NCT02053129

Evaluation of PTB Screening in ANC in Lusaka, Zambia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,033 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
OTHER	TB screening Questionnaire	All subjects will be screened with the questionnaire which assesses TB symptoms.
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

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-10-01
• Completion: 2013-12-01
• First posted: 2014-02-03
• Last updated: 2017-09-15

Locations

1 site across 1 country: Zambia