Tuberculosis (TB)NCT04333485
Tuberculosis (TB) Aftermath
A study testing Home-based Active Case Finding (HACF) and Telephonic Active Case Finding (TACF) in people with Tuberculosis (TB), run by Johns Hopkins University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- Home-based Active Case Finding (HACF) and Telephonic Active Case Finding (TACF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,094 participants
- Where
- 1 siteIndia
- Study dates
- 29 Jan 2021to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Dr. D.Y. Patil Medical College, Hospital and Research Centre
Pune, Maharashtra, 411018
About this study
Official title: 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
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).
Read more
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.
Read the 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, which has the largest TB burden worldwide. Although patients recently treated for TB are at high risk of developing TB again, evidence around effective active case finding (ACF) strategies in this population is scarce. The investigators will conduct a hybrid type I effectiveness-implementation non-inferiority randomized trial to compare the effectiveness, cost-effectiveness, and feasibility of two ACF strategies among individuals who have completed TB treatment and the household contacts (HHCs).
The investigators will enroll 1076 adults (≥ 18 years) who have completed TB treatment at a public TB unit (TU) in Pune, India, along with the HHCs (averaging two per patient, n = 2152). Participants will undergo symptom-based ACF by existing healthcare workers (HCWs) at 6-month intervals and will be randomized to either home-based ACF (HACF) or telephonic ACF (TACF). Symptomatic participants will undergo microbiologic testing through the program. Asymptomatic HHCs will be referred for TB preventive treatment (TPT) per national guidelines. The primary outcome is rate per 100 person-years of people diagnosed with new or recurrent TB by study arm, within 12 months following treatment completion. The secondary outcome is proportion of HHCs < 6 years, by study arm, initiated on TPT after ruling out TB disease. Study staff will collect socio-demographic and clinical data to identify risk factors for TB recurrence and will measure post-TB lung impairment. In both arms, an 18-month "mop-up" visit will be conducted to ascertain outcomes. The investigators will use the RE-AIM framework to characterize implementation processes and explore acceptability through in-depth interviews with index patients, HHCs and HCWs (n = 100). Cost-effectiveness will be assessed by calculating the incremental cost per TB case detected within 12 months and projected for disability-adjusted life years averted based on modeled estimates of morbidity, mortality, and time with infectious TB.
This novel trial will guide India's scale-up of post-treatment ACF and provide an evidence base for designing strategies to detect recurrent and new TB in other high burden settings.
- Conditions
- Tuberculosis (TB)
- Being tested
- Home-based Active Case Finding (HACF), Telephonic Active Case Finding (TACF)
- Keywords
- Household Contacts, Tuberculosis (TB), Recurrence, Active case finding, India, Hybrid effectiveness-implementation trial
- Medical subject headings
- Tuberculosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Active Case Finding (HACF) | Active comparator | Not described Receives: Other: Home-based Active Case Finding (HACF) |
| Telephonic Active Case Finding (TACF) | Active comparator | Not described Receives: Other: Telephonic Active Case Finding (TACF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
At enrolment, participants will report names of HHCs < 6 years of age and their history of TPT. Children who have not yet initiated TPT will be the denominator and children who initiate TPT following index patient enrolment will be the numerator.
Measured: Up to 18 months following index TB patient's treatment completion date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start29 Jan 2021
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,094 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Dr. D.Y. Patil Medical College, Hospital and Research Centre
- Responsible party
- Sponsor
- Investigators
- Jonathan Golub, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333485
- Sponsor's protocol ID
- IRB00247239
- Other IDs
- 1R01AI143748-01A1
- Status last verified
- Jul 2025
- First submitted
- 1 Apr 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cox SR, Kadam A, Valawalkar S, Lele G, Moe AH, Dhamale V, Gupte AN, Suryavanshi N, Kendall EA, Sohn H, Hoffmann CJ, Kakrani A, Thompson R, Gupte N, Barthwal MS, Golub JE, Mave V; TB Aftermath study team. Phone-based screening versus home-based screening after tuberculosis in India (TB Aftermath): a multicentre, open-label, randomised, controlled, non-inferiority trial. Lancet Glob Health. 2026 Jul 2:103971. doi: 10.1016/j.langlo.2026.103971. Online ahead of print.
PubMed 42392121Cox 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.
PubMed 35932062
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04333485
- Acronym / sponsor ID
- IRB00247239
- Conditions
- Tuberculosis (TB)
- Keywords
- Household Contacts, Tuberculosis (TB), Recurrence, Active case finding, India, Hybrid effectiveness-implementation trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,094 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Dr. D.Y. Patil Medical College, Hospital and Research Centre
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, which has the largest TB burden worldwide. Although patients recently treated for TB are at high risk of developing TB again, evidence around effective active case finding (ACF) strategies in this population is scarce. The investigators will conduct a hybrid type I effectiveness-implementation non-inferiority randomized trial to compare the effectiveness, cost-effectiveness, and feasibility of two ACF strategies among individuals who have completed TB treatment and the household contacts (HHCs).
The investigators will enroll 1076 adults (≥ 18 years) who have completed TB treatment at a public TB unit (TU) in Pune, India, along with the HHCs (averaging two per patient, n = 2152). Participants will undergo symptom-based ACF by existing healthcare workers (HCWs) at 6-month intervals and will be randomized to either home-based ACF (HACF) or telephonic ACF (TACF). Symptomatic participants will undergo microbiologic testing through the program. Asymptomatic HHCs will be referred for TB preventive treatment (TPT) per national guidelines. The primary outcome is rate per 100 person-years of people diagnosed with new or recurrent TB by study arm, within 12 months following treatment completion. The secondary outcome is proportion of HHCs < 6 years, by study arm, initiated on TPT after ruling out TB disease. Study staff will collect socio-demographic and clinical data to identify risk factors for TB recurrence and will measure post-TB lung impairment. In both arms, an 18-month "mop-up" visit will be conducted to ascertain outcomes. The investigators will use the RE-AIM framework to characterize implementation processes and explore acceptability through in-depth interviews with index patients, HHCs and HCWs (n = 100). Cost-effectiveness will be assessed by calculating the incremental cost per TB case detected within 12 months and projected for disability-adjusted life years averted based on modeled estimates of morbidity, mortality, and time with infectious TB.
This novel trial will guide India's scale-up of post-treatment ACF and provide an evidence base for designing strategies to detect recurrent and new TB in other high burden settings.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based Active Case Finding (HACF)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. | Other | Home-based Active Case Finding (HACF) |
| Telephonic Active Case Finding (TACF)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. | Other | Telephonic Active Case Finding (TACF) |
Primary outcome
Rate per 100 person-years of people diagnosed with new or recurrent TB by study arm.
Time frame: Within 12 months following index TB patient's treatment completion date.
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).
1 secondary outcome
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.
Time frame: Up to 18 months following index TB patient's treatment completion date.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Derived from this study: PubMed 42392121Cox SR, Kadam A, Valawalkar S, Lele G, Moe AH, Dhamale V, Gupte AN, Suryavanshi N, Kendall EA, Sohn H, Hoffmann CJ, Kakrani A, Thompson R, Gupte N, Barthwal MS, Golub JE, Mave V; TB Aftermath study team. Phone-based screening versus home-based screening after tuberculosis in India (TB Aftermath): a multicentre, open-label, randomised, controlled, non-inferiority trial. Lancet Glob Health. 2026 Jul 2:103971. doi: 10.1016/j.langlo.2026.103971. Online ahead of print.
- Derived from this study: PubMed 35932062Cox 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Golub, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Active Case Finding (HACF) and Telephonic Active Case Finding (TACF) in people with Tuberculosis (TB), run by Johns Hopkins University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate per 100 person-years of people diagnosed with new or recurrent TB by study arm. (time frame: Within 12 months following index TB patient's treatment completion date.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333485, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.