Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa

Completed

• Conditions: HIV Infections; Tuberculosis

• Registration Number: NCT00096681
• Lead Sponsor: CIPRA SA

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 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 Timeline

• Study First Submitted: 2004-11-12
• Study First Submitted QC: 2004-11-12
• Study First Posted: 2004-11-15
• Study Start: 2005-02
• Primary Completion: 2005-08
• Study Completion: 2006-02
• Results First Submitted: 2011-01-14
• Results First Submitted QC: 2011-01-21
• Status Verified: 2011-02
• Results First Posted: 2011-02-17
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 762

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Positive HIV Test	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.