Evaluation of PTB Screening in ANC in Lusaka, Zambia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia

Conditions
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Pulmonary Tuberculosis

Intervention / Treatment
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* Other: TB screening Questionnaire
* Other: Sputum smear and culture (only in HIV negative women who are symptomatic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: HIV negative without any TB symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIV negative pregnant women<br>Pregnant women who are HIV negative attending their first ANC visit | Other: TB screening Questionnaire<br>* All subjects will be screened with the questionnaire which assesses TB symptoms.<br>* Other names: Pilot TB symptom questionnaire;|
| Other: HIV positive pregnant women<br>Pregnant women who are HIV positive accessing antenatal care. | Other: TB screening Questionnaire<br>* All subjects will be screened with the questionnaire which assesses TB symptoms.<br>* Other names: Pilot TB symptom questionnaire;Other: Sputum smear and culture (only in HIV negative women who are symptomatic)<br>* specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day of screening (first antenatal visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day of screening visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, tuberculosis, pregnancy