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Completed

NCT Number: NCT02053129

Evaluation of PTB Screening in ANC in Lusaka, Zambia

This is a pilot pulmonary TB screening program done in three antenatal care clinics in Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and to determine the sensitivity and specificity of symptom-based TB screening.

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

About this study

5000 pregnant women attending antenatal clinics will be evaluated by piloting a TB symptom questionnaire as part of the general health screening done at each visit. Due to the atypical and subclinical presentation of TB in HIV infected patients, culture will be performed on all HIV-infected pregnant women, with or without symptoms, and on all symptomatic HIVnegative women. Referrals for TB treatment in accordance with current national guidelines will be offered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women
  • 18 years or older
  • HIV-negative women with any TB symptoms or HIV-infected women regardless of TB symptoms
  • Attending first ANC visit at one of program clinics

Exclusion criteria

  • HIV negative without any TB symptoms

Treatment and study plan

TB screening Questionnaire

Other

All subjects will be screened with the questionnaire which assesses TB symptoms.

Other names: Pilot TB symptom questionnaire

Sputum smear and culture (only in HIV negative women who are symptomatic)

Other

specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines

Primary outcomes

  1. number of positive pulmonary tuberculosis (PTB) tests

    Time frame: 1 day of screening (first antenatal visit)

    The prevalence of culture confirmed PTB among HIV positive and HIV negative pregnant women will be measured to determine if there is a substantial amount of undiagnosed TB in the HIV positive population accessing antenatal care.

Secondary outcomes

  1. Sensitivity and specificity of symptom-based TB screening

    Time frame: 1 day of screening visit

    To determine the sensitivity and specificity of symptom based TB screening (compared to TB culture), enrollees will have TB symptoms assessed by administration of a questionnaire. Culture will then be performed on all HIV infected pregnant women, with or without symptoms, and on all symptomatic HIV negative women.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Centre for Infectious Disease Research in Zambia

Registry information

Official study title

Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 3, 2014
Registry last updated
Sep 15, 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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