Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146,539
- 试验地点
- 2
- 主要终点
- Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •On treatment for, or diagnosed with but not yet treated for, active TB
研究组 & 干预措施
No intervention
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
干预措施: Active TB case finding with linkage to preventive therapy (ACF/TPT) (Other)
Facility-based ACF/TPT
ACF/TPT intervention will be delivered on the grounds of a health facility (hospital or large public health center)
干预措施: Active TB case finding with linkage to preventive therapy (ACF/TPT) (Other)
结局指标
主要结局
Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility
时间窗: 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.
次要结局
- Number screened by study(During four-month intervention periods (6 periods per cluster over 48 months))
- Number referred for TPT(During four-month intervention periods (6 periods per cluster over 48 months))
- Study-initiated TB notifications, hotspot vs facility(From the start to two weeks after the end of each four-month intervention period)
- Number diagnosed by study(During four-month intervention periods (6 periods per cluster over 48 months))
- Number evaluated for latent tuberculosis infection (LTBI) with tuberculin skin testing (TST)(During four-month intervention periods (6 periods per cluster over 48 months))
- Contacts screened(During four-month intervention periods (6 periods per cluster over 48 months))
- Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control(48 months from start of interventions in each "triplet" of clusters)
- 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)
- 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)
- TPT initiations, hotspot vs facility(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(From the start to two weeks after the end of each four-month intervention period)