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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
CIPRA SA
ClinicalTrials.gov Identifier:
NCT00096681
First received: November 12, 2004
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
Results First Received: January 14, 2011  
Study Type: Observational
Study Design: Observational Model: Ecologic or Community;   Time Perspective: Prospective
Conditions: HIV Infections
Tuberculosis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participants From the Community The number of participants from the community who attended the clinic for a once off study visit

Participant Flow:   Overall Study
    Participants From the Community  
STARTED     762  
COMPLETED     762  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Participants From the Community The number of participants from the community who attended the clinic for a once off study visit

Baseline Measures
    Participants From the Community  
Number of Participants  
[units: participants]
 		  762  
Age  
[units: participants]
 		 
<=18 years     26  
Between 18 and 65 years     726  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation 		  30  ± 11.1  
Gender  
[units: participants]
 		 
Female     422  
Male     340  
Region of Enrollment  
[units: participants]
 		 
South Africa     762  



  Outcome Measures
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1.  Primary:   Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis   [ Time Frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit ]
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2.  Secondary:   Number of Participants With a Positive HIV Test   [ Time Frame: HIV status at the time of the study visit ]
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  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Participants From the Community The number of participants from the community who attended the clinic for a once off study visit

Serious Adverse Events
    Participants From the Community  
Total, serious adverse events    
# participants affected / at risk     0/762 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Prof LG Bekker
Organization: Desmond Tutu HIV Centre
phone: +2721 633 6599 ext 21
e-mail: Linda-Gail.Bekker@hiv-research.org.za


Publications:


Responsible Party: James McIntyre, CIPRA SA
ClinicalTrials.gov Identifier: NCT00096681     History of Changes
Other Study ID Numbers: CIPRA-SA Project 3A, U19AI053217, CIPRA, Project 3A
Study First Received: November 12, 2004
Results First Received: January 14, 2011
Last Updated: February 17, 2011
Health Authority: United States: Federal Government