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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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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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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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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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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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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
OCR for page 126
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.
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Representative terms from entire chapter:
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