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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346476
First Posted: June 30, 2006
Last Update Posted: February 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Comprehensive International Program of Research on AIDS
Information provided by:
CIPRA SA
Results First Submitted: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Participants Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV

Participant Flow:   Overall Study
    Participants
STARTED   1250 
COMPLETED   1250 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Participants Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV

Baseline Measures
   Participants 
Overall Participants Analyzed 
[Units: Participants]
 1250 
Age 
[Units: Participants]
 
<=18 years   55 
Between 18 and 65 years   1185 
>=65 years   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.9  (9.5) 
Gender 
[Units: Participants]
 
Female   602 
Male   648 
Region of Enrollment 
[Units: Participants]
 
South Africa   1250 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Microbiologically Confirmed Tuberculosis Infection   [ Time Frame: At Year 5 ]

2.  Primary:   Number of Participants With HIV Infection   [ Time Frame: At Year 5 ]

3.  Secondary:   Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants   [ Time Frame: Year 1 to Year 5 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART   [ Time Frame: Year 1 to Year 5 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants   [ Time Frame: Year 1 to Year 5 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants   [ Time Frame: At Year 5 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information