Dual Strategy for Pregnancy and STI/HIV Prevention by Novel and Unique Approach

Background: Women are the fastest growing demographic of STI/HIV infections worldwide. They are vulnerable and suffer more from the consequences of these infections. Ulcerative and non-ulcerative STIs enhance the transmission of HIV. With no cure or vaccine, STI/HIV continues to spread despite the use of the condom. Thus far microbicides have failed to impact the spread of these infections. Therefore, STI/HIV prevention should focus on covert female-controlled prevention modalities.

Objectives: A) To provide women with a coitally- independent and covert female-controlled prevention modalities. B) To kill the STI/HIV organisms upon deposition into the vagina, and before they enter the cervix C) To shield the cervix from STI/HIV invasion and microbicides irritation, by delivering the microbicide only on the vaginal side.

Methods: The FemCap is an FDA approved cervical barrier that’s designed to shield the cervix, (site of CCR-5 and CXCR-4 receptors), from microbicide irritation and STI/HIV invasion. The FemCap delivers the microbicide on the vaginal side, to encounter the STI/HIV organisms upon deposition into the vagina. Ten women applied the microbicide mixed with Gentian dye onto the vaginal side of the FemCap, and inserted it vaginally. The cervix and vagina were photographed before, during, and 6 hours after removal of the FemCap.

Results: The bulk of the microbicide/dye came out upon removal of the FemCap without staining the cervix, while the vaginal walls were lightly stained with the dye.

Conclusions: This dual strategy of a FemCap, with microbicide can prevent pregnancy and potentially STI/HIV infections and promote safer sex without decreasing its pleasurable sensations. The microbicide on the vaginal side will encounter the STI/HIV organisms before they enter the cervix.

Implications for Programs, Policy, and/or Research: To provide women with coitally- independent alternative to the condom.