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

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ClinicalTrials.gov Identifier: NCT00096681
Recruitment Status : Completed
First Posted : November 15, 2004
Results First Posted : February 17, 2011
Last Update Posted : March 14, 2011
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Study Description
Brief Summary:
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 or disease
HIV Infections Tuberculosis

Detailed Description:

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.

Study Design

Study Type : Observational
Actual Enrollment : 762 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township
Study Start Date : February 2005
Primary Completion Date : August 2005
Study Completion Date : February 2006

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U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis [ Time Frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit ]
    Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.

Secondary Outcome Measures :
  1. Number of Participants With a Positive HIV Test [ Time Frame: HIV status at the time of the study visit ]
    Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.

Biospecimen Retention:   Samples With DNA
Sputum samples

Eligibility Criteria

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Residents of the Masiphumelele township of Cape Town, South Africa

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096681

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Linda Gail Bekker, MBChB, FCP, PhD Department of Medicine, University of Cape Town
Principal Investigator: James McIntyre, MBChB, MRCOG University of the Witwatersrand and Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
More Information

Responsible Party: James McIntyre, CIPRA SA
ClinicalTrials.gov Identifier: NCT00096681     History of Changes
Other Study ID Numbers: CIPRA-SA Project 3A
U19AI053217 ( U.S. NIH Grant/Contract )
Project 3A
First Posted: November 15, 2004    Key Record Dates
Results First Posted: February 17, 2011
Last Update Posted: March 14, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections