Pulmonary Tuberculosis
Conditions
Keywords
tuberculosis, HIV, pregnancy
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.
Interventions
OTHERTB screening Questionnaire
All subjects will be screened with the questionnaire which assesses TB symptoms.
OTHERSputum 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
Sponsors
Centre for Infectious Disease Research in Zambia
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Zambia
Outcome results
None listed