PREVENT Study

STUDY BASICS

Are you 18-45 years old and comfortable discussing your sexual history with researchers? If so, you may be able to participate in a research study to help find out if an investigational microbicide enema called Q-GRFT is safe when applied inside the rectum, to learn more about how Q-GRFT works in the body, and to better understand how people feel about using this product. Compensation provided.

STUDY PURPOSE

Having unprotected anal sex can increase the risk of becoming infected with the human immunodeficiency virus (HIV). Microbicides are drugs designed to prevent or reduce the sexual transmission of HIV or other sexually transmitted infections when applied inside the rectum.

The purpose of this study is to find out if an investigational microbicide called Q-GRFT is safe when applied inside the rectum, to learn more about how Q-GRFT works in the body, and to better understand how people feel about using this product. It is currently unknown if Q-GRFT protects against HIV infection. Researchers hope their findings may lead to new ways to prevent the spread of HIV and other sexually transmitted infections in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Males and females aged 18-45
• HIV-negative & willing to be tested for HIV
• Had receptive anal sex at least 5 times in your lifetime and at least once in the past year
• No sexually transmitted disease in the past 3 months
• No HIV-positive sexual partners within the past 6 months
• No participation in anal sex without use of condoms with more than one partner in the past six months

WHAT PARTICIPANTS CAN EXPECT

Eligible participants will have about 5 visits over about 12 weeks Participants will be randomly assigned (like the flip of a coin) to receive a single dose of either the Q-GRFT enema or a placebo enema (an enema without Q-GRFT). The enema will be administered by a study clinician.

Tests and assessments during the study include questionnaires, physical exams, urine and blood tests (including testing for HIV infection), and collection of fluid and tissue from the rectum.