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Completed

NCT Number: NCT02520973

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Perinatal HIV Research Unit

Klerksdorp, Northwest, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sputum sample

Other

Primary outcomes

  1. Proportion of women diagnosed with TB

    Time frame: One year

    • Proportion of women who are diagnosed with TB in each arm

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • University of Witwatersrand, South Africa

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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