Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment (ACT4)
Latent Tuberculosis Infection
About this trial
This is an interventional prevention trial for Latent Tuberculosis Infection focused on measuring Tuberculosis
Eligibility Criteria
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:
- Newly diagnosed patients with microbiologically confirmed active pulmonary Tuberculosis (Pulmonary Tuberculosis - smear or culture or GeneXpert positive or Nucleic Acid Amplification test (NAAT)
- Age ≥ 18 years old
- At least 1 Household contact, with contact investigation underway
- Signed informed consent
Exclusion Criteria:
- Health care worker
- Only extra-pulmonary Tuberculosis
Household contacts questionnaire
Inclusion Criteria:
- Age ≥ 18 years old
- Informed consent signed
- Sleeps in the same house at least 1 night per week during the past 3 months with person who has confirmed active Tuberculosis OR
- Spent more than one hour per day in the house for at least 5 days per week with person who has active Tuberculosis - in the past 3 months
Exclusion criteria:
- Adult contact (age ≥ 18) who has already completed the child contact questionnaire
- Currently has active Tuberculosis
- Health Care worker
Health Care worker questionnaire:
Inclusion criteria:
- Health care worker involved in care of Tuberculosis patients, and/or their contacts
- Age ≥ 18 years old
- Signed informed consent
Exclusion criteria:
- Has ACTIVE TUBERCULOSIS (currently or in the past)
- Parents of Children (under 5 years of age) who were Household contact
Inclusion criteria:
- Age ≥ 18 years old
- Signed informed consent
- Parent/legal guardian/responsible caregiver of child under 5 years of age
And one of the following two mandatory eligibility criteria:
- Child sleeps in the same house at least 1 night per week during the past 3 months with person who has active pulmonary Tuberculosis OR
- Child spent more than one hour per day in the house for at least 5 days per week with person who has active pulmonary Tuberculosis ( in the past 3 months)
Exclusion criteria:
- The parent is the source (Index) case
- The parents is an Aadult contact who has already completed the contact questionnaire for adults
- The child currently has active Tuberculosis
Sites / Locations
- Centre de Pneumo-Phthysiologie
- University of Calgary
- University of Alberta
- University of British Columbia
- Montreal Chest Institute
- Komfo Anokye Teaching Hospital (KATH)
- University Padjadjaran (UNPAD)
- Vietnam national university
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
Control
Intervention
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.