Clinic-based Versus Hotspot-focused Active TB Case Finding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active TB case finding with linkage to preventive therapy (ACF/TPT).
- Who it may be relevant to
- Registry conditions: Tuberculosis, Pulmonary, Mycobacterium Tuberculosis Infection. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial
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.
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 and eligible for TPT (limited in April 2024 to those with close TB contact or known HIV infection).
Primary outcome 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]
Secondary outcome measures (11)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Uganda · 1 center
- Walimu — Kampala
Identifiers
NCT: NCT05285202 · IRB00300939 · 2R01HL138728