Comparing two methods for finding recurrent tuberculosis cases in India
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
This study is testing two different ways to find people with recurring tuberculosis in India to see which method works better and is more affordable for those who have finished treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3228 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Pune, Maharashtra) |
| Trial ID | NCT04333485 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness, cost-effectiveness, and feasibility of two active case finding (ACF) strategies for detecting recurrent tuberculosis (TB) among individuals who have completed TB treatment and their household contacts in Pune, India. Participants will be randomized to either home-based ACF (HACF) or telephonic ACF (TACF), with healthcare workers conducting symptom-based assessments at six-month intervals. The study will also analyze the implementation processes of these strategies and model their impact and cost-effectiveness to inform future scaling efforts.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have recently completed TB treatment and their household contacts.
Not a fit: Patients currently undergoing TB treatment or those who have not completed their treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of recurrent TB, ultimately reducing the burden of the disease.
How similar studies have performed: Other studies have shown promise in using active case finding strategies for TB detection, but this specific comparison of HACF and TACF is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Pune, Maharashtra
- Dr. D.Y. Patil Medical College, Hospital and Research Centre — Pune, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Jonathan Golub, PhD — Johns Hopkins University
- Study coordinator: Vidya Mave, MD
- Email: vidyamave@gmail.com
- Phone: + 912026052419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.