Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa
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| ClinicalTrials.gov Identifier: NCT00096681 |
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Recruitment Status
:
Completed
First Posted
: November 15, 2004
Results First Posted
: February 17, 2011
Last Update Posted
: March 14, 2011
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| Condition or disease |
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| HIV Infections Tuberculosis |
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.
| Study Type : | Observational |
| Actual Enrollment : | 762 participants |
| 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 |
| Study Start Date : | February 2005 |
| Actual Primary Completion Date : | August 2005 |
| Actual Study Completion Date : | February 2006 |
- Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis [ Time Frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit ]Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.
- Number of Participants With a Positive HIV Test [ Time Frame: HIV status at the time of the study visit ]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
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096681
| 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 |
Publications:
| Responsible Party: | James McIntyre, CIPRA SA |
| ClinicalTrials.gov Identifier: | NCT00096681 History of Changes |
| Other Study ID Numbers: |
CIPRA-SA Project 3A U19AI053217 ( U.S. NIH Grant/Contract ) CIPRA Project 3A |
| First Posted: | November 15, 2004 Key Record Dates |
| Results First Posted: | February 17, 2011 |
| Last Update Posted: | March 14, 2011 |
| Last Verified: | February 2011 |
Additional relevant MeSH terms:
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HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |