NCT04333485Completed
Tuberculosis (TB) Aftermath
Tuberculosis (TB) Aftermath: 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
Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3094 (actual)
- First submitted
- 1 Apr 2020
- Start date
- 29 Jan 2021
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Johns Hopkins University
- Diseases
- Tuberculosis
- NCT number
- NCT04333485
What you commit to
- Study type: Interventional
- Participants enrolled: 3094
- From 29 Jan 2021 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. D.Y. Patil Medical College, Hospital and Research Centre Coordinator of this site? Confirm its status | Pune | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.