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

NCT00346476 | Completed Results

• 2 other identifiers: CIPRA-SA Project 3BU19AI053217
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV Infections; Tuberculosis

Keywords

TB; Transmission; Genetic Diversity; Genetic Testing; RFLP

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Microbiologically Confirmed Tuberculosis Infection

  At Year 5

• Number of Participants With HIV Infection

  At Year 5

Secondary Outcomes (4)

• Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants

  Year 1 to Year 5

• Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART

  Year 1 to Year 5

• Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants

  Year 1 to Year 5

• Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants

  At Year 5

Study Arms (1)

Participants

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV and TB infected and uninfected individuals

You may qualify if:

• Willing to comply with study requirements
• Parent or guardian willing to provide informed consent, if applicable
• Live in Masiphumelele Township, Cape Town, South Africa for at least 1 week
• Live in Masiphumelele Township, Cape Town, South Africa
• Registered TB patient at the study site

You may not qualify if:

• Currently incarcerated
• No Mycobacterium tuberculosis specimen obtained from the participant for genetic analysis

Sponsors & Collaborators

• CIPRA SA: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Comprehensive International Program of Research on AIDS: collaborator

Study Sites (2)

Desmond Tutu HIV Centre Department of Medicine

Cape Town, Western Cape, 7925, South Africa

Location

Desmond Tutu HIV Centre Department of Medicine

Cape Town, 8005, South Africa

Location

Related Publications (7)

• Aaron L, Saadoun D, Calatroni I, Launay O, Memain N, Vincent V, Marchal G, Dupont B, Bouchaud O, Valeyre D, Lortholary O. Tuberculosis in HIV-infected patients: a comprehensive review. Clin Microbiol Infect. 2004 May;10(5):388-98. doi: 10.1111/j.1469-0691.2004.00758.x.

  PMID: 15113314 BACKGROUND

• Badri M, Ehrlich R, Wood R, Pulerwitz T, Maartens G. Association between tuberculosis and HIV disease progression in a high tuberculosis prevalence area. Int J Tuberc Lung Dis. 2001 Mar;5(3):225-32.

  PMID: 11326821 BACKGROUND

• Friedland G, Harries A, Coetzee D. Implementation issues in tuberculosis/HIV program collaboration and integration: 3 case studies. J Infect Dis. 2007 Aug 15;196 Suppl 1:S114-23. doi: 10.1086/518664.

  PMID: 17624820 BACKGROUND

• Kwara A, Flanigan TP, Carter EJ. Highly active antiretroviral therapy (HAART) in adults with tuberculosis: current status. Int J Tuberc Lung Dis. 2005 Mar;9(3):248-57.

  PMID: 15786886 BACKGROUND

• Maher D, Harries A, Getahun H. Tuberculosis and HIV interaction in sub-Saharan Africa: impact on patients and programmes; implications for policies. Trop Med Int Health. 2005 Aug;10(8):734-42. doi: 10.1111/j.1365-3156.2005.01456.x.

  PMID: 16045459 BACKGROUND

• Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis. 2007 Aug 15;196 Suppl 1:S15-27. doi: 10.1086/518656.

  PMID: 17624822 BACKGROUND

• Wood R, Maartens G, Lombard CJ. Risk factors for developing tuberculosis in HIV-1-infected adults from communities with a low or very high incidence of tuberculosis. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):75-80. doi: 10.1097/00126334-200001010-00010.

  PMID: 10708059 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sputum, Saliva

MeSH Terms

Conditions

HIV Infections; Tuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: Prof LG Bekker
• Organization: Desmond Tutu HIV Centre

Linda-Gail.Bekker@hiv-research.org.za

+27216506966

Study Officials

• Linda Gail Bekker, MBChB, FCP, PhD

  Department of Medicine, University of Cape Town

  STUDY CHAIR

• James McIntyre, MBChB, MRCOG

  University of the Witwatersrand, Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 30, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 11, 2011
• Results First Posted: February 9, 2011

Record last verified: 2011-02

Locations

ZA (2)