Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U19AI053217 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Comprehensive International Program of Research on AIDS | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Microbiologically Confirmed Tuberculosis Infection | At Year 5 | |
| Number of Participants With HIV Infection | At Year 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria for All Participants:
Inclusion Criteria for Participants in First Part of the Study:
Inclusion Criteria for Participants in Second Part of the Study:
Exclusion Criteria for All Participants:
Exclusion Criteria for Participants in Second Part of the Study:
Not provided
Not provided
Not provided
HIV and TB infected and uninfected individuals
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desmond Tutu HIV Centre Department of Medicine | Cape Town | Western Cape | 7925 | South Africa | ||
| Desmond Tutu HIV Centre Department of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15113314 | Background | 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. | |
| 11326821 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Microbiologically Confirmed Tuberculosis Infection | Posted | Jan 2011 | Number | participants | At Year 5 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof LG Bekker | Desmond Tutu HIV Centre | +27216506966 | Linda-Gail.Bekker@hiv-research.org.za |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Sputum, Saliva
| 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 |
| Cape Town |
| 8005 |
| South Africa |
| 17624820 | 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. |
| 15786886 | 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. |
| 16045459 | 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. |
| 17624822 | 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. |
| 10708059 | 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants | Not Posted | Year 1 to Year 5 |
| Secondary | Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART | Not Posted | Year 1 to Year 5 |
| Secondary | Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants | Not Posted | Year 1 to Year 5 |
| Secondary | Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants | Not Posted | At Year 5 |
| Primary | Number of Participants With HIV Infection | Posted | Jan 2011 | Number | participants | At Year 5 |
|
|
|
| 0 |
| 1,250 |
| 0 |
| 1,250 |
Not provided
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |