Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,852
- 试验地点
- 2
- 主要终点
- Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms
研究概览
简要总结
The purpose of this study is to compare three strategies for finding TB cases in a rural Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2) Conducting household contact investigations of newly diagnosed TB cases; 3) Providing incentives to newly diagnosed TB cases and their contacts to promote contact screening for TB. For each intervention, investigators will measure comparative effectiveness in terms of cases identified as well as the cost-effectiveness and feasibility of implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Facility-based screening arm
- •Age 0-99 years
- •Informed consent provided (or assent plus parent/guardian consent)
- •Attending any of the study 28 study clinics in the facility-based screening arm
- •Contact tracing arm- Index Case
- •Age 0-99 years
- •Informed consent provided (or assent plus parent/guardian consent)
- •Newly diagnosed (last 2 months) with TB at any of the 28 study clinics in the contact tracing arm
- •Contact tracing arm- Household Contact
- •Age 0-99 years
- •Informed consent provided (or assent plus parent/guardian consent)
- •Living in the same household as an enrolled Index case (see above)
- •Contact tracing arm- Non-household Close Contact
- •Age 0-99 years
- •Informed consent provided (or assent plus parent/guardian consent)
- •Referred to the study as a close contact of an enrolled Index case (see above)
排除标准
- •(all arms):
- •Unable to provide informed consent.
研究组 & 干预措施
Facility-based screening
This strategy will be implemented at all clinics (n=28) within this arm for 18 months. Study staff will encourage providers at each of the clinics to screen all consenting patients attending the clinic, regardless of the original reason for clinic presentation. Upon presenting for care (e.g., while waiting for their healthcare provider), patients will be informed about the study and screened for cough of any duration, fever, weight loss, or night sweats. Participants who are symptomatic and provide a sputum specimen (according to the clinic standard of care) will be given a study flyer informing them that they may be contacted by study staff, and a brief summary of the study. Per standard of care, all sputum samples will be sent to the local National Health Laboratory Service laboratory for Xpert testing.
干预措施: Active TB case finding (Other)
Contact screening
This arm is comprised of two sub-arms:
In the household contact screening sub-arm, a mobile field team visits the household of each consenting newly diagnosed pulmonary TB index case. Each visit consists of a household census, consent of all eligible household members for TB screening, administration of a brief questionnaire, sputum collection for testing with Xpert Mycobacterium tuberculosis (MTB)/rifampin (RIF) and the offer of HIV testing.
In the incentive-based contact screening sub-arm, all consenting newly diagnosed active TB cases are provided with 10 coupons for free TB screening to give to close contacts. When a contact presents at clinic with a coupon, they and the index case each receive a small amount of money. If the contact is diagnosed with active TB and starts treatment, the index case receives an additional larger amount of money. Each contact receives a brief questionnaire, TB symptom screen, optional HIV testing, and sputum sample collection for Xpert MTB/RIF.
干预措施: Active TB case finding (Other)
结局指标
主要结局
Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms
时间窗: 36 months
The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics in the two contact tracing arms, excluding the six-month washout period.
Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics
时间窗: 18 months
The primary analysis was based on the facility- level rate ratio, and we first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% confidence interval (CI). We then adjusted for any residual confounding by district stratification and the historical annual number of people started on TB following a two-stage approach. The first step of this approach fits a Poisson regression to the facility-level counts and the district and historical volume covariates irrespective of study arm. The residuals ratios, calculated as the ratio of the observed over the expected counts, are then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.
次要结局
- Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing(36 months)
- Total Cost of Household Contact Investigation Strategies(36 months)
- Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms(36 months)
- Cost Per Secondary Case of TB Identified Among Contacts, Per Arm(36 months)
- Incremental Cost-effectiveness Ratio(36 months)