CERTAIN aims to evaluate the feasibility within an exploratory randomised controlled trial of running a larger trial designed to test the clinical (as measured by tobacco cessation) and cost effectiveness of a complex intervention of a face-to-face counselling intervention coupled with a mobile phone calls and messaging intervention delivered to smokeless tobacco users visiting Indian primary care clinics in addition to routine care provided by the primary care professional against routine care alone. The study will develop and test an innovative mobile telephone-based counselling system to assist tobacco users give up using tobacco over a period of 18 months (October 2019 to March 2020).
The overall responsibility for the study rests with University College of London and Public Health Foundation of India. The Chief Investigator (UK) is Dr Irwin Nazareth, Professor of Primary Care and Population Sciences University College London Medical School and Director of PRIMENT Clinical Trials Unit. Co-investigator and Principal Investigator (India) is Dr. Rajmohan Panda, Additional Professor, Public Health Foundation of India. Other Co-investigators include Rumana Omar, Professor of Medical Statistics and Statistical Science University College London and Rachael Maree Hunter, Associate Professor of Health Economics at Primary Care and Population Health University College London and Dr Hazel Gilbert of Primary Care and Population Sciences University College London Medical School is a study collaborator. The study is funded by the Medical Research Council (MRC) through a development grant under Joint Global Health Trials Initiative MRC/DfID/Wellcome Trust ref: MR/P021166/1 and has ethical approval from the Institutional Ethics Committee of the Public Health Foundation of India- Reference Number: TRC-IEC-391/19. It has received ethical clearance from Indian Council of Medical Research’s Indian Health Ministry’s Screening Committee (HMSC), Government of India. This Trial is carried out in Urban Primary Care Health Centres (UHCs) in partnership with MKCG Medical College and Hospital, Berhampur, Ganjam district, Odisha, Department of Community Medicine after approval from Department of Health and Family Welfare, Odisha. This exploratory clinical trial is prospectively registered with the Clinical Trial Registry, Reference Number: CTRI/2019/05/019484 [Registered on: 31/05/2019].