Abstract
Objectives: (A) HIV prevention, using a mechanical cervical barrier in combination with microbicide. (B) Prevention of pregnancy. (C) Shield the cervix to prevent sperm penetration and Gonorrhea, Chlamydia and HIV virus invasion. Methods: We investigated a new FDA approved cervical barrier FemCap (Figure 1). The FemCap is a contraceptive device that is designed with a unique delivery system for microbicides on its cervical and vaginal sides (Figure 4) to ensure better coverage, and retention of gel on the cervix and vagina. We also compared the acceptability and adherence with the FemCap, and retention of a stained vaginal lubricant when delivered with the FemCap versus the vaginal lubricant when delivered using a traditional vaginal applicator (Figure 2). We used the same vaginal applicator utilized in the CAPRISA 0041 study, to deliver Tenofovir microbicide. Thirty women compared the use of a vaginal applicator to deliver a high viscosity stained vaginal lubricant before and after intercourse, versus the FemCap to deliver the same lubricant once before intercourse. The acceptability and efficacy of this delivery system was evaluated. Results: Forty percent (12) women missed the application of the lubricant with the vaginal applicator before intercourse and 10% missed it after intercourse. Amongst FemCap users (3) women (10%) missed application of the vaginal lubricant before intercourse and all of them inserted it after intercourse. The stained gel was better retained over the cervix (Figure 5) by single application with the FemCap versus two applications with the traditional applicator (Figure 2). Conclusions: Women in this study preferred the FemCap due to elimination of leakage and the single application, method versus two applications with the traditional vaginal applicator. The use of the FemCap, can prevent pregnancy, HIV mother-to-child transmission, enhance compliance and retention of gel over the cervix and vagina that may potentially prevent STIs and increase the efficacy of Tenofovir.
Highlights
Despite numerous effective evidence-based preventive interventions, such as the condom [2,3], circumcision, Tenfovir gel [1], the HIV pandemic is still outpacing all the above methods
We compared the acceptability and adherence with the FemCap, and retention of a stained vaginal lubricant when delivered with the FemCap versus the vaginal lubricant when delivered using a traditional vaginal applicator (Figure 3)
We used the same vaginal applicator utilized in the CAPRISA 004 [1] study, to deliver Tenofovir microbicide
Summary
Despite numerous effective evidence-based preventive interventions, such as the condom [2,3], circumcision, Tenfovir gel [1], the HIV pandemic is still outpacing all the above methods. Suffer disproportionately more from the consequences of unplanned pregnancy and STIs/HIV infections. The cervix is the main portal of entry for the HIV virus. This is due to the presence of high concentration of the Chemokine receptors CCR5 and CRX4 on the cervix [5]. Gonorrhea and Chlamydia are intracellular organisms and they invade and colonize the endocervical canal. These non-ulcerative STIs, when present, enhance the invasion of HIV [6]. Covering the cervix by a cervical barrier in combination of spermicide/microbicide can 1) prevent sperm penetration 2) potentially prevent Gonorrhea Chlamydia, and 3) potentially prevent HIV virus invasion of the cervix
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