Start 4 All - DARE-TB
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60,000
- 主要终点
- Primary Endpoint: Diagnostic accuracy (sensitivity, specificity, PPV, NPV) of NPOC assays (tongue swab and sputum swab) compared against the microbiological reference standard (MRS: sputum culture).
研究概览
简要总结
DARE-TB has been designed to address critical evidence gaps on the diagnostic performance and operational value of near point-of-care (NPOC) nucleic acid amplification tests (NAATs) within community-based case finding (CBCF) strategies. Although World Health Organization (WHO) recommends wider access to molecular testing, its use remains concentrated in facility-based settings well short of the global targets and largely dependent on sputum production. This creates a substantial diagnostic gap for people reached through community screening who either cannot provide sputum or whose sputum specimens cannot be tested on a NAAT at a facility, particularly for marginalized, hard-to-reach populations with poor access to healthcare.
详细描述
By embedding NPOC swab testing into CBCF strategies in Bangladesh, Cameroon, and Nigeria, this study will generate:
- Diagnostic accuracy estimates for NPOC among adults ≥15 years and young adolescents (10-14 years) identified through lung health camps after screening with CAD CXR-AI.
- Direct evidence on NPOC use in non-sputum producers in community settings, addressing one of the most pressing gaps highlighted by WHO and national TB programmes.
- Feasibility and acceptability insights on integrating NPOC into CBCF algorithms, complementing existing facility-based evidence.
- Cost and cost-effectiveness estimate of using NPOC in CBCF.
The findings will directly support future WHO guideline development and inform national programme decisions on incorporating NPOC assays into CBCF models to reach populations at greatest risk of being missed by sputum-based approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 15 years and above
- •Young adolescents aged 10-14 years
- •Community setting:
- •o Rural and urban poor, elderly, marginalized groups, internally displaced persons (IDP) in camps and host communities, nomadic communities, and contacts of people with TB who attend community-based case finding (CBCF) campaigns.
- •Screening eligibility:
- •Screen positive on CAD CXR-AI (CAD score threshold ≥ 0.3).
- •Written informed consent (and assent for adolescents if recruited) must be obtained according to local ethics and regulatory requirements.
排除标准
- •Age o Below 10 years at enrolment
- •Screening eligibility
- •o Do not screen positive with CAD CXR-AI (CAD score threshold <0.3).
- •Consent and follow-up
- •o Unable or unwilling to provide written informed consent (and assent where applicable) or unwilling to agree to follow-up visits.
- •Current TB treatment
- •o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.
- •Recent TB preventive therapy
- •o Receipt of TB preventive therapy within the last 6 months prior to enrolment.
- •Clinical danger signs
- •o Presence of severe illness at screening, including but not limited to:
- •▪ Respiratory rate >30/min St
- •Fever >39°C
- •Pulse rate >120/min
- •Inability to walk unaided
- •Duplicate enrolment o Previous enrolment in DARE-TB.
研究组 & 干预措施
Diagnostic
Diagnostic
干预措施: Culture (reference standard) (Diagnostic Test)
Diagnostic
Diagnostic
干预措施: Sputum smear microscopy (Diagnostic Test)
Diagnostic
Diagnostic
干预措施: Near point of care (NPOC) NAATs (Diagnostic Test)
Diagnostic
Diagnostic
干预措施: Low-complexity nucleic acid amplification tests (LC-NAATs) (Diagnostic Test)
Diagnostic
Diagnostic
干预措施: LC-NAAT using pooled testing (Diagnostic Test)
Diagnostic
Diagnostic
干预措施: Computer-Aided Detection (CAD) Chest X-ray (CXR-AI) (Diagnostic Test)
结局指标
主要结局
Primary Endpoint: Diagnostic accuracy (sensitivity, specificity, PPV, NPV) of NPOC assays (tongue swab and sputum swab) compared against the microbiological reference standard (MRS: sputum culture).
时间窗: The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027
WHO: All participants with interpretable NPOC results WHAT: Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of NPOC oral and sputum swabs WHEN: Calculated after completion of reference standard testing (culture) WHERE: Central data analysis and across Bangladesh, Cameroon, and Nigeria WHY: To provide robust evidence of NPOC performance against the microbiological reference standard in CBCF settings HOW MEASURED: * Reference standard = culture * Accuracy estimates presented with 95% confidence intervals * Pre-specified handling of invalid/error results * Disaggregated by sample type (tongue vs sputum swab)
次要结局
- Secondary Endpoint 1: Diagnostic Yield among Non-Sputum Producers and people with difficulty to produce sputum(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)
- Secondary Endpoint 2: cost and cost-effectiveness of NPOC diagnostics in community-based case-finding (CBCF) setting and diagnostic algorithms among adults (15 years and above) and young adolescents (10-14 years)(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)
- Secondary Endpoint 3.1: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)
- Secondary Endpoint 3.2: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)
- Secondary Endpoint 3.3: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)
- Secondary Endpoint 4.1: Diagnostic yield of TB among participants using self-collected swabs compared with HCW-collected swabs(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)
- Secondary Endpoint 4.2: Diagnostic accuracy of self-collected tongue swabs(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)
- Secondary Endpoint 4.3: Diagnostic accuracy of HCW-collected tongue swabs(The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027)