Title{1} | Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial |
Trial registration {2a and 2b} | The study protocol has been registered in the clinicaltrials.gov identified with NCT04600167 since 23 Oct 2020 |
Protocol version{3} | Protocol Version 1.1 dated 25 March 2021 Protocol Number: NIMR-MB-002 |
Funding {4} | This project is part of the European and Developing Countries Clinical Trials Partnership (EDCTP) 2 programme supported by the European Union (grant number RIA2018CO-2514-PROTID). |
Author details{5a} |
*¤ Contributed equally to this publication 1National Institute for Medical Research (NIMR), Mbeya Medical Research Centre, Tanzania 2Dept of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), The Netherlands 3The Good Samaritan Foundation (Kilimanjaro Christian Medical Centre GSF KCMC), Tanzania 4Kilimanjaro Christian Medical University College 5Department of Internal Medicine, School of Medicine, College of Health Sciences, Makerere University, Uganda 6Uganda Martyrs Hospital Lubaga, Uganda 7St George’s University of London, United Kingdom 8King’s College London, United Kingdom 9Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands 10Mbeya Zonal Referral Hospital (MZRH), Tanzania 11Otago Global Health Institute, University of Otago, New Zealand 12Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Corresponding Author: Dr Nyanda Elias Ntinginya; National Institute for Medical research (NIMR)-Mbeya Medical Research Centre; nelias@nimr-mmrc.org |
Name and contact information for the trial sponsor {5b} |
National Institute for Medical research (NIMR)-Mbeya Medical Research Centre (MMRC) Hospital Hill Rd, P.O.Box 2410 Mbeya Tanzania Tel: +255 25 250 3364 |
Role of sponsor {5c} | The sponsor is involved in the study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to publish. The funder (EDCTP ) was not involved in the study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to publish |