MTN-038 Study – Vaginal Ring Research Study

STUDY BASICS

Are you a female aged 18-45 who is healthy, HIV-negative, and not at risk for becoming pregnant (due to reliable use of birth control pills or patch, IUD, tubal ligation, male partner vasectomy, same-sex partner, or abstinence)? If so, you may be able to take part in a research study to help find out if a vaginal ring is safe and well-tolerated. Compensation is provided.

STUDY PURPOSE

Having unprotected sex can increase the risk of becoming infected with the human immunodeficiency virus (HIV), but anti-HIV medications can help prevent the spread of the disease. The purpose of this study is to find out if an investigational vaginal ring that contains an anti-HIV medication called tenofovir is safe and well-tolerated in women, and to find out how much medication enters and exits the body. Tenofovir in pill form is FDA-approved for the treatment and prevention of HIV, but tenofovir delivered by a vaginal ring is not. Researchers hope their findings will lead to the development of better ways to prevent the spread of HIV in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18-45
• Healthy and HIV-negative
• Not pregnant or breastfeeding
• Currently using an effective method of birth control, such as birth control pills or patch, IUD, tubal ligation (tubes “tied”), have male partner(s) with a vasectomy, have same-sex partner(s) only, or are abstinent (have not had sex for at least the past 90 days)
• Have regular menstrual cycles (at least 21 days between periods) when not using hormonal birth control
• Able to communicate in spoken and written English

WHAT PARTICIPANTS CAN EXPECT

This study involves 10 visits over the course of up to 4.5 months. During an initial screening visit to be sure you are eligible to participate, you will undergo a physical and pelvic exam, provide a urine sample, and have blood samples taken. If eligible after screening, you will be randomly assigned (like rolling a dice) to one of two study groups. One group will receive the vaginal ring containing tenofovir, and one study group will receive a vaginal ring with no study drug. During the study, participants will have physical and/or pelvic exams, blood collection, urine collection, and vaginal and rectal fluid collection. Cervical biopsies will be collected at two visits. You will also be asked to complete several questionnaires.