Tuberculosis (TB) Aftermath: a trial to find recurrent TB among people who have had TB previously

Not Applicable

• Conditions: Health Condition 1: A150- Tuberculosis of lung

• Registration Number: CTRI/2020/05/025059
• Lead Sponsor: ational Institutes Of Health NIH USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. 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).

2. Confirmed treatment completion or cure status by the referring medical officer of the study TU.

3. Date of treatment completion within 60 days of date of enrolment.

4. Ability and willingness of participant or legal guardian/representative to provide informed consent to participate in Arm 1 House Hold Active Case Finding (HHACF) or Arm 2 Active case finding through telephone(TACF)

(NOTE: Illiterate participants or participants with cognitive disabilities may be enrolled based on local regulatory policies, with the appropriate provisions for informed consent.)

5. All household contacts of TB cases who are able and willing to provide informed consent to participate are eligible. HH contacts who are <18 years old are eligible for enrolment if a legal guardian/representative provides informed consent.

Exclusion Criteria

1. 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)

2. Actively on anti-TB treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study will be number of TB cases diagnosed per enrolled index TB patient, by study arm, within 12 months following index TB patientâ??s treatment completion date. TB disease will be diagnosed as microbiologically confirmed (positive acid fast bacilli smear or positive Xpert® MTB/RIF assays or positive culture) or clinically diagnosed (initiated on TB treatment with no microbiological confirmation).Timepoint: The enrolment of TB cases will be within 60 days from the treatment completion and follow up with them and their household will be at 6th month, 12th month and 18th month from the enrolment date.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be proportion of eligible Household (HH) contacts 6 years of age, by study arm, initiated on TB Preventative Therapy (TPT) after ruling out active TB disease.Timepoint: Follow up at 6th, 12th and 18th month