MTN-044 Study

STUDY BASICS

Are you a woman aged 18-45 who is not using hormonal birth control and is not at risk for pregnancy? If so, you may be able to take part in a research study to help develop a vaginal ring for HIV and pregnancy prevention. Compensation is provided.

STUDY PURPOSE

Researchers are working to develop a vaginal ring that can prevent both pregnancy and the spread of HIV. The vaginal ring contains two medications: dapivirine, a drug being studied to prevent HIV, and levonorgestrel, a contraceptive hormone used in different types of birth control such as pills, IUDs, and implants. The purpose of this study is to find out how dapivirine and levonorgestrel enter and exit the body when a vaginal ring containing the two drugs is used continuously (without being taken out) or cyclically (worn for approximately 28 days, taken out for 2 days, and re-inserted back into the vagina) over 3 months. Another purpose is to find out more about the acceptability of the ring and its effects on vaginal bleeding. Researchers hope their findings will help develop vaginal rings that can be used to prevent both pregnancy and HIV.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18-45
• Not using hormonal birth control (ex., birth control pills, hormone-containing IUDs or implants)
• Not at risk for pregnancy
• HIV-negative
• Have regular menstrual periods (approximately once every 21-35 days with no bleeding in-between periods)

WHAT PARTICIPANTS CAN EXPECT

This study involves 15 visits and at least one phone call over about 6-8.5 months. During an initial visit to see if you qualify for the study, you will have a physical exam, pelvic exam, urine pregnancy test, and blood draw. If eligible after screening, you will be randomly assigned (like the flip of a coin) to one of two study groups. Some participants will use the vaginal ring continuously for 90 days and some will use the ring for 28 days and then remove it for 2 days for a total of three cycles. During the remaining visits, participants will have additional blood draws and exams, and the collection of vaginal fluids and cervical tissue. Participants will also be asked to complete questionnaires and answer daily text messages.