Clinical trial NCT00096681: Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa
Official title: Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Tuberculosis
Lead sponsor: CIPRA SA
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2004-11-15
Enrollment: 762
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of the Masiphumelele township of Cape Town, South Africa

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis
timeFrame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit
Secondary outcomes:
measure: Number of Participants With a Positive HIV Test
timeFrame: HIV status at the time of the study visit
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medicine, University of Cape Town
name: Linda Gail Bekker, MBChB, FCP, PhD
role: STUDY_CHAIR
affiliation: University of the Witwatersrand and Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
name: James McIntyre, MBChB, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aaron L, Saadoun D, Calatroni I, Launay O, Memain 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. doi: 10.1111/j.1469-0691.2004.00758.x.
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. doi: 10.1016/S0140-6736(02)08904-3.