Implementation of a New Strategic TB Case-Finding, Treatment and Prevention Public Health Pack in Thailand
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 10,000
- Locations
- 20
- Primary Endpoint
- Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by age group (<15, ≥15 years)
Study Overview
Brief Summary
The project aimed to test a strategy for the early detection and prevention of tuberculosis in household contacts of tuberculosis patients in order to reduce the morbidity, mortality and transmission of this disease in Thailand. This strategy will be evaluated in comparison with the current programmatic approach through a pragmatic trial with cluster randomization (cluster randomized controlled trial) which will be conducted over the next 3 years. This project is carried out in collaboration with the Tuberculosis Division of the Ministry of Public Health of Thailand, the TB/HIV Research Foundation in Thailand and the London School of Hygiene and Tropical Medicine in England.
Detailed Description
Title: Implementation of a new Strategic TB Case-Finding, Treatment and Prevention Public Health Pack in Thailand (CapThai) Phase: IV, cluster randomized trial
Population:
adults (>= 18 years old) with pulmonary TB and their household contacts. Sites: 20 clusters (provincial hospitals) in Thailand
Duration of the study:
36 months
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion of the index cases
- •Age ≥18 years
- •Newly bacteriologically confirmed TB case (within 1 month of diagnosis)
- •Living in the same household for the last 3 months
- •Reporting at least one HH contact
- •Providing written informed consent for participation in the study
- •Inclusion of contacts
- •All contacts living in the same HH, defined as any person who shared the same enclosed living space as the index TB case for one or more nights or for frequent or extended daytime periods for at least one month before the TB diagnosis is made.
- •Providing written informed consent (signed by adult (≥18 years) contacts; or by parents/guardians for minors < 13 years or incapacitated people; written assent for children ≥13 years and < 18 years).
Exclusion Criteria
- •Exclusion of index cases
- •Index case who do not live in the catchment area of the study cluster
- •Index cases diagnosed with rifampicin resistance, multidrug resistance (MDR) or extensively drug-resistant (XDR-TB)
- •Index cases who are incarcerated
- •Exclusion of the contacts
- •contact currently on TPT or on TB treatment or who finished such treatment in the last 3 months.
Outcomes
Primary Outcomes
Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by age group (<15, ≥15 years)
Time Frame: Month18
Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by age group (\<15, ≥15 years)
Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - overall
Time Frame: Month18
Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - overall
Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by gender
Time Frame: Month18
Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by gender
Secondary Outcomes
- Proportion of participants who initiate TPT for whom treatment is discontinued due to adverse events or intolerance in the Intervention phase(Month 18)
- Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by age group (<15, ≥15 years)(Month 18)
- Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by gender(Month 18)
- Proportion of participants initiated on TPT who completed TPT(Month 18)
- Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - overall(Month 18)