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FREQUENTLY ASKED QUESTIONS

off  What is this study testing?

The purpose of this study is to find out if Truvada®, a medication used for the treatment of HIV infection, can be taken safely by HIV-negative gay/bi men who are at risk for HIV infection and whether it can lower the chance of getting infected with HIV.
off  Who is doing this study?

PREPARE is part of an international study sponsored by the National Institutes of Health (NIH) and Gladstone Institute of Virology and Immunology, associated with the University of California, San Francisco. We plan to enroll 3,000 men in the study. The sites in the U.S. are in Boston and San Francisco.
off  You are eligible if:
  • you are 18 years or older
  • you are a man who has sex with other men
  • you don't have HIV
  • you have an active sex life
off  Why should I participate?

Be a part of the solution! As the HIV epidemic continues to grow around the world and in our communities, we need new prevention tools.
off  Why study Truvada®?

Truvada® was chosen for this study for several reasons. We know that it has low levels of side effects compared to other medications used to treat HIV. It can be taken once a day. HIV does not easily become resistant to Truvada®. Studies in animals have shown that Truvada® can sometimes prevent infection with a virus similar to HIV.
off  What's involved in PREPARE?
  • You will come in for monthly visits for up to 2 years.
  • You will take one pill each day.
  • Half of the participants will get Truvada® and the other half will get placebo (dummy pill).
  • Neither you nor the study staff will know what you received until after the study is over.
  • Participation in this study is completely voluntary and you may quit at any time.
off  What happens during study visits?
  • HIV antibody testing and obtain you results the same day (rapid HIV test)
  • Sexually Transmitted Infection (STI) testing
  • Hepatitis B and C testing, and Hepatitis B vaccination if needed
  • Counseling about how to better protect yourself from HIV and STIs
  • Provide your medical history and receive a physical exam
  • Blood and urine samples will be taken at some visits
  • Participants who agree to the bone density and metabolic substudy will have a bone density scan (a special X-ray that measures the thickness of your bones) every 6 months
  • Every 3 months you will use a computer program to report sexual and substance use activity and whether you are able to take a pill every day
off  Why is it important that I continue to practice safer sex while in this study?
  • It is unknown whether Truvada® prevents HIV infection.
  • You may be taking the placebo, which does not protect against HIV.
off  What happens if I become HIV+ while enrolled in this study?
  • You will stop taking study pills.
  • We will offer you medical and other referrals for HIV care.
  • You will continue to come in for visits until the end of the study.
  • We will check your CD4 count, viral load, and viral resistance at these visits.
off  How will I be compensated for my time?

Study participants will receive $50 for their time and travel costs.