Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa
Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township
4 other identifiers
observational
762
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2005
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2004
CompletedFirst Posted
Study publicly available on registry
November 15, 2004
CompletedStudy Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedResults Posted
Study results publicly available
February 17, 2011
CompletedMarch 14, 2011
February 1, 2011
6 months
November 12, 2004
January 14, 2011
February 17, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis
Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.
Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit
Secondary Outcomes (1)
Number of Participants With a Positive HIV Test
HIV status at the time of the study visit
Eligibility Criteria
Residents of the Masiphumelele township of Cape Town, South Africa
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 15113314BACKGROUNDBadri 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.
PMID: 12086758BACKGROUND
Biospecimen
Sputum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof LG Bekker
- Organization
- Desmond Tutu HIV Centre
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
November 12, 2004
First Posted
November 15, 2004
Study Start
February 1, 2005
Primary Completion
August 1, 2005
Study Completion
February 1, 2006
Last Updated
March 14, 2011
Results First Posted
February 17, 2011
Record last verified: 2011-02