Advancing Lung Health in Zambia Through Increasing Access to Integrated and Comprehensive Screening, Diagnosis and Management of TB and Other Chronic Respiratory Diseases at Community and Primary Care Levels
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20,300
- 试验地点
- 1
- 主要终点
- Number of Participants Diagnosed With Tuberculosis or Other Respiratory Diseases Through the Integrated Screening and Detection Model
研究概览
简要总结
The Advancing Lung Health in Zambia project aims to improve access to integrated screening, diagnosis, and management of tuberculosis (TB) and other priority respiratory diseases at community and primary healthcare levels. The project recognizes that many lung diseases present with similar symptoms, such as persistent cough, shortness of breath, chest pain, and difficulty breathing. Because of this overlap, focusing on a single disease can result in missed or delayed diagnoses for patients with other serious respiratory conditions.
Guided by the World Health Organization's Practical Approach to Lung Health (PAL), the project promotes integrated assessment of people presenting with respiratory symptoms. The main conditions of interest include TB, post-TB lung disease (PTLD), pneumonia, silicosis, and chronic obstructive pulmonary disease (COPD). This approach ensures that patients receive comprehensive evaluation and appropriate care regardless of the underlying cause of their symptoms.
A key feature of the project is the use of AI-enabled digital chest X-ray technology to support early and accurate detection of lung abnormalities. The technology assists healthcare workers in identifying signs of TB and other respiratory diseases, improving clinical decision-making and timely referral for further diagnosis and treatment.
The project also strengthens healthcare worker capacity, expands access to diagnostic services, enhances community awareness, and improves referral and follow-up systems. In addition, it seeks to generate evidence on the burden and patterns of non-TB respiratory diseases in Zambia while documenting good practices and lessons learned from integrated lung health screening. The evidence generated will help inform policy, strengthen primary healthcare services, and support the scale-up of integrated lung health approaches, ultimately improving respiratory health outcomes and access to quality care across Zambia.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the intergrated service delivery screening for lung health conditions:
- •Presumptive TB patients (individuals with symptoms or findings suggestive of TB).
- •Household contacts of confirmed TB patients.
- •Newly diagnosed people living with HIV (PLHIV).
- •People with respiratory conditions.
- •Workers from dust-generating industries within the district, such as mining and related
- •Persons who have a history of cigarrete smoking
- •Any person who feels at risk of lung health conditions, with or without symptoms.
- •For the nested sub-studies the following are the inclusion criteria:
- •Evaluation of the sound AI screening tool:
- •Presumptive TB patient either by symptoms or determined by chest Xray
- •Aged 18 and above
- •Provides written informed consent to participate in the study
- •Post-TB Lung disease sub-study
- •Persons diagnosed with bacteriologically confirmed TB with WHO Recommended Rapid Molecular diagnostic tests or sputum smear
- •Aged 18 and above
- •Provides written informed consent to participate in the sub-study
排除标准
- •For the nested sub-studies, the following are the exclusion criteria
- •Evaluation of the sound AI screening tool:
- •Aged less than 18
- •Does not provide written informed consent
- •Not a presumptive TB patient by chest Xray or clinical symptoms.
- •Post-TB Lung disease sub-study
- •Aged less than 18
- •Does not provide written informed consent
- •Clinically diagnosed TB.
结局指标
主要结局
Number of Participants Diagnosed With Tuberculosis or Other Respiratory Diseases Through the Integrated Screening and Detection Model
时间窗: 18 Months
Total number of participants diagnosed with tuberculosis, post-TB lung disease, silicosis, asthma, COPD, or other respiratory diseases through implementation of the Integrated Screening and Detection model.
次要结局
- Number of Individuals Screened for Tuberculosis and Other Respiratory Diseases(18 months)
- Number of Presumptive Tuberculosis Cases Identified(18 months)
- Number of Individuals Evaluated for Tuberculosis(18 Months)
- Number of All-Form Tuberculosis Cases Notified(18 months)
- Number of Bacteriologically Confirmed Tuberculosis Cases Diagnosed(18 Months)
- Number of Participants Diagnosed With Other Respiratory Diseases other than Tuberculosis(18 Months)
- The Prevalence of Post-Tuberculosis Lung Disease (PTLD)(From Enrollment at the start of TB treatment up to the end of treatment in 6 months)
- Diagnostic Accuracy of the AI-Enabled Cough Sound Screening Tool for Tuberculosis (Sub-Study)(Each participant spends approximately 30 minutes to 2 hours participating in the evaluation.)