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.

Condition
HIV Infections Tuberculosis

Further Study Details: 

Expected Total Enrollment:  1000

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.

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Resident of the Masiphumelele township for at least 1 week prior to study entry
• Willing to provide informed consent
• Willing to comply with study requirements

Study chairs or principal investigators

Linda Gail Bekker, MBChB, FCP, PhD,  Study Chair,  Department of Medicine, University of Cape Town   
James McIntyre, MBChB, MRCOG,  Principal Investigator,  University of the Witwatersrand and Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital   

Study ID Numbers:  CIPRA-SA Project 3A; CIPRA; Project 3A
Record last reviewed:  March 2005
Last Updated:  March 9, 2005
Record first received:  November 12, 2004
ClinicalTrials.gov Identifier:  NCT00096681
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08