Evaluation of PTB Screening in ANC in Lusaka, Zambia

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT02053129

Collaborator

Centre for Infectious Disease Research in Zambia (Other)

5,033

Enrollment

Location

Arms

Duration (Months)

201.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pulmonary Tuberculosis	Other: TB screening Questionnaire Other: Sputum smear and culture (only in HIV negative women who are symptomatic)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5033 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

number of positive pulmonary tuberculosis (PTB) tests [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 Outcome Measures

Sensitivity and specificity of symptom-based TB screening [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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