Test and Treat TB: A Proof of Concept Trial in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,815
- 试验地点
- 1
- 主要终点
- Number of patients who complete tuberculosis treatment
研究概览
简要总结
The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test & Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English or Zulu speaking
- •presenting for screening at mobile unit
- •voluntarily undergoing HIV testing
- •able and willing to give informed consent
- •willing to share HIV and TB test results
- •willing to attend one of six local clinics for treatment
- •access to a mobile phone
排除标准
- 未提供
研究组 & 干预措施
Usual Care
Patients in the usual care arm will be screened for tuberculosis (TB) on a mobile unit and referred for treatment according to the current standard of care in South Africa
Test-and-Treat Intervention
Patients in the intervention arm will partake in a Test-and-Treat TB strategy involving mobile GeneXpert MTB/RIF testing, facilitated TB treatment initiation, SMS reminders for clinic visits, and cashless incentives.
干预措施: Test-and-Treat TB (Other)
结局指标
主要结局
Number of patients who complete tuberculosis treatment
时间窗: 6 months
次要结局
- Proportion of mobile testers screened for tuberculosis(20 months)
- Prevalence of tuberculosis and rifampin resistance(20 months)
- Prevalence of TB among those tested(20 months)
- ART initiation date as documented by clinic record for those HIV co-infected(6 months)
- Distribution of TB symptoms ascertained from TB symptom screen questionnaire(20 months)
- Proportion of eligible participants able to produce sputum samples(20 months)
- Proportion returning to the mobile tester for TB test result(20 months)
- Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record)(1 month)
研究者
Ingrid V. Bassett, MD, MPH
Associate Professor of Medicine
Massachusetts General Hospital