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

NCT02520973 | Completed

• 1 other identifier: 00039194
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Proportion of women diagnosed with TB

  1\. Proportion of women who are diagnosed with TB in each arm

  One year

Study Arms (2)

Universal screening

EXPERIMENTAL

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

Other: Sputum sample

Symptom- directed screening

ACTIVE COMPARATOR

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

Other: Sputum sample

Interventions

Sputum sample OTHER

Symptom- directed screening; Universal screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

Perinatal HIV Research Unit

Klerksdorp, Northwest, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Richard Chaisson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: August 13, 2015
• Study Start: May 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

ZA (1)