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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
CIPRA SA
ClinicalTrials.gov Identifier:
NCT00096681
First received: November 12, 2004
Last updated: February 17, 2011
Last verified: February 2011

November 12, 2004
February 17, 2011
February 2005
August 2005   (final data collection date for primary outcome measure)
Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis [ Time Frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit ] [ Designated as safety issue: No ]
Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.
Not Provided
Complete list of historical versions of study NCT00096681 on ClinicalTrials.gov Archive Site
Number of Participants With a Positive HIV Test [ Time Frame: HIV status at the time of the study visit ] [ Designated as safety issue: No ]
Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Sputum samples

Probability Sample

Residents of the Masiphumelele township of Cape Town, South Africa

  • HIV Infections
  • Tuberculosis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
762
February 2006
August 2005   (final data collection date for primary outcome measure)

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
Both
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00096681
CIPRA-SA Project 3A, U19AI053217, CIPRA, Project 3A
No
James McIntyre, CIPRA SA
CIPRA SA
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
CIPRA SA
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP