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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096681
• Other study ID #: CIPRA-SA Project 3A
• Secondary ID: U19AI053217CIPRA
• Status: Completed
• Phase: N/A
• First received: November 12, 2004
• Last updated: February 17, 2011
• Start date: February 2005
• Est. completion date: February 2006

Study information

• Verified date: February 2011
• Source: CIPRA SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CIPRA SA	National Institute of Allergy and Infectious Diseases (NIAID)

References & Publications (2)

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

Outcome

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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