Clinical trial NCT02053129: Evaluation of PTB Screening in ANC in Lusaka, Zambia
Official title: Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Tuberculosis
Keywords: tuberculosis
HIV
pregnancy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
First posted: 2014-02-03
Enrollment: 5033
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of positive pulmonary tuberculosis (PTB) tests
timeFrame: 1 day of screening (first antenatal visit)
Secondary outcomes:
measure: Sensitivity and specificity of symptom-based TB screening
timeFrame: 1 day of screening visit
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: Centre for Infectious Disease Research in Zambia
name: Stewart Reid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Infectious Disease Research in Zambia
name: Nzali Kancheya, MMED, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, University of Alabama
name: Michael Saag, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Infectious Disease Research in Zambia
name: German Henostroza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Infectious Disease Research in Zambia
name: Annika Kruuner, MD
role: PRINCIPAL_INVESTIGATOR
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