Clinic-based Versus Hotspot-focused Active TB Case Finding

Not Applicable

Recruiting

• Conditions: Tuberculosis, Pulmonary; Mycobacterium Tuberculosis Infection
• Interventions: Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)

• Registration Number: NCT05285202
• Lead Sponsor: Johns Hopkins University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Study Start: 2022-06-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80000

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hotspot-focused ACF/TPT	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	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)

Primary Outcome Measures

Name	Time	Method
Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility	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 Outcome Measures

Name	Time	Method
Number screened by study	During four-month intervention periods (6 periods per cluster over 48 months)	Total number of people screened for TB with each intervention.
Number referred for TPT	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
Study-initiated TB notifications, hotspot vs facility	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 diagnosed by study	During four-month intervention periods (6 periods per cluster over 48 months)	Number of study participants found to have Xpert-positive sputum.
Number evaluated for latent tuberculosis infection (LTBI) with tuberculin skin testing (TST)	During four-month intervention periods (6 periods per cluster over 48 months)	Total number of people completing TST placement and reading by the study
Contacts screened	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
Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control	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	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.
Cost effectiveness (hotspot vs facility) as assessed by cost per disability-adjusted life year averted	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).
TPT initiations, hotspot vs facility	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.
Cost effectiveness (ACF/TPT vs no intervention) as assessed by cost per disability-adjusted life year averted	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.

Trial Locations

Locations (1)

Walimu; 🇺🇬 Kampala, Uganda