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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
5,033
All subjects will be screened with the questionnaire which assesses TB symptoms.
specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
number of positive pulmonary tuberculosis (PTB) tests
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.
Time frame: 1 day of screening (first antenatal visit)
Sensitivity and specificity of symptom-based TB screening
To determine the sensitivity and specificity of symptom based TB screening (compared to TB culture), enrollees will have TB symptoms assessed by administration of a questionnaire. Culture will then be performed on all HIV infected pregnant women, with or without symptoms, and on all symptomatic HIV negative women.
Time frame: 1 day of screening visit
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