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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520973
• Other study ID #: 00039194
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: August 15, 2017
• Start date: May 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Sputum sample

Locations

Country	Name	City	State
South Africa	Perinatal HIV Research Unit	Klerksdorp	Northwest

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women diagnosed with TB	1. Proportion of women who are diagnosed with TB in each arm	One year