Can telephone support improve adherence to tuberculosis treatment?

INTERVENTION: This is an open‐label randomized clinical trial, with no masking of participants or the research team responsible for delivering the intervention. Eligible patients will be randomly allocated to one of two groups: intervention, with 42 participants, or control, with 42 participants. To ensure comparability between the groups, a stratified randomization strategy will be used. Initially, participants will be classified into two distinct strata based on their treatment history: Stratum A: New tuberculosis cases, defined as patients with no documented previous treatment for the disease. Stratum B: Retreatment cases, comprising patients with a history of relapse or treatment failure following previous treatment. After stratification (new cases and retreatment cases), participants will be randomly and independently allocated to the control or intervention group. An electronic program will be used to generate random allocation sequences in blocks of four, ensuring that participants have an equal probability of being assigned to either the intervention group (additional remote follow‐up) or the control group (standard treatment). Intervention Group: Besides the usual care provided for tuberculosis treatment, participants allocated to the intervention group will receive additional follow‐up through periodic telephone calls or messages via Short Message Service (SMS) or WhatsApp, conducted biweekly by the research team over a period of 6 months. Telephone calls will last approximately 3 to 10 minutes. The purpose of this follow‐up is to monitor treatment progress, reinforce the importance of adherence, and clarify any questions from participants. To ensure standardization, a protocol will be established using a structured script (Appendi X2) for both calls and messages. For initial contact attempts, a telephone call will be made at the previously scheduled date and time. If there is no response, up to three call attempts will be made at different times on the same day, with a minimum interval of two hours between attempts. If contact is not established after three attempts, a standardized message will be sent via Short Message Service (SMS) or WhatsApp. Follow‐up will be conducted for si Xmonths, corresponding to the standard treatment duration for patients with tuberculosis. If the participant does not respond within 48 hours, a new contact attempt will only be made on the next scheduled biweekly follow‐up, in accordance with the study timeline. In cases of loss to follow‐up (defined as no contact for four consecutive biweekly periods), the participant will be considered non‐adherent to remote monitoring but will continue to receive standard care from the health service. Follow‐up will also be discontinued if the participant explicitly requests it. Control Group: Participants will receive only the standard tuberculosis treatment and care routinely provided by the health service for si Xmonths, without additional telephone calls or messaging follow‐up CONDITION: C01.221 Tuberculosis, Treatment Adherence and Compliance ; Communicable Diseases PRIMARY OUTCOME: The primary outcome of this study is the treatment dropout rate, defined as failure to attend the health facility for more than 30 consecutive days following the last medication intake during directly observed therapy or after the scheduled return date. The treatment dropout rate in the control group is expected to be approximately 18.8%, based on data provided by the Municipal Epidemiological Surveillance unit for 2023. It is assumed that this rate will be reduced to 5% in the intervention group, in accordance with the guidelines of the Brazilian Ministry of Health. SECONDARY OUTCOME: A low level of intervention acceptance will be indicated by the frequency of patients who request to stop contact or who are excluded from the intervention due to non‐response over four consecutive two‐week periods of contact attempts. Perceived barriers to treatment continuity, assessed via telephone interviews with patients who discontinued treatment, conducted si Xmonths after treatment initiation. Sociodemographic information (age, sex, marital status, number of children, race/color/ethnicity, and place of residence) will be collected from the tuberculosis patient management system (TBWeb) for sample characterization and the conduct of secondary analyses. Socioeconomic information (income, education, occupation, housing conditions, access to services, and social class) will be collected from the tuberculosis patient management system (TBWeb) to characterize the sample and conduct secondary analyses. INCLUSION CRITERIA: Patients diagnosed with tuberculosis; aged 18 years or older; initiating treatment or retreatment in the municipality of Guarujá within 15 days before the recruitment date; having an active telephone number; agreeing to participate in the study by signing the Informed Consent Form