Screening for TB in Pregnancy. on HIV-Infected Pregnant Women

Study Overview
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Brief Summary
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Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .

Official Title
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Screening for TB in Pregnancy A Supplement to: The Effect of Tuberculosis and Its Treatment on HIV-Infected Pregnant Women and Their Infants

Conditions
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Tuberculosis

Intervention / Treatment
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* Other: Sputum sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA >1000 copies/mL Pregnancy confirmed by urine pregnancy test or clinical exam Estimated gestational age of 13 weeks or older Age 18 years or greater Willing to provide verbal consent Exclusion Criteria: Currently diagnosed with TB Completed TB treatment within the last 6 months Inability to communicate in one of the study languages. Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Universal screening<br>All HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen | Other: Sputum sample<br> <br> |
| Active Comparator: Symptom- directed screening<br>Only symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB | Other: Sputum sample<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women diagnosed with TB | 1. Proportion of women who are diagnosed with TB in each arm | One year |