1. A public cervix announcement: CERVICAL BARRIER METHODS AND HIV/STI PREVENTION
Ibis Reproductive Health is a non-profit organization based in Cambridge, MA that aims to improve women’s reproductive health, choices and autonomy. Ibis’s work includes clinical and social science research, policy analysis, and evidence-based advocacy.
The Cervical Barrier Advancement Society (CBAS) is an international professional networking organization that aims to raise the profile of cervical barrier methods both for preventing pregnancy and potentially HIV and other sexually transmitted infections (STIs).
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
The presentation is divided into 6 sections which can put together or rearranged as appropriate for any particular audience.
The 6 sections are as follows:
Section 1: What are cervical barriers?
Section 2: About cervical barriers: 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: New cervical barrier products
Section 6: Regulatory issues and N-9

3. What are cervical barriers (CBs)?
SECTION 1
What are cervical barriers (CBs)?
Section 1: What are cervical barriers?
Cervical barriers, including diaphragms and cervical caps, are latex or silicone cups that fit at the upper end of the vaginal tract, covering the cervix.
This photo shows a variety of available cervical barrier methods.
A Public Cervix Announcement

4. Diaphragm
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
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
A diaphragm is 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.
Current indications for use dictate that a diaphragm must be coated in spermicide and inserted before intercourse.
Users should apply more spermicide before additional acts of intercourse.
After intercourse, the user should leave the diaphragm in place for at least 6 hours
But a diaphragm should not be worn for more than 24 consecutive hours

5. The diaphragm is designed to be held in place by the vaginal walls, the posterior fornix, and the pubic arch.
This diagram shows proper insertion of the diaphragm. When it is being worn, a diaphragm is held in place by the walls of the vagina, the posterior fornix, and the pubic arch.

6. Diaphragms in the US Ortho All-Flex, by Ortho-McNeil Pharmaceutical
Ortho Coil Spring, by Ortho-McNeil Pharmaceutical
Wide Seal, by Milex Products, Inc.
3 different diaphragms are available in the US
-Ortho All Flex (latex)
-Ortho Coil Spring (latex)
-Milex Wide Seal (silicone, wide rim)

7. Other diaphragms Semina, by Semina Industries and Commerce, Ltd.
Flat Spring, by Reflexions
Other diaphragms include
-Semina (silicone, coil spring, available in Brazil)
-Flat spring (available in Britain)

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
A cervical cap is a small, firm latex cup designed to adhere to the cervix by suction and to hold gel close to the cervix.
Current indications for use instruct users to fill the cup with spermicide and insert it before intercourse.
Reapplication of spermicide is OPTIONAL
Users should leave a cervical cap in place for at least 8 hours after intercourse.
Cervical caps can be worn longer than diaphragms. They are approved to be worn for 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
Unlike the diaphragm, the cervical cap is held in place by suction. It covers the cervix at the top of the vagina.
Whereas the diaphragm is held in place by the physical structures of the reproductive tract, the cervical cap adheres to the cervix and is held in place by suction. It is positioned at the top of the vagina, covering the cervix.
This diagram compares diaphragm and cap insertion.

10. Cervical Caps in the US
Prentif cervical cap, by Lamberts (Dalston), Ltd.
FemCap cervical cap, by FemCap, Inc.
In the US, there are 2 cervical caps available
-Prentif
-FemCap

11. Other cervical caps Oves cervical cap, by Veos UK, Ltd.
Dumas, by Lamberts (Dalston), Ltd., UK
Vimule, by Lamberts (Dalston), Ltd., UK
3 different caps are available outside of the US
-Oves (disposable)
-Dumas
-Vimule

12. Other cervical barrier methods
Lea’s Shield contraceptive, by Yama, Inc.
The Lea’s Shield contraceptive is a new one-size fits all silicone barrier method. Lea’s shield has a removal loop and a valve for the passage of cervical secretions and menstrual fluid. It is FDA approved and available in the US.

13. New CBs under development
SILCS diaphragm, by PATH
BufferGel cup, by ReProtect, Inc.
New types of cervical barrier methods are currently being developed
The BufferGel cup is a one-size cup that is disposible and pre-loaded with BufferGel, a candidate microbicide and contraceptive. It is called a cervico-vaginal device (CVD), to emphasize that its intent is to protect the cervix and vagina.
Finally, SILCS is a new type of diaphragm that will come in 1 size. It is shaped with an arched rim and small finger cup for easy removal.

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

15. History of cervical barriers
Ancient methods: crocodile dung pessaries, lemon halves, and beeswax plugs
First CBs developed in Europe in 1842
Rising usage in Europe in the early 20th century
Popularized in the US by Sanger in the 1920s
By 1930, most frequently prescribed contraceptive
Historically, cervical barriers have been used for thousands of years.
Ancient texts document the use of crocodile dung pessaries, lemon halves, and beeswax plugs
The first modern cervical barriers were developed in Europe in 1842.
By the early 20th century, cervical barriers had gained popularity throughout Europe
And in the 1920s, Margaret Sanger popularized cervical barriers in New York City and throughout America
In fact, by 1930, the diaphragm was the most frequently prescribed contraceptive method in the USA

16. Establishing a protocol in the US
Early History – grassroots birth control
Medicalization of contraceptive devices
Legal constraints (Comstock Laws)
Distribution: Physicians vs. Over the Counter
Fitting requirement?
Early efforts by Sanger and others promoted a grassroots birth control movement where women from all walks of life could use contraceptives without reliance on doctors.
However, this position proved to be extremely challenging given the legal obstacles presented by the Comstock Laws, which prohibited or restricted the sale and advertisement of contraception in many states.
After consultation with a Dutch doctor (Dr. Aletta Jacobs), Sanger began to promote physician control over the distribution of contraceptive information and technology.
Promotion and advertisement of cervical barrier methods focused on the superiority of fitted diaphragms over the cervical caps and pessaries available over the counter. Sanger and doctors affiliated with her claimed that physician fitting greatly improved the contraceptive efficacy of barrier methods.
In this way, physician-fittings became the norm, and this norm was codified into FDA protocol in Since then, research on diaphragm fitting has often been weak and/or inconclusive. The existing clinical trial literature does not indicate that diaphragm fitting is necessary, but nor does it provide adequate evidence that fitting is needless.
Future studies may help clarify this question.
Currently, however, the fitting requirement remains in place and may help to explain low usage rates in some settings

17. Current use Approved for family planning purposes BUT
Limited distribution worldwide
Limited clientele in the US (client demand, provider bias)
Myths and misconceptions
Currently, cervical barriers are approved around the world for family planning purposes.
However, low usage rates stem from
-limited distribution worldwide
-limited clientele in the US – due in part to provider bias about the types of patients who can and should use these methods as well as a selection bias on the part of patients themselves.
-Many women do not have a demand for cervical barriers because they do not have good accurate information about these methods.
Diaphragm use as percentage of methods used by
contracepting women in the US:
1995 – All 1.9% (Whites, 2.1%; Blacks, 0.8%)
1988 – All 5.7% (Whites, 6.4%; Blacks, 1.9%)
(CDC data from NSFG survey

18. Contraceptive efficacy
Effectiveness depends on correct and consistent use
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
Cervical barriers can be a very effective means of pregnancy prevention, but effectiveness depends on correct and consistent use. Efficacy rates are distinguished for perfect use, which is always correct and consistent, and typical use.
It is also important to note that the effectiveness of the cervical cap is affected by parity, with nulliparous women having higher efficacy rates than parous women.
Average efficacy rates for diaphragms and cervical caps are shown.
With perfect use, the diaphragm compares favorably, even with hormonal methods. It is 94% effective with perfect use. With typical use, the diaphragm is about 84% effective.
For non-parous women, the cervical cap is 91% effective with perfect use, and 84% effective with typical use. Effectiveness decreases for parous women. With perfect use, the cervical cap is 74% effective, and it is 68% effective for parous women with typical use patterns.
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)
Bacterial Vaginosis (BV) – clear association, causality not established (Hooton, Mauck)
Toxic Shock Syndrome (TSS) – very rare, associated with wear >24 hours (Baehler, Hyde)
Cervical barriers are extremely safe, and users report very few side effects. However, patients and providers should be aware of potential complications with urinary tract infections (UTI), bacterial vaginosis (BV), and toxic shock syndrome (TSS).
Currently available information about the association between cervical barriers and the aforementioned medical conditions indicates
-Evidence implicates spermicide used together with a diaphragm (not the diaphragm itself) in the increase in UTIs among diaphragm users. This evidence is gathered primarily from trial of N-9 which showed a dose dependent association between use of the product and UTI. Propsective randomized trails are needed to separate the effect of the cervical barrier device itself from that of the spermicide.
-There is an association between cervical barriers and BV, but causality has not been established.
-TSS is very rare and associated with prolonged wear of the diaphragm (more than 24 hours).

20. Acceptability
Acceptability is used to describe both the initial selection of a method and satisfaction with use of that method.
Influences on acceptability
Selection
Provider Bias
Perceived Efficacy
Perceived Safety
Convenience
Use
Partner Attitude
Service Provision
Side Effects
Ease of use
If the diaphragm does prove to be effective against HIV, then it’s widespread use will be governed not only by distribution, but also by acceptability. The term acceptability is used to describe both selection and use of the diaphragm. However, the differences between initial choice and use should be clearly defined and evaluated given that studies have shown differences between perceptions of and experiences with the diaphragm.
Acceptability is particularly hard to assess because there are a variety of strong influences on both selection and continued use of cervical barrier methods. Patient and provider perceptions impact whether or not the patient selects a particular method.
Once a woman has decided to try a barrier method, the quality and continuation of use is affected by partner attitudes, the quality of associated care and by any potential side effects that a user may experience. How a woman experiences her contraceptive method is multifaceted, and evaluating and understanding her experience is key to understanding acceptability 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 May;63(5):
Brazil
do Lago TD et al. Acceptability of the Diaphragm Among Low-Income Women in Sao Paulo, Brazil. International Family Planning Perspectives Sep:21(3):
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
Research into the topic of diaphragm acceptability has been conducted around the world. Studies in developing countries such as Columbia, Turkey, Philippines, Brazil, and India have shown that many women find the diaphragm to be an acceptable contraceptive method.

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

23. Reasons to consider cervical barriers as potential HIV prevention methods
Woman-initiated, woman-controlled
Need not interrupt sexual activity
May be used without partner knowledge
Durable, reusable
Good track record
May be used with a microbicide
Approved by regulatory authorities
Cervical barriers have characteristics that may make them good potential HIV protection methods for women and girls.
CBs are used and controlled by the woman
If inserted before sex, CBs don’t interrupt sexual activity.
CBs may be used without a partner’s knowledge or consent
They are reusable and durable and have a good track record with respect to safety
May be used in conjunction with (eventual) microbicide
Finally, CBs are approved and currently in use

24. Why cover the cervix? 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
Bacterial pathogens (gonorrhea, chlamydia)
Human papilloma virus
Concentration of HIV receptor sites
Protection of the upper genital tract
Why cover the cervix?
-First, the cervix is extremely fragile. The entrance to the cervix is lined with delicate columnar epithelial cells which are only 1 layer thick. The vagina, on the other hand, is lined with a tough squamous epithelium.
-Secondly, the cervix is the preferential site of infection for many STIs, including bacterial pathogens such as gonorrhea and chlamydia as well as human papilloma virus.
-Also, new evidence shows a concentration of HIV receptor and co-receptor sites in the delicate lining of the entrance to the cervix.
-Finally, the cervix is the entryway to the upper genital tract, and covering the cervix will also protect these vulnerable areas from infection
Moench T, Chipato T, Padian N Preventing disease by protecting the cervix:  the unexplored promise of internal vaginal barrier devices.  AIDS, 15(13):

25. Recent research on HIV virology and immunology shows a concentration of HIV receptors and coreceptors in the cervix and UGT. (from Deborah Anderson) Covering the cervix with a diaphragm or cap could protect these vulnerable areas. However, it is important to note the there are receptors in the vagina, an area that would not be protected by a cervical barrier, and this area may be especially vulnerable in women who are infected with ulcerative an ulcerative STI.
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)
Protection of the cervix alone is likely to be incomplete
Covering the cervix, while promising for the reasons just noted, also places some limitations on the potential for dual protection. It leaves some areas physically unprotected. Cervical barriers offer no protection for the vagina, vulva or urethra. And, because it has been noted that hysterectomized women can still get HIV, cervical barriers do not offer complete protection from potential infections.

27. Data supporting the potential for diaphragms as STI preventives
Observational studies of diaphragm use with spermicide
20-55% reduction in gonorrhea
(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)
In addition to the biological premise for testing CBs for HIV/STI prevention, observational studies of the diaphragm used with spermicide indicate a potential protective effect.
These studies show between 20-70% reduction in STI transmission among diaphragm users.
Of course, these data are just observational, and do not come from RCT. We cannot recommend CBs for STI prevention based on this data, but more research using a more rigorous design is now underway.
See also: Rosenberg and Gollub, 1992 (Am J Public Health, 82:1473-8)

28. Observational Studies Reporting the Association Between Diaphragm Use and STIs
From: Moench T, Chipato T, Padian N Preventing disease by protecting the cervix:  the unexplored promise of internal vaginal barrier devices.  AIDS, 15(13):
Design Sample STI Odds Ratio % Con Limit Author
Case Control STD Clinic GC Austin et al
Cross Sec STD Clinic GC Magder et al
Cross Sec STD Clinic GC .32* Rosenberg et al Trich * CT
Case Control CIN II, III .3* Becker et al
Case Control STD Clinic PID Wolner-Hansen
et al
Case Control Hospital PID Keleghan et al
*Also significantly protective when compared to condom users
This chart, adapted from a paper by Moench, Chipato, and Padian, show details of the findings of the observational studies I just showed you. In 6 cases the women who used the diaphragm were statistically significantly less likely to have PID, CIN, GC, and Trich. The 2 others studies show a reduction, but it was not statistically significant.

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

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
among women
How does it work?
All participants receive condoms, safe
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
When will we know the results? By 2007
Research is currently underway to investigate whether or not diaphragm use may reduce transmission of HIV and other STIs. This study is called the Methods for Improving Reproductive Health in Africa (MIRA) trial. Ibis is collaborating with UCSF, UZ, MRC, PHRU to work on this trial.
What is it? A randomized, controlled trial to measure the effectiveness of the diaphragm used with lubricant gel in preventing HIV infection among women
How does it work?
All participants receive condoms, safe 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
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)
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)
Other planned trials
Efficacy
Safety
Acceptability
There are other research projects on the diaphragm for HIV/STI prevention as well.
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 (Population Council). This study will go into the field very soon.
CONRAD is funding a safety study of use of the diaphragm together with CS. This study is being conducted in Zim by UZ-UCSF and will also go into the field soon.
Other planned trials include:
-safety and efficacy trials of new products and combination CB+microbicide products
-acceptability studies, including quantitative and qualitative studies of at-risk American women and use patterns among commercial sex workers

32. UZ-UCSF Diaphragm Acceptability Study Comfort using 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
89% were very
comfortable having the
diaphragm inside them
86% were very
comfortable with leaving
the diaphragm in for 6
hours after sex
In addition to determining clinical efficacy, it is important to know whether or not the diaprhagm would be an acceptable method of HIV prevention, particularly for women at the highest risk for infection.
In Zimbabwe, the UZ-UCSF collaborative programme in Women's health conducted a study of diaphragm acceptability among sexually active urbanized women who were inconsistent condom users. Their study concluded that, if proven effective against STI/HIV, DA used alone or in combination with a microbicide could provide an acceptable alternative to male condoms in at risk Zimbabwean women. 
Results from this study indicate that after 6 months of use,
93% were very comfortable putting k-y jelly on the diaphragm and cleaning the diaphragm
92% were very comfortable inserting and removing the diaphragm
89% were very comfortable having the diaphragm inside them
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.
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
They were confident about their ability to use the method, and
If the diaphragm offered protection against HIV.
In the US, Marie Harvey at Univ. of Oregon led a study in which 140 ethnically-diverse women at risk for HIV/STIs participated in 25 focus groups and completed questionnaires. Their responses were based on hypothetical use.
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
They were confident about their ability to use the method, and
If the diaphragm offered protection against HIV.
Interestingly, this research points out that the factors that the participants found problematic or less desirable are all changeable through product modification and provider intervention.
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 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 (3):85-93.
Harvey SM et al. Women’s Health Issues Nov; 13:
Maher JE, Harvey SM, Bird ST, Stevens VJ, Beckman LJ. Perspectives on Sexual and Reproductive Health (2):64-71.
In the US, Marie Harvey and Sheryl Thorburn Bird are currently collaborating on research on diaphragm acceptability for HIV/STI prevention.
Three recent publications include:
Bird ST, Harvey SM, Maher JE, Beckman LJ. Women’s Health Issues (3):85-93.
Harvey SM et al. Women’s Health Issues Nov; 13:
Maher JE, Harvey SM, Bird ST, Stevens VJ, Beckman LJ. Perspectives on Sexual and Reproductive Health (2):64-71.

35. Future Directions in Research
Acceptability of CBs in different settings
Safety and risks of CB use
Importance of fitting
Continuous vs. episodic use
Impact of use with or without chemical barriers such as spermicide
Surrogate markers of exposure to semen to validate research methods
Current and future needs will inform research priorities and directions. Undoubtedly, research will continue on the three key areas I mentioned (efficacy, safety, and acceptability), and there are emerging trends toward validating and improving research methods. Potential topics for future research include
More research on the acceptability of CBs in different settings: how to study acceptability, selection, level and quality of use, qualitative data
Safety and risks of CB use, including BV, UTI and others
Importance of fitting and the potential for One-size-fits-all barriers
Continuous vs. episodic use of cervical barriers
Impact of use with or without chemical barriers such as spermicide
Surrogate markers of exposure to semen to validate research methods

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

37. HIV/STIs and women
Worldwide, half of all new HIV infections occur in women
Africa (UNAIDS)
In 2003, 58% of the 26.6 million HIV+ people in SSA were women.
Women ages are 2.5 times more likely to be HIV+ than young men.
United States (CDC)
During , 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.
Women and girls worldwide are deeply affected by HIV/AIDS, and the statistics shown here reflect women and girls’ particular vulnerability.
Africa (UNAIDS)
In 2003, 58% of the 26.6 million HIV+ people in SSA were women.
Women ages are 2.5 times more likely to be HIV+ than young men.
United States (CDC)
During , 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
Larger exposed mucosal surfaces, high viral concentration in infected semen, untreated STIs
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
Women are more vulnerable to HIV/AIDS for many reasons:
Biologically: women are twice as likely as men to get HIV from unprotected sex; they have larger exposed mucosal surfaces (esp young women); there is a higher virus concentration in semen than vaginal fluid, and women with STIs are more likely than men to go untreated.
Economically: women often lack control over monetary resources, and they don’t have as many opportunities to work; many women depend on their husbands/partners for economic security; commercial sex and sex for food/grades/favors.
Social/Cultural factors: gender norms about sexuality, mixed-age sexual couples, and gender-based violence all contribute to women and girls’ vulnerability.
It is important to note that current prevention methods (including abstinence, fidelity, and condom use) require male consent. Women need alternatives that they can control – we can see this very clearly through the number of women with one lifetime partner who are infected in spite of their efforts to reduce risk by staying abstinent until marriage and being loyal to their partners.

39. Female-controlled methods
Expanding Options:
Cervical barriers (being researched)
Female condom (currently available)
Microbicides (under development)
There are a range of female-controlled methods that are currently being researched. The female condom is currently available as an HIV/STI prevention and contraceptive method that women can control. Cervical barriers are being investigated as potential methods, and research is underway to develop a safe, effective microbicide. Cervical barriers have been discussed previously, and this section will give brief information on the female condom and microbicides.

40. Female Health Company, USA
Female Condom
The female condom is an effective and acceptable woman-controlled method for dual protection. Female condoms are barrier devices designed to protect the cervix, vagina, and part of the vulva. They are highly acceptable to some women and offer very effective protection from pregnancy and STIs. However, relative to the diaphragm and cervical cap, they are less discreet and more difficult to use without their partners’ knowledge and cooperation. The Reality female condom (produced by the Female Health Company) is currently on the market in the US, and an Indian company is developing a latex version called the Reddy female condom.
Reality Female Condom
Female Health Company, USA

41. What is a female condom?
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
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
The female condom is a safe and effective woman-controlled method for dual protection. Female condoms are barrier devices designed to protect the cervix, vagina, and part of the vulva. They are highly acceptable to some women and offer very effective protection from pregnancy and STIs.
Use of the female condom is not dependent on male erection, does not constrict the penis, and does not require immediate withdrawal after ejaculation. However they are difficult to use without their partners’ knowledge and cooperation.
The female condom is made of polyurethane, which is 40% stronger than latex and can be used with either water or oil-based lubricants. However, it is more costly because of this.

42. Facts about the female condom
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)
Less breakage and potentially less irritation than male condoms
Approved by US FDA; European Union CE Mark for Quality
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
Availability of the female condom increases the number of protected acts of intercourse
The female condom offers a 97% reduction in the risk of HIV infection has a contraceptive failure rate of just 5%
It is approved by regulatory authorities in the US and Europe
It is available through the public sector in 80 countries worldwide, and it is commercially available in 17 countries
Studies show that between 50-93% of male and female study participants around the world found the female condom to be acceptable. This is a very wide range, and the female condom is obviously a very good option for some, but not so desirable for others.
Finally, studies show that the availability of the female condom increases the number of protected sex acts. That is, if people have access to both the male and female condom, there is a higher proportion of safe sex acts than when people only have access to the male condom.

43. Microbicides For more information on microbicides
Carraguard® Micralax® applicator
In the future, microbicides formulated as gels, creams, foams, or films may prove protective against STIs (particularly in combination with a barrier method). This may offer women a new option for HIV prevention. Microbicides are an interesting alternative to other methods because they may allow women to pursue fertility goals while protecting themselves from HIV/STIs. There are no microbicides currently on the market, but development and research is currently underway.
The microbicide community has launched an impressive and effective policy and advocacy strategy that has aimed to increase women’s options for protecting themselves from HIV and other STIs. For more information, I’d encourage you to visit the website I’ve listed here.
For more information on microbicides
Global Campaign for Microbicides
Alliance for Microbicide Development
International Partnership for Microbicides

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
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
A microbicide is NOT yet available to the public
A microbicide is any substance (i.e. gel, cream, film, suppository, sponge, etc.) that can substantially reduce transmission of HIV or other STIs when applied topically (show disposable and reusable applicators)
Works by disabling pathogens, enhancing natural defenses, blocking or preventing the spread of infection
Could be produced in both contraceptive and non-contraceptive form
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
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
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
Although we have lots of laboratory data on many of the current microbicide candidates, no product has been shown to work in women
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*
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): ; Ellertson C et al. A randomized, placebo-controlled, triple-blind, expanded safety trial of Carraguard® microbicide gel in South Africa. Oral presentation. 13th International AIDS Conference, Barcelona, July 2002.

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

47. US Food and Drug Administration – regulatory status of CBs
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
Classification based on advisory input
The US FDA has three classes for approved devices. They are:
Class I – Low risk
Class II – Moderate risk
Class III – High risk [16]
The diaphragm and cervical cap are class II devices. They carry both general and special controls.
Generally, the FDA’s classification system is based on current effectiveness and safety data. However, devices in distribution in the US prior to 1976 were classified in the late 1970s based on input from advisory panels. The diaphragm and cervical cap fall into this category, as use by women in the US was widespread before the 1950s.

48. Regulatory issues and the diaphragm
Diaphragm fitting requirement
Based on advisory input
May be a barrier to access
Labeling for use with spermicide
HIV/STI vs. contraception vs. dual use
Often easier to increase rather than ease restrictions
More research necessary to ensure access isn’t unnecessarily impeded
A few regulatory issues related to diaphragm use have recently emerged more prominently – the need for fittings and the labeling of diaphragms for use with spermicide.
Currently, most family planning programs require clinician fittings for diaphragm provision. The FDA established this requirement in the late 1970s based on common practice at that time. Some experts now challenge the need for fittings, and until further research determines their necessity, this requirement may be a barrier to access for some women. This is especially important for those women who may desire to use the diaphragm for HIV/STI prevention in the future if it is proven effective.
Diaphragms and cervical caps are labeled for use with spermicide. The only currently available spermicides contain nonoxynol-9 (N9). While N9 remains a viable contraceptive option for some women, we now know that it cannot be used for HIV/STI prevention. For countries interested in labeling the diaphragm as an HIV/STI prevention method in the future, it will be important to consider the distinctions between labeling for HIV/STI prevention, for contraception, and potentially for dual protection. There is not yet rigorous evidence on the contraceptive efficacy of the diaphragm used without spermicide, but even when this information becomes available, the fact remains that it is often easier to add requirements than to ease restrictions.

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 should not be used to prevent HIV/STIs
N-9 should not be used rectally
The current use recommendations for N-9 are as follows:
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 rectally
(A fact sheet with more information about nonoxynol-9 is available at

50. N9 policy issues 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)
Need to preserve and expand woman-controlled OTC options for contraception
In terms of current policy issues, the FDA recently proposed a change in labeling for N-9 products, informing consumers that N-9 does not offer protection against HIV/STIs. The FDA has received public comments and is currently working on revised labeling for these products.
The Global Campaign for Microbicides ( is spearheading a drive to educate consumers about the risks posed by rectal exposure to Nonoxynol-9.  All evidence suggests that rectal use of N9 causes cell damage and may increase susceptibility to HIV/STIs. As part of the effort to ban rectal use, the Global Campaign has been working with legislators, activists to raise awareness and urging condom manufacturers to stop the production of N9 condoms – evidence shows that N9 lubricated condoms offer no additional protection against pregnancy or HIV/STIs
In the U.S., there are only two OTC female-controlled contraceptive options available – the female condom and N-9 spermicides. There is a need expand OTC contraceptive options available to women, including the development of alternative spermicides. In addition, research must continue on the development of a safe and effective microbicide

51. Summary
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.
A range of female-controlled HIV/STI prevention and contraceptive options is necessary to meet women’s needs.
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.
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)
Ibis Reproductive Health
Diaphragm Renaissance Conference
For more information about cervical barriers, please check out the following websites.
Cervical Barrier Advancement Society (CBAS)
Ibis Reproductive Health
Diaphragm Renaissance Conference