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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI053217 | U.S. NIH Grant/Contract | View source | |
| CIPRA | |||
| Project 3A |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis | Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit. | Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Positive HIV Test | Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit. | HIV status at the time of the study visit |
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Inclusion Criteria:
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Residents of the Masiphumelele township of Cape Town, South Africa
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| 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 and Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital | Principal Investigator |
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| 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. | |
| 12086758 | Background | Badri M, Wilson D, Wood R. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet. 2002 Jun 15;359(9323):2059-64. doi: 10.1016/S0140-6736(02)08904-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants From the Community | The number of participants from the community who attended the clinic for a once off study visit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants From the Community | The number of participants from the community who attended the clinic for a once off study visit |
| Units | Counts |
|---|---|
| Participants |
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| 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 Pulmonary Tuberculosis | Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit. | Posted | Jan 2011 | Number | Participants | Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants From the Community | The number of participants from the community who attended the clinic for a once off study visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof LG Bekker | Desmond Tutu HIV Centre | +2721 633 6599 | 21 | Linda-Gail.Bekker@hiv-research.org.za |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Sputum samples
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants With a Positive HIV Test | Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit. | Posted | Number | Participants | HIV status at the time of the study visit |
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| 0 |
| 762 |
| 0 |
| 762 |
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| 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 |