Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment (ACT4)
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|ClinicalTrials.gov Identifier: NCT02810678|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Latent Tuberculosis Infection||Other: Latent Tuberculosis Infection program evaluation & diagnosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment: A Pragmatic Cluster Randomized Trial|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||April 2019|
No Intervention: Control
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.
Active Comparator: Intervention
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 [ 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. ]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.
- Health system costs related to the implementation of the LTBI program evaluation and strengthening approach [ Time Frame: 18 months ]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.
- Cross-over [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810678
|Centre de Pneumo-Phthysiologie|
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2R3|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z4|
|Montreal Chest Institute|
|Montreal, Quebec, Canada, H4A 3J1|
|Komfo Anokye Teaching Hospital (KATH)|
|University Padjadjaran (UNPAD)|
|Vietnam national university|
|Principal Investigator:||Dick Menzies, MD||Research Institute of McGill University Health Centre|