Evaluation of PTB Screening in ANC in Lusaka, Zambia

Not Applicable

Completed

• Conditions: Pulmonary Tuberculosis
• Interventions: Other: TB screening Questionnaire; Other: Sputum smear and culture (only in HIV negative women who are symptomatic)

• Registration Number: NCT02053129
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2012-10
• Study Completion: 2013-12
• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Status Verified: 2014-12
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5033

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV negative pregnant women	TB screening Questionnaire	Pregnant women who are HIV negative attending their first ANC visit
HIV positive pregnant women	Sputum smear and culture (only in HIV negative women who are symptomatic)	Pregnant women who are HIV positive accessing antenatal care.
HIV positive pregnant women	TB screening Questionnaire	Pregnant women who are HIV positive accessing antenatal care.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia