An interventional study of Latent Tuberculosis Infection program evaluation & diagnosis in Latent Tuberculosis Infection, sponsored by McGill University. Completed at 8 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by McGill University · Not applicable, Interventional, and Prevention
The study is a pragmatic cluster randomized trial that is being conducted in 5 countries, with sites in 4 cities in Canada, Benin, Ghana, Indonesia and Vietnam. The unit of randomization is the health facility (24 health facilities randomized). The trial tests a complex intervention-a two phase programmatic public health package which includes a standardized public health evaluation and analysis, to identify problems and barriers limiting Latent Tuberculosis Infection diagnosis and treatment among close contacts of active Tuberculosis cases. This will be followed by implementation of appropriate solutions and strengthening of the LTBI clinical program. The primary objective will be to estimate the increase the number of household contacts initiating LTBI treatment per newly diagnosed index patient, within 3 months of diagnosis of the index patient. A secondary objective is to evaluate the cost effectiveness of this two phase intervention. If successful, this approach can be expanded throughout these countries. After initial preparations, including administrative and ethical review, all participating sites will be randomized to intervention or control. Immediately after this, Phase 1 will begin in intervention sites with the standardized public health evaluation to identify barriers to LTBI diagnosis and treatment initiation and the selection of solutions to be used in Phase 2. To ensure standardization of data gathering research staff will use (i) current indicators of the Latent Tuberculosis Infection cascade of care in intervention facilities (number of contacts per index case registered, investigated, started on treatment and completing treatment) and (ii) interviewer administered questionnaires for patients with active pulmonary Tuberculosis, adult and child household contacts and clinic staff. These questionnaires will assess latent Tuberculosis-related knowledge, attitudes and beliefs from the perspective of these different participants. Results from intervention sites in Phase 1 will be analyzed, and used by the investigators, together with local public health officials, to decide on appropriate corrective solutions in each sites. Contact Investigation registries will also be developed with research staff from sites. In Phase 2, solutions for problems identified will be selected and implemented at the intervention sites, Contact Investigation registries will be implemented and clinical training will be provided to strengthen LTBI health care worker knowledge and clinical programs. Study outcomes and costs will be measured at all intervention and control sites throughout Phase 1 \& 2. The main study will run for 18 months. Upon completion of the main study, a 1 year cross over study will be conducted where control sites will receive a streamlined version of the intervention and original intervention sites will be used to evaluate the sustainability of the intervention. Results will be disseminated within each country through existing links with National Tuberculosis Programs, and through international organizations such as the World Health Organization.
Details vary depending on the study tool/measurement being taken. For Phase 1 questionniares (in 4 different populations) criteria are as follows:
Index case questionnaire:
Inclusion Criteria:
Exclusion Criteria:
Household contacts questionnaire
Inclusion Criteria:
Exclusion criteria:
Health Care worker questionnaire:
Inclusion criteria:
Exclusion criteria:
Inclusion criteria:
And one of the following two mandatory eligibility criteria:
Exclusion criteria:
No Intervention: Program runs as per usual. Minimal interference and visits from study staff. Main study outcomes evaluated in first and last 6 months of trial. Minimal visits to collect information on costing at control sites.
Latent Tuberculosis Infection program evaluation \& diagnosis: In intervention health facilities the current Latent Tuberculosis Infection program will be evaluated and gaps in the Latent Tuberculosis Infection cascade of care will be identified. Gaps in the current cascade will be quantified and solution proposed that are unique to the problems identified in each site. In phase 2 of the study low cost solutions will be implemented and the Latent Tuberculosis Infection program scaled up and improved. Study outcomes are evaluated in the first and last 6 months of trial. Costing evaluations are done throughout the trial.
Other: Latent Tuberculosis Infection program evaluation & diagnosis
The primary outcome will be the change in the number of household contacts (HHC) initiating treatment per newly diagnosed TB index patient within 3- 4 months from index patient diagnosis, between Phase 1 and Phase 2
A new TB index patient will be microbiologically confirmed using AFB smear, culture, and/or molecular tests such as Xpert®MTB/RIF, depending on local protocols. A HHC will be defined as someone who slept in the same house at least one night per week, or spent more than one hour in the house at least five days per week, on average, over the preceding 3 months. The house will be defined as the dwelling, or buildings, which the family unit occupies and uses regularly. In each of the 6 month periods, the total number of index patients, the number of their contacts who were recorded in clinic documents, and the number of these HHC who initiate LTBI therapy will be collected in both the control and intervention arms. For TB index patients diagnosed towards the end of each 6-month period in most sites we will allow up to 3 or 4 additional months for the HHC to be started on LTBI treatment.
Time frame: The primary outcome will be recorded at all health facilities for the full duration of phase 1 (6 months) and for the last 6 months of phase 2.
Health system costs related to the implementation of the LTBI program evaluation and strengthening approach
Throughout the trial, costs related to the implementation of the LTBI program evaluation and strengthening will be measured in each setting, using time and activity logs for research staff, investigators, health care workers and management staff involved in implementation. Country specific budgets will be used to obtain expenditures related to services, supplies and materials. To estimate LTBI related health system personnel costs, time and motion studies will be conducted at the start of phase 1 and the end of phase 2.
Time frame: 18 months
Cross-over
To evaluate the sustained effect of this complex intervention for one year after the end of the randomized trial - at original intervention sites.To evaluate the costs, and impact of a stream-lined Phase 1 and 2 - administered to control sites, after the 18 month trial.
Time frame: 12 months
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McGill University