HIV Infections Clinical Trial
Official title:
Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township
The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa. Data collected in this study will be used to predict the effect of introducing anti-HIV therapy in this community.
TB is the most common opportunistic infection among HIV infected people, and is the most
common cause of death in HIV infected people in Africa. The Masiphumelele township of Cape
Town, South Africa, with its high rates of TB and HIV, is representative of many poor
communities of Africa. Via random sampling, this study will assess the prevalence of HIV and
TB infections in the Masiphumelele township. Knowledge gained from this study will be used
to predict if introducing antiretroviral therapy will reduce the prevalence of TB in this
community.
Selection and enrollment of participants will last about 4 months. Potential participants
will be visited in their homes by fieldworkers, who will explain the study. Participants
will be invited to either go to the clinic on the day of the fieldworker's visit or to go on
a different day. Participants who go to the clinic on the day of the visit will have two
sputum samples collected with a nebulizer. Participants who do not go to the clinic on the
visit day will be given a sputum sample bottle and will be asked to collect a sputum sample
in the early morning the day before their clinic appointment. At the clinic appointment,
another sputum sample will be collected from these participants. Direct smear acid-fast
bacilli and Mycobacterium tuberculosis cultures will be done on both sputum samples.
Participants who test positive for TB will be referred for TB treatment at the clinic.
Participants will also be asked to complete a study questionnaire and will undergo an
anonymous oral HIV test at the clinic visit.
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Observational Model: Ecologic or Community, Time Perspective: Prospective
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