HIV Infections Clinical Trial
Official title:
A Study of the Effects of Antiretroviral Therapy on Rates and Transmission of Tuberculosis
The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV. This study will also examine the genetics of TB and the relationships among active TB infection, new HIV infections, and HIV disease progression.
TB is the most common opportunistic infection and the single most common cause of death in
HIV infected people in Africa today. Latent TB infection has been known to revert to active
TB following new infection in HIV infected people; also, TB has been shown to accelerate the
progression of HIV disease. These epidemiologic relationships between TB and HIV and the
high prevalence of these diseases in sub-Saharan Africa make studying TB and HIV infected
populations in this region of the world important. The Masiphumelele Township of Cape Town,
South Africa, with its high rates of TB and HIV, is representative of many poor communities
in Africa. The purpose of this study is to observe people from the Masiphumelele Township
over a 5-year period to assess the prevalence of TB and HIV infections in a random sample of
people and the clinical and genetic characteristics of active TB infection.
This study has two parts: a random cross-sectional survey and a clinical and genetic
assessment of TB patients. Participants in the random survey will only be involved with the
study for a maximum of 2 days. The purpose of the first part of the study is to compare the
prevalence of active TB and the prevalence of HIV infection in a random sample of people
from the Masiphumelele Township. In this part of the study, children and adults will be
randomly selected from the township population to determine the prevalence of active TB and
the prevalence of HIV infection in this group of people. Fieldworkers will identify eligible
participants in the township and will ask them to visit the clinic that day or the next. At
the clinic, participants will be asked to complete a demographics and TB history
questionnaire and provide a saliva sample for anonymous HIV testing. A sputum sample will be
collected from each participant with a nebulizer; each participant will also be given a
sputum sample bottle and will be asked to collect an early morning sputum sample on the next
day that will be returned to the clinic.
The second part of the study will enroll TB patients. Participants in this part of this
study will be followed for the course of their TB treatment for at least 6 months. The
purpose of the second part of the study is to assess changes through time of the clustering
and transmission of TB among HIV infected and uninfected people in the Masiphumelele
Township. This assessment will include examining the diversity of TB strains in this
population and determining the relationship between recurrent cases of TB and HIV infection.
All sputum samples indicating TB infections that were previously collected from participants
will undergo genetic testing by restriction fragment length polymorphism (RFLP) analysis.
Participants will be asked to complete a demographics and TB history questionnaire and
provide a saliva sample for anonymous HIV testing. Participants will also be interviewed
about treatment they have received for TB, their responses to this treatment, and whether
they are currently on highly active antiretroviral therapy (HAART) for the treatment of HIV
infection.
Participants who are found to be infected with TB during the first part of the study will be
offered TB treatment through the clinic and will be invited to participate in the second
part of this study. Participants who are found to be infected with HIV during the study will
be referred to further treatment and evaluation.
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Observational Model: Ecologic or Community, Time Perspective: Prospective
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