Evaluation of PTB Screening in ANC in Lusaka, Zambia

University of North Carolina (UNC)

Status: Completed

Conditions: Pulmonary Tuberculosis

Treatments: Other: Sputum smear and culture (only in HIV negative women who are symptomatic); Other: TB screening Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT02053129

CIDRZ 1217/IRB12-0417

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,033 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,033 participants in 2 patient groups

HIV negative pregnant women

Other group

Description:

Pregnant women who are HIV negative attending their first ANC visit

Treatment:

Other: TB screening Questionnaire

HIV positive pregnant women

Other group

Description:

Pregnant women who are HIV positive accessing antenatal care.

Treatment:

Other: Sputum smear and culture (only in HIV negative women who are symptomatic)

Other: TB screening Questionnaire