HIV Infections Clinical Trial
Official title:
Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township
Verified date | February 2011 |
Source | CIPRA SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 762 |
Est. completion date | February 2006 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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 |
Observational Model: Ecologic or Community, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
CIPRA SA | National Institute of Allergy and Infectious Diseases (NIAID) |
Aaron L, Saadoun D, Calatroni I, Launay O, Mémain 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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit | No |
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. | HIV status at the time of the study visit | No |
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