Tuberculosis, PulmonaryCHASE-TBNCT05285202
Clinic-based Versus Hotspot-focused Active TB Case Finding
A study testing Active TB case finding with linkage to preventive therapy (ACF/TPT) in people with Tuberculosis, Pulmonary and Mycobacterium Tuberculosis Infection, run by Johns Hopkins University at 1 site in Uganda.
Trial summary
This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary, Mycobacterium Tuberculosis Infection
- What is being tested?
- Active TB case finding with linkage to preventive therapy (ACF/TPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146,539 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jun 2022to 30 Jul 2026
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB,
- Provision of oral informed consent, or, if age <18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental informed consent (ages 5-17) to participate in the study
- Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant
Who cannot join
- On treatment for, or diagnosed with but not yet treated for, active TB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial
This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda. The two strategies differ in the location where ACF activities are performed: A "facility-based" ACF/TPT strategy will perform ACF, plus linkage to TPT, in the immediate vicinity of a large public health facility and will primarily recruit individuals who are attending the health facility, irrespective of TB suspicion or symptoms. Alternatively, a "hotspot-based" strategy will use routine notification data and local expertise to identify local TB hotspots - defined as the geographic areas though to have the highest burden of undiagnosed TB per estimated population. The same infrastructure (personnel, equipment, supplies, etc.) for ACF/TPT will then be placed in those zones for a period of four months at a time, and the general population will be recruited for screening and linkage to TPT.
The two interventions will be compared in a Type 1 hybrid effectiveness-implementation trial with a cluster-randomized, multiple-period crossover design. The study will evaluate whether hotspot-focused ACF/TPT results in a greater number of TB patients diagnosed and linked to care, and a greater number of individuals started on preventive therapy, than facility-based ACF/TPT. Secondarily, it will also compare the two interventions in terms of number of people initiated on TPT, and it will compare TB cases detected in regions performing ACF/TPT (either approach) against cases detected in regions that continue to perform the standard of care.
- Being tested
- Active TB case finding with linkage to preventive therapy (ACF/TPT)
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TB case finding with linkage to preventive therapy (ACF/TPT)Other
ACF/TPT in both intervention arms will consist of TB screening by mobile chest X-ray (with artificial intelligence-based reading, followed by confirmatory sputum testing with Xpert MTB/RIF Ultra for participants with abnormal x-rays), and linkage to preventive therapy for those who are TB-negative and eligible for TPT (limited in April 2024 to those with close TB contact or known HIV infection).
| Study group | Role | What they receive |
|---|---|---|
| Hotspot-focused ACF/TPT | Experimental | ACF/TPT intervention will be delivered in a community setting, in geographic areas judged likely to have a high burden of undiagnosed TB Receives: Other: Active TB case finding with linkage to preventive therapy (ACF/TPT) |
| Facility-based ACF/TPT | Experimental | ACF/TPT intervention will be delivered on the grounds of a health facility (hospital or large public health center) Receives: Other: Active TB case finding with linkage to preventive therapy (ACF/TPT) |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility
Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing periods in which regions performed hotspot-focused ACF/TPT to those in which facility-based ACF/TPT was performed.
Measured: From the start to two weeks after the end of each four-month intervention period
Secondary outcomes (11)
TPT initiations, hotspot vs facility
Number of study region residents initiating TPT during intervention periods, comparing periods in which regions performed hotspot-focused ACF/TPT to those in which facility-based ACF/TPT was performed.
Measured: From the start to two weeks after the end of each four-month intervention period
Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control
Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing intervention regions to control regions.
Measured: 48 months from start of interventions in each "triplet" of clusters
TB notification trend (intervention vs control)
Trend in TB notification rate over the span of study intervention involvement, comparing intervention clusters to control clusters
Measured: Approximately 38 to 46 months per cluster (5 to 6 four-month intervention periods, plus intervening washout periods)
Study-initiated TB notifications, hotspot vs facility
Number of people diagnosed with TB through study participation and initiating treatment for TB, hotspot-focused and facility-based ACF/TPT.
Measured: From the start to two weeks after the end of each four-month intervention period
Number screened by study
Total number of people screened for TB with each intervention.
Measured: During four-month intervention periods (6 periods per cluster over 48 months)
Number diagnosed by study
Number of study participants found to have Xpert-positive sputum.
Measured: During four-month intervention periods (6 periods per cluster over 48 months)
Cost effectiveness (hotspot vs facility) as assessed by cost per disability-adjusted life year averted
Incremental cost per disability-adjusted life year (DALY) averted, comparing the more to the less effective ACF/TPT intervention (if an effectiveness difference is found).
Measured: From the start to two weeks after the end of each four-month intervention period
Cost effectiveness (ACF/TPT vs no intervention) as assessed by cost per disability-adjusted life year averted
Incremental cost per disability-adjusted life year (DALY) averted, comparing ACF/TPT to no ACF/TPT.
Measured: From the start to two weeks after the end of each four-month intervention period
Number evaluated for latent tuberculosis infection (LTBI) with tuberculin skin testing (TST)
Total number of people completing TST placement and reading by the study
Measured: During four-month intervention periods (6 periods per cluster over 48 months)
Number referred for TPT
Number of participants referred for TB preventive therapy based on TST result or other eligibility criteria
Measured: During four-month intervention periods (6 periods per cluster over 48 months)
Contacts screened
Number of people screened for TB who are identified as contacts of a person diagnosed with TB through the study
Measured: During four-month intervention periods (6 periods per cluster over 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jun 2022
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies 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
- Crossover
- Model description
- Twelve clusters or study regions (of which eight will be randomized to receive interventions) will be defined according to the catchment areas of twelve participating Ugandan district hospitals/major health centers. Eight study areas will receive a total of six 4-month intervention periods (alternating between the facility-based and the hotspot focused strategy, for three periods of each type) over a four-year period, with a 4-month wash-out period after each intervention period. Four additional areas will be used as control sites; the only involvement of participants in these sites will be through retrospective collection of de-identified data.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 146,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Walimu
- Responsible party
- Sponsor
- Investigators
- Emily Kendall, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285202
- Sponsor's protocol ID
- IRB00300939
- Other IDs
- 2R01HL138728
- Acronym
- CHASE-TB
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that underlie results in publications
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05285202
- Acronym / sponsor ID
- CHASE-TB / IRB00300939
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146,539 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Walimu
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 17 Mar 2022 (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.
This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda. The two strategies differ in the location where ACF activities are performed: A "facility-based" ACF/TPT strategy will perform ACF, plus linkage to TPT, in the immediate vicinity of a large public health facility and will primarily recruit individuals who are attending the health facility, irrespective of TB suspicion or symptoms. Alternatively, a "hotspot-based" strategy will use routine notification data and local expertise to identify local TB hotspots - defined as the geographic areas though to have the highest burden of undiagnosed TB per estimated population. The same infrastructure (personnel, equipment, supplies, etc.) for ACF/TPT will then be placed in those zones for a period of four months at a time, and the general population will be recruited for screening and linkage to TPT.
The two interventions will be compared in a Type 1 hybrid effectiveness-implementation trial with a cluster-randomized, multiple-period crossover design. The study will evaluate whether hotspot-focused ACF/TPT results in a greater number of TB patients diagnosed and linked to care, and a greater number of individuals started on preventive therapy, than facility-based ACF/TPT. Secondarily, it will also compare the two interventions in terms of number of people initiated on TPT, and it will compare TB cases detected in regions performing ACF/TPT (either approach) against cases detected in regions that continue to perform the standard of care.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Twelve clusters or study regions (of which eight will be randomized to receive interventions) will be defined according to the catchment areas of twelve participating Ugandan district hospitals/major health centers. Eight study areas will receive a total of six 4-month intervention periods (alternating between the facility-based and the hotspot focused strategy, for three periods of each type) over a four-year period, with a 4-month wash-out period after each intervention period. Four additional areas will be used as control sites; the only involvement of participants in these sites will be through retrospective collection of de-identified data.
| Arm | Type | Receives |
|---|---|---|
| Hotspot-focused ACF/TPT | Experimental | Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)ACF/TPT intervention will be delivered in a community setting, in geographic areas judged likely to have a high burden of undiagnosed TB |
| Facility-based ACF/TPT | Experimental | Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)ACF/TPT intervention will be delivered on the grounds of a health facility (hospital or large public health center) |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB,
- Provision of oral informed consent, or, if age <18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental informed consent (ages 5-17) to participate in the study
- Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant
Key exclusion criteria (1 listed)
- On treatment for, or diagnosed with but not yet treated for, active TB
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 |
|---|---|---|
| Active TB case finding with linkage to preventive therapy (ACF/TPT)ACF/TPT in both intervention arms will consist of TB screening by mobile chest X-ray (with artificial intelligence-based reading, followed by confirmatory sputum testing with Xpert MTB/RIF Ultra for participants with abnormal x-rays), and linkage to preventive therapy for those who are TB-negative and eligible for TPT (limited in April 2024 to those with close TB contact or known HIV infection). | Other | Facility-based ACF/TPT, Hotspot-focused ACF/TPT |
Primary outcome
Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility
Time frame: From the start to two weeks after the end of each four-month intervention period
Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing periods in which regions performed hotspot-focused ACF/TPT to those in which facility-based ACF/TPT was performed.
11 secondary outcomes
TPT initiations, hotspot vs facility
Time frame: From the start to two weeks after the end of each four-month intervention period
Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control
Time frame: 48 months from start of interventions in each "triplet" of clusters
TB notification trend (intervention vs control)
Time frame: Approximately 38 to 46 months per cluster (5 to 6 four-month intervention periods, plus intervening washout periods)
Study-initiated TB notifications, hotspot vs facility
Time frame: From the start to two weeks after the end of each four-month intervention period
Number screened by study
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Number diagnosed by study
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Cost effectiveness (hotspot vs facility) as assessed by cost per disability-adjusted life year averted
Time frame: From the start to two weeks after the end of each four-month intervention period
Cost effectiveness (ACF/TPT vs no intervention) as assessed by cost per disability-adjusted life year averted
Time frame: From the start to two weeks after the end of each four-month intervention period
Number evaluated for latent tuberculosis infection (LTBI) with tuberculin skin testing (TST)
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Number referred for TPT
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Contacts screened
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Data that underlie results in publications
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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.
Emily Kendall, MD 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 Active TB case finding with linkage to preventive therapy (ACF/TPT) in people with Tuberculosis, Pulmonary and Mycobacterium Tuberculosis Infection, run by Johns Hopkins University at 1 site in Uganda.
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 3 inclusion and 1 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 12 Aug 2026. 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 Uganda. 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?
Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility (time frame: From the start to two weeks after the end of each four-month intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.