Enhancing the public health impact of latent TB infection diagnosis and treatment: A pragmatic cluster randomised trial
STUDY SITES: Quang Nam and Da Nang province
TIMELINE: Oct 2017 – Mar 2019
PROJECT IMPLEMENTER: National Lung Hospital / National TB Program
PARTICIPATING COUNTRIES: Canada, Benin, Ghana, Brazil, Indonesia, Vietnam
FUNDED BY: McGill University - Canada
CORE STAKEHOLDER: Da Nang Lung Hospital and Quang Nam Pham Ngoc Thach Hospital
PRIMARY OBJECTIVE: To estimate the increase in number of close contacts (of pulmonary TB patients) who are identified, investigated, initiated, and completed latent tuberculosis infection (LTBI) therapy. The intervention is a standardised public health evaluation (Cascade analysis), with use of operational modeling analysis to select effective interventions from a "public health toolkit".
This is a cluster-randomised stepped-wedge trial conducted in two phases.
In Phase 1, a standardised public health evaluation will be conducted at all sites to identify barriers to LTBI diagnosis and treatment initiation, in order to select the interventions to be used in Phase 2. This will include measurement of the key study outcomes. To ensure standardisation of data gathering we will use interviewer-administered standardised questionnaires – for patients with newly diagnosed active TB, contacts of these patients, clinic staff and administrators. These questionnaires will assess management of contacts, LTBI diagnosis and therapy, as well as TB-related knowledge, attitudes and beliefs from the perspective of these different participants. Results from this phase will be analysed, and used by the investigators, together with local public health officials, to decide on appropriate interventions to address the problems identified.
In Phase 2, interventions will be selected from a package of standardised interventions, and implemented at the involved sites every 2 months. The order of implementation will be allocated randomly. Randomisation will be restricted to ensure equal number of participants receiving or not receiving the intervention. In the first 2 months no sites will have the intervention; in the last 4 months all sites will have the interventions. Preparations and training of staff will be conducted in the month before the intervention begins. The intervention will begin on the first of the month, and the change from no intervention to intervention will be made overnight. All outcomes will be measured at all sites through-out Phase 2.