Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,033
- 试验地点
- 1
- 主要终点
- number of positive pulmonary tuberculosis (PTB) tests
研究概览
简要总结
This is a pilot pulmonary TB screening program done in three antenatal care clinics in Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and to determine the sensitivity and specificity of symptom-based TB screening.
详细描述
5000 pregnant women attending antenatal clinics will be evaluated by piloting a TB symptom questionnaire as part of the general health screening done at each visit. Due to the atypical and subclinical presentation of TB in HIV infected patients, culture will be performed on all HIV-infected pregnant women, with or without symptoms, and on all symptomatic HIVnegative women. Referrals for TB treatment in accordance with current national guidelines will be offered.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •18 years or older
- •HIV-negative women with any TB symptoms or HIV-infected women regardless of TB symptoms
- •Attending first ANC visit at one of program clinics
排除标准
- •HIV negative without any TB symptoms
研究组 & 干预措施
HIV negative pregnant women
Pregnant women who are HIV negative attending their first ANC visit
干预措施: TB screening Questionnaire (Other)
HIV positive pregnant women
Pregnant women who are HIV positive accessing antenatal care.
干预措施: TB screening Questionnaire (Other)
HIV positive pregnant women
Pregnant women who are HIV positive accessing antenatal care.
干预措施: Sputum smear and culture (only in HIV negative women who are symptomatic) (Other)
结局指标
主要结局
number of positive pulmonary tuberculosis (PTB) tests
时间窗: 1 day of screening (first antenatal visit)
The prevalence of culture confirmed PTB among HIV positive and HIV negative pregnant women will be measured to determine if there is a substantial amount of undiagnosed TB in the HIV positive population accessing antenatal care.
次要结局
- Sensitivity and specificity of symptom-based TB screening(1 day of screening visit)