Community management of patients requiring injectable therapy as part of the TB re-treatment regimen Infections and Infestations Tuberculosis
Conditions
Interventions
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 tra
Sponsors
Liverpool School of Tropical Medicine (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Patients identified as having Multi-drug-resistant tuberculosis (MDR-TB) on GXP or drug sensitivity testing using culture (these patients will be referred to the NTP MDR programme) 2. Pregnant women 3. Patients not planning to stay in Blantyre/Lilongwe for the 2-month duration of the intervention 4. Patients unable to give informed consent 5. Patients unable to identify a suitable treatment supporter
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Primary
| Measure | Time frame |
|---|---|
| Patient still alive and on TB treatment at the end of the two-month intervention period | — |
Countries
Malawi
Outcome results
None listed