed study with other district activities to avoid any negative interference with routine health care activities within the district. The project was set up in collaboration with Dr Lebohang Sao, District Health Manager of Butha-Buthe, and Dr Kabelo Matjeane, District Health Manager of Mokhotlong. 2. Ministry of Health of Lesotho: The Research Coordination Unit (RCU) is the Unit responsible for research at the Ministry of Health with extensive experience in supporting the conduct of country-wide surveys and in monitoring studies conducted in Lesotho. The RCU will oversee the implementation of the study, including compliance with the national and ethical standards. The person responsible at RCU is the Unit’s Head, Dr. Kyaw Thin, who heads the unit since 2008. 3. Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland: The Swiss TPH has the overall scientific responsibility for design, implementation, and analysis of the study. Swiss TPH is an institute of the University of Basel with longstanding experience in conducting health projects and studies in Sub- Saharan Africa. Dr. Niklaus Labhardt is the principal leader of the Towards 90-90-90 project. He has lived and worked in Lesotho from 2010-12, has successfully conducted studies and trials in Lesotho and has since remained closely connected to the country. He knows the country context very well in terms of clinical work, project management and research. Tracy Glass is the co-investigator of the Towards 90- 90-90 project and the principal investigator of HOSENG. She is a biostatistician with 15 years of experi- ence working in clinical and observational studies in HIV, the last 5 years in resource-limited settings. Alain Amstutz is a physician researcher and the local principal investigator. He pursues his PhD in clinical HIV research within the research consortium and currently lives in Lesotho. 4. SolidarMed, Swiss Organization for Health in Africa, Lesotho: SolidarMed is a Swiss not-for-profit or- ganization, working in Lesotho for over 50 years (www.solidarmed.ch). Of note, SolidarMed is a long- standing implementing partner of the Ministry of Health in Lesotho, working under a signed Memoran- dum of Understanding that includes activities related to the project “Towards 90-90-90”. SolidarMed has the responsibility to coordinate the proposed project. For implementation of the study SolidarMed will provide infrastructure, such as cars and transport, study personnel, and administrative support. Sol- idarMed will provide substantial additional funds for the proposed project, i.e. it will cover majority of cost for routine VL monitoring. The person responsible for the project at SolidarMed is Dr. Josephine Muhairwe, Country Director of SolidarMed Lesotho, who has extensive experience in project planning and implementation in Sub-Saharan Africa. 5. Molecular Virology, Department of Biomedicine (DBM), University of Basel, Switzerland: The Molecu- lar Virology laboratory contributes all critical laboratory expertise to the proposed project. It provides training, mentoring and quality control for the virologic analyses conducted at the laboratory of Butha- Buthe. The person responsible is Prof. Dr. Thomas Klimkait, who for more than 15 years heads an ac- credited diagnostic laboratory for clinical diagnostics in Basel, Switzerland. He has experience in molec- ular test development and in establishing and auditing certified laboratories in Switzerland as well as Sub-Saharan Africa. 3 of 49 VIBRA study / study protocol version nr 7 25.09.2018 V. Signatures Principal Investigator and Co-Investigators who sign below have approved the current study protocol version 6, date 20.04.2018, and confirm hereby to conduct the project according to the plan, the current version of the World Medical Association Declaration of Helsinki and the principles of Good Clinical Practice (GCP). Principal Investigator Signature 12.01.2018 (electronically signed) Name Niklaus Daniel Labhardt Date of Signature Title MD, MIH Institution Swiss Tropical and Public Health Institute Address Socinstrasse 57; 4002 Basel Phone +41 612848255 Co -investigators in Switzerland Signature 12.01.2018 (electronically signed) Name Tracy Renée Glass Date of Signature Title PhD Institution Swiss Tropical and Public Health Institute Address Socinstrasse 57; 4002 Basel Phone +41 612848714 Signature Basel, Jan. 12, 2018 (electronically signed) Name Thomas Klimkait Date of Signature Title PhD Institution Molecular Virology, Dept. of Biomedicine - Petersplatz, University
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