Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3: Cluster Randomised Controlled Trial of A Diagnostic Package to Increase the Number of Tuberculosis Cases Notified
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40,000
- 试验地点
- 1
- 主要终点
- Change in TB case notifications per population attending healthcare facilities
研究概览
简要总结
The goal of this cluster-randomised controlled trial (CRCT) is to learn whether the use of new non-sputum-based diagnostic tests and other intervention components for tuberculosis (TB) diagnosis in healthcare facilities (HCF) can increase TB notifications. The main questions it aims to answer are: (1) Does the diagnostic intervention package raise TB notifications by HCF?; (2) Does the diagnostic intervention package raise the proportion of patients with TB who are diagnosed with microbiological tests, lower the time needed for TB diagnosis, lower the number of visits to HCF before TB diagnosis, raise the use of TB tests by healthcare providers, and lower the costs for TB diagnosis?
Researchers will compare the diagnostic intervention package provided to HCFs and the community in the intervention arm with the standard of care in the control arm to assess the intervention's effect. Healthcare providers will be trained to provide diagnostic interventions to patients visiting their HCFs and to community residents in the areas surrounding HCFs.
详细描述
TB remains a critical public health problem worldwide. Most of the patients with TB were from low- and middle-income countries with limited resources. A large proportion of them visited HCFs without sufficient laboratory services to diagnose TB, causing a delay in TB diagnosis and treatment. In addition, while up to half of patients with presumptive TB cannot produce adequate sputum specimens, current TB diagnostics rely on sputum-based tests. Therefore, the use of near point-of-care (nPOC) or point-of-care (POC) non-sputum-based tests can potentially provide more accessible TB diagnosis and reduce delays.
This CRCT is part of a larger series of studies within the EVIDENT Research Project in Indonesia. Based on a clinical validation study (EVIDENT work package 1) and a diagnostic yield, feasibility, and cost study (EVIDENT work package 2), the CRCT (EVIDENT work package 3) will provide evidence of the effects of implementation of a multi-component public health intervention in the intervention arm, compared to the control arm. Carefully designed clinical algorithms will be employed to incorporate the new diagnostic test, using sputum and/or tongue swab specimens, into the health services. To increase patients' attendance and utilisation of the new diagnostic test, a promotional package will be provided to clinics unable to host it and to selected pharmacies. Finally, a household contact investigation will be conducted, involving community health volunteers.
Clusters are the community health centre (CHC) catchment areas, defined as geographical areas surrounding a CHC where the TB programme is expected to be implemented. The interventions will be administered in HCFs and the community in the intervention arm, while the control arm will continue standard of care with no intervention, except for refresher training on TB case notification into the National TB Information System (locally known as Sistem Informasi Tuberkulosis or SITB) before the intervention roll-out. The primary and secondary endpoints will be assessed over the 12-month post-intervention roll-out (follow-up period), with adjustment for baseline (12-month pre-randomisation period). TB case notification data will be obtained from the National TB Information System.
In addition to the main study, several sub-studies will be conducted to assess the secondary objectives: the Patient Pathway & Patient Costing Sub-study, the Standardised Patient Sub-study, and the Health System Costing Sub-study. The Patient Pathway & Patient Costing study is a cross-sectional study of patients recently diagnosed with TB at the selected HCF in the intervention and control arms. In the Standardised Patient Sub-study, trained standardised patients will visit selected HCFs to present a clinical scenario and record their experiences regarding examinations, diagnostic testing, and referrals. The health system costing study will gather information on the costs of diagnosing TB in HCFs and communities in the intervention and control arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statisticians and investigators who will conduct the primary data analysis.
入排标准
- 年龄范围
- 29 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between >28 days and 14 years old with the following symptoms:
- •Cough ≥2 weeks
- •Acute malnutrition
- •Weight loss or weight faltering during the past 3 months among those who had contact history with patients with TB in the past 12 months.
- •Aged ≥15 years old who had a cough for ≥2 weeks or bloody cough, with or without the following symptoms:
- •Cough with/without sputum
- •Weight loss
- •Night sweat
- •Chest pain/discomfort
- •Breathlessness
- •Loss of appetite
- •Shivering
排除标准
- •Have started TB treatment or TB prophylaxis therapy.
研究组 & 干预措施
Near Point-of-Care (nPOC) Testing
The intervention arm will comprise HCFs operating in the selected CHC catchment areas, including CHCs, public hospitals, private hospitals, private clinics, and private laboratories. A multi-component public health intervention package, which will incorporate nPOC testing for TB diagnosis, will be provided for these HCFs, including patients visiting the HCFs and the community residents in the selected CHC catchment areas.
干预措施: nPOC Testing Intervention Package (Diagnostic Test)
Standard of Care
HCFs in the control arm will continue standard of care with no intervention, except for refresher training on reporting and notifying TB cases to the National TB Information System before the intervention package is rolled out.
结局指标
主要结局
Change in TB case notifications per population attending healthcare facilities
时间窗: The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.
Difference in average TB notification rate per population attending healthcare facilities in intervention and control arms.
次要结局
- Change in TB case notifications in CHC areas, who live in the area, per CHC area population(The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.)
- Change in proportion of microbiologically confirmed TB cases over all diagnosed TB cases(The outcome is measured over the 12 months before the commencement of any study procedures and over a 12-month follow-up period starting 6 months after the start of intervention roll-out.)
- Difference in time to TB diagnosis from the beginning of symptoms (Patient Pathway and Patient Costing Sub-study)(Up to 10 months during the follow-up period)
- Difference in time to TB diagnosis from the first visit to a formal HCF (Patient Pathway and Patient Costing Sub-study)(Up to 10 months during the follow-up period.)
- Number of visits to healthcare facilities before TB diagnosis (Patient Pathway and Patient Costing Sub-study)(Up to 10 months during the follow-up period.)
- Propensity to test for TB (Standardised Patient Sub-study)(Up to 6 months during the follow-up period)
- Patient costs for TB diagnosis (Patient Pathway and Patient Cost Sub-study)(Up to 10 months during the follow-up period.)
- TB diagnostic costs in the healthcare facilities and community settings (Health System Costing Sub-study)(Up to 6 months during the follow-up period.)