- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02810678
Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment (ACT4)
Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment: A Pragmatic Cluster Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cotonou, Benin
- Centre de Pneumo-Phthysiologie
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Alberta
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Calgary, Alberta, Canada, T2N 1N4
- University of Calgary
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Edmonton, Alberta, Canada, T6G 2R3
- University of Alberta
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British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z4
- University of British Columbia
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Montreal Chest Institute
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Kumasi, Ghana
- Komfo Anokye Teaching Hospital (KATH)
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Bandung, Indonesia
- University Padjadjaran (UNPAD)
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Hanoi, Vietnam
- Vietnam National University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Health system costs related to the implementation of the LTBI program evaluation and strengthening approach
Time Frame: 18 months
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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.
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18 months
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Cross-over
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dick Menzies, MD, Research Institute of McGill University Health Centre
Publications and helpful links
General Publications
- Oxlade O, Benedetti A, Adjobimey M, Alsdurf H, Anagonou S, Cook VJ, Fisher D, Fox GJ, Fregonese F, Hadisoemarto P, Hill PC, Johnston J, Khan FA, Long R, Nguyen NV, Nguyen TA, Obeng J, Ruslami R, Schwartzman K, Trajman A, Valiquette C, Menzies D. Effectiveness and cost-effectiveness of a health systems intervention for latent tuberculosis infection management (ACT4): a cluster-randomised trial. Lancet Public Health. 2021 May;6(5):e272-e282. doi: 10.1016/S2468-2667(20)30261-9. Epub 2021 Mar 22.
- Oxlade O, Trajman A, Benedetti A, Adjobimey M, Cook VJ, Fisher D, Fox GJ, Fregonese F, Hadisoemarto P, Hill PC, Johnston J, Long R, Obeng J, Ruslami R, Valiquette C, Menzies D. Enhancing the public health impact of latent tuberculosis infection diagnosis and treatment (ACT4): protocol for a cluster randomised trial. BMJ Open. 2019 Mar 20;9(3):e025831. doi: 10.1136/bmjopen-2018-025831.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FND-143350
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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