Hospital versus community management during the intensive phase of the tuberculosis (TB) re-treatment regimen

INTERVENTION: There will be a 2‐stage enrolment and recruitment process. In the first stage, all patients starting retreatment regimen will be approached to identify a treatment supporter (guardian) who will be trained in the technique of intramuscular injection. In the second stage, those who are deemed clinically fit for discharge and whose guardian becomes competent at injection technique will be randomised to receive standard of care (i.e. remain in hospital for the duration of the intensive phase of TB treatment) or to the intervention arm (i.e. to complete the intensive phase of treatment in the community). Group 1: 134 patients, randomised to receive the intervention. These participants will be discharged home where they will receive daily oral treatment and intramuscular streptomycin injections administered by their trained guardian, until the 2 month course of injections is completed. Group 2: 134 patients, randomised to receive standard of care. These participants will remain in hospital where they will receive daily oral treatment and intramuscular streptomycin injections administered by nursing staff, until the 2 month course of injections is completed. Participants will all be reviewed at home or in hospital by the study team at 1, 3, 5 and 7 weeks post randomisation, and more frequently if required. At the end of the 2 month intervention period, all patients will continue to receive TB treatment under routine care and complete the 8 month course of oral TB treatment as per national guidelines. CONDITION: Community management of patients requiring injectable therapy as part of the TB re‐treatment regimen ; Infections and Infestations ; Tuberculosis PRIMARY OUTCOME: Patient still alive and on TB treatment at the end of the two‐month intervention period SECONDARY OUTCOME: 1. 2‐month culture conversion in those culture positive at baseline; 2. 8‐month programmatic TB outcome ; 3. Serious adverse events during the intensive phase of treatment; 4. Karnofsky score 1, 3, 5, and 7 weeks post randomisation; 5. Mental health status at 2 months using a Chichewa validated self‐reporting questionnaire (SRQ) INCLUSION CRITERIA: 1. Adults = 16 years of age starting TB re‐treatment regimen 2. Patients who are able to give informed consent 3. Patients who are able to identify a suitable treatment supporter