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

Johns Hopkins University

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Sputum sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02520973

00039194

Details and patient eligibility

About

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 .

Enrollment: 1,400 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

Universal screening

Experimental group

Description:

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

Treatment:

Other: Sputum sample

Symptom- directed screening

Active Comparator group

Description:

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

Treatment:

Other: Sputum sample