MTN-036 Study of Extended Duration Dapivirine Vaginal Ring for HIV Prevention How do I know if I’m Eligible to join? Women who join the study must meet the following criteria: HIV-negative, in good health Born female, age 18 through 45 years Regular menstrual cycles Not pregnant or breast feeding and using/willing to use reliable contraception Women will need to be willing to refrain from using non-study vaginal products during the study and abstain from receptive sex for 72 hours prior to each study visit. Study staff will thoroughly review your eligibility if you decide to screen for the study. For more information, contact:   <study coordinator> <email> <phone> Information and FAQs MTN-036 Study of Extended Duration Dapivirine Vaginal Ring for HIV Prevention  

Are there any risks to participation? What is this study? The main purpose of this research study is to find out how the anti-HIV medication, dapivirine, enters and exits the body when administered via a vaginal ring. The study will compare vaginal rings with a dose of either 100mg or 200mg of dapivirine, worn consistently for 13 weeks, to a 25mg ring worn for 4 or 5 weeks at a time.   This research will also help determine if there are any differences in safety between the three rings. Why is this study being done? Since there is no cure for HIV/AIDS, studies are being done to find ways to prevent getting HIV. It may be especially important to have HIV prevention options available to women that fit their lifestyle. Vaginal rings can be cheap, discrete, and easy to use. Thousands of women have participated in clinical trials testing the monthly 25mg dapivirine vaginal ring, which has been found to be safe and effective at preventing HIV. This study is the first step in determining whether the two dapivirine vaginal rings intended for extended use could also provide a safe option for women. Are there any risks to participation?   Some women may feel uncomfortable wearing the ring or experience side effects, like vaginal irritation. Study staff will discuss the risks of study participation and any concerns you may have at the screening visit and again before you make a final decision about joining the study. Are there any benefits? There may be no direct benefit to women who participate. However, study participants will receive counseling and testing for HIV and other sexually transmitted infections, and referrals for additional care, if necessary. Information learned from this study may help in the development of new HIV prevention methods. What will I be asked to do if I join the study? If study staff think you may be a good fit for MTN-036, a screening visit will be scheduled so you can learn more about the study and investigators can determine if you are eligible to be enrolled. If you are found to be eligible and decide to enroll in the study, you will be asked to complete ten additional study visits over the course of approximately 13 weeks. You will be at assigned at random to one of the three dapivirine vaginal ring types used in this study. Additionally, when you come for study visits, you may: Be asked questions about your health Have a physical exam and pelvic exam Provide blood, urine, vaginal fluid, rectal fluid, and cervical tissue samples You will be reimbursed for your time, effort, and travel to/from the study clinic.