Clinic-based Versus Hotspot-focused Active TB Case Finding

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Screening
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 31, 2027

Interventions

  • Other: 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 for eligible for TPT (interested after counseling and either positive tuberculin skin test or known HIV infection).

Arms, Groups and Cohorts

  • Experimental: Hotspot-focused 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
  • Experimental: Facility-based 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • Notification trend (intervention vs control) as assessed by Average percent change in number of TB notifications
    • Time Frame: First 16 months following start of interventions in a cluster “triplet”, versus final 16 months of the interventions (including 4 months of washout after the final intervention) in each triplet
    • Average percent change in number of TB notifications, from the first 16 months of intervention to the final 16 months of intervention, comparing intervention clusters to control clusters.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥15 years – Provision of oral informed consent, or, if age <18 years and not legally emancipated, oral informed assent and parental informed consent 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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emily Kendall, MD PhD, Principal Investigator, Johns Hopkins University
  • Overall Contact(s)
    • Emily A Kendall, MD PhD, 410-502-8234, ekendall@jhmi.edu

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