Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096681
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
2004-11-12
Brief Title:
Prevalence of HIV and Tuberculosis in Masiphumelele Township Cape Town South Africa
Sponsor:
CIPRA SA
Organization:
CIPRA SA
Study Overview
Official Title:
Protocol for Cross-Sectional Survey of Acid-Fast Bacilli AFB Smear Positive andor Culture Positive Tuberculosis in the Masiphumelele Township
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 fieldworkers 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
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 fieldworkers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Project 3A | US NIH GrantContract | None | httpsreporternihgovquickSearchU19AI053217 |
| U19AI053217 | NIH | None | None |
| CIPRA | None | None | None |