Tuberculosis (TB) Aftermath

NCT04333485 | Completed

• 2 other identifiers: IRB002472391R01AI143748-01A1
• Study Type: interventional
• Target: 3,094
• Locations: 1 country
• Sites: 1

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 strategy. The specific aims are: Primary Aim 1: To conduct a non-inferiority randomized trial to measure the comparative effectiveness of two potentially implementable ACF strategies within India's National TB Elimination Program (NTEP), conducted by existing NTEP healthcare workers (HCWs): (i) home-based ACF (HACF) and (ii) telephonic ACF (TACF). Primary Aim 2: To characterize implementation processes of the ACF strategies using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to inform future scale-up and sustainability. Primary Aim 3: To model the impact and cost effectiveness of the ACF strategies evaluated in the trial, and of potential alternative strategies for the targeting and timing of those strategies. Secondary Aim: To measure the association of the severity, chronicity and progression of post-TB lung impairment with recurrent TB disease.

Conditions

Tuberculosis (TB)

Keywords

Household Contacts; Tuberculosis (TB); Recurrence; Active case finding; India; Hybrid effectiveness-implementation trial

Outcome Measures

Primary Outcomes (1)

• Rate per 100 person-years of people diagnosed with new or recurrent TB by study arm.

  TB disease will be diagnosed as microbiologically confirmed (positive acid fast bacilli smear or positive Xpert® Mycobacterium tuberculosis/resistance to rifampin (MTB/RIF) assays or positive culture) or clinically diagnosed (initiated on TB treatment with no microbiological confirmation).

  Within 12 months following index TB patient's treatment completion date.

Secondary Outcomes (1)

• Proportion of eligible household contacts (HHCs) <6 years of age, by study arm, initiated on TB preventive treatment (TPT) after ruling out active TB disease.

  Up to 18 months following index TB patient's treatment completion date.

Study Arms (2)

Home-based Active Case Finding (HACF)

ACTIVE COMPARATOR

Other: Home-based Active Case Finding (HACF)

Telephonic Active Case Finding (TACF)

ACTIVE COMPARATOR

Other: Telephonic Active Case Finding (TACF)

Interventions

Home-based Active Case Finding (HACF) OTHER

Existing healthcare workers at the participating NTEP TB units will visit all patient homes at 6 and 12 months post-treatment completion. They will administer a standardized TB symptom screen questionnaire to treated TB cases and their household contacts (HHC). All those who screen positive will have a spot sputum taken at the home for microbiological testing at the TB unit.

Home-based Active Case Finding (HACF)

Telephonic Active Case Finding (TACF) OTHER

Existing healthcare workers at the participating NTEP TB Units will administer a standardized TB symptom screen questionnaire to the index patient via telephone calls at 6 and 12 months post-treatment completion. The index patient will also be asked about any TB symptoms among household contacts (HHCs). If TB is suspected among any HH members, a home visit will be conducted and spot sputum specimens will be collected for microbiological testing at the TB unit.

Telephonic Active Case Finding (TACF)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Dr. D.Y. Patil Medical College, Hospital and Research Centre: collaborator

Study Sites (1)

Dr. D.Y. Patil Medical College, Hospital and Research Centre

Pune, Maharashtra, 411018, India

Location

Related Publications (1)

• Cox SR, Kadam A, Atre S, Gupte AN, Sohn H, Gupte N, Sawant T, Mhadeshwar V, Thompson R, Kendall E, Hoffmann C, Suryavanshi N, Kerrigan D, Tripathy S, Kakrani A, Barthwal MS, Mave V, Golub JE; TB Aftermath study team. Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts. Trials. 2022 Aug 5;23(1):635. doi: 10.1186/s13063-022-06503-6.

  PMID: 35932062 DERIVED

MeSH Terms

Conditions

Tuberculosis; Recurrence

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Golub, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: January 29, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

IN (1)