Evaluation of PTB Screening in ANC in Lusaka, Zambia

This study has been completed.
Sponsor:
Collaborator:
Centre for Infectious Disease Research in Zambia
Information provided by (Responsible Party):
Stewart Reid, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02053129
First received: January 31, 2014
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Pulmonary Tuberculosis
Other: TB screening Questionnaire
Other: Sputum smear and culture (only in HIV negative women who are symptomatic)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • number of positive pulmonary tuberculosis (PTB) tests [ Time Frame: 1 day of screening (first antenatal visit) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Sensitivity and specificity of symptom-based TB screening [ Time Frame: 1 day of screening visit ] [ Designated as safety issue: No ]
    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.


Enrollment: 5033
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HIV negative pregnant women
Pregnant women who are HIV negative attending their first ANC visit
Other: TB screening Questionnaire
All subjects will be screened with the questionnaire which assesses TB symptoms.
Other Name: Pilot TB symptom questionnaire
HIV positive pregnant women
Pregnant women who are HIV positive accessing antenatal care.
Other: TB screening Questionnaire
All subjects will be screened with the questionnaire which assesses TB symptoms.
Other Name: Pilot TB symptom questionnaire
Other: Sputum smear and culture (only in HIV negative women who are symptomatic)
specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02053129

Locations
Zambia
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centre for Infectious Disease Research in Zambia
Investigators
Principal Investigator: Stewart Reid, MD Centre for Infectious Disease Research in Zambia
Principal Investigator: Nzali Kancheya, MMED, MPH Centre for Infectious Disease Research in Zambia
Principal Investigator: Michael Saag, MD Professor, University of Alabama
Principal Investigator: German Henostroza, MD Centre for Infectious Disease Research in Zambia
Principal Investigator: Annika Kruuner, MD Centre for Infectious Disease Research in Zambia
  More Information

Additional Information:
Publications:

Responsible Party: Stewart Reid, MD, Professor, Medical Director, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02053129     History of Changes
Other Study ID Numbers: 12-0417
Study First Received: January 31, 2014
Last Updated: February 6, 2014
Health Authority: Zambia: Ministry of Health
Zambia: Research Ethics Committee

Keywords provided by University of North Carolina, Chapel Hill:
tuberculosis
HIV
pregnancy

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 30, 2014