Real-World Implementation and Effectiveness of Tuberculosis Preventive Treatment in School Health Services in China
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Incident active tuberculosis
研究概览
简要总结
The goal of this study is to learn whether taking short-course preventive treatment in high school and college freshmen with strong positive tuberculosis (TB) skin tests can safely and effectively protect them from developing active TB over a 3-to-4-years period.
Main question: Does taking short-course preventive treatment reduce the risk of active TB in freshmen who have strong positive TB skin tests?
All freshmen across 26 schools in Meishan City, Sichuan Province, China were screened for TB. Among them, the students with strong positive skin tests (indicating latent TB infection) and no active disease entered the study. Students voluntarily chose to either take a 3-month short-course preventive treatment under campus medical supervision or receive routine health observation without medication. Researchers tracked all participants for 3 to 4 years to monitor who developed active TB and evaluate the treatment's safety and effectiveness.
详细描述
The Latent Infection Freshmen Tracking for Tuberculosis (LIFT-TB) study is a prospective, multi-center, real-world implementation cohort designed to evaluate the programmatic feasibility, safety, and long-term effectiveness of school-integrated short-course tuberculosis preventive treatment (TPT) among matriculating freshmen. Embedded within routine campus health services across 26 educational institutions (secondary vocational schools, colleges, and universities) in Meishan City, Sichuan Province, China, the protocol operationalizes proactive case-finding and preventive intervention at student entry.
Screening cascade and baseline stratification Under mandatory institutional biosecurity regulations, all newly enrolled freshmen underwent entry health evaluations comprising tuberculin skin testing (TST with 5 TU PPD-RT23), active symptom screening, and digital chest radiography (CXR). To maximize population coverage (>99%) and minimize non-response bias, a 2-week catch-up window was instituted for students initially absent. To account for widespread neonatal BCG vaccination, baseline infection risk was operationalized using TST induration thresholds.
Control cohort: Students with TST indurations <15 mm (subdivided into TST <5 mm, 5-9 mm, and 10-14 mm).
Target Cohort: Students with strong TST reactivity (≥15 mm or local severe reactions such as blisters/necrosis) in whom active TB was clinically excluded.
Intervention workflows and adherence monitoring Within the target cohort, TPT initiation was managed through shared decision-making. Eligible participants voluntarily initiated one of two WHO-recommended 3-month short-course regimens: Daily fixed-dose combination isoniazid/rifampicin (3HR). Twice-weekly isoniazid plus rifapentine (3H2P2). Treatment administration was embedded within campus health clinics using a hybrid directly observed therapy model combining in-person clinic DOT with smartphone-based video DOT (vDOT). Participants receiving medical observation alone without medication served as the No-TPT comparison group. Adverse events were routinely graded per CTCAE v5.0, with regular safety monitoring to capture potential hepatotoxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Matriculating freshmen aged 14-24 years enrolled across 26 participating educational institutions
- •Completion of baseline tuberculosis screening, including systematic symptom screening, digital chest radiography, and tuberculin skin test (TST)
- •Target cohort requirement: TST strong reactivity (induration ≥15 mm or severe local reactions such as blisters, necrosis, or lymphangitis) with active TB ruled out at baseline
- •Control cohort requirement: TST induration <15 mm (including negative <5 mm, weakly positive 5-9 mm, and moderately positive 10-14 mm)
排除标准
- •Presence of active TB at baseline screening
- •Voluntary receipt of Vaccae vaccination (for the target cohort)
研究组 & 干预措施
TPT Group
Initiation of a short-course TPT regimen (3HR or 3H2P2) within a 14-day grace period following being defined as the date of LTBI diagnosis/eligibility confirmation by school health services.
干预措施: tuberculosis preventive treatment (Drug)
No-TPT Group
Non-initiation of TPT, receiving standard observation and symptom monitoring through school health services.
结局指标
主要结局
Incident active tuberculosis
时间窗: Up to 4 years post-baseline screening (from T0 through August 31, 2026)
Incidence of newly diagnosed active tuberculosis (pulmonary or extrapulmonary) occurring during the 4-year prospective follow-up period among eligible study participants. Active TB cases were systematically tracked and confirmed through three integrated surveillance pathways managed by school health services: routine annual campus health evaluations; symptomatic student self-reports and clinical evaluations at campus health centers; linkage with the national electronic TB surveillance system managed by local CDC. Diagnosis was established per national school TB guidelines. Confirmed active TB required clinical/radiological findings with microbiological/molecular confirmation (M. tuberculosis culture, AFB smear, or GeneXpert MTB/RIF). Bacteriologically negative cases were diagnosed based on chest radiography, persistent symptoms, antibiotic non-responsiveness, and expert consensus.
次要结局
未报告次要终点
研究者
Gang Qin, MD, PhD
Associate Professor
Affiliated Hospital of Nantong University