FREQUENTLY ASKED QUESTIONS

off  What is this study about?

This study will find out if HIV-negative gay/bi men who are at risk for HIV infection can safely take the HIV-drug Truvada® over a period of time, and whether taking it may reduce their chance of getting HIV. Truvada® is currently used to treat HIV- positive people.

Using a drug on an ongoing basis to prevent infection is a prevention strategy called pre-exposure prophylaxis, or PrEP. PrEP can be compared to the birth control pill - where a woman takes a pill every day to prevent herself from becoming pregnant.

Similar approaches have been used successfully against malaria and tuberculosis.
off  Who are you looking for to participate?

Globally, 3,000 men will be enrolled in this study. In San Francisco, we are planning to enroll 140.

You may be eligible for the study if:

  • you are 18 years or older
  • you are a man who has sex with other men
  • you are a transgender woman who has sex with men
  • you are HIV-negative
  • you have an active sex life
off  What is it like to be in the study?

Your first few visits are really about us getting to know each other - you learn more about the study and meet the study staff, and we get to know more about you. After you enroll in the study you will come in for monthly visits for up to two and a half years, and take one pill a day.

This is a double-blind, placebo controlled study, which means you have a 50/50 chance of getting Truvada®, or getting a placebo (dummy pill). Neither you nor the study staff will know which you got until after the study is over.

At most visits, you will receive testing and counseling for HIV and other STDs, and staff will talk to you about how you are doing with taking the pill every day, and how you are feeling.

When the study is finished, we will let you know whether you received Truvada® or the placebo, and let you know about the study results.
off  What are the side effects?

Truvada® was chosen for this study because, compared to other HIV drugs, the side effects are uncommon. Among those who do experience side effects, most are relatively mild. The most common are stomach problems, rash, or headaches.

A study doctor will be available to you at all times to discuss any other discomforts or potential problems.
off  Why study Truvada®?

Truvada® was chosen for this study for several reasons:

  1. It has fewer side effects compared to other HIV drugs
  2. It can be taken once a day.
  3. 3. HIV does not easily become resistant to Truvada®
off  Why do you offer risk reduction counseling to volunteers in the study?

Your safety is the single most important aspect of this trial. Right now, the best way known to protect against HIV is using a condom every time you have sex.

There are three reasons that condoms continue to be important for participants in PREPARE:

  1. We don't know whether Truvada® works to prevent HIV
  2. Even if Truvada® offers some protection, it may not be 100%
  3. Participants are just as likely to get a placebo, which we know offers no protection, as they are to get Truvada®

For these reasons, all participants in PREPARE will be counseled to reduce their risk for HIV, and to use condoms and lube.
off  What do I get for participating?

If you enroll in the study, you will be a part of a ground-breaking study that may lead to a new method for preventing HIV right here in San Francisco, and around the world.

You will also receive $50 a visit for your time and transportation, and free counseling and testing for HIV and other STDs. You will also receive free medical and physical exams and have access to a study clinician at all times to answer any questions or concerns that arise from study participation.
off  How will we know if it works?

This is a placebo-controlled double-blind study. 'Placebo-controlled' means participants will be randomly assigned to a group that takes the active study drug or a group that takes the placebo (dummy pill). In PREPARE, half of participants will get Truvada®, and half will get placebo. 'Double blind' means that neither the study staff nor the participants will know who got which until after the study is over.

All men will get counseling to help them reduce their risk behavior during the study. After all of the study participants have completed their final visits, investigators will compare the Truvada® and placebo groups to see if there is a difference in the number of people who became HIV positive. For example, if Truvada ® is effective in offering protection against HIV, we would expect to see fewer HIV infections in that group than in the group that took the placebo.

For safety reasons, an independent panel of reviewers will periodically examine the study data, and will know which participants received study drug or placebo. That panel has the power to end the study early if it appears that taking Truvada® causes unanticipated harm, or if the study does not need to continue because the results become clear earlier than expected.

off  Why do some people have to take placebo, or dummy pill?

Half of the participants in PREPARE will take a placebo so investigators have a group with whom to compare the Truvada® group. Without a placebo group, researchers would not know whether results they see in the Truvada® group have to do with the drug, or with other factors such as, the risk reduction counseling provided, or with something else happening in the community as a whole. Because participants are randomly assigned to get either Truvada® or the placebo, the only difference between the two groups is the drug.

The reason participants aren't told whether they are getting Truvada® or placebo is because a participant who knows he is taking Truvada® might get the idea that he has extra protection and take more risks than someone who is taking the placebo. This might put him in danger, because we don't know whether Truvada® is protective, and it also would make it more difficult to tell whether the drug itself was effective.

Similarly, staff members don't know which participants got which pill so that they can't offer certain participants one or the other, and so they aren't tempted to counsel participants differently.

This kind of study, placebo-controlled and double-blind, is considered the gold standard for clinical research.
off  If you are offering risk reduction counseling, why do you think some participants will still get HIV?

If education and counseling were enough to stop risk behavior altogether, we would not still be seeing 7-10 new HIV infections in San Francisco every week.

We are committed to offering the best counseling and support we can to all of our participants, and we would hope that none become HIV positive during the study. But sexual behavior is complicated, and there are many reasons a person might find it difficult to protect himself.

Furthermore, people are not always in control of their own risk, for reasons such as alcohol and drug use, stigma and homophobia, or imbalance of power in their relationships due to economic status, gender, or other issues.

It is for these reasons that new HIV prevention methods are so urgently needed.
off  What happens if I become HIV+ while enrolled in this study?
off  Why is this study only recruiting gay/bi men?
off  Who is sponsoring the study?