MATRIX-003 Study

STUDY BASICS

Are you 18-45 years old? Were you assigned female at birth? You may be eligible to participate in a research study to assess the safety and acceptability of two placebo vaginal products. Compensation is provided.

STUDY PURPOSE

The purpose of this research study is to assess the safety and acceptability of two vaginal placebo products in approximately 100 women across sites in the US and Africa. The products are being used in HIV research. However, the products that are being used in this study are placebos and do not contain any medication. They do not prevent HIV.

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants:

• Were assigned female at birth
• Are 18-45 years old 
• Are not pregnant or breastfeeding

WHAT PARTICIPANTS CAN EXPECT

There are a total of 9 study contacts at UPMC Magee-Womens Hospital over approximately 9-11 weeks. The visits consist of 7 office visits and 2 phone calls. In-person study visits take approximately 1 hour and phone calls typically take 5 minutes or less. Study participants use two slightly different placebo vaginal products, leaving them in place for 28 days each time. You would be given instructions and asked to insert the vaginal product yourself. If you were unable to insert it successfully, a study clinician would use a speculum to place it for you.

We also collect saliva, blood, urine, and genital specimens to check general health, vaginal health, to test for pregnancy, HIV and STIs. We ask participants to avoid using any other vaginal products for the entire duration of the study. For the first two weeks each product is in place, we also ask participants to abstain from sexual activity involving the vagina.