Clinic-based Versus Hotspot-focused Active TB Case Finding

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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).

Первичные конечные точки

• Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility [Срок оценки: From the start to two weeks after the end of each four-month intervention period]

Вторичные конечные точки (11)

• TPT initiations, hotspot vs facility [Срок оценки: From the start to two weeks after the end of each four-month intervention period]
• Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control [Срок оценки: 48 months from start of interventions in each "triplet" of clusters]
• TB notification trend (intervention vs control) [Срок оценки: 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 [Срок оценки: From the start to two weeks after the end of each four-month intervention period]
• Number screened by study [Срок оценки: During four-month intervention periods (6 periods per cluster over 48 months)]
• Number diagnosed by study [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: During four-month intervention periods (6 periods per cluster over 48 months)]
• Number referred for TPT [Срок оценки: During four-month intervention periods (6 periods per cluster over 48 months)]
• Contacts screened [Срок оценки: During four-month intervention periods (6 periods per cluster over 48 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Uganda · 1 центр

• Walimu — Kampala

Идентификаторы

NCT: NCT05285202 · IRB00300939 · 2R01HL138728

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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