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Cervical Barrier Methods


June 2-6, 2008
http://my.ibpinitiative.org/cervicalbarriers

This discussion reviewed the latest guidance on cervical barrier methods featured in Family Planning: A Global Handbook for Providers. 

Discussion Statistics


Number of participants: 97
Number of participants' countries: 34
Number of contributions: 30
% of contributions from developing countries: About 50%
Number of countries contributing: 11 countries

Contributing countries: Brazil , Democratic Republic of the Congo, France, Ghana, India, Kenya, Pakistan, Rwanda, South Africa, United States, Zambia


Purpose and Objectives

This week long discussion focused on availability of and demand for diaphragms, women’s perspectives, recent research on the diaphragm for HIV prevention and in combination with novel spermicides for contraception, incorporating and providing diaphragm services, and future research and programming opportunities..

This forum provided an opportunity to review the latest guidance on diaphragms featured in the World Health Organization’s Family Planning: A Global Handbook for Providers (www.fphandbook.org) and to exchange information and expertise with colleagues who are working to provide good-quality contraception and HIV/STI prevention services. The discussion will be guided by the interest of the participants.

It also provided an opportunity to collaborate with your colleagues and exchange your knowledge and experiences related to diaphragms.
                                                                                                                                
Day 1.  Availability 

Questions:

  1.  Are diaphragms available as part of family planning programs in your country? Were they in the past? If so, what do you think led to a change in diaphragm availability? 
  2. What types of diaphragms are available in your country? Have there been any recent changes in availability of certain types?
  3. If diaphragms are not available in your country or the family planning programs you know of, do you believe there is there a role for them? Who do you see as potential users of diaphragms in your country?
  4. Is there an unmet need for barrier methods in your communities? Could the diaphragm potentially address that need? What advantages do you see for a diaphragm over other female-initiated barrier methods?

Emerging themes and issues:

Today’s contributions highlight the perceived need for improved access to female barrier methods. Participants agree that diaphragms (or other cervical barriers) could help address this unmet need, if women had knowledge/experience with them, and if they were available. This perspective is consistent with study results from countries as diverse as Brazil, Colombia, India, Kenya, Madagascar, the Philippines, Turkey, and Zimbabwe where diaphragm use and acceptability has been studied (see Outlook in the Diaphragm Resource Library for older studies, and the CBAS website for recently completed studies). Participants also identified significant factors that contribute to limiting access to female barriers, such as the role of negative bias by health care providers and other stakeholders, as well as regulatory decisions, and even strategies for marketing relative to other contraceptive products.

As suggested by our colleague in South Africa, lessons from Female Condom introduction are relevant for expanding access to diaphragms and other cervical barriers. For example, diaphragm introduction needs to be integrated into the broader RH program, as well as understanding the needs and values of specific target audiences. As with other products, women’s groups will likely have an important role to play in expanding awareness of and advocating for improved access to diaphragms as a woman’s protection option.

A number of the postings received on Monday mentioned the possibility of using cervical barriers for HIV/STI prevention. Some of the key reasons why this might make sense are described in the article by Tom Moench, Tsungai Chipato and Nancy Padian.

Researchers have been working to evaluate the diaphragm as an HIV/STI prevention device. The Methods for Improving Reproductive Health in Africa (MIRA) trial examined whether adding a diaphragm to a state-of-the-art comprehensive HIV prevention package (including safer sex counseling, provision of condoms and diagnosis and treatment of STIs) could reduce HIV incidence. All women in the trial received the comprehensive HIV prevention package and half of the women were randomly selected to receive a diaphragm and lubricant gel in addition. The MIRA trial did not find evidence of additional protection among women who received the diaphragm and gel, and HIV incidence was essentially the same in both study arms (see publication Padian et al. in the Lancet in the diaphragm resource list for detailed study results). MIRA was not, however designed to answer the question of whether the diaphragm alone could prevent HIV infection or whether it might work as well as a condom or other barrier method—which are important questions as well. Additional research studies will evaluate whether a diaphragm with a microbicide could provide additional protection, and will also look at continuous use of the diaphragm (removing the diaphragm only once per day to wash it instead of inserting it prior to sexual activity) as potential avenues to prevent HIV.
                                                                 
                                                
Day 2. Awareness and use 

Questions:

  1. Are women in your country aware of diaphragms as a family planning option?
  2. What are the advantages of diaphragms that appeal to women in your country? What do they see as the disadvantages?
  3.  In your country, do you think women could use diaphragms without their partner knowing (i.e., covert use)? 
  4. Is diaphragm use easily negotiated with partners? What kinds of strategies might women in your country use to negotiate diaphragm use?

Emerging themes and issues:

Today's contributions highlight the lack of availability of diaphragms in many countries and touch upon some of the characteristics of the diaphragm that are perceived as making using this method a challenge for some women.

Diaphragms, which used to be available in family planning programs in countries such as India, Kenya and Zimbabwe, are generally no longer available. Also, many younger healthcare providers have not been trained in diaphragm provision, which further limits their availability .

We’d like to note that the diaphragm is known to be quite effective for contraception, especially when used correctly and in combination with a spermicide. The Family Planning Handbook notes that, with perfect use, 6 out of 100 women will become pregnant within the first year. With typical use, the risk of pregnancy is 16 out of 100 women. This typical use effectiveness rate is similar to other barrier methods, like condoms. Hormonal methods are more effective, and they have increasingly overtaken diaphragms in most family planning programs. Data showing N9 (nonoxynol 9, the spermicide commonly used with diaphragms) may increase risk of HIV infection particularly with frequent use means that women in high HIV prevalence settings are advised not to use the diaphragm with N9, although research on alternative spermicides might help increase access (see Day 3 questions). The move to hormonal method access is a positive development, but some women may not be able to or may not choose to use a hormonal method, and diaphragms may in the future prove to be useful dual methods, potentially offering some disease prevention alone or in combination with a microbicide. The diaphragm remains an effective and potentially appealing option for many women, and the Day 3 questions will address some potential solutions to this and other challenges to diaphragm use mentioned so far.

Regarding the point that women might have trouble using diaphragms, we would like to mention some recent studies that have found that women can easily learn to insert and remove the diaphragm. In fact, in the MIRA trial fewer than 1% of over 10,000 women screened were unable to successfully insert and remove the device after training from a nurse and up to five practice tries.

We are very interested in the contribution from Kenya that covert use during sex work or with casual partners and coital independence are seen as distinct advantages of diaphragm use. We agree that diaphragms can be used covertly in some instances. For example, in a study in Madras, India, one woman whose husband was an alcoholic reported that she was still using the diaphragm after six months without his knowledge. In a study of 186 women in Zimbabwe, 10-13% of the women said their partner never knew when she was using the diaphragm and 14-17% said they never told their partner when they were using the diaphragm. In a study of current diaphragm users in the USA, satisfied diaphragm users (n=115) were more likely than dissatisfied users to agree that the diaphragm can be used without their partner knowing.

However, studies also report that some male partners are aware of the diaphragm during use. In a study of the acceptability of the diaphragm in Colombia, Philippines and Turkey, only 9% of the women said that their partners were not aware of the diaphragm at all. Low-income women in Madras, India, reported that husbands were very supportive of their diaphragm use and that most of the women had received permission from their husbands prior to beginning use during the study. At the six-month visit in the Zimbabwe study noted above, the vast majority of women reported that their partner knew they used the diaphragm sometimes (64% ) or always (25%). Interestingly, in this study, the likelihood of consistent use was increased if partners either knew or did not know when the woman used a diaphragm. This suggests that diaphragms may offer two distinct options: 1) allowing women in disempowered situations to protect themselves through discreet or covert use and/or 2) enhancing women's empowerment by encouraging partner cooperation and possibly bolstering sexual negotiation skills.

Partner violence in scenarios of covert use must be recognized as a potential pitfall to diaphragm use. Providers should include discussions about how a woman plans to use, whether she will involve her partner and the possibility that he might discover she is using the method with women who are interested in using diaphragms. Women who choose to use diaphragms discreetly should be counseled about potential backlash related to covert or discreet use. Finally research about discreet and or covert use of microbicides will be useful in developing strategies and guidance regarding diaphragm use as well.

           
Day 3. Challenges

Questions:

  1. What are challenges/concerns about introducing and promoting diaphragms in family planning programs in your country? 
  2. Have you ever received formal training or information about diaphragms? What strategies would you recommend to train service providers in diaphragm fitting and provision?
  3. Would a single-size diaphragm that did not require a pelvic exam to assess fit be something you think providers and/or women would be interested in? 
  4. Research shows that the diaphragm used with Buffergel—a microbicide candidate that also is a contraceptive—has the same contraceptive efficacy as the diaphragm used with nonoxynol-9 spermicide? Would being able to use a non-N9 spermicide influence your interest in diaphragms? 
  5. What level of evidence would you need before your program (or the programs you know) would commit resources to incorporating a new barrier method into your method mix?

Emerging themes and issues:

While availability of diaphragms in developing country reproductive health programs is limited, we are happy to see that a variety of countries are expressing interest in diaphragms primarily because of their role in protecting women’s health. We were very interested to hear from our colleague in Sudan that women are aware of the diaphragm and its potential advantages, and would like to hear more about whether diaphragms are available and being used in that country. We would also like to hear from others about any current diaphragm programs or interest and enthusiasm in launching efforts to raise awareness about cervical barrier methods.

Research is underway to identify potential ways to improve upon and potentially increase interest in and access to cervical barriers and particularly diaphragm devices in the future. As we mentioned yesterday, N9 spermicides are not recommended for use among women at risk of HIV. Researchers have been working to identify alternative spermicides and recent research highlighted that a diaphragm used with Buffergel, a candidate microbicide which also appears to be spermicidal but is not yet approved for use, was as effective for contraception as the diaphragm used with N9 (see article by Barnhart et al. in the resource list for more details). This could provide an alternative where N9 is not available or is not recommended.

For programs that are interested in planning for diaphragm introduction, there is good news on the horizon. Several new cervical barriers have been developed in the past decade that may expand women’s options for barrier protection. Some of these have been developed specifically to address issues that have limited access or acceptability of standard diaphragms.

Two cervical barriers that have been approved by the U.S. FDA and are available in some countries include:

  • FemCap (see http://www.femcap.com)
  • Lea’s Shield (see http://www.leasshield.com)

Two other cervical barriers are still undergoing clinical trials and may be available in the next few years are:

  • SILCS diaphragm: a single-size diaphragm designed for easier insertion and removal, and service provision. A Phase II/III contraceptive effectiveness study is underway in the U.S. (see Resource library for this discussion).
  • Duet: a single use cervical barrier that is pre-loaded with BufferGel® microbicide (http://www.reprotect.com/products.shtml) .

                                                                 
                                                    
Day 4. Next steps

Questions:

  1. Do you consider diaphragms a cost-effective method of family planning? Why or why not? Do you see a role for them in the method mix in the country programs you are aware of? 
  2. What else could be done to achieve renewed interest in diaphragms in countries where providers do not know about diaphragms and few women currently use them? 
  3. What is needed to attract the interest of donor agencies or governments in scaling-up the diaphragm as part of family planning programs?
  4. Last year, results from a large multi site study (called the MIRA study) were released indicating no significant increase in protection against HIV infection when the diaphragm was added to a comprehensive HIV prevention program (i.e. comprehensive counseling and condom provision). Have these results affected your opinion or the opinions of others in your country about role of diaphragms for protecting women’s health?
  5. Work is underway to evaluate diaphragms as a delivery system for a microbicide. Do you think using diaphragms as a microbicide delivery system will help or hinder future introduction and promotion of the diaphragm?
  6. Do you see a stronger role for diaphragms in family planning or HIV prevention programs in the future? Why?

Emerging themes and issues:

In closing this e-forum, we would like to address a few remaining points that were raised in the contributions from Day 4. We agree that not having spermicides that are not detergents (also known as non-ionic surfactants) makes diaphgram programming challenging in high HIV prevalence areas. We look forward to the introduction of new contraceptive gels such as BufferGel that may make this type of programming more viable and will expand women's contraceptive options in high prevalence areas.

We also agree that the current Medical Eligibility Criteria (MEC) relating to the use of spermicides with diaphgrams should be clarified to refer to detergent/surfactant spermicides, and we call upon our colleagues at WHO to make the MEC recommendation more specific to detergent-based spermicidal gels and lay the groundwork for the availability of non-surfactant spermicide/contraceptive products.

As Kathy Shapiro’s postings indicate, using the diaphragm for HIV/STI prevention would potentially be important to many women. We would like to note, however that in order to be able to recommend or promote the diaphragm for HIV/STI prevention we need more robust data; although the observational studies are suggestive and the MIRA results leave room for a potential effect of the diaphragm against HIV, neither is definitive and in the case of MIRA similar incidence across the two study arms could also be due to over-reporting of condom use in the condom-only arm. We are also excited that the Madagascar trial will soon be underway and hope that study and others will help provide more data on the question.

                                                                 
Program Examples
  • Diaphragms or other cervical barriers could help address unmet need for contraception it they are available, and if women had knowledge of/experience with them. 
  • Factors that contribute to limiting access to female barrier methods include: negative bias of health care providers and stakeholders, regulatory decisions, and strategies for marketing relative to other contraceptive methods. 
  • Partner violence in scenarios of covert use must be recognized as a potential disadvantage to diaphragm use
Post-forum survey results

N/A

References and resources
     Africa and Thailand. Journal of Family Planning and Reproductive Health Care
Organizing groups

Ibis Reproductive Health, PATH, and the INFO Project based at the Johns Hopkins Bloomberg School of Public Health's Center for Communication Programs with support from partners of the Implementing Best Practices (IBP) Initiative.

Contributing experts/facilitators 

Patricia Coffey, PATH

Maggie Kilbourne-Brook, PATH

Kelly Blanchard, Ibis Reproductive Health

Kelsey Otis, Ibis Reproductive Health

Moderators

Heather Sanders, JHU/CCP

Megan O’Brien, JHU/CCP