Evaluation of PTB Screening in ANC in Lusaka, Zambia

September 13, 2017 updated by: University of North Carolina, Chapel Hill

Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5033

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Centre for Infectious Disease Research in Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Pilot TB symptom questionnaire
Other: 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day of screening (first antenatal visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day of screening visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIDRZ 1217/IRB12-0417

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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