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NCT Number: NCT05285202

Clinic-based Versus Hotspot-focused Active TB Case Finding

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walimu

Kampala, Uganda

Location status: Recruiting

Location contact

Achilles Katamba

CONTACT

[email protected]

256-414-530-021,

Achilles Katamba, MBChB PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • On treatment for, or diagnosed with but not yet treated for, active TB

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. TPT initiations, 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 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.

  2. Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control

    Time frame: 48 months from start of interventions in each "triplet" of clusters

    Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing intervention regions to control regions.

  3. 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)

    Trend in TB notification rate over the span of study intervention involvement, comparing intervention clusters to control clusters

  4. 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 of people diagnosed with TB through study participation and initiating treatment for TB, hotspot-focused and facility-based ACF/TPT.

  5. Number screened by study

    Time frame: During four-month intervention periods (6 periods per cluster over 48 months)

    Total number of people screened for TB with each intervention.

  6. Number diagnosed by study

    Time frame: During four-month intervention periods (6 periods per cluster over 48 months)

    Number of study participants found to have Xpert-positive sputum.

  7. 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

    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).

  8. 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

    Incremental cost per disability-adjusted life year (DALY) averted, comparing ACF/TPT to no ACF/TPT.

  9. 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)

    Total number of people completing TST placement and reading by the study

  10. Number referred for TPT

    Time frame: During four-month intervention periods (6 periods per cluster over 48 months)

    Number of participants referred for TB preventive therapy based on TST result or other eligibility criteria

  11. Contacts screened

    Time frame: During four-month intervention periods (6 periods per cluster over 48 months)

    Number of people screened for TB who are identified as contacts of a person diagnosed with TB through the study

Study contacts

Contact information is provided by the study sponsor or research team.

David W Dowdy, MD PhD

CONTACT

[email protected]

Emily A Kendall, MD PhD

CONTACT

[email protected]

410-502-8234

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Walimu

Registry information

Official study title

Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial

Acronym: CHASE-TB

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2022
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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