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

This study has been completed.
Sponsor:
Collaborators:
Comprehensive International Program of Research on AIDS
Information provided by:
CIPRA SA
ClinicalTrials.gov Identifier:
NCT00346476
First received: June 28, 2006
Last updated: February 9, 2011
Last verified: February 2011
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 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.
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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  
Number of Participants  
[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
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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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof LG Bekker
Organization: Desmond Tutu HIV Centre
phone: +27216506966
e-mail: Linda-Gail.Bekker@hiv-research.org.za


Publications:

Responsible Party: James McIntyre, CIPRA SA
ClinicalTrials.gov Identifier: NCT00346476     History of Changes
Other Study ID Numbers: CIPRA-SA Project 3B, U19AI053217
Study First Received: June 28, 2006
Results First Received: January 14, 2011
Last Updated: February 9, 2011
Health Authority: United States: Federal Government