MTN-035

STUDY BASICS

Are you a cisgender male (gender identity matches the sex assigned at birth), transgender male, or transgender female? Are you HIV-negative? Have you had at least 3 experiences of receptive anal sex in the past 3 months? You may be able to take part in a research study to help find out if three different rectal products are acceptable and well-tolerated. Compensation provided.

STUDY PURPOSE

Having unprotected anal sex can increase the risk of becoming infected with the human immunodeficiency virus (HIV). While there are treatments that can be applied inside the rectum to help prevent or reduce the sexual transmission of HIV, researchers are not sure which type of products users prefer. The purpose of this study is to help researchers learn more about three different rectal products and find out if people would accept, tolerate, and potentially use these products to deliver anti-HIV drugs into the rectum before receptive anal sex. All three rectal products in this research study are placebos, which means that they do not contain any active drug and cannot be used as protection from acquiring HIV or any other sexually transmitted infection. Researchers hope their findings will lead to better ways to prevent the spread of HIV in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Cisgender males (gender matches the sex assigned at birth), transgender males, and transgender females
• Ages 18 to 35
• HIV-negative
• Have reported at least three experiences of receptive anal sex (penis into rectum) in the past three months

WHAT PARTICIPANTS CAN EXPECT

Participation in this study involves an initial 15-20 minute phone call and screening exams that may require multiple visits and can take up to 1.5 months to complete. Eligible participants will have 8 visits that last about 1-2 hours each. Participants will be asked to use three different rectal products (rectal douche, rectal insert, and rectal suppository) before receptive anal sex for 4 weeks. The order in which you will use the three products will be decided by chance. Participants will also have blood draws and will be asked to respond to weekly text messages from the study team.