Status:
COMPLETED
Tuberculosis (TB) Aftermath
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Dr. D.Y. Patil Medical College, Hospital and Research Centre
Conditions:
Tuberculosis (TB)
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
TB Aftermath will compare effectiveness, cost-effectiveness and feasibility of two ACF strategies for detecting recurrent TB and provide evidence needed to implement and scale the preferred ACF strate...
Detailed Description
Approximately 7% of all reported tuberculosis (TB) cases each year are recurrent, occurring among people who have had TB in the recent or distant past. TB recurrence is particularly common in India, w...
Eligibility Criteria
Inclusion
- Those who are registered at one of the study TB Units (TUs) in Pune district as treatment completed or cured (regardless of type of TB or duration of treatment).
- Confirmed treatment completion or cure status by the referring medical officer of the study TU.
- Date of treatment completion within 60 days of date of enrolment.
- Ability and willingness of participant or legal guardian/representative to provide informed consent to participate in the home-based ACF (HACF) or telephonic ACF arm (TACF).
- (NOTE: Illiterate participants or participants with cognitive disabilities may be enrolled based on local regulatory policies, with the appropriate provisions for informed consent.)
- \- All household contacts of TB cases who are able and willing to provide informed consent to participate are eligible. Household contacts who are \<18 years old are eligible for enrolment if a legal guardian/representative provides informed consent.
Exclusion
- Completed anti-TB treatment at a private sector clinic or TU outside of the study (final visit not registered at one of the study TB units)
- Actively on anti-TB treatment
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
3094 Patients enrolled
Trial Details
Trial ID
NCT04333485
Start Date
January 29 2021
End Date
June 1 2025
Last Update
August 1 2025
Active Locations (1)
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1
Dr. D.Y. Patil Medical College, Hospital and Research Centre
Pune, Maharashtra, India, 411018