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Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach

Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach. Alfred Shihata, MD. Current Problems. No Cure No Vaccine Condom is not an option for many women So far Microbicides, have failed. The Condom. Microbicides. Kill the HIV virus in the in-vitro

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Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach

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  1. Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach Alfred Shihata, MD

  2. Current Problems • No Cure • No Vaccine • Condom is not an option for many women • So far Microbicides, have failed

  3. The Condom

  4. Microbicides • Kill the HIV virus in the in-vitro • So far microbicides are not proven to be effective in the vagina • N-9 and Cellulose sulfate increased the HIV transmission when compared to placebo • Pro-2000,Buffergel,and Carragaurd were safe but not effective

  5. Valuable Lessonsfrom the Microbicides clinical trials

  6. We must not forget… • Anatomy • Physiology • Immunology of the cervix and the vagina

  7. Anatomy and Physiology of the Vagina

  8. Immunology Unlike all other viruses, the HIV virus attacks and destroys the immune cells. Therefore the more immune cells at the cervix, the higher the risk for HIV transmission.

  9. Microbicides irritate the cervix and provoke an immune response

  10. Objectives for STI/ HIV prevention by this new dual strategy • It must be woman-controlled, and coitally independent. • To kill the HIV virus before it enters the cervical or vaginal cells. • To shield the cervix and vagina from HIV invasion and microbicide irritation. • Eliminate or minimize contact of the HIV virus to the genital mucous membrane . • To prevent pregnancy.

  11. Microbicides still hold the best promise for HIV prevention The FemCap is designed to enhance the safety and efficacy of microbicides

  12. Criteria for the ideal Microbicide • Should be gentle enough not to irritate the cervix or provoke an immune response • It should be strong enough to kill the STIs and HIV microorganisms • It should NOT disrupt the vaginal ecosystem. • Stronger is not better

  13. The FemCap prevents sperm and STI/HIV from entering the cervix

  14. The FemCap’s MicrobicideDelivery System Mimics Test Tube Condition This unique delivery system is facing the vaginal opening to protect the cervix.

  15. The FemCap effectively protects the cervix and prevents sperm, bacteria and viruses from entering the cervix Uterus (Womb) The FemCapcovering the cervix Vagina

  16. New Delivery System FemCap

  17. FemCap with Microbicide& Gentian Violet

  18. Healthy Cervix and Vagina

  19. FemCap + Microbicide / Gentian Violet dye left in situ for 6 hours Microbicide / Gentian Violet dye in the FemCap Delivery System

  20. Cervix and Vagina after removal of FemCap Result, No stain was visible over the cervix

  21. Facts • HIV virus is very fragile in-vitro. • The cervix is the main portal of entry to the HIV virus. • Thus far all Microbicides have failed • Microbicides applied by applicator or diaphragm may elicit an immune response and disrupt the vaginal ecology. • Many people do not accept the condom due to interruption of spontaneity and reduced sexual sensations.

  22. FemCap • The FemCap does not interrupt spontaneity or reduce sexual pleasure to both partners. • It is a fit and forget for 48 hours. • Itis woman-controlled and coitally independent. • It is re-usable for one-two years, and does not pose any environmental hazards • It is FDA approved, inexpensive and made of non-allergenic materials

  23. Feasibility and acceptability of cervical barriers (CB) among vulnerable youth:in Africa, A pilot study in Zimbabwe FemCap February 7, 2007 (Revised) US Principal Investigator: Ariane van der Straten, PhD, MPH Women’s Global Health Imperative Department of Obstetrics, Gynecology and Reproductive Sciences University of California, San Francisco Zimbabwe Principal Investigator: Michael Chirenje, MD, MRCOG, FRCOG University of Zimbabwe: University of California, San Francisco Collaborative Programme in Women’s Health

  24. HIV PREGNANCY STI In Summary This dual strategy of FemCap/Microibicide can potentially achieve the three critical goals: • Prevent HIV transmission • STI infections • Prevent Pregnancy

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