Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa

NCT ID: NCT00096681

Last Updated: 2011-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

762 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Tuberculosis

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

CIPRA SA

NETWORK

Sponsor Role lead

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 and Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

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.

Reference Type BACKGROUND
PMID: 15113314 (View on PubMed)

Badri M, Wilson D, Wood R. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet. 2002 Jun 15;359(9323):2059-64. doi: 10.1016/S0140-6736(02)08904-3.

Reference Type BACKGROUND
PMID: 12086758 (View on PubMed)

Other Identifiers

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U19AI053217

Identifier Type: NIH

Identifier Source: secondary_id

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CIPRA

Identifier Type: -

Identifier Source: secondary_id

Project 3A

Identifier Type: -

Identifier Source: secondary_id

CIPRA-SA Project 3A

Identifier Type: -

Identifier Source: org_study_id

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