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
  Purpose

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.


Condition
HIV Infections
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township

Resource links provided by NLM:


Further study details as provided by CIPRA SA:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Sputum samples


Enrollment: 762
Study Start Date: February 2005
Study Completion Date: February 2006
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Residents of the Masiphumelele township of Cape Town, South Africa

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096681

Sponsors and Collaborators
CIPRA SA
Investigators
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
  More Information

Additional Information:
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014