Cost-effectiveness of a Population-based Active TB Control Program for Tuberculosis, Lima, Peru
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,900
- 试验地点
- 1
- 主要终点
- Active Tuberculosis
研究概览
简要总结
The purpose of this study is to determine the effectiveness and cost-effectiveness of a new population-based active case-finding program among adult household contacts of new infectious TB cases to detect active TB cases in the largest district, Lima, Peru.
详细描述
The Ministry of Health TB program of the District SJL (DISA NTP) is undertaking new public health intervention that involves the active evaluation of household contacts. We are collaborating to roll this intervention out as a stepped wedge pragmatic randomized controlled trial in order to evaluate the effectiveness and cost-effectiveness of this intervention.
Intervention Model
The intervention is rolled out across all clusters (or health centres) in the form of a stepped wedge design, that is a unidirectional crossover, such that all clusters start in the control arm and are then randomized to the time point of cross over to the intervention arm. This continues in steps until all clusters (or health centres) have crossed over to the intervention arm. The randomization of health centres is to the timepoint at which they will cross over to the intervention arm. This randomization was stratified by clinicTB rates <100/100,000, TB rates 100 to 200/100,000, and clinics with TB rates >200/100,000, to ensure balance of clinic sizes randomized to the intervention arm at each time point.
Power analysis
Given that the number of clusters, or health centres (n=35) is fixed, a power analysis was undertaken to estimate the smallest detectable difference between the overall yields of the active intervention (ACF) and the passive case finding (PCF) in the current study. The power analysis for stepped wedge clustered designs must be modified to account for the stepped implementation and the variation in cluster sizes we are likely to observe. In a parallel study designed to achieve a specified level of power, the same population in a stepped wedge design will have less the specified level of power, and the standard normal deviates should be increased by an inflation factor. Using a similar approach and accounting for stepped wedge design and the varying cluster sizes within the sample, in comparison to the expected baseline 1% case detection among household contacts we anticipate in passive case finding, we should have a power of greater than 90% detect differences between 3% and 4% ( with overall yields of ACF with 4 or 5%) between the intervention and control arms. Based on previous studies, we anticipate this should be adequate to determine an effect that would be of clinical and programmatic importance.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Index TB cases will be included if they are ≥15 years old, sputum smear positive and identify at least one household contact on questioning. All TB household contacts identified will be included if they meet the program household contact definition and have not previously been diagnosed or under current TB treatment.
排除标准
- •Patients who are receiving treatment from private clinics, are in prison or otherwise institutionalized, will be excluded from enrollment as index cases as per current DISA NTP practice. TB cases reported outside of the Ministry of Health clinics will not be included unless they are referred and enter the Ministry of Health system and the DOTS program
研究组 & 干预措施
Passive Household Contact Evaluation
Passive case finding refers to the current National TB program of voluntary self-reporting of symptomatic patients to the health system for diagnosis of TB and initiation of effective chemotherapy
Active Household Contact Evaluation
The intervention program includes households visits of all newly diagnosed TB cases enrolled in TB treatment within a DISA NTP clinic in SJL district. During the home visit health staff will evaluate all household contacts for symptoms of active TB. Any person reporting cough for >14 days will be asked to provide a spot sputum for microscopy and referred to the clinic for chest x-ray and clinical evaluation. All household contacts ≤19 years will be referred to the clinic for chest x-ray, pediatric clinical evaluation and initiation of treatment for active or latent TB as required. Counseling including TB infection control practices and importance of diagnosis and treatment completion for TB cases will be provided to household members.
干预措施: Active Household Contact Evaluation (Other)
结局指标
主要结局
Active Tuberculosis
时间窗: 6 months
Evaluation of active Tuberculosis in exposed household contacts of TB patients enrolled in treatment
次要结局
未报告次要终点
研究者
Lena Shah
Doctoral Student
McGill University