HIV/STIs and Pregnancy Prevention, Using a Cervical Barrier and Microbicide

Alfred A. Shihata, Steven A. Brody

.

DOI: 10.4236/wja.2011.14018                

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.

Keywords

HIV Prevention, Microbicide Tenofovir, FemCap Delivery System

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	Q. A. Karim, S. S. A. Karim, J. A. Frohlich, et al., “Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women,” Science, Vol. 329, No. 5996, 2010, pp. 1168- 1174.
[2]	T. Silvio, D. Martinelli, C. Germinario, et al., “Determining Factors for Condom Use: A Survey of Young Italian Adults,” European Journal of Contraception Reproductive Health Care, Vo. 15, No. 1, 2010, pp. 24-30. doi:10.3109/13625180903427683
[3]	R. A. Crosby, W. L. Yarber, C. A. Graham, et al., “Does It Fit Okay? Problems with Condom Use as a Function of Self-Reported Poor Fit,” Sexually Transmitted Infections, Vo. 86, No. 1, 2010, pp. 36-38. doi:10.1136/sti.2009.036665
[4]	World Savvy Monitor, “HIV/AIDS and Sexually Transmitted Infections,” Global Status of Women, 2009. http://worldsavvy.org/monitor/index.php?option=com_content&view=article&id=582&Itemid=1029
[5]	J. Pudney, A. J. Quayle and D. J. Anderson, “Immunological Microenvironments in the Human Vagina and Cervix: Mediators of Cellular Immunity Are Concentrated in the Cervical Transformation Zone,” Biology of Reproduction, Vol. 73, No. 6, 2005, pp. 1253-1263. doi:10.1095/biolreprod.105.043133
[6]	M. Laga, A. Manoka, M. Kivuvu, et al., “Non-Ulcerative Sexually Transmitted Diseases as Risk Factors for HIV-1 Transmission in Women: Results from a Cohort Study,” AIDS, Vol. 7, No. 1, 1993, pp. 95-102. doi:10.1097/00002030-199301000-00015
[7]	L. Van Damme, G. Ramjee, M. Alary, et al., “Effectiveness of COL-1492, a Nonoxynol-9 Vaginal Gel, on HIV-1 Transmission in Female Sex Workers: A Randomised Controlled Trial,” Lancet, Vol. 360, No. 9938, 2002, pp. 971-977. doi:10.1016/S0140-6736(02)11079-8
[8]	L. Van Damme, R. Govinden, F. Mirembe, et al., “Lack of Effectiveness of Cellulose Sulfate Gel for the Prevention of Vaginal HIV Transmission,” The New England Journal of Medicine, Vol. 359, 2008, pp. 463-472. doi:10.1056/NEJMoa0707957
[9]	S. Salim, “HIV Prevention Gel Proven Ineffective in Largest Clinical Trials,” Centre for the AIDS Program of Research in South Africa (CAPRISA), University of KwaZulu-Natal, 2009, pp. 527-529.
[10]	S. Skoler-Karpoff, G. Ramjee, K. Ahmed, et al., “Efficacy of Carraguard for Prevention of HIV in Women in South Africa,” Lancet, Vol. 372, No. 9654, 2008, pp. 1977-1987. doi:10.1016/S0140-6736(08)61842-5
[11]	A. Shihata and S. Brody, “HIV Prevention by Enhancing Compliance of Tenofovir Microbicide. Using a Novel Delivery System,” HIV &AIDS Review, Vol. 9, No. 4, 2010, pp. 107-110.
[12]	H. Carcio, M. Clarke Secor and R. Koeniger-Donohue, “Advanced Health Assessment of Women: Clinical Skills and Procedures, Chapter 15 The FemCap,” Springer Publishing Company, New York, 2010, pp. 271-278.
[13]	R. Koeniger-Donohue, “The FemCap: A Non-Hormonal Contraceptive,” Women’s Health Care, Vol. 5, No. 4, 2006, pp. 79-91.
[14]	A. Shihata, “The FemCap?, a New Contraceptive Choice,” European Journal of Contraception Reproductive Health Care, Vol. 3, 1998, pp. 160-166.
[15]	D. Shoupe and S. Kjos, “The Handbook of Contraception, Barrier Contraceptives,” Humana Press, Totowa, 2006, pp. 147-177.
[16]	A. Shihata, “Microbicides Delivery System,” 5th European Congress on Tropical Medicine and International Health, Amsterdam, 24-28 May 2007, pp. 131-134.
[17]	A. Shihata, “Novel Delivery System for Microbicides,” 2007 National HIV Prevention Conference, Atlanta, 2-5 December 2007, p. 378.
[18]	A. Shihata, “New FDA Approved Woman-Controlled, Latex-Free Barrier Contraceptive Device ‘FemCap?’,” Fertility and Sterility, Vol. 5, No. 103, 2004, pp. 303-330.
[19]	A. Shihata and E. Gollub, “Acceptability of a New Intravaginal Barrier Contraceptive Device FemCap,” Contraception, Vol. 46, No. 6, 1992, pp. 511-519. doi:10.1016/0010-7824(92)90115-A
[20]	A. van der Straten, N. Sahin-Hodoglugil, K. Clouse, S. Mtetwa and M. Z. Chirenje, “Feasibility and Potential Acceptability of Three Cervical Barriers among Vulnerable Young Women in Zimbabwe,” Journal of Family Planning and Reproductive Health Care, Vol. 36, No. 1, 2010, pp. 13-19.