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A public cervix announcement: CERVICAL BARRIER METHODS AND HIV/STI PREVENTION Ibis Reproductive Health Cervical Barrier Advancement Society Version 2 ©

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Presentation on theme: "A public cervix announcement: CERVICAL BARRIER METHODS AND HIV/STI PREVENTION Ibis Reproductive Health Cervical Barrier Advancement Society Version 2 ©"— Presentation transcript:

1 A public cervix announcement: CERVICAL BARRIER METHODS AND HIV/STI PREVENTION Ibis Reproductive Health Cervical Barrier Advancement Society Version 2 © September 2004

2 Overview Section 1: What are cervical barriers? Section 2: About cervical barriers: history, effectiveness, safety, and acceptability Section 3: The logic behind testing cervical barriers for HIV/STI prevention Section 4: Clinical and acceptability research on cervical barriers for HIV/STI prevention Section 5: Female controlled HIV/STI prevention – expanding options Section 6: Regulatory issues and N-9

3 A Public Cervix Announcement What are cervical barriers (CBs)? SECTION 1

4 Diaphragm Indications for use as a contraceptive: Insert diaphragm with spermicide before intercourse Apply more spermicide before additional acts of intercourse Leave the diaphragm in place for at least six hours after intercourse Do not wear for more than 24 hours What is it? A latex or silicone cup with a firm flexible rim and shallow dome that can be coated with gel and folded for insertion into the vagina

5 The diaphragm is designed to be held in place by the vaginal walls, the posterior fornix, and the pubic arch.

6 Diaphragms in the US Ortho All-Flex, by Ortho- McNeil Pharmaceutical Ortho All-Flex, by Ortho- McNeil Pharmaceutical Ortho Coil Spring, by Ortho-McNeil Pharmaceutical Ortho Coil Spring, by Ortho-McNeil Pharmaceutical Wide Seal, by Milex Products, Inc. Wide Seal, by Milex Products, Inc.

7 Other diaphragms Semina, by Semina Industries and Commerce, Ltd. Semina, by Semina Industries and Commerce, Ltd. Flat Spring, by Reflexions Flat Spring, by Reflexions

8 Cervical Cap What is it? A small, firm latex or silicone cup designed to adhere to the cervix by suction and to hold gel close to the cervix Indications for use as a contraceptive: Insert cap with spermicide before intercourse It is optional to apply more spermicide before additional acts of intercourse Leave the cap in place for at least eight hours after intercourse Cervical caps are approved to be worn up to 48 hours in the US and up to 72 hours in Europe

9 Unlike the diaphragm, the cervical cap is held in place by suction. It covers the cervix at the top of the vagina.

10 Cervical Caps in the US Prentif cervical cap, by Lamberts (Dalston), Ltd. Prentif cervical cap, by Lamberts (Dalston), Ltd. FemCap cervical cap, by FemCap, Inc. FemCap cervical cap, by FemCap, Inc.

11 Other cervical caps Oves cervical cap, by Veos UK, Ltd. Oves cervical cap, by Veos UK, Ltd. Dumas, by Lamberts (Dalston), Ltd., UK Dumas, by Lamberts (Dalston), Ltd., UK Vimule, by Lamberts (Dalston), Ltd., UK Vimule, by Lamberts (Dalston), Ltd., UK

12 Other cervical barrier methods Lea’s Shield contraceptive, by Yama, Inc. Lea’s Shield contraceptive, by Yama, Inc.

13 New CBs under development SILCS diaphragm, by PATH SILCS diaphragm, by PATH BufferGel cup, by ReProtect, Inc. BufferGel cup, by ReProtect, Inc.

14 A Public Cervix Announcement About cervical barriers: history, effectiveness, safety, and acceptability SECTION 2

15 History of cervical barriers Ancient methods: crocodile dung pessaries, lemon halves, and beeswax plugs Ancient methods: crocodile dung pessaries, lemon halves, and beeswax plugs First CBs developed in Europe in 1842 First CBs developed in Europe in 1842 Rising usage in Europe in the early 20 th century Rising usage in Europe in the early 20 th century Popularized in the US by Sanger in the 1920s Popularized in the US by Sanger in the 1920s By 1930, most frequently prescribed contraceptive By 1930, most frequently prescribed contraceptive

16 Establishing a protocol in the US Early History – grassroots birth control Early History – grassroots birth control Medicalization of contraceptive devices Medicalization of contraceptive devices –Legal constraints (Comstock Laws) –Distribution: Physicians vs. Over the Counter Fitting requirement? Fitting requirement?

17 Current use Approved for family planning purposes Approved for family planning purposes BUT BUT –Limited distribution worldwide –Limited clientele in the US (client demand, provider bias) –Myths and misconceptions

18 Contraceptive efficacy Effectiveness depends on correct and consistent use Effectiveness depends on correct and consistent use Effectiveness of the cervical cap is lower for women who have already given birth Effectiveness of the cervical cap is lower for women who have already given birth Diaphragm (plus spermicide) Efficacy Rates Cervical Cap (plus spermicide) Efficacy Rates Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Nelson A, Cates W, Guest F, Kowal D. Contraceptive Technology: Eighteenth Revised Edition. New York, NY: Ardent Media, 2004.

19 Safety In general, CB users report few side effects. However, users should be aware of Urinary Tract Infections (UTI) – some evidence implicates spermicide (Fihn, Handley) Urinary Tract Infections (UTI) – some evidence implicates spermicide (Fihn, Handley) Bacterial Vaginosis (BV) – clear association, causality not established (Hooton, Mauck) Bacterial Vaginosis (BV) – clear association, causality not established (Hooton, Mauck) Toxic Shock Syndrome (TSS) – very rare, associated with wear >24 hours (Baehler, Hyde) Toxic Shock Syndrome (TSS) – very rare, associated with wear >24 hours (Baehler, Hyde)

20 Acceptability Acceptability is used to describe both the initial selection of a method and satisfaction with use of that method. Acceptability is used to describe both the initial selection of a method and satisfaction with use of that method. Influences on acceptability Influences on acceptability –Selection  Provider Bias  Perceived Efficacy  Perceived Safety  Convenience –Use  Partner Attitude  Service Provision  Side Effects  Ease of use

21 Research on diaphragm acceptability –Colombia, Turkey, Philippines Bulut A et al. Assessing the acceptability, service delivery requirements, and use-effectiveness of the diaphragm in Colombia, Philippines, and Turkey. Contraception. 2001 May;63(5):267-75. –Brazil do Lago TD et al. Acceptability of the Diaphragm Among Low-Income Women in Sao Paulo, Brazil. International Family Planning Perspectives. 1995 Sep:21(3):114-118. –India Ravindran TKS and Rao SS, Is the diaphragm a suitable method of contraception for low-income women: a user perspectives study, Madras India. Available at http://www.who.int/reproductive- health/publications/beyond_acceptability_users_perspectives_on_contracepti on/ravindran.en.pdf http://www.who.int/reproductive- health/publications/beyond_acceptability_users_perspectives_on_contracepti on/ravindran.en.pdf http://www.who.int/reproductive- health/publications/beyond_acceptability_users_perspectives_on_contracepti on/ravindran.en.pdf

22 A Public Cervix Announcement The logic behind testing cervical barriers for HIV/STI prevention SECTION 3

23 Reasons to consider cervical barriers as potential HIV prevention methods Woman-initiated, woman-controlled Woman-initiated, woman-controlled Need not interrupt sexual activity Need not interrupt sexual activity May be used without partner knowledge May be used without partner knowledge Durable, reusable Durable, reusable Good track record Good track record May be used with a microbicide May be used with a microbicide Approved by regulatory authorities Approved by regulatory authorities

24 Why cover the cervix? The cervix is fragile The cervix is fragile –Entrance lined with delicate columnar epithelial cells –This layer is only 1 cell thick Preferential site of infection for many STIs Preferential site of infection for many STIs –Bacterial pathogens (gonorrhea, chlamydia) –Human papilloma virus Concentration of HIV receptor sites Concentration of HIV receptor sites Protection of the upper genital tract Protection of the upper genital tract Moench T, Chipato T, Padian N. 2001. Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barrier devices. AIDS, 15(13):1595-1602.

25 Anderson D. HIV immunology. Oral presentation, Diaphragm Renaissance; Sept 2002.

26 Potential limitations to using CBs for HIV/STI prevention No protection for the vulva, urethra, and vagina (unless used with a microbicide) No protection for the vulva, urethra, and vagina (unless used with a microbicide) Protection of the cervix alone is likely to be incomplete Protection of the cervix alone is likely to be incomplete

27 Data supporting the potential for diaphragms as STI preventives Observational studies of diaphragm use with spermicide Observational studies of diaphragm use with spermicide –20-55% reduction in gonorrhea (Austin, Quinn, Rosenberg) (Austin, Quinn, Rosenberg) –Up to 75% reduction in chlamydia and trichomonosis (McCormick, Magder, Cramer, Rosenberg, Park) –60-70% reduction in pelvic inflamatory disease (PID) (Kelaghan, Wolner-Hanssen) –70% reduction in cervical neoplasia (CIN) (Hildesheim, Becker) See also: Rosenberg and Gollub, 1992 (Am J Public Health, 82:1473-8)

28 Observational Studies Reporting the Association Between Diaphragm Use and STIs Design Sample STI Odds Ratio 95% Con Limit Author Case Control STD Clinic GC.45.15-1.3 Austin et al Cross Sec STD Clinic GC.8 Magder et al Cross Sec STD Clinic GC.32*.16-.45 Rosenberg et al Trich.24*.12-.48 CT.25.05-1.36 Case Control CIN II, III.3*.1-.8 Becker et al Case Control STD Clinic PID.3.09-.75 Wolner-Hansen et al et al Case Control Hospital PID.4.2-.7 Keleghan et al *Also significantly protective when compared to condom users From: Moench T, Chipato T, Padian N. 2001. Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barrier devices. AIDS, 15(13):1595-1602.

29 A Public Cervix Announcement Clinical and acceptability research on cervical barriers for HIV/STI prevention SECTION 4

30 MIRA Trial What is it? A randomized, controlled trial to measure the effectiveness of the diaphragm used with lubricant gel in preventing HIV infection What is it? A randomized, controlled trial to measure the effectiveness of the diaphragm used with lubricant gel in preventing HIV infection among women among women How does it work? How does it work? –All participants receive condoms, safe sex counseling, and STI treatment sex counseling, and STI treatment –Half also receive a diaphragm and gel and counseling on use –We will compare outcomes between these groups Where is it happening? South Africa and Zimbabwe Where is it happening? South Africa and Zimbabwe When will we know the results? By 2007 When will we know the results? By 2007

31 Other research on the diaphragm for HIV/STI prevention Kenya: Acceptability of the diaphragm for HIV/STI prevention among family planning clinic clients and sex workers (by CDC/International Center for RH) Kenya: Acceptability of the diaphragm for HIV/STI prevention among family planning clinic clients and sex workers (by CDC/International Center for RH) Dominican Republic: Study of the diaphragm’s protective effects against chlamydia and gonorrhea in sex workers (by Population Council) Dominican Republic: Study of the diaphragm’s protective effects against chlamydia and gonorrhea in sex workers (by Population Council) Zimbabwe: Phase I trial to examine the safety of diaphragm use with cellulose sulfate gel (a candidate microbicide) (by CONRAD/UZ-UCSF) Zimbabwe: Phase I trial to examine the safety of diaphragm use with cellulose sulfate gel (a candidate microbicide) (by CONRAD/UZ-UCSF) Other planned trials Other planned trials –Efficacy –Safety –Acceptability

32 UZ-UCSF Diaphragm Acceptability Study Comfort using the diaphragm UZ-UCSF Diaphragm Acceptability Study Comfort using the diaphragm 93% were very comfortable putting k-y jelly on the diaphragm and cleaning the diaphragm 93% were very comfortable putting k-y jelly on the diaphragm and cleaning the diaphragm 92% were very comfortable inserting and removing the diaphragm 92% were very comfortable inserting and removing the diaphragm 89% were very 89% were very comfortable having the diaphragm inside them 86% were very 86% were very comfortable with leaving the diaphragm in for 6 hours after sex

33 Acceptability of the diaphragm for HIV prevention among US women at risk N=140 ethnically-diverse women at risk for HIV/STIs. N=140 ethnically-diverse women at risk for HIV/STIs. Findings Findings –diaphragm has positive attributes –but messy and difficult to insert/remove. –disadvantages noted may be overcome by product design or provider intervention. About 3/4 of these women would be more likely to use the diaphragm if About 3/4 of these women would be more likely to use the diaphragm if –They were confident about their ability to use the method, and –If the diaphragm offered protection against HIV. Harvey SM, Bird ST. A new look at an old method: exploring diaprhagm use among women in two U.S. samples. Poster presentation. Microbicides 2004, London, March 2004. Harvey SM, et al. Exploring diaphragm use as a potential HIV prevention strategy among women at risk. Forthcoming.

34 Recent publications on diaphragm acceptability in the US Bird ST, Harvey SM, Maher JE, Beckman LJ. Women’s Health Issues. 2004 14(3):85-93. Harvey SM et al. Women’s Health Issues. 2003 Nov; 13:185-93. Maher JE, Harvey SM, Bird ST, Stevens VJ, Beckman LJ. Perspectives on Sexual and Reproductive Health. 2004 36(2):64-71.

35 Future Directions in Research Acceptability of CBs in different settings Acceptability of CBs in different settings Safety and risks of CB use Safety and risks of CB use Importance of fitting Importance of fitting Continuous vs. episodic use Continuous vs. episodic use Impact of use with or without chemical barriers such as spermicide Impact of use with or without chemical barriers such as spermicide Surrogate markers of exposure to semen to validate research methods Surrogate markers of exposure to semen to validate research methods

36 Female-controlled HIV/STI prevention – expanding options A Public Cervix Announcement SECTION 5

37 HIV/STIs and women Worldwide, half of all new HIV infections occur in women Africa (UNAIDS) Africa (UNAIDS) –In 2003, 58% of the 26.6 million HIV+ people in SSA were women. –Women ages 15-24 are 2.5 times more likely to be HIV+ than young men. United States (CDC) United States (CDC) –During 1999-2002, 64% of heterosexually acquired HIV infections occurred among women. –64% of new HIV infections among women occurred in African- Americans and 18% in Latinas. –Women are expected to experience 50% of all new HIV infections by 2010.

38 Why are female-controlled methods important? Women are biologically more vulnerable to HIV/AIDS Women are biologically more vulnerable to HIV/AIDS –Larger exposed mucosal surfaces, high viral concentration in infected semen, untreated STIs Some HIV prevention messages may be ineffective for women who lack power Some HIV prevention messages may be ineffective for women who lack power –Economic need or dependency –Social and cultural norms –Gender-based violence Current methods (abstinence, fidelity, and condom use) often require male consent, knowledge, or cooperation Current methods (abstinence, fidelity, and condom use) often require male consent, knowledge, or cooperation

39 Female-controlled methods Expanding Options: Cervical barriers (being researched) Cervical barriers (being researched) Female condom (currently available) Female condom (currently available) Microbicides (under development) Microbicides (under development)

40 Female Condom Reality Female Condom Female Health Company, USA www.femalehealth.com www.femalecondom.org

41 What is a female condom? A highly effective, woman-controlled barrier method that has been tested and approved by the FDA and WHO A highly effective, woman-controlled barrier method that has been tested and approved by the FDA and WHO Offers dual protection against pregnancy AND sexually transmitted infections Offers dual protection against pregnancy AND sexually transmitted infections Use is not dependent on male erection, does not constrict the penis, and does not require immediate withdrawal after ejaculation Use is not dependent on male erection, does not constrict the penis, and does not require immediate withdrawal after ejaculation Polyurethane is 40% stronger than latex used in male condoms and can be used with either water or oil-based lubricants Polyurethane is 40% stronger than latex used in male condoms and can be used with either water or oil-based lubricants

42 Facts about the female condom Estimated reduction of risk of HIV infection 97.1% Estimated reduction of risk of HIV infection 97.1% Contraceptive failure rate (one year, consistent and correct use) 5% (compared to 3% male condom, 6% diaphragm) Contraceptive failure rate (one year, consistent and correct use) 5% (compared to 3% male condom, 6% diaphragm) Less breakage and potentially less irritation than male condoms Less breakage and potentially less irritation than male condoms Approved by US FDA; European Union CE Mark for Quality Approved by US FDA; European Union CE Mark for Quality Available through the public sector in 80 countries; commercially available in 17 Available through the public sector in 80 countries; commercially available in 17 50-93% of male and female study participants around the world found the female condom acceptable 50-93% of male and female study participants around the world found the female condom acceptable Availability of the female condom increases the number of protected acts of intercourse Availability of the female condom increases the number of protected acts of intercourse

43 Carraguard® Micralax® applicator For more information on microbicides Global Campaign for Microbicides www.global-campaign.org Alliance for Microbicide Development www.microbicide.org International Partnership for Microbicides www.ipm-microbicides.orgMicrobicides

44 What is a microbicide? Any substance (i.e. gel, cream, film, suppository, sponge, etc.) that can substantially reduce transmission of HIV or other STIs when applied topically Any substance (i.e. gel, cream, film, suppository, sponge, etc.) that can substantially reduce transmission of HIV or other STIs when applied topically Could work by disabling pathogens, enhancing natural defenses, blocking or preventing the spread of infection Could work by disabling pathogens, enhancing natural defenses, blocking or preventing the spread of infection Could be produced in both contraceptive and non-contraceptive form Could be produced in both contraceptive and non-contraceptive form A microbicide is NOT yet available to the public A microbicide is NOT yet available to the public

45 Facts about microbicides Although we have lots of laboratory data on many of the current microbicide candidates, no product has yet been shown to work in women Although we have lots of laboratory data on many of the current microbicide candidates, no product has yet been shown to work in women A microbicide could be available in about 5-7 years A microbicide could be available in about 5-7 years Research around the world has found that women and men like the idea of a microbicide and say they would use it or would support their partner using it Research around the world has found that women and men like the idea of a microbicide and say they would use it or would support their partner using it Data from clinical trials confirm that women find microbicides acceptable—even where “dry sex” is practiced and many women report improved sexual pleasure with microbicide use Data from clinical trials confirm that women find microbicides acceptable—even where “dry sex” is practiced and many women report improved sexual pleasure with microbicide use See for example: Coggins C, Blanchard K, Friedland B. Men’s attitudes toward a potential vaginal microbicide in Zimbabwe, Mexico and the USA. Reproductive Health Matters 2000;8(15):132-141.; Ellertson C et al. A randomized, placebo-controlled, triple-blind, expanded safety trial of Carraguard® microbicide gel in South Africa. Oral presentation. 13 th International AIDS Conference, Barcelona, July 2002.

46 Regulatory issues and Nonoxynol-9 (N9) A Public Cervix Announcement SECTION 6

47 US Food and Drug Administration – regulatory status of CBs Device classification Device classification –I (Low risk; general controls) –II (Moderate risk; general & special controls) –III (High risk; general controls & premarket approval) Diaphragm and cervical caps are class II Diaphragm and cervical caps are class II Classification based on advisory input Classification based on advisory input

48 Regulatory issues and the diaphragm Diaphragm fitting requirement Diaphragm fitting requirement –Based on advisory input –May be a barrier to access Labeling for use with spermicide Labeling for use with spermicide –HIV/STI vs. contraception vs. dual use Often easier to increase rather than ease restrictions Often easier to increase rather than ease restrictions More research necessary to ensure access isn’t unnecessarily impeded More research necessary to ensure access isn’t unnecessarily impeded

49 N9 use recommendations CDC and WHO agree on the following: N-9 is a safe, effective contraceptive option for women at low risk for HIV/STIs who do not use the product more than once a day N-9 is a safe, effective contraceptive option for women at low risk for HIV/STIs who do not use the product more than once a day N-9 should not be used to prevent HIV/STIs N-9 should not be used to prevent HIV/STIs N-9 should not be used rectally N-9 should not be used rectally

50 N9 policy issues FDA proposed label change for N-9 products FDA proposed label change for N-9 products –Offers no protection from HIV/STIs –Public comments received, no change yet Call to discontinue rectal use of N-9 (Global Campaign for Microbicides and others) Call to discontinue rectal use of N-9 (Global Campaign for Microbicides and others) Need to preserve and expand woman- controlled OTC options for contraception Need to preserve and expand woman- controlled OTC options for contraception

51 Summary Cervical barriers are safe, effective woman-controlled contraceptives with a long history of use. Cervical barriers are safe, effective woman-controlled contraceptives with a long history of use. Cervical barriers are currently being studied to see if they reduce transmission of HIV/STIs. Cervical barriers are currently being studied to see if they reduce transmission of HIV/STIs. A range of female-controlled HIV/STI prevention and contraceptive options is necessary to meet women’s needs. A range of female-controlled HIV/STI prevention and contraceptive options is necessary to meet women’s needs.

52 More information Cervical Barrier Advancement Society (CBAS) Cervical Barrier Advancement Society (CBAS) –www.cervicalbarriers.org www.cervicalbarriers.org Ibis Reproductive Health Ibis Reproductive Health –www.ibisreproductivehealth.org www.ibisreproductivehealth.org Diaphragm Renaissance Conference Diaphragm Renaissance Conference – –www.rho.org/html/cont_diaphragm_renaissance.htmwww.rho.org/html/cont_diaphragm_renaissance.htm


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