Characteristics and Prevalence of Tuberculosis and HIV in Masiphumelele Township, Cape Town, South Africa
NCT ID: NCT00346476
Last Updated: 2011-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
1250 participants
OBSERVATIONAL
2006-04-30
2010-12-31
Brief Summary
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Detailed Description
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This study has two parts: a random cross-sectional survey and a clinical and genetic assessment of TB patients. Participants in the random survey will only be involved with the study for a maximum of 2 days. The purpose of the first part of the study is to compare the prevalence of active TB and the prevalence of HIV infection in a random sample of people from the Masiphumelele Township. In this part of the study, children and adults will be randomly selected from the township population to determine the prevalence of active TB and the prevalence of HIV infection in this group of people. Fieldworkers will identify eligible participants in the township and will ask them to visit the clinic that day or the next. At the clinic, participants will be asked to complete a demographics and TB history questionnaire and provide a saliva sample for anonymous HIV testing. A sputum sample will be collected from each participant with a nebulizer; each participant will also be given a sputum sample bottle and will be asked to collect an early morning sputum sample on the next day that will be returned to the clinic.
The second part of the study will enroll TB patients. Participants in this part of this study will be followed for the course of their TB treatment for at least 6 months. The purpose of the second part of the study is to assess changes through time of the clustering and transmission of TB among HIV infected and uninfected people in the Masiphumelele Township. This assessment will include examining the diversity of TB strains in this population and determining the relationship between recurrent cases of TB and HIV infection. All sputum samples indicating TB infections that were previously collected from participants will undergo genetic testing by restriction fragment length polymorphism (RFLP) analysis. Participants will be asked to complete a demographics and TB history questionnaire and provide a saliva sample for anonymous HIV testing. Participants will also be interviewed about treatment they have received for TB, their responses to this treatment, and whether they are currently on highly active antiretroviral therapy (HAART) for the treatment of HIV infection.
Participants who are found to be infected with TB during the first part of the study will be offered TB treatment through the clinic and will be invited to participate in the second part of this study. Participants who are found to be infected with HIV during the study will be referred to further treatment and evaluation.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Participants
Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Parent or guardian willing to provide informed consent, if applicable
* Live in Masiphumelele Township, Cape Town, South Africa for at least 1 week
* Live in Masiphumelele Township, Cape Town, South Africa
* Registered TB patient at the study site
Exclusion Criteria
* No Mycobacterium tuberculosis specimen obtained from the participant for genetic analysis
15 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Comprehensive International Program of Research on AIDS
OTHER
CIPRA SA
NETWORK
Responsible Party
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CIPRA SA
Principal Investigators
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Linda Gail Bekker, MBChB, FCP, PhD
Role: STUDY_CHAIR
Department of Medicine, University of Cape Town
James McIntyre, MBChB, MRCOG
Role: PRINCIPAL_INVESTIGATOR
University of the Witwatersrand, Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Locations
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Desmond Tutu HIV Centre Department of Medicine
Cape Town, Western Cape, South Africa
Desmond Tutu HIV Centre Department of Medicine
Cape Town, , South Africa
Countries
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References
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Aaron L, Saadoun D, Calatroni I, Launay O, Memain N, Vincent V, Marchal G, Dupont B, Bouchaud O, Valeyre D, Lortholary O. Tuberculosis in HIV-infected patients: a comprehensive review. Clin Microbiol Infect. 2004 May;10(5):388-98. doi: 10.1111/j.1469-0691.2004.00758.x.
Badri M, Ehrlich R, Wood R, Pulerwitz T, Maartens G. Association between tuberculosis and HIV disease progression in a high tuberculosis prevalence area. Int J Tuberc Lung Dis. 2001 Mar;5(3):225-32.
Friedland G, Harries A, Coetzee D. Implementation issues in tuberculosis/HIV program collaboration and integration: 3 case studies. J Infect Dis. 2007 Aug 15;196 Suppl 1:S114-23. doi: 10.1086/518664.
Kwara A, Flanigan TP, Carter EJ. Highly active antiretroviral therapy (HAART) in adults with tuberculosis: current status. Int J Tuberc Lung Dis. 2005 Mar;9(3):248-57.
Maher D, Harries A, Getahun H. Tuberculosis and HIV interaction in sub-Saharan Africa: impact on patients and programmes; implications for policies. Trop Med Int Health. 2005 Aug;10(8):734-42. doi: 10.1111/j.1365-3156.2005.01456.x.
Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis. 2007 Aug 15;196 Suppl 1:S15-27. doi: 10.1086/518656.
Wood R, Maartens G, Lombard CJ. Risk factors for developing tuberculosis in HIV-1-infected adults from communities with a low or very high incidence of tuberculosis. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):75-80. doi: 10.1097/00126334-200001010-00010.
Other Identifiers
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CIPRA-SA Project 3B
Identifier Type: -
Identifier Source: org_study_id
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