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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-30

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 .

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Detailed Description

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Conditions

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Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Universal screening

All HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen

Group Type EXPERIMENTAL

Sputum sample

Intervention Type OTHER

Symptom- directed screening

Only symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB

Group Type ACTIVE_COMPARATOR

Sputum sample

Intervention Type OTHER

Interventions

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Sputum sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA \>1000 copies/mL
2. Pregnancy confirmed by urine pregnancy test or clinical exam
3. Estimated gestational age of 13 weeks or older
4. Age 18 years or greater
5. Willing to provide verbal consent

Exclusion Criteria

1. Currently diagnosed with TB
2. Completed TB treatment within the last 6 months
3. Inability to communicate in one of the study languages.
4. Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No