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4 Improving Contraceptive Use and Acceptability Decisions about the contraceptive leads that should have highest priority and the delivery mechanisms that should be chosen require more than information on technology and biological sciences. Better under- standing of various other factors, such as whether, how, under which cir- cumstances, and by whom a method will be used, should influence whether to begin or continue development of a new contraceptive method. Furthermore, predicting whether couples will use a method consistently and correctly, or whether they will use it at all, requires substantive behavioral research that is performed before as well as after a delivery system is selected. Even though contraceptive use is an integral part of modern life in most developed countries, at any given time a small proportion of women and their partners who are at risk for unintended pregnancy are not using any method. Studies have shown that in the United States, 7 percent of women at risk for unintended pregnancy were using no method of contra- ception in any given month. Almost half (47 percent) of all unintended pregnancies each year occurred among these women. The remaining 53 percent of all unintended pregnancies occurred among the 93 percent of U.S. couples who do use methods of contraception, largely because of the inconsistent and incorrect use of effective methods (Alan Guttmacher Institute, 2000; Henshaw, 1998~. The same trend has been observed in other developed countries (Larsson et al., 2002; Rasch, 2002~. In less developed countries, pregnancies that result from nonuse and the use of ineffective, traditional methods of contraception are more common (Diaz et al., 1997), for a variety of reasons that include women's 108

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 109 attitudes (Brophy, 1990), opposition by husbands (Casterline et al., 2001), lack of knowledge about contraception (Xiao et al., 1999), and rural isola- tion (Saha, 1994). In a study of 43 developing countries, there was a corre- lation between a lower number of contraceptive methods available and percentage of married women of reproductive age with unmet contra- ceptive needs (Benagiano et al., 1999). In 2003, an estimated 705 million women (28.5 percent) in developing countries were at high risk for unintended pregnancy because they were using no contraceptive at all (19.5 percent) or were relying on a traditional method (periodic absti- nence, withdrawal, or other nonsupply methods) likely to have relatively high failure rates (9.0 percent). These women accounted for an estimated 79 percent of the 76 million unintended pregnancies that occur annually in developing countries (Singh et al., 2003). In general, the rates of unintended pregnancy associated with typical use of any contraceptive method (typical use failure rates) are higher than the rates of pregnancy that occur under conditions of perfect use of a method (perfect use or method failure rates). This gap reflects the difficul- ties that many couples have using their methods of choice correctly and consistently. For example, it is estimated that under conditions of perfect use, no more than 0.1 percent of women relying on combination oral con- traceptives (the pill) will experience an unintended pregnancy within the first year of use (Trussell and Stewart, 1998). In fact, however, in the United States, an estimated 7.5 percent of women using the pill have an unintended pregnancy (Ranjit et al., 2001). Surveys of women using oral contraceptives in developing countries indicate that the unintended preg- nancy rate is at least 7 percent. This rate is probably higher, however, since many of the unintended pregnancies ending in abortion are not reported by survey respondents (Cleland and All, forthcoming). Contraceptive use effectiveness rates vary widely across sociodemo- graphic subgroups of users, indicating that difficulties in using the avail- able methods successfully are affected by personal characteristics. For example, in the United States, the highest use failure rates among women relying on reversible contraceptive methods were found among those who were under age 25, not in a stable union, poor, and African American (Ranjit et al., 2001). Although some of these differences reflect ongoing disadvantage and resource limitations, others, such as age and personal union status, also reflect differences across stages of women's reproduc- tive lives (Forrest, 1993). Most women and men spend the overwhelming majority of their reproductive years trying to avoid having children. In the United States, women typically become sexually active at age 17.4, marry at 25.1, have their first child at 26.0, and by age 30.9 have had all the children that they want to have; men in the United States usually have first intercourse by

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0 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH age 16.9, marry by age 26.7, become fathers at age 28.5, and by age 33.2 intend to have no more children (Alan Guttmacher Institute, 2002~. These key milestones among men occur slightly earlier in Latin America and the Caribbean and somewhat later in sub-Saharan Africa. Additionally, most men in sub-Saharan Africa continue to want more children until they are into their 50s (Alan Guttmacher Institute, 2003~. Patterns of contraceptive method use differ widely across the world, not only by region but also by couples' reproductive life stages and the desire to space or limit future births (Table 4.1~. Women and men who are trying to delay the birth of their first child or to space subsequent births are typically in situations different from those of couples who do not want more children and have different patterns of method use. Women and men in the former group are typically younger. TABLE 4.1 The Most Commonly Used Contraceptive Methods Among All Couples, Those Seeking to Delay and Space Childbearing, and Those Who Want No Further Births, by Region of the Developing World, Late l990s and Early 2000s Couples Seeking to Delay and Space Couples Who Want Region All Couples Childbearing No Further Births Africa Eastern Africa Injectable or implant Oral contraceptives Injectable or implant Middle Africa Periodic abstinence Periodic abstinence Periodic abstinence Southern Africa Injectable or implant Injectable or implant Injectable or implant Western Africa Periodic abstinence Periodic abstinence Periodic abstinence Northern Africa IUDa IUD IUD Asia Eastern Asia-China China Female sterilization IUD Female sterilization Female sterilization IUD Female sterilization South-central Asia Female sterilization Condom Female sterilization Southeastern Asia Injectable or implant Injectable or implant IUD Oceania-Micronesia Injectable or implant Injectable or implant Injectable or implant Western Asia Withdrawal Withdrawal Withdrawal Latin America and the Caribbean Caribbean Central America South America Female sterilization Female sterilization Female sterilization Oral contraceptives Oral contraceptives Oral contraceptives Female sterilization Female sterilization Female sterilization aIUD = intrauterine device. SOURCE: J.E. Darroch, tabulations for The Alan Guttmacher Institute (Singh et al., 2003~.

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 111 A recent study found that one-third of all couples in developing coun- tries who were at risk for unintended pregnancy were trying to delay or space births; among these couples, 56 percent used a reversible modern method, 11 percent used traditional methods, and 32 percent used no contraceptive at all. The other two-thirds of couples at risk for unintended pregnancy are much more likely to be using a contraceptive method: half rely on contraceptive sterilization, 29 percent use reversible modern methods, 8 percent use traditional methods, and 13 percent use no contra- ceptive. Because those trying to delay and space future births were much more likely to be using no method and because the methods that they did use are typically less effective than contraceptive sterilization, they ac- counted for 51 percent of all unintended pregnancies in developing coun- tries (Singh et al., 2003~. Thus, although the inherent effectiveness of a contraceptive method is important, the effectiveness of a contraceptive method is ultimately determined largely by whether couples use the method consistently and correctly. In addition to method acceptability, other factors affect consis- tent and correct use, including those related to the partner, the social and cultural context in which contraceptive use occurs, aspects of the contra- ceptive method itself, and aspects of the health care delivery system. In short, contraceptive methods must be attractive to potential users, condu- cive to their ongoing consistent and correct use, and feasible for provision by distribution systems. It is important to conduct research designed to understand and inte- grate the views of potential users, their partners, and their providers as early as possible in the development process. In this way, the views of users can influence decisions that must be made over the course of method development to ensure that the ultimate method will best meet user and provider needs. Such information will also be helpful in determining country-specific needs and in crafting the best ways to introduce new contraceptive technology. Funding is scarce for such research in the United States because the projects are often targeted toward clinical ap- plication and fail to satisfy criteria for traditional ROl-type research grants at the National Institutes of Health, as they are too focused on the product introduction stage to fit into method development budgets, which generally focus on earlier stages of product development. Although the primary purpose of phase I and II is to evaluate safety and to begin testing efficacy, undertaking separate behavioral/acceptability studies before the end of phase II trials is prudent from a resource and market perspective. Such data are generally necessary to secure funding for the large, very costly phase III studies, even within big pharmaceutical companies. To wait until late in the development process and then discover that a new product is unacceptable to a large population is not cost efficient. Knowl-

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2 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH edge about user preferences early on could perhaps lead to modifications during development that would result in a more acceptable product in the end. Thus innovative approaches to research are needed to predict and increase contraceptive use. There are a number of options for inte- grating behavioral and operations research into or in parallel with early stage clinical studies so that they will be complementary to the efficient measurement of safety and efficacy. Research in several particular groups of individuals is also of a high priority, as discussed below. RESEARCH PRIORITIES FOR WOMEN AND MEN Currently available contraceptives have generally been developed to meet broad safety and efficacy standards. Today, however, there is a growing appreciation of the need to consider contraceptives in the context of various physiological issues that affect women and men at different points in their reproductive lives, as well as in the context of the changing demographics of childbearing. Each of these will affect method appropri- ateness and acceptability. Therefore, the needs of different groups should be considered and are described below. Men Despite the paucity of methods currently available for men (condoms, withdrawal, and vasectomy), men account for a large proportion of cur- rent contraceptive users: 17 percent of users in the developing world and 32 percent of users in the United States (Piccinino and Mosher, 1998; Singh et al., 2003~. However, the services of family planning providers are ori- ented primarily toward women and such providers have little experience with providing contraceptive services for men (Alan Guttmacher Insti- tute, 2002, 2003~. Moreover, specific safety and biological issues must be taken into account when new methods of contraception are developed for men. The newer hormonal methods in development for men need to take into account both short- and long-term biological effects, as is the case for hormonal methods for women. Effects on the libido will affect men across the life cycle, whereas the potential reversibility of effects on spermatoge- nesis is likely to vary across the life span. Potential adverse effects related to cardiovascular disease, prostate cancer, muscle mass, and bone loss must also be considered and will affect the acceptability of new methods. Perimenopausal Women Because most women and men want far fewer children than would be biologically possible during their reproductive lives, they must use con-

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 113 traceptive methods for most of the interval between the time that they become sexually active and the time that they or their partners reach menopause (Alan Guttmacher Institute, 1995~. Thus, women need to con- tinue to use contraception while they are experiencing perimenopausal changes (Gebbie et al., 1995~. In much of the developed world, it is not uncommon for women to postpone childbearing until their late 30s and 40s. Thus, women increasingly need to have available reversible methods of contraception for longer periods of time. As shown in Table 4.1, in many regions of the developing world, the contraceptive methods most com- monly used throughout the life span are reversible. Contraceptive methods are used against a background of changing biology and, particularly, changing health risks. For women in their 40s, the increasing risk for fibroids, breast cancer, cardiovascular disease, and osteoporosis need to be taken into consideration when hormonal methods of contraception are used (Glacier and Gebbie, 1996; World Health Orga- nization, 2000~. For women in developing countries, where routine health care screening for these conditions is rarely available and where the burden of reproductive disease is enormous, these considerations may be even more pertinent (Elias and Sherris, 2003~. New technologies that do not contribute to an increased risk for these conditions, or perhaps even decrease the risk, would benefit these women. Adolescent Women Adolescence is typically the time when young people across the world begin to have sexual intercourse, but in the developed world and in many countries in the developing world, childbearing is expected to be delayed until after adolescence (Alan Guttmacher Institute, 1998~. Increased atten- tion is being paid to the behavioral vulnerability of adolescents; but, like women approaching menopause, adolescents have certain biological vulnerabilities that present some special challenges, and opportunities, in the development of contraceptive methods for this group. For example, because of their age and stage of physical development, there may be concerns about an increased prevalence of cervical ectopy and its possible relationship to HIV infection. Bone development is another important fac- tor. With increasing worldwide concerns about the nutritional practices and the lack of exercise among adolescents, it is essential that methods not compromise peak bone development. Overall, methods that do not exacerbate these conditions that affect adolescents or that have positive impacts on these conditions would be especially useful for this group. Many sexually active adolescents are unmarried and have multiple, serial relationships, and some adolescents, especially younger girls, have little power in relationships with older males. There is thus a potential

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4 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH benefit both for short-acting methods that can be used episodically and for longer-acting methods that demand little user input. Methods that pro- vide protection against both conception and sexually transmitted infections (see below) would also be useful for adolescents. Women, HIV Infection, and Contraceptive Methods Women infected with HIV have particular needs for contraception. Challenges include limiting the risk of transmission to their partners and to their infants during and after pregnancy. Additionally, decision making about the contraceptive to be used must take into account the impact of the contraceptive on the disease itself, along with any interactions of the contraceptive with other therapies such as antiretroviral drugs or local traditional therapies. However, so little is known about the progression of HIV infection and its relationship to contraception that it is difficult to determine how different contraceptive methods could affect HIV-positive women. Women at risk for HIV infection have contraceptive needs different from those of HIV-infected women: they need to know how their contra- ceptive choices will affect their chance of infection in terms of both increased protection and increased susceptibility. They may also want to know the safest means of becoming pregnant without becoming infected if their husband or partner is infected. To date, few studies have assessed the contraceptive desires and factors that affect contraceptive use among HIV-infected and uninfected women. In a sample of HIV-infected and uninfected women in four U.S. states (Wilson et al., 2003), inconsistent condom use was associated with alcohol use, the intention to abort if preg- nant, and the belief that a pregnancy would not be upsetting. The scientific evidence on the effects of contraceptive methods on HIV transmission is limited at present: condom use has been shown to be at least 85 percent effective in preventing HIV infection (National Institutes of Health, 2001), but information on the effects of other contraceptive methods on HIV transmission is limited. A forthcoming NICHD prospec- tive observational study entitled Hormonal Contraception and Risk of HIV Transmission is investigating the hypothesis that hormonal contra- ceptives may increase the risk of HIV transmission during heterosexual sex, but the evidence is not yet conclusive. No systematic information on the impact of intrauterine devices (IUDs) or other barrier methods like Personal communication, Joanne Luoto, medical officer, Contraception and Reproduc- tive Health Branch, Center for Population Research, National Institute of Child Health and Human Development.

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 115 diaphragms or cervical caps on the transmission of HIV infection is avail- able. Furthermore, little is known about whether hormonal contraceptives have an impact on the progression of HIV infection (such studies are ongoing). To address the health and contraceptive needs of the increasingly large group of women at risk for or infected with HIV, the interactions between various contraceptive methods and the risk of both the acquisi- tion and the transmission (sexually and perinatally) of HIV infection must be examined in future studies. Finally, to reduce the risk of unplanned and unsafe pregnancies as well as the burden of HIV disease, direct links need to be established between family planning providers and health care providers for those infected with HIV as well as others with expertise with STIs. METHODOLOGICAL RESEARCH ON CONTRACEPTIVE USE AND ACCEPTABILITY New methodological research is needed to develop tools that can better predict the characteristics of contraceptive methods that will be attractive to users in different settings and that will accurately predict rates of use and acceptability. Work is needed to understand the limita- tions of current approaches and, if feasible, to improve them. For example, current studies may not be tapping all relevant domains that influence contraceptive method choice and patterns of use. It is not easy to measure the acceptability of contraceptive methods to users, both potential and current (Sundari Ravindran et al., 1997~. Accept- ability is determined by many factors, including inherent (and often unexplained) preferences regarding particular types of methods, the per- ceived and actual risks and side effects, and the influences of other people and circumstances in a person's life, as well as how the methods are provided. Hypothetical acceptability has been used as a surrogate to predict the rates of use of new methods before they are marketed, with research done by organizations such as Gallup/Multi-Sponsor Surveys, Inc., which pro- vide insights into women's stated preferences for contraception.2 There are no definitive data comparing women's stated preferences with their actual choices or behaviors in using particular methods. In turn, uptake and continuation rates have traditionally been used as surrogates for the acceptability of existing methods. This approach is simplistic. Couples Multi-Sponsor Surveys, Inc., which conducts the Gallup syndicated studies under a li- cense agreement with The Gallup Organization.

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6 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH may use a particular method not because they like it especially but because it may be "the best of a bad lot." For example, a recent study on contra- ceptive acceptability, choice, and use found that neither hypothetical acceptability nor conventional measures of acceptability predicted use (Minnie et al., 2003~. Acceptability should be measured across different subgroups of potential users because, although some methods may be very attractive to particular subgroups of women and men, they may not become widely used, and research can identify why this is the case. A survey of U.S. women about their potential interest in using a vaginal microbicide found widely varying levels of interest depending on both the characteristics of the women, especially their potential risk for STIs or HIV infection, and the possible characteristics of the microbicide, including its effectiveness in preventing STIs and HIV infection and its cost (Darroch and Frost, 1999~. Also in the United States, women using IUDs have typically reported higher levels of satisfaction with the method than women using other contraceptives (Forrest and Fordyce, 1993~; but fear of the method, lack of familiarity with it, and provider reluctance to recommend IUDs have resulted in very low levels of IUD use (Hubacher, 2002; Piccinino and Mosher, 1998~. Methodological approaches that assess the importance of various characteristics of contraceptive methods to potential or current users as well as their perceptions of how different methods rank in terms of such characteristics may be useful to determine their value for prediction of future rates of use (Severy, 1999; Severy and McKillop, 1990; Silverman et al., 1987; Tanfer et al., 2000~. Methodologies developed in other fields might also be used to improve the predictive value of early research on method use and acceptability. One example is shared decision analysis tools developed to help people understand the risks, benefits, and impli- cations of alternative surgical choices for medical care in the context of their personal situations and preferences (O'Connor et al., 2003~. Recent work by Daniel Gilbert and George Loewenstern aims to provide insight into the cognitive mechanisms involved in predicting future satisfaction among various options (Gertner, 2003~. They found, for example, that people were better able to predict their future happiness when choosing an option if they were informed about other people's experience with the option. People's views of the consequences (costs and benefits) of contracep- tive method use are affected not only by their goals regarding pregnancy prevention and their perceptions of side effects and other characteristics of a particular method but also by social factors, including attitudes and beliefs tied to a particular social environment, such as religious upbring- ing and the expectations of partners, peers, or family members (Raine et

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 117 al., 2003~. In some cultures, the characteristics of certain methods, such as amenorrhea, breakthrough bleeding, touching of the genitals, moistness, and lubrication, make particular methods unattractive (Ladipo and Konje, 1999). How methods are provided can also be important to their accept- ability and to the users' comfort and skill in using them. For example, women who have been counseled about the probability of certain side effects associated with particular methods, such as amenorrhea from some progestin-only methods, are more likely to continue use of the method than those who were not prepared for them (Led et al., 1996) . In addition, the importance of the male partner's preference with regard to both pregnancy and the method of contraception has been high- lighted in many studies (Alan Guttmacher Institute, 2002, 2003; Mbizvo and Adamchak, 1991; Zotti and Siegel, 1995) that have shown the strong effect of male partners' attitudes on women's contraceptive choice and use. Re- search with couples is another area needing support to improve the meth- odologies and research techniques for evaluating the acceptabilities of contraceptive methods. One limitation is the greater level of resources required to obtain data from partners, especially unmarried partners. Another is the question of how to measure and determine the conse- quences of disagreements between partners regarding family planning and contraceptive use. Additionally, research has not fully captured de- terminants of acceptability that predict or influence the long-term consis- tent and correct use of any user-controlled contraceptive method. The preventive and elective nature of contraception as well as the high costs of contraceptive development (see Chapter 5) relative to the modest monetary return potential of the contraceptive market compared with that of the market for medications used to treat chronic diseases- suggests the need for a paradigm shift to advance the field. That is, another important frontier in contraceptive development should be the determi- nation of more accurate measures of acceptability and potential use. Once developed, these measures would be most valuable when applied early in the research and development process so that a "go" or "no go" decision about continued development is made before the expenditure of resources for a method that lacks consumer and provider appeal. Moreover, if a "go" decision for continued drug or device development ensues on the basis of a predicted level of acceptability, the characteristics of a method can be market tested with diverse populations when phase II and phase III trials are being conducted. The information gained in such a process can then drive faster and more efficient implementation and delivery of the method (see the section on operations research on page 119~. Accept- ability research, as described above, can serve as a guide for offering a method in such a way as to enhance uptake and rates of use.

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8 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH RISK BEHAVIORS AND PERCEPTIONS OF RISK Contraceptive use has some important similarities to other behaviors, such as cigarette smoking and seat belt use, which provide potentially useful research and public health models for successful risk reduction. Research on risk taking and risk reduction has identified the importance of social, economic, and demographic differences in risk behaviors. These include the strong role of social and economic disadvantage in promoting risk taking, not only because of barriers that limit access to care but also because of the lack of assurance that avoiding outcomes such as unin- tended pregnancy will be effective toward bettering lives (Darroch et al., 2001~. Research regarding contraceptive use and risk taking should pay attention not only to personal factors but also to influences within the relationship, family, and community. Attention should also be given not only to factors that influence risk but also to their wider causes. For example, research in the United States has shown that good education programs on sexuality can be effective in reducing sexual risk taking among young people, primarily by decreas- ing multiple sexual partners and increasing contraceptive use. In contrast, the few adequate studies of education programs that focus solely on abstinence have shown that such programs have little, if any, effect on postponing sexual involvement (Frost and Forrest, 1995; Kirby, 2001~. Nevertheless, substantial funding in the United States has been directed toward educational programs that promote abstinence and that bar the provision of any information about contraception or condom use except to emphasize their failure rates (Dailard, 2002; Landry et al., 2003~. On the other hand, in 1975 Sweden changed its compulsory sex edu- cation curriculum so that it no longer explicitly recommends that sexual activity take place only within marriage and no longer solely promotes abstinence. This revision in the curriculum was accompanied by the estab- lishment of special youth clinics, which provide easy access to contracep- tion. In addition, Sweden's abortion law was revised to allow abortion without charge (Santow and Bracher, 1999~. Since these changes were adopted, Sweden has experienced an increase in the number of adoles- cents using highly effective forms of contraception and a decline in the abortion rate that is unparalleled in the United States and most other developed and developing countries (Darroch et al., 2001; Santow and Bracher, 1999~. These examples highlight the need for more effective ways to inform the public and policy makers about research findings in this area of risk behaviors to promote policy that is congruent with effective contraceptive use. In the seat belt and cigarette examples mentioned earlier, broad-based public education backed by supportive public policy enabled massive .

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 123 rian cancer (World Health Organization, 1992) and endometrial cancer (Beral et al., 1999) is perceived as an advantage by providers and enhances continuation rates among well-informed women (Rosenberg et al., 1998~. A contraceptive method which actually reduced the risk of breast cancer (Pike and Spicer, 2000; Spicer and Pike, 2000; Ursin et al., 1994) would be enormously attractive to large numbers of women. For young people, the attraction of contraception may be increased if contraceptive use became fashionable (through energetic marketing campaigns) or if it conferred cosmetic benefits such as reducing acne or weight gain. The development of drugs with two mechanisms and optimizing a single compound for both mechanisms is complex and time-consuming, so the task of developing products that have contraceptive and non- contraceptive effects will be challenging, both synthetically and clinically, but it is an achievable and worthy goal. Alternatively, researchers in the field of contraceptives should consider the potential positive impact that side effects can have on usage as they focus on developing new methods of contraception. The research agenda outlined in Chapters 2 and 3 of this report, however, focuses on highly specific targets (with the exception of dual-action microbicides and contraceptives; see below) with the hope of reducing the side effects of contraceptives. This approach will also undoubtedly limit some, if not all, noncontraceptive benefits (positive side effects). Strategies to combine a new contraceptive with some other agent that prevents a disease might be another more feasible approach to achieve the goal of dual activities in new contraceptive agents/devices. Similarly, a contraceptive method that also conferred protection against HIV infection or other STIs would also likely be appealing. In a study conducted among college students in California (Holt Young et al., submitted for publication; Holt Young et al., 2002) women indicated that they would be more likely to use a contraceptive method that was also prophylactic for infectious diseases. The need for woman-controlled contraceptive methods that also protect against bacterial and viral patho- gens is widely recognized (Butler, 1993; Cates and Stone, 1992; Elias and Heise, 1993; McCormack et al., 2001; Stein, 1992, 1993~. Universally, women constitute the fastest-growing category of individuals with sexu- ally transmitted HIV infection (UNAIDS,2002~. In the absence of an effec- tive vaccine or widely available treatment, contraceptive methods capable of preventing sexual transmission of HIV as well as other STIs are crucial for protecting the health of women. Although the same sexual behaviors put individuals at risk for both STIs (including HIV infection) and unintended pregnancy, a challenge arises because the most effective methods of pregnancy prevention (Swahn et al., 1996) do not protect against STIs, whereas the most effective means of STI prevention (male condoms) are less effective for pregnancy

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24 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH prevention. The result is a trade-off between methods that provide pro- tection against pregnancy and those that provide protection against STIs (Cates and Steiner, 2002; Cates and Stone, 1992~. Although one obvious solution to this dilemma is to recommend the use of two methods one to prevent pregnancy and another to prevent STIs such an option may not always be acceptable to users; for example, because of cost or factors asso- ciated with the use of multiple methods (Cates and Steiner, 2002~. Thus, although the need for new methods to decrease unintended pregnancy is important, research to accomplish this objective should not be done in isolation from research to prevent infectious diseases, including HIV infection and other STIs. Moreover, the addition of a health benefit such as reduced suscepti- bility to STIs and HIV infection might actually increase interest in using a pregnancy prevention product. In the most recent Institute of Medicine report on contraceptives (1996), the committee clearly spelled out the obvious: unprotected intercourse can result in both unintended pregnancy and HIV infection and other STIs. At that time, the committee recom- mended that family planning services be integrated into comprehensive programs for reproductive health. The present committee concurs with that recommendation and reemphasizes the recommendation to give high priority to research on new methods that provide dual protection. Never- theless, it is not always possible to assess the effects of new methods on infectious disease outcomes at the outset of development. Consequently, examination of the effects of new contraceptive methods on STI and HIV transmission should be undertaken in parallel with work on pregnancy prevention. This integration of outcomes might also result in scientific breakthroughs in which the same methods applied to achieve one outcome might be applied to others. Ultimately, the best outcomes will be reached via an integration of research among scientists who work on the preven- tion of STIs and HIV infection, pregnancy prevention, and even infertility. Finally, it must be emphasized that although treatment can substan- tially reduce mother- to-child HIV transmission (National Research Council, 1999), the most effective strategy to prevent mother-to-child transmission of HIV is pregnancy prevention among HIV-infected women, regardless of the effect of such methods on STIs and HIV infection. Issues related to maternal morbidity and mortality among HIV-infected women must also be taken into account in the development of new contraceptive methods, regardless of their direct effect on HIV infection and other STIs. IMPROVING EXISTING METHODS As discussed above, research is simultaneously needed to better understand the reasons behind the choice of a contraceptive method and

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 125 discontinuation of its use and the reasons for gaps in method use and incorrect and inconsistent use. Such factors are likely to affect the uptake of new methods as well as the use of existing, effective methods. Although a number of reversible methods of contraception are available, modern methods fall into only three categories: barrier methods, hormonal methods, and IUDs. All have their drawbacks. Gaps between use failure and method failure rates and differences across subgroups are widest for methods that require greater user involvement and methods over which users have greater control over use and continuation (Ranjit et al., 2001; Trussell and Stewart, 1998~. Currently available barrier methods have rela- tively high failure rates (Cleland and All, forthcoming; Ranjit et al., 2001; Trussell and Stewart, 1998), and effectiveness depends on correct and con- sistent use. The use of such methods is not easy: women relying on male condoms are overrepresented among women having abortions Jones et al., 2002~. Hormonal methods are available in a number of different deliv- ery systems, some of which (e.g., implants) make no demands on compli- ance. However, the most popular route of administration, oral contracep- tion, relies heavily on compliance for effectiveness (Emans et al., 1987; Potter et al., 1996; Ranjit et al., 2001; Rosenberg and Waugh, 1999; Trussell and Stewart, 1998~. Combined hormonal methods have been associated with a very small increased risk of cardiovascular disease (Beral et al., 1999; Kemmeren et al., 2001; Tanis et al., 2001; World Health Organization, 1998) and of breast cancer (Collaborative Group on Hormonal Factors in Breast Cancer, 1996) and cervical cancer (Smith et al., 2003~. In the case of breast cancer, a slight increase in relative risk for breast cancer among women under age 40 has been observed, but the absolute risk is very low because the risk of breast cancer in this age group is so low. When the overall risk of breast cancer across all age groups is assessed, no increase in risk is seen. However, among the various studies undertaken to examine the risk for disease associated with hormonal methods, no single study adjusted for all known confounding factors simultaneously. Thus, the debate as to whether the reported risks are real continues. In any case, if there is a real increase in disease risk, it is very low. Low-dose progestin-only methods are associ- ated with a high incidence of irregular bleeding (D'Arcangues et al., 1992), and IUDs have historically been relatively unpopular in most developed countries (Hubacher, 2002; Oddens et al., 1994~. Continuation rates are not a surrogate for acceptability (Severy, 1999; Severy and Thapa, 1994), and acceptability does not guarantee use (Minnie et al., 2003~. Fear of serious health risks and fear of side effects often lead to discontinuation (Grubb, 1987; Larsson et al., 1997) or deter many women from even starting any existing hormonal methods (Svare et al., 1997~. Overall, most currently available methods have discontinuation

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26 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH rates approaching 50 percent after 1 year of use, usually because of side effects (Rosenberg et al., 1995; Trussell and Vaughan, 1999~. Women who continue using a method often do so despite the side effects, which they are prepared to tolerate in return for pregnancy prevention. Nevertheless, difficulties with compliance and contraceptive discontinuation account for large numbers of unintended pregnancies (Iones et al., 2002; Rosenberg et al., 1995~. Indeed, more than half the women obtaining abortions in the United States in 2000 claimed to have been using a method of contracep- tion during the month that they became pregnant (Iones et al., 2002~: 14 percent had been using the contraceptive pill, and 28 percent had been using the male condom. Improvements in efficacy (Rice et al., 1999; Task Force on Post- ovulatory Methods of Fertility Regulation, 1998) and reduction of the side effects (Task Force on Postovulatory Methods of Fertility Regulation, 1998; Wildemeersch et al., 1999) resulting from the use of existing methods have been made over the last four decades, and new delivery systems have also been developed over that time. Nevertheless, efforts should continue to increase the range of acceptable methods, their accessibility, and their efficacy and ease of use. RECOMMENDATIONS To be successful, contraceptive methods must be attractive to poten- tial users and must be feasible for distribution systems to provide. Under- standing and integrating the views of potential users, their partners, and their providers early in the development process can influence the course of development and help ensure that the resultant method will meet user and provider needs. There are a number of options for integrating behav- ioral and operations research into or in parallel with early stage clinical studies so that they will be complementary to the efficient measurement of safety and efficacy. In addition, the development of contraceptives that provide addi- tional benefits beyond pregnancy prevention would enhance their attrac- tiveness. Current methods offer a number of added benefits, including alleviation of dysmenorrhea, acne, or premenstrual syndrome; improved endometrial bleeding patterns; or amenorrhea. The protective effect of the combined pill on ovarian and endometrial cancer also enhances continua- tion rates among well-informed women. Thus, contraceptives that re- duced the risk of other diseases such as breast or prostate cancer would likely have wide appeal. A contraceptive method that also conferred pro- tection against HIV infection and other STIs is likely to have widespread benefit as well. Moreover, the development, evaluation, and implementa-

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IMPROVING CONTRACEPTIVE USE AND ACCEPTABILITY 127 lion of innovative models of health care delivery that integrate family planning, STI, and HIV infection services could be very beneficial. Recommendation 8: Provide incentives and mechanisms for the integration of behavioral and operations research, including the views of providers as well as those of potential users and their part- ners, early in the contraceptive research and development process. Acceptability is determined by many factors, including inherent (and often unexplained) preferences; the perceived and actual risks and side effects; life stage and whether more children are desired eventually; social factors, including cultural preferences and the expectations of partners, peers, or family members. More accurate measures of acceptability and potential use would be valuable when applied early in the development process to improve decisions about continued development before the expenditure of resources for a method that lacks consumer and provider appeal. New methodological research is also needed to develop tools that can better predict the characteristics of contraceptive methods that will be attractive to users in different settings and life stages. Providers play a vital role in influencing both uptake rates and con- tinuation rates of contraceptive method use. Thus, research that deter- mines which service delivery practices are effective for increasing accep- tance and use of contraceptives would be useful as well. Recommendation 9: During the development of drugs and drug delivery systems, efforts should be made to discover, enhance, and promote the noncontraceptive health benefits of existing and new methods of contraception. Intensified efforts to develop new con- traceptive methods that are prophylactic for HIV infection and other STIs are especially important. Clinical evaluation and registration of a single product for two indi- cations is more complex and time-consuming, but it is feasible and has been accomplished for some therapeutic agents. Furthermore, several for- mulations that exhibit both spermicidal and microbicidal effects are now in clinical trials, lending credence to the potential for success in achieving this goal. REFERENCES Alan Guttmacher Institute (AGI). 1995. Hopes and Realities: Closing the Gap between Women's Aspirations and Their Reproductive Experiences. New York: AGI. Alan Guttmacher Institute (AGI). 1998. Into a New World: Young Women's Sexual and Repro- ductive Lives. New York: AGI. Alan Guttmacher Institute (AGI). 2000. Fulfilling the Promise: Public Policy and U.S. Family Planning Clinics. New York: AGI.

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