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Why
do this study with young adults in Botswana?
In Botswana, many young
women and men are getting infected with HIV, the virus that causes AIDS.
There are several ways to protect against getting or giving HIV including:
people who have tested negative being faithful to each other, using condoms
correctly every time a person has sex, and choosing not to have sex for a
while. But for many young adults, it is hard to behave safely all the time.
And every time they behave unsafely, they take a chance on getting or giving
HIV. In Botswana, sexually-active men and women younger than 30 are getting
infected more rapidly than people at other ages so it is especially urgent
to find additional ways to prevent HIV infection among them. Having more
effective prevention tools will help to achieve the Vision 2016 goal of no
new infections in Batswana youth.
What is Pre-Exposure Prophylaxis?
Pre-exposure prophylaxis is a medical term for giving antibiotics or
vaccines before people come in contact with an infectious agent to try and
keep them from getting infected when the contact occurs. We think this might
also work for HIV prevention because:
- giving newborns an antiretroviral when they are born seems to help
protect them from virus they are exposed to during birth
- giving a single antiretroviral to health care workers hours to days
after they are exposed to HIV by a prick from an contaminated needle
will protect most against getting infected
- giving antiretrovirals to monkeys before exposing them to SIV (the
monkey form of HIV) protects most against getting infected
What are Tenofovir (TDF) and Emtricitabine (FTC)?
TDF and FTC are antiretroviral medicines that come together in a single
pill. It is used, in combination with other antiretrovirals, to treat people
who have HIV infection. It prevents HIV from growing and spreading in the
body.
Why do we think it is safe?
TDF/FTC is widely used for treatment in the United States, Europe, and in
some African countries but not yet in Botswana. For treatment of HIV
infection, it is taken once a day, doesn't cause many side effects, and is
very slow to develop resistance. It has been tested in a few people without
HIV infection for a short period of time and it appeared to be safe for
them.
How will the study be done?
We will invite 1200 men and women in Francistown and Gaborone to join the
study. They must be citizens of Botswana, 18-29 years old, already sexually
active, and healthy. The study will be carefully explained and those people
who fully understand the study will be asked to give their consent to be in
the study. We will help everyone in the study to reduce their risk of
getting HIV infection by providing frequent counseling, diagnosis and
treatment for sexually transmitted infections, and free male and female
condoms. In addition, everyone will be given pills to take daily. Half of
the people will be randomly assigned to take TDF/FTC and half will be
randomly assigned to take a pill that looks and tastes just like TDF/FTC but
has no medicine in it (a placebo). Study participants and staff will not
know who is taking which pill. That way the hopes and fears we have about
TDF/FTC will not affect what we see during the study.
We will see study participants once a month for at least 12 months so
that we can see how they feel, how well they are doing in taking a pill
every day, and how their sexual behavior may be changing. At each visit, we
will do an HIV test and a pregnancy test for women. At some visits we will
also do physical examinations and blood tests to check how TDF/FTC and
placebo pills may be affecting people in the study. We will stop the pills
if a study participant becomes infected or pregnant or there is evidence of
developing health problems on the blood tests or exams.
Since often we cannot get people to use condoms every time they have sex,
we expect that some people in the study will put themselves at risk from
time- to-time and become exposed to HIV. At the end of the study, we will
compare how many HIV infections occurred in those who took TDF/FTC and those
who took placebo when they didn't use condoms or didn't use them correctly.
Who is doing this study?
The study is being done by the BOTUSA Project, a collaboration between
the Botswana government and the U.S. Centers for Disease Control and
Prevention.
The Health Research Development Committee in the Ministry of Health and
an ethics committee at the U.S. Centers for Disease Control and Prevention
will review and approve the study procedures before we start and will check
during the study to see that participants are safe. An international
committee of scientists who are not part of this study will also look at the
information we collect to see that participants are safe.
In addition, advice is given to the study team by a national reference
group, community advisory groups in Francistown and Gaborone, and
participant advisory groups in the two cities.
For more information about the TDF2 HIV Prevention Study,
please contact:
HIV Prevention Research Section
BOTUSA
P.O. Box 90 Gaborone
Dr. Poloko Kebaabetswe: 390-1696
FAX 397-3117
Francistown Clinic: 241-0646
Gaborone Clinic: 319-1375
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