DREAM-01 Research Study

STUDY BASICS

Are you an HIV-negative man who is comfortable discussing your sexual history with researchers? If so, you may be able to participate in a research study to find out if an investigational microbicide enema is safe and effective for HIV prevention. Participants must have flexible schedules. Compensation provided.

STUDY PURPOSE

HIV-negative men who have sex with other men are less likely to become infected with HIV if they take HIV medications on a daily basis. HIV medications taken in this way are called HIV pre-exposure prophylaxis (PrEP). The medication being used in this study is called tenofovir. Tenofovir is FDA-approved when used in a combination tablet with another HIV medication as pre-exposure prophylaxis (PrEP). In this study, tenofovir is considered to be investigational because it is the first study in humans in which tenofovir is delivered using an enema. Researchers do not currently know if tenofovir enemas protect against HIV infection. The purpose of this study is to find out if tenofovir enemas are safe and effective when used for the prevention of HIV infection associated with anal sex.

COULD THIS STUDY BE RIGHT FOR YOU?

• Males ages 18 and up
• HIV-negative
• History of consensual receptive anal intercourse at least five times and at least once in the prior 3 months
• Have used an enema or douche in past year

WHAT PARTICIPANTS CAN EXPECT

Participation in this study requires 16 in-person study visits at the Magee-Womens Hospital Clinical and Translational Research Center (CTRC) over about 5-6 months. Certain study visits are long, so participants need to have flexible schedules. Some tests and procedures that will be performed at study visits are: answering questions by research staff or completing computerized questionnaires, physical examinations which may include rectal exams, urine and blood tests including STD/HIV testing, and collection of rectal fluid and rectal biopsies (small samples of tissue the size of a grain of rice).