'Next Generation' Contraceptives: Who Will Benefit and How?

All USAID-supported family planning programs are built on the foundation of voluntary use and informed choice. Education is the key: when women and men, youth and adult, understand the consequences of too many births, too closely spaced, and starting at a very young age, they usually seek some sort of way to plan and ultimately limit their family size. When you add a second dimension of protecting oneself against other reproductive health concerns, such as HIV, the potential for use increases even more so. This is one reason why USAID is investing in the development of multipurpose prevention technologies. But again, education is key to expanding use of all prevention methods.

The major focus of USAID's work is on getting existing methods more accessible and increased use of these methods. any biomedical work we currently do is focused on reducing side effects and improving counseling about side effects. We are not currently working on the above issue. However,I think NIH is working on this issue but I am not in a position to provide details of their work.

Thank you Dr. Sharma for your thoughtful comment. There are many reasons that the Indian Family Planning Program has not achieved as much as it could possibly have over the last several decades, in spite of being the first major public sector program. One of the major reasons is possibly a lack of choice of methods and a narrow focus on sterilization, and lack of a whole program approach that we now know is required for success. To be more specific, successful FP programs have many elements. Some of these include: a wide choice of methods for both spacing and limiting; appropriate counseling; mass media and awareness raising; appropriate systems for training, monitoring, supervision, etc.;involving men and women (and not just women alone); having programs for young people, rural populations, urban poor, etc.; improved comprehensive access which includes removal of psychosocial and other barriers for women and men to access services-these are all part of a comprehensive approach to FP and other health services. In addition, political commitment and a good mix of public and private sector approaches seem to be necessary for success.

The demographic argument works well at the macro policy level, while at the micro individual level, well planned FP/RH programs try to directly address women's and men's needs. In India, depending on the State, there is a huge unmet need for contraception, both for spacing and limiting. In addition, there is limited choice of spacing methods and limited access to services for some key sections of the population. Also, majority of people in India seem to get their health services from the private sector, while the majority of FP services are in the public sector and of questionable quality. These are all factors to consider.

In spite of these drawbacks, some States have made remarkable strides in recent years, and the most recent NFHS, I think, shows that about 10 States/union territories have reached replacement level fertilty and several others are close. The major advantage for donors like USAID to work in india, is that unlike a lot of developing countries, India is pretty self sufficinet financially and a very small percent of its overall budget comes from outside sources. So, in theory, any technical advances and new approaches could be introduced in a sustainable way in India and USAID has had some success in this regard in UP, Uttarkhand and Jharkhand (the India USAID Mission will have more information about the details). The donors in india therefore focus on technical support. Of course, moving anything through the Indian bureaucracy has its own challenges!!!

The majority of USAID's portfolio is on increasing the use of existing contraceptives, through improved counseling, improved approaches to reaching women and men from all walks of life - rural and urban, with an added focus on reaching the lower economic quintiles and youth. We have a comprehensive operations and program research portfolio to improve access and quality of services and information and develop innovative approaches to reach the underserved with a larger choice of existing methods, for both spacing and limiting. At the same time, we are focusing some attention on improving existing methods or developing new ones that have significant marginal advantages and fill some critical gaps in our current repertoire of methods. Some examples include - the development, testing and rapidly increasing use of two scientific, simple and highly effective fertility awareness based methods (the Standard Days Method, SDM, and The Lactational Amenorrhea Method, LAM please refer to irh.org for more information), a one-size fits most diaphragm (the PATH SILCS) and a 12 month hormonal ring that can be inserted and removed by women and is expected to fill an important gap in our choice of methods.

So our research program at USAID is a balanced approach to improving access, quality and use of contraception.

One of the purposes of developing new methods or improving existing ones is to decrease side effects to increase acceptability and continuation. The three newer methods that have no side effects and are highly effective (over 95% in perfect use and over 89% in typical use) are the fertiltiy awareness based modern methods, the Standard Days Method (SDM),the Lactational Amenorrhea Method (LAM),and the Twoday method (TDM). Please refer to irh.org for more information on these methods.

However, it is important to note that contraceptive counseling with clients should include a discussion of possible side-effects and ways to ameliorate these effects. Unfortunately,counseling tends to be one of the weaker links in most systems with women either not being aware that the majority of side effects of hormonoal contraceptives and IUDs are not harmful and also what to do when experiencing them.

One of USAID's goals in improving existing methods and developing new methods is to reduce side effects, which are often the primary reason for discontinuation. Besides refining the type of hormone used to reduce related side effects (such as intermenstrual bleeding), we are also working on better counseling during method provision and follow-up to ensure that users are fully informed as to what to expect and how to manage any side effects, especially during the first few months of use (when the side effects of a hormonal method tend to be most apparent). Thus, dealing with side effects is a two-pronged approach: improve the active compound to reduce side effects, and improve client counseling re expectations of possible side effects.

Contraceptives do not lead to an increase in STDs and HIV. STDs and HIV are a direct result of unprotected intercourse with an infected partner or an exchange of infected bodily fluids through some other means such as blood transfusions or infected needles.

The means to protect oneself from these infections is decreasing the number of partners, using condoms consistently and correctly, using clean needles and testing blood in blood banks.

Contraceptives do not increase these infections. In fact, two contraceptives actually provide excellent protection for women and men against these infections - male and female condoms, when used correctly and consistently.

If the fear is that contraceptives make youth more promiscuous, there is no evidence for this and there is evidence that providing comprehensive information and services to women, men and youth, about all ways to protect themselves, including abstinence, actually is beneficial in improving behaviors and reproductive health outcomes.

If you mean USE of contraceptives, certainly not -- in fact, the barrier methods available (male and female condoms, diaphragms, cervical caps) actually provide the additional benefit of reducing STI transmission, along with preventing pregnancy. Use of contraceptives has been shown to increase user perceptions of other reproductive health concerns, such as STIs, and their own relative risk. And amongst HIV+ women, use of contraceptives has been demonstrated to be THE most effective way to prevent mother to child transmission of HIV.

Hopefully the introduction of new methods will help to increase the method mix, and thus enable women to find a contraceptive method that most suits them. Meeting women's contraceptive needs at different points in their reproductive lives will do much to increase quality of care around family planning. And anything we can do to increase contraceptive use will help meet unmet need and reduce unwanted pregnancy.

Research has shown that every time a new method is added to a program it increases CPR. This also means methods that are new to a particular program and not just newly developed methods. For example, if a program currently has only condoms and pills, then adding injectables alone can increase CPR, and adding other short and long term methods will increase it further, etc. But adding a new method has to include a systems approach covering all aspects of adding the method - from policy change, to training to IEC, ensuring commodity supply, counseling, monitoring and evaluation etc. so the method has to be fully integrated into the entire system, both in the public and private sectors to see maximum impact.

As for completely new methods being developed or recently developed- these were developed based on a felt need by clients because existing methods all have pros and cons in the perception of the individual user and the current choice of methods may not cover everyone's needs. so we, in USAID, and other agencies are constantly studying women's and men's needs, perceptions, behaviors and program strenghts and weaknesses to ensure the maximum possible choice for individuals around the world. For example, the 12 month hormonal ring, currently under development by the Population Council,will be the first of its kind - a woman controlled longer acting reversible hormonal method. Preliminary information shows us it has the potential to be highly acceptable in some sections of a population and will be a viable choice for many women around the world.

Similarly, the fertility awarness based methods, the Standard Days Method (SDM), the Lactational Amenorrhea Method (LAM)and the TwoDay method (TDM), are scientifically tested, highly effective methods that are easy to provide through multi-method FP/RH programs and have increased access for men and women who are interested in fertility awareness based methods. Research in several countries has already shown that clients completely new to family planning are accessing services to use these methods and thereby increasing CPR as mentioned above when new methods are added to a program. More information on these methods are available at the website irh.org.

Increasing method choice thereby decreases unmet need,as briefly described above, by addressing the needs of clients who are either not using a method currently or discontinued other methods for various reasons.

Quality of care is a related issue. Every method should be provided as part of a package of options so that clients can make informed choices. Optimal counseling, awareness raising, access to the commodities at an affordable cost, etc., are all aspects of quality of care (Please see the Bruce-Jain framework and many other similar documents for a complete discussion of quality of care). Adding new methods to the mix directly affects quality of care by increasing choice (as long as they are actually offered!!) Also, every time a new method is added to a program, it should involve new training of personnel, an examination of existing policies and other systems, etc. all of which may benefit other services including the improved provision of other methods. For example, research has shown that adding the SDM (see above) actually has improved condom counseling as condoms are offered as an option to manage the fertile period in many programs.

The hormonal methods being developed for men ( avery complex issue) are further away from FDA approval and the market than new hormonal methods for women. The new contraceptives that are in the most advanced stages of development currently are the SILCS diaphragm (developed by PATH), a novel one size fits most barrier method for use by women, and a 12 month hormonal ring (developed by the Population Council) which is a unique woman-controlled longer acting method. Both these products are completeing final stages of clinical testing and should be going through FDA approval processes relatively soon.

Having said that, there are a couple of new methods, the Standard Days Method (SDM) and the TwoDay Method (TDM)that are truly "couple" methods. These are modern, highly effctive, scientifically validated fertiltiy awareness based methods developed by Georgetown University's Institute for Reproductive health. Their basic premise is identifying a woman's fertile period in an easy and effective manner (without any chemicals or test kits) and then allowing the couple to choose to either abstain or use a barrier method during the fertile period to prevent a pregnancy. More information on thse can be obtained at irh.org. These methods are currently being programmed around the world through public and private sector family planning and other health programs.

The new methods being developed with USAID support focus on use by women, with the aim of increasing acceptability, affordability, and ease of provision and use. There are several methods nearing introduction status, including the NES-EE vaginal ring (a one-year hormonal method), Depo SQ in Uniject (an easier to provide version of the existing hormonal injection), and the SILCS diaphragm (which does not have to be fitted by a clinician, and may provide additional protection against STIs and RTIs, in addition to pregnancy). USAID is supporting the development of other types of multipurpose prevention technologies that would combine active compounds, hormones, barriers, etc in order to provide protection against pregnancy, STIs (including HIV) and RTIs in one single method.

There is considerable contraceptive research underway in Asian countries. Korea was a setting for much early contraceptive research. China has an active contraceptive research program for hormonal and nonhormonal methods for men as well as non-surgical methods for vasecectomy (vas occlusion). The Sino Implant for women profiled in our recent PRB policy brief was developed in China. Research supported by the National Institutes of Health and WHO is underway in a number of Asian countries, including Indonesia. It is important that clinical trials are conducted in different parts of the world both because of cultural differences that may affect acceptability as well as to uncover potential biological differences. For example, in a WHO-supported clinical trial of the male hormone, testosterone undecanoate, it was found that sperm suppression was greater among Asian men than among non-Asian men.

As you suggest, research on some of these novel contraceptive approaches has been underway for 20 years, but new discoveries are being made. CONRAD, a contraceptive research program funded by the U.S. government and other donors, is presently researching seven different compounds for disrupting sperm function in men, and it has a Phase IIb (contraceptive efficacy) clinical trial of TU/NET-EN (testosterone undecanoate/norethisertione enanthate) involving 400 couples in 7 countries. The non-hormonal approaches CONRAD and others are investigating are still at an early stage of development. Phase I and II clinical trials of the HCG vaccine have been conducted in humans, and pharmaceutical companies are developing contraceptive vaccines as an alternative to castration for pets, zoos and farm animals. Although the pharmaceutical companies seem less interested in human applications, this work may ultimately help advance contraceptive vaccines for humans.

In terms of program cost-effectiveness, perhaps the greatest savings to clients can be realized through increasing access to non-clinical methods, e.g., delivery of injectables by community health workers, which is proving popular in several countries. Long-acting methods such as implants and IUDs are more cost-effective in terms of cost per duration of pregnancy prevention. Given that the great majority of the population of sub-Saharan Africa live in rural areas, a method lasting for a number of years can be considered a big advantage by women who want to delay the next birth by several years or stop having children. Probably the most important thing is increasing access to a range of methods that can meet the diversity of needs of women and men in varying circumstances.

The new contraceptive methods to be discussed are those developed specifically for use in resource-poor settings with high fertility rates, which is USAID's mandate. Criteria include high effectiveness, high acceptability, low cost, and ease of service delivery and use by women. New USAID-supported products to be discussed include Depo SQ in Uniject, the NES-EE one-year vaginal ring, and the SILCS diaphragm.

The hormonal methods for men currently in clinical trials are highly effective in suppressing sperm (the method of action)in most men. The acceptability among couples enrolled in clinical trials has been high, particularly among couples who have experienced unacceptable side effects with female methods or who dislike the condom and are not ready for either male or female sterilization. A survey conducted among 9,000 men by the pharmaceutical company Schering found that the majority (55 percent)of men were interested in new methods to control male fertility,
and 40 percent of the American men who responded said they would be willing to receive regular injections or use an implant. These methods are not likely to become available in the next 5 years however.

USAID is not supporting the development of male hormonal contraceptives given our focus on low-cost methods appropriate for women in low resource settings. However, WHO is currently conducting a Phase II contraceptive effectiveness trial of an injectable hormonal contraceptive for men, and the NICHD (a branch of the NIH) has several activities underway to foster development of a male contraceptive. Suggest you check the websites of those two organizations if you would like further information on their respective activities in this area.

Hi Betty,

you have touched on all the major issues that we, at USAID, and other organizations consider important and are working on. To touch upon, firstly, my favorite topic - male involvement. For the last 20 years i have been advocating for working with men and have also said several times that one of the mistakes (in hind sight) that the world has made in FP/RH is not involving me from the beginning!! We would have been further ahead today I feel. Given that, a lot of headway has been made in the last decade with many successful pilots that have worked with men and found very positive results for women's health and FP use. please see the WHO compilation of male involvement programs and programs addressing gender issues (Gary barker et. al.). it has now been finally recognized that addressing gender issues is critical for longer term success of FP/RH and other ehalth programs. It is also a misperception that men are opposed to contraception (even in sub-Saharan Africa). the amjorituy, in fact, want smaller family sizes (please see DHS surveys from multiple countries- you will find very few outliers). The problem is lack of communication among partners leading to misperceptions.

All the other factors aer systemic issues that you have mentioned - such as quality of care, provider workloads. etc. Operations and program research have identified many best practices to address many of these issues. a big problem is getting successful interventions scaled up in a consistent and systematic manner. Also, sometimes one good intervention can have multiple effects on other systems issues if implemented well. For example, adding the Standard days Method (irh.org)has not only improved method choice and added a method with no side effects, but has also proven to improve couple communication, increase male involvement, improve condom use and provider counseling skills. the caveat of course, is proper introduction through the entire system. new methods such as the SDM and TDM do decrease the need for commodities and we are in fact looking at new approaches to directly reahc the consumer with these methods without having to go theough the health system. The Institute for reproductive health can provide more information.

As for the other new methods, they all address specfic gaps identified in teh field. The new 12 month hormonal ring is the first woman controlled long acting hormonal method. Al hormonal methods and methods such as the IUD will have side effects. Some of the reasons women discontinue these methods is due to inadequate counseling and advice on how to deal with the side effects and lack of choice.

At USAID we have developed a minimum list of best practices, tools etc. that have a strong evidence base and that should be part of programs and have the potential for impact. Please e-mail me or nandita Thatte to get this draft list. My e-mail is mkarra@usaid.gov and Nandita, is our Utilization Advisor, here at GH/PRH/RTU USAID/Washington and her e-mail is nthatte@usaid.gov.

We continue to conduct program research across the world and provide technical assistance through all of our USAID and partner programs to assist governements and the private sector to increase access to high quality services, not only through the health sector, but also by integrating FP information and services through other sectors to increase reach.

We agree that meeting unmet need for contraception is vital to poverty reduction, reaching the Millennium Development Goals for reducing child and maternal mortality, and improving the lives of women and their families. In Uganda alone, it has been estimated (as reported in the PRB publication Family Planning Saves Lives) that meeting the unmet need for contraception between 2005 and 2015 would prevent 4.6 million unintended pregnancies, avert 1.2 million abortions, 800,000 deaths to children under age 5 and nearly 17,000 maternal deaths.

You raise some critical issues, including the implications of the health worker shortage in Africa for the broadening of access to family planning and reproductive health. One solution is greater community-based distribution of injectables and pills, and access to methods through pharmacies. The new Depo Sub Q is easier to administer and the packaging in Uniject will assure that needles are not re-used. Another response to health worker shortage is to expand use of long-acting methods. While most still require a visit to a health clinic, a woman needs only to visit once every couple of years for an implant. However, as you noted, stockoouts of these methods are common and highly unfair to the women who have traveled great distances or stood in line only to be told that the method of their choice is not available. All countries need an effective logistical system to assure that supplies increase as demand for contraception grows and that a full method mix reaches all parts of the country. As for new methods for men, the methods under development that are described in answers to other questions here are not going to be available in the near term.

Hi Rich,

In fact, an improtant focus of our programmatic and social science research agenda, here at USAID, is gender. We have had some success in the last decade in improving women's lives by working with men and women to address inequities in gender norms. Most of these have been small pilots and our challenges in the coming years are to scale up successful pilots and find new approaches to addressing gender dynamics, and measuring changes in gender dynamics, and the specific impact of these changes on specific FP/RH behaviors. Several scales for measuring gender norm changes have been developed and some of the studies conducted by researchers such as Julie Pulerwitz and others at ICRW, AED, the Population Council,(to name just a few)are beginning to throw light on these issues including the possibility of gender dynamics and norms being a "gateway factor" for changing multiple RH behaviors.

The contraceptive innovations profiled in the PRB brief do have several advantages that may have gender implications. These include lower cost (Sino implant II), easier access, e.g., through community-based health workers (Depo-Sub Q), longer duration of protection against pregnancy and not requiring refrigeration (NES-EE), and protection against sexually transmitted infections (SILCS diaphragm). Injectables also have the potential to be self-administered, and appear to a method that some women are choosing to use on their own. About 7 percent of currently married women in the 2008 Nigeria DHS who were using contraception (only 15 percent total) said their husbands did not know they were using a method of contraception.

While opposition of the male partner is a factor in low contraceptive use among women in some of these settings, it is often the case that women have not actually discussed contraception with their husbands. Encouraging couples to talk about the health benefits of spacing births at least two years apart is one strategy for overcoming the presumed objections of men. However, the overwhelming majority of women in Nigeria, particularly in the North, had not heard or seen any message about family planning, and 92 percent had not discusssed family planning with either a field worker or in a health facility. Until information about the advantages and means of family planning reach more women, particularly those who are poorly educated or have limited mobility, it will be difficult for innovations in contraceptives such as those described above to make a difference.

Historically, most cultures have relied on methods, that in some form or other,try to identify the fertile period to allow for the use of abstinence or withdrawal during those periods. The Western world's fertiltiy transition started with these methods. However, depending on the context and historica and traditional ways of passing information form older generations to younger ones, the efficacy of these methods can vary. For example,research has shown that in modern times, in countries such as Turkey and Pakistan withdrawal is well used with high efficacy rates 9less than 10% failure), while the same method has much higher failure rates in latin America.

Therefore, for programs, it is important to focus on methods that are scientifically tested, easy to use, safe and effective. That is the premise of all modern FP/RH and health programs. That is not to say that cultural issues are ignored. In fact, understanding cultural issues and tailoring programs such that men and women have maximum access to these modern methods are critical for success.

Moreoever, we have not abandoned the historical interest in fertiltiy awareness based methods which have no side effects. In fact, we have used modern science to improve them. The Billings and Basal Body temperature methods have been arounf for several decades. These are highly effective. they are a little complex to teach and learn and require mutliple contacts with clients, which is not possible for most FP/RH programs. That is one of the reasons why these methods are not available through these multi-method programs. More recently, we have developed, tested and are currently expnading the use of three modern fertiltiy awareness based methods - the Standard Days Method, The Lactational Amenorrhea Method and The TwoDay method - all of which have been validated through clinical trials and multiple operations research studies around the world. Please look up irh.org for more information on these methods.

It is certainly true that cultures have used, and many still use, natural methods to prevent unintended pregnancy. Withdrawal remains a very widely used method in Turkey and other countries in the Middle East. The problem is that withdrawal is not highly effective and the unintended pregnancies that result often lead to abortions which may be unsafe. Long-term exclusive breastfeeding for up to two years is an effective means of spacing births that is still used in many countries. This practice is probably responsible for the fact that women in "natural fertilty" populations have on average 6 or 7 births each rather than 9 or 10, over the course of their lifetimes. However, now that desired family size has fallen, especially in Ethiopia, where young women want on average two fewer children than their mothers wanted, reliance on these natural methods will not be sufficient to achieve their family size goals. Women and couples will increasingly need to rely on methods that are nearly 100 percent effective if they really prefer 2-3 children to 5 or 6.

This is an extremely important area. We have known for nearly two decades that community health workers and other non-physician type workers can provide injectables safely and effectively. in fact the ealiest demonstration of this was in bangladesh. Since then, organizations such as Family Health International have conducted multiple studies in Bolivia, Uganda, etc. to show that CBD workers can safely and effectively provide injectables and that clients are egarer to get these methods from their CBD workders.

USAID is currently expanding this approach in multiple countries through its partners and through both the public and private sectors. for more specific information about a country or a program please contact either Victoria Graham at USAID - vgraham@usaid.gov or Dr. John Stanback at FHI - jstanback@fhi.org.

Free and informed choice is a cornerstone of the International Conference on Population and Development Programme of Action which has guided the global expansion of family planning for the past 15 years. One of the benefits of a number of contraceptive innovations is that they will enable greater user control, privacy and autonomy. Having a range of affordable methods to meet the needs of people at different stages in their lives is also important. The greatest ethical barrier in my view is that millions of women who would like to prevent or delay their next birth still have have no means to control their own fertility.

Every method has its pros and cons. which is why the concept of informed choice is our "mantra". Even if theoretically one method is more effective than another it all depends on how the individual client uses it. To take your own example of the IUCD and hormonal methods, you seem to prefer the IUD as it is not hormonal. However, many women prefer hormonal methods to the IUD as they are able to deal with the side effects and mode of us eof the hormones better. So individuals are very different and our role as program managers and providers is not to make the judgement and decision for them but to provide them with all the information and help them make the choice that is most appropriate for their life styles, stage of life, and tolerance for various side effects. similarly, how long a method is effective may matter less to one woman than another.

As for natural methods, as I have mentioned in my answer to other question please look up the Standard Days Method (SDM), the Twoday method 9TDM) and the Lactational Amenorhea method (LAM)at irh.org. these are highly effective, scientificall validated methods that we are inrtoducing into programs and taking to scale in several countries.

as for methods for me, some hormonal methods are under development. However, they will also have side effects just as with women's methods. the current two male methods - condoms and vasectomy, are excellent. however, we have not spent as much effort in reaching men directly with these methods and going through all the aspects of cousneling etc. that we have routinely programmed for women. in fact, where the effort was made uptake of these methods have been good (please see Engenderhealth's present and past programs though AVSC and other such programs).

There are many reasons why people use or don't use contraceptives, in India or elsewhere. Some of these have to do with the supply side - program issues such as poor method choice, poor quality of care,etc. and demand side issues such as misperceptions about method safety and side effects, psychosocial barriers to accessing the contraceptives etc. In the Indian context all these factors have existed and continue to exist. although contraceptives may be provided for free, counseling is generally poor or absent, choice of methods is limited (with a heavy emphasis on permanent methods, misperceptions about methods and side effects are rampant, and social norms such as early marriage and having the first child soon after marriage hinder optimal birth spacing.

The Indian program, with help from experts, is dealing with these issues. at the same time, in spite of some of these factors, many states have made great strides. social factors such as improved ediucations, better gender norms, etc. all have an impact on contraceptive use.

Given all this howver, your first point that it would be good to have contrcaeptives that actually increase sexual pleasure is valid. The perception of sexual pleasure is also very individual and current reserach is focused on trying to develop or improve existing methods to decrease side effects, improve user control, etc.

For a poor country, Cuba has long had a very efficient public health system. Access is excellent and contraceptives are very affordable if not free. Poverty may also have a bearing on how many children families choose to have.

The diaphragm is a method that some women prefer for that very reason. It has no side effects and can be inserted just prior to intercourse. The female condom has similar advantages.

This is an extremely important area. We are considering such issues as priority in our research agenda. For now, the condom and other barrier methods and the fertility- awareness based methods SDM and TDM (look up irh.org) are the best options and these are all very effective, safe methods that we are promoting and expanding around the world.

There is always room for improvement in anything. However, from my perspective in the Research division at PRH/USAID, I feel that the contraceptive development field is a relatively smallfield and all the actors know each other very well. There is also information exchange between US govenement agencies so that we genrally have a good broad picture of the focus of various research agendas. Within USAID' own portfolio, we have a very good handle on who is involved in what and what leads are being followed etc.

The knids of mecahnisms that exist within USAID are annual portfolio reviews of our various partner organizations, major conferences where information is exchanged which we attend, external consultations with experts from both the public and private sectors etc. If you are interested in more detail please contact any one of us in the RTU division at USAID/washington. My e-mail is mkarra@usaid.gov and some of my colleagues such as Dr. Judy Manning and Dr. sarah harbison and Dr. Lee claypool could either answer yuor specific questions or get answers for you form other experts.

There is some collaboration amongst the major donors and University-based researchers, less so with the pharmaceutical industry. Some of this collaboration takes place through WHO, e.g., its Task Force on Male Fertility Regulation, which brings together scientists from around the world for an annual review of the status of clinical research. A few years ago, CONRAD, in partnership with Schering AG set up two networks of contraceptive research investigators, one looking at novel leads for male methods and the other for female methods. However, when Bayer AG took over Schering in 2006, these collaborations were no longer supported. PATH convened a meeting of researchers on barrier methods several years ago as it was developing the SILCS diaphragm. These opportunities for collaborative exchange are probably not frequent enough.

From the biological and stage of life cycle stand point all the non-permanent methods we have today are OK for young people to use - including the IUD. State of the art research by Family Health International, several years ago, showed that even IUDs are safe to use by nulliparous women. Therefore, all the factors that are important to enable older women and men to use these methods appropriately are valid for young people too.

The bigger issue is what you have referred to in the latter part of your question- the phychosocial barriers that prevent young people from accessing or using these methods. USAID and other organizations are doing a lot of research and technical assistance to improve approaches to reach young people with information and services and change behaviors of both providers and clients for improving RH outcomes for youth.

PRB is preparing a chartbook on youth reproductive health in Sub-Saharan Africa (available in June, 2010). We have looked at the use of contraception among 15 to 19 year old women in 15 countries. In all of these countries, sexually active unmarried women were more likely to use modern contraception than married women of the same age. The most widely used modern method was condoms, and this is appropriate given the exposure to nonmonogamous partners and the risk of HIV in most of these countries. It would be a concern if these young women were using a modern method that did not include a condom. Dual method use, that is, of a barrier method and a more effective modern method, is the safest bet for young people. The SILCS diaphragm has shown some appeal for young women who like the fact that it is non-hormonal and that it appears to offer some protection against sexually transmitted diseases. The traditional diaphragm has fallen out of use, but at one time it was the most widely used female method in the U.S. and many other countries. The new SILCS design will make it easier to insert and remove, and young women who only have sex occassionally may prefer to use a method that can be inserted just prior to sex. A big barrier to overcome remains provider biases against giving youth access to reproductive health information and services that they urgently need to protect their health.

Dear Dr. Djerassi,

The majority of USAID's effort IS focused on improving the use of existing methods through improved program approaches to reach populations with unmet need,improving knowledge and awareness of methods, health benefits of spacing and limiting, improving access to a wider range of methods etc. - all aspects of good FP programs. However, we do continue within our current portfolio to try to identify opportunities to improve existing methods- for example, to reduce side effects, or develop novel methods like the 12 month ring (Population Council) to have a woman-controlled longer acting method. so you are correct and we are focusing on approaches that will yield results in the more immediate future.

The use of the term "next generation" was not intended to limit the discussion to the 5 contraceptive innovations discussed in the PRB policy brief. While progress on truly new methods has undoubtedly been slowed by the lack of pharmaceutical interest, the WHO, USAID, and university- based researchers throughout the world continue to invest in researching reversible methods for men and other novel approaches. Given that these new methods are unlikely to be on the market in the next 5-10 years, underutilization of existing methods and addressing the large unmet need for contraception are certainly critical issues for the coming decade. You brought up Nigeria and Pakistan, two of the largest countries in the world. It is sobering that in Nigeria, a country of 150 million people, (nearly half the population of the United States), only 10 percent of all women use a modern method and nearly 30 percent of women have not even heard of modern contraception. Contraceptive prevalence has risen very slowly over the last decade, but ideal family sizes remain high at more than six children and women still have on average nearly six births during their lives. According to the 2008 Demographic and Health Survey, 55 percent of Nigerian women say they have no intention to use a method in the future. The main reasons for not intending to use are opposition to use by the woman or her husband/partner, high fertility desires and factors related to the method, especially fear of side effects. As you know, in other countries, demand for family planning has been positively influenced by educating parents about the health benefits of spacing, while use and continuation are improved by counseling women and couples about the potential for contraceptive side effects. Clearly, insufficient attention has been given to these strategies in many countries, including Nigeria.

The SILCS diaphragm is 77 mm long, 67 mm wide and has an eliptical shape which folds to make it easier to insert. Although it has potential as a delivery system for a microbicide, a successful microbicide candidate has not yet been identified.

Eventually, there will be new methods for men, but presently, the innovations for men include modifications to condoms to make them better able to transmit heat and sensitivity, and nonsurgical vasectomy, using various materials to block the vas deferens.

The evidence is that more and more people are using contraception world-wide, even in very traditional societies. The greater problem is keeping up with the demand and fulfilling unmet need for women who say they want to space or prevent the next birth but are not using a method. We still need to identify why these women are not using, expand access and information, and help them find an appropriate method. Until we have delivered quality services, steady supply and adequate method mix, we shouldn't assume that women are disinterested in using any method of contraception.

Multipurpose prevention technologies would include the diaphgram with a microbicide that could prevent both pregnancy and sexually transmitted disease, including HIV.

I don't have the answer to your question but you may be able to find them at the Population Council website, www.popcouncil.org. Search for the One-Year Contraceptive Ring or the Nes-EE Vaginal Ring.

According to USAID, Microgynon will replace the low-dose combination pill, Lo-Femenal, and Microlut will replace the progestin-only pill, Ovrette, for public sector programs. Combination3 (which is the same formulation as Microgynon) will replace Duofem for social marketing programs.