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
  Purpose

The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV. This study will also examine the genetics of TB and the relationships among active TB infection, new HIV infections, and HIV disease progression.


Condition
HIV Infections
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Study of the Effects of Antiretroviral Therapy on Rates and Transmission of Tuberculosis

Resource links provided by NLM:


Further study details as provided by CIPRA SA:

Primary Outcome Measures:
  • Number of Participants With Microbiologically Confirmed Tuberculosis Infection [ Time Frame: At Year 5 ] [ Designated as safety issue: No ]
  • Number of Participants With HIV Infection [ Time Frame: At Year 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants [ Time Frame: Year 1 to Year 5 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Sputum, Saliva


Enrollment: 1250
Study Start Date: April 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants
Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV

Detailed Description:

TB is the most common opportunistic infection and the single most common cause of death in HIV infected people in Africa today. Latent TB infection has been known to revert to active TB following new infection in HIV infected people; also, TB has been shown to accelerate the progression of HIV disease. These epidemiologic relationships between TB and HIV and the high prevalence of these diseases in sub-Saharan Africa make studying TB and HIV infected populations in this region of the world important. The Masiphumelele Township of Cape Town, South Africa, with its high rates of TB and HIV, is representative of many poor communities in Africa. The purpose of this study is to observe people from the Masiphumelele Township over a 5-year period to assess the prevalence of TB and HIV infections in a random sample of people and the clinical and genetic characteristics of active TB infection.

This study has two parts: a random cross-sectional survey and a clinical and genetic assessment of TB patients. Participants in the random survey will only be involved with the study for a maximum of 2 days. The purpose of the first part of the study is to compare the prevalence of active TB and the prevalence of HIV infection in a random sample of people from the Masiphumelele Township. In this part of the study, children and adults will be randomly selected from the township population to determine the prevalence of active TB and the prevalence of HIV infection in this group of people. Fieldworkers will identify eligible participants in the township and will ask them to visit the clinic that day or the next. At the clinic, participants will be asked to complete a demographics and TB history questionnaire and provide a saliva sample for anonymous HIV testing. A sputum sample will be collected from each participant with a nebulizer; each participant will also be given a sputum sample bottle and will be asked to collect an early morning sputum sample on the next day that will be returned to the clinic.

The second part of the study will enroll TB patients. Participants in this part of this study will be followed for the course of their TB treatment for at least 6 months. The purpose of the second part of the study is to assess changes through time of the clustering and transmission of TB among HIV infected and uninfected people in the Masiphumelele Township. This assessment will include examining the diversity of TB strains in this population and determining the relationship between recurrent cases of TB and HIV infection. All sputum samples indicating TB infections that were previously collected from participants will undergo genetic testing by restriction fragment length polymorphism (RFLP) analysis. Participants will be asked to complete a demographics and TB history questionnaire and provide a saliva sample for anonymous HIV testing. Participants will also be interviewed about treatment they have received for TB, their responses to this treatment, and whether they are currently on highly active antiretroviral therapy (HAART) for the treatment of HIV infection.

Participants who are found to be infected with TB during the first part of the study will be offered TB treatment through the clinic and will be invited to participate in the second part of this study. Participants who are found to be infected with HIV during the study will be referred to further treatment and evaluation.

  Eligibility

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

HIV and TB infected and uninfected individuals

Criteria

Inclusion Criteria for All Participants:

  • Willing to comply with study requirements
  • Parent or guardian willing to provide informed consent, if applicable

Inclusion Criteria for Participants in First Part of the Study:

  • Live in Masiphumelele Township, Cape Town, South Africa for at least 1 week

Inclusion Criteria for Participants in Second Part of the Study:

  • Live in Masiphumelele Township, Cape Town, South Africa
  • Registered TB patient at the study site

Exclusion Criteria for All Participants:

  • Currently incarcerated

Exclusion Criteria for Participants in Second Part of the Study:

  • No Mycobacterium tuberculosis specimen obtained from the participant for genetic analysis
  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: NCT00346476

Locations
South Africa
Desmond Tutu HIV Centre Department of Medicine
Cape Town, Western Cape, South Africa, 7925
Desmond Tutu HIV Centre Department of Medicine
Cape Town, South Africa, 8005
Sponsors and Collaborators
CIPRA SA
Comprehensive International Program of Research on AIDS
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, Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
  More Information

Additional Information:
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

Keywords provided by CIPRA SA:
TB
Transmission
Genetic Diversity
Genetic Testing
RFLP

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

ClinicalTrials.gov processed this record on July 23, 2014