Victor Williams

56 Chapter 3 and an alpha of 5%, the estimated power of this study is 98%. A sample size range of 106 – 582 has been used in similar studies (18, 33-36) therefore this anticipated sample size will be adequate for the different outcomes. One doctor and one nurse will be purposively selected and interviewed per health facility until saturation is achieved in each group and no more new information is obtained from the healthcare workers (37). Since the study will be conducted at 12 health facilities, there will be a minimum of 24 study participants for the qualitative study. Inclusion Criteria New patients aged 18 and above who will initiate treatment for any form of TB at any of the 12 selected health facilities from 01 June 2022 up to 30 September 2022 will be eligible for inclusion irrespective of sex. Patients meeting the above criteria who are able and willing to provide informed consent will be included. Healthcare workers to be included in the study must have clinical training (doctors or nurses), regularly review patients’ medical records, have worked at the health facility for a minimum of twelve months, and be willing to provide informed consent to participate in the study. Data Collection Data collection from patients (baseline and during follow-up) and interviews of healthcare workers will be conducted by two trained research staff conversant with TB data. Data from patients will be entered into an electronic form developed using Research Electronic Data Capture (REDCap). Patients’ demographic and clinical information will be extracted at baseline and during follow-up visits (Month 2, Month 5/End of Treatment) till patients are discharged from care and have a treatment outcome documented in their case file per updated WHO guidance (38) (Supplementary file 1). A structured questionnaire developed in REDCap will be administered electronically to healthcare workers to identify their views on DM-TB management and challenges to DM-TB services provision at the health facilities. This questionnaire has three sections that should take approximately 15 minutes to complete – demographic information, occupational information, and patient care-related questions. An interview will complement the electronically administered questionnaire (Supplementary file 2) to obtain healthcare workers' perspectives on service delivery and recommendations for improvement. An interview guide has been developed to assist the interviewers during

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