Policy and Behavioral Interventions for STDs 24

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Policy and Behavioral Interventions for STDs

Jonathan M. Zenilman, M.D.

Policy making in public health is a multidisciplinary activity that has a major impact on how public health problems are addressed. While most assume that relevant science should form the basic foundation for development of public health policy, the way that connection is bridged and how the science is inter- preted are frequently influenced by the political arena within which they exist.

STD prevention and reproductive health are not immune to this reality.

This chapter will first describe and define the core functions of public health, which provide a critical context for policy making. The basis and spe- cific domains of policy making and how they relate to preventing STDs will be explored, using case study examples to highlight specific points. The inter- face of science and policy making and the political arena within which they function will also be woven into the discussion.

Core Public Health Functions

The Institute of Medicine (IOM) defined public health as consisting of three core functions—assessment, assurance, and policy development (1–3). Policy devel- opment will be discussed here in the context of the other two major components.

In addition, many authorities also propose communication as a fourth function.

Assessment is the collection, analysis, and dissemination of health status

information in a systematic manner. For STD control, assessment includes the collection of morbidity data, the collection of behavioral surveillance data(4), as well as outbreak investigations. These activities include support of surveil- lance systems at local, state, and federal levels, and publication of documents such as CDC’s annual STD Surveillance Report and MMWR articles.

Assurance is the provision of access to necessary community-wide health

services. In many settings, especially care settings where clinical care has a direct impact on disease transmission, assurance may involve a public health agency directly providing care (5). Although clinical care provision is often perceived by the public as a major function of public health, this endeavor can be treacherous to public health agencies, because uncompensated clinical care in an environment without universal health care coverage is expensive. Besides clinical care and counseling activities, the assurance function is the basis for many regulatory activities, such as quality regulation of drugs and laborato- ries, and licensing of providers.

Behavioral Interventions for Prevention and Control of Sexually Transmitted Diseases.

Aral SO, Douglas JM Jr, eds. Lipshutz JA, assoc ed. New York: Springer Science+ Business Media, LLC; 2007.

Policy development (1) is the process through which decisions about

problems are made, followed by the establishment of goals and a means to reach them. According to the Institute of Medicine, public health policy deci- sions should have a sound scientific knowledge base (1). In classical political theory, as outlined by Lasswell, the outcome of this process (i.e., the policy) is a commitment to a particular course of action with broad implications for soci- ety (6). While policies can be developed by the private sector and government, only those established by government are binding. In an ideal world, policies are developed with objective data along with logical conclusions and recom- mendations. However, consensus about conclusions and resulting recommen- dations is typically difficult to achieve. In turn, politics almost always play a role in policy development. It is thus important to distinguish policy from pol- itics. Politics is a process of bargaining, negotiation, and compromise that determines “who gets what, when, and how” (7) and frequently influences pol- icy development. Furthermore, politics are necessarily linked to values and not uniformly linked to science. A policy perspective of an issue is intended to

“elucidate and expand the range of alternatives” for a resolution to a problem while a political perspective by nature aims to decrease the range of alterna- tives based on a particular set of values (8). A good example of an STD policy document is the Institute of Medicine report in 1997—The Hidden Epidemic (9)—which identified four major policy objectives to address the epidemic of STDs in the United States:

1. Overcome barriers to adoption of healthy sexual behaviors.

2. Develop strong leadership, strengthen investment, and improve information systems for STD prevention.

3. Design and implement essential STD services in innovative ways for ado- lescents and under served populations.

4. Ensure access to quality clinical STD services.

Communication (10,11) includes provision of health promotion messages and

realistic risk assessment. Besides delivering messages to the general population, a major communication objective is to insure that public health officials have appropriate training and tools to adequately address public health needs, espe- cially in times of crisis. Communication is also audience-dependent, a nuance that is often overlooked. Communication skills for a medical audience would dif- fer substantially from those required for policymakers or special interest groups.

Process for Policy Development and Implementation

Public health policy is developed and implemented through legislation, regu- lation, and guidance.

Legislation

Legislation provides the legal framework for defining and establishing public

health policy as well as the vehicle that provides funding to implement such

policy. One of the prime examples of how legislation has impacted public

health policy for STD control was the passage of federal venereal disease con-

trol legislation during the 1930s, which provided justification and federal

authorization of spending for public health services related to STD control.

The justification for federal involvement was the potential for the transmission of STDs across state lines.

Authorizing legislation (12) provides support for surveillance; public health control functions, such as partner notification; and laboratory testing, which is typically part of large initiatives. Initiatives can be either through specific authorizations, such as the Ryan White Care Act, which began in 1991 (13) or as part of an overall budgetary process, such as the national gonorrhea screen- ing program which began in 1972 (14) and the Infertility Prevention Program (focused on chlamydia screening), which became a part of the STD prevention budget in the late 1980s (15–17). Delineating specific federal and local roles is important. For example, federal funds under the STD public health acts can- not be used for the provision of clinical care, which is primarily seen as a local function.

Legislation invariably has to adapt to specific political needs. One of the major issues facing STD controllers is that a large number of individuals at particularly high-risk for STIs are marginalized, may be incarcerated, do not or cannot vote, and therefore have poor political representation. Stigmatization of persons with STDs has been historically problematic. Effective develop- ment of public health programs requires developing and building a con- stituency, partnering with impacted groups, enlisting the support of the provider community and finally, convincing legislators that there is potential for the public good.

Regulation

Regulation is one expression of policy and can take a number of forms. Since this is a very broad topic, discussion will be limited to regulatory frameworks that are relevant for STD control. Regulation usually requires underlying leg- islation to provide a legal framework, which is critical for enforcement.

Regulation of Professionals

All states require credentialing and licensing for professionals involved in the care of patients, including physicians, nurses, social workers, pharmacists, and laboratory technologists. Such practice is intended to assure competency, and often is required for reimbursement. Currently, there are no credentialing requirements for public health professionals who are not direct care providers, such as epidemiologists or program managers.

Laboratory Regulation

Clinical laboratories are regulated by state and federal governments, with a

major focus on quality assurance and tracking of specimens. The Clinical

Laboratory Improvement Act of 1988 (CLIA) is the major federal laboratory

regulatory legislation which has impacted STD care providers. Quality assur-

ance is especially important in STD care because of the implications of clin-

ical results. Regulation can also include reporting requirements by

laboratories for communicable diseases. Before new diagnostic tests can be

used in patient care, they have to be approved, usually by the FDA (see

below).

Drug, Vaccine, and Diagnostic Test Regulation

This function is performed by the Food and Drug Administration, whose man- date is to assure that drugs used are effective and safe. The manufacturer must meet stringent criteria and present results of carefully conducted clinical trials.

Case Studies: Regulation Over-the-Counter Acyclovir

Acyclovir is a highly effective antiviral medication that is indicated for the treatment and suppression of genital herpes. The drug has minimal side effects, and most experts consider it safe to use even in pregnancy (18). In the mid-1990s, advocacy groups and the manufacturer proposed to the FDA that the drug be licensed for over the counter (OTC) sale (19). The major supporting argument was that acyclovir is most effective when taken early in the course of a herpes outbreak. Since patients often have to wait several days before being able to see a health care provider, and since the drug is safe, OTC status would facilitate rapid treatment. Arguments against licen- sure included concern over self-diagnosis and misdiagnosis of other genital ulcer diseases as well as concerns over development of antiviral resistance due to potential overuse (20,21). After active debate in the literature as well as at regulatory hearings. Nevertheless, the FDA elected not to approve acyclovir as an OTC drug. This debate was largely informed by scientific considerations.

Plan B (Over-the-Counter Emergency Contraceptive)

Plan B (emergency contraception) was proposed as an OTC drug in 2003. Plan B is most effective when taken within 48 hours after unprotected intercourse (22). The arguments in favor of approval were based on scientific evidence and implementation practicalities (23,24). Similar to those presented for the acy- clovir debate, the drug’s safety record was impeccable, and women often had to wait more than 48 hours to see a physician or health care provider, espe- cially on weekends and holidays. Furthermore, experience with OTC use in both Western Europe and a number of states was highly favorable (25). In con- trast, the arguments against Plan B were politically rather than scientifically driven. Contrary to scientific evidence (26), antiabortion activists claimed that Plan B was an abortifacient. Other groups contended that OTC licensure would lead to behavioral disinhibition and increased high-risk sexual behav- iors (27) though scientific evidence counters this concern (28). The FDA Advisory Committee voted overwhelmingly to approve Plan B as an OTC. In an unprecedented move, however, the Commissioner overruled the committee.

Because of the perception that the Commissioner’s decision was influenced by

conservative political pressure and not guided by the recommendations of the

scientific advisory committee, Dr. Susan Wood, the FDA official in charge of

women’s health, resigned. Women’s health groups felt that this impasse was a

critical issue and used it as a tool to address what they felt to be governmental

disregard for the scientific basis for reproductive health policies and the FDA

regulatory policy in particular (29). In 2006, the issue was mostly resolved

when the FDA approved OTC Plan B for women over 18 years old. This deci-

sion was based on the science indicating a likely high level of benefit with

minimal harm.

Partner-Delivered Therapy

Treatment of exposed partners is a cornerstone of control policy for bacterial STDs. However, partner notification (PN) and treatment is not widely imple- mented for gonorrhea and chlamydia. This occurs for three reasons. First, PN is labor intensive and in an era of limited budgets, many health departments have either reduced these resources or redirected them to HIV and syphilis con- trol. Second, index cases often refuse to name exposed partners. Third, there are no data to demonstrate that PN provided by health department personnel is cost-effective (30,31).

Partner-delivered therapy (PDT) has been proposed as an alternative to tra- ditional partner services (32–34). PDT has been shown to reduce re-infection rates in persons with gonorrhea and chlamydia. However, implementing PDT faces a number of regulatory challenges (35), including;

1. Physician issues: In prescribing PDT, does a third party (the unnamed part- ner) become a patient by proxy, and does the physician incur liability, especially for prescribing drugs without seeing the patient?

2. Can a pharmacy dispense drugs to an individual without a prescription?

3. Do these issues result in violations of the Medical Practice Acts and Pharmacy laws, which may subject the practitioners to disciplinary action?

Because the drugs commonly used are safe, STD programs have lobbied in a number of states to establish PDT as a recognized standard of care, includ- ing changing the appropriate regulations. In California, this was done through lobbying, advocating, and ultimately enacting changes in the laws and regula- tions. Under current law, California physicians are allowed to provide med- ication to sexual partners of individuals diagnosed with chlamydia without fear of regulatory action by state medical boards. In Washington State, another approach has been for the Health Department to act as agent. Partners of indi- viduals diagnosed with gonorrhea or chlamydia are directed to designated pharmacies where they can confidentially obtain medications, subsidized by the Health Department. In this setting, the Health Department received a reg- ulatory interpretation which allowed pharmacies to dispense the medication without a direct prescription.

Guidance

Guidance is developed by government agencies to help responsible parties

adhere to laws, regulations or recommendations promulgated by the govern-

ment. From the clinical perspective, the CDC’s Sexually Transmitted Diseases

nicians with current clinical practice recommendations. Although the document

clearly states that they are “only guidelines,” they are widely adopted and rec-

ognized as “clinical standard of care” by STD programs and other provider

communities. CDC’s guidelines for HIV counseling and testing, which were

first released in 1986, targeted a wide audience, including clinicians, public

health program managers, and the larger private health community (36). These

guidelines were instrumental in the rapid dissemination of HIV testing

resources throughout the country, and in ascertaining quality assurance for lab

performance and behavioral counseling. Other examples are CDC’s recent rec-

ommendations by the Advisory Committee on Immunization Practice (ACIP)

for use of quadrivalent HPV vaccine (37), which provides guidance on the use of newly licensed vaccines, and CDC recommendations on HIV testing in health care settings, which encourages routine HIV testing in a variety of health care settings (38).

Relationship of Core Public Health Functions

to Policy: Assessment and Assurance in the STD Context

Development of STD policy and programs requires a clear understanding of morbidity and other assessment measures, underscoring the need for effective disease and behavioral surveillance. Surveillance should proactively guide policy that results in the development of interventions. For example, the focus of the syphilis elimination program on African-American populations was a direct response to increases in syphilis in that population during the early 1990s, which was in part related to drug abuse (39). The chlamydia interven- tion screening programs developed during the 1980s were a response to increased recognition that chlamydia was an important cause of pelvic inflam- matory disease (40) as well as technological innovation which made chlamy- dia testing possible in the typical clinical setting (41).

The STD control issues which face policy makers in the United States include an expanding and diverse population, persistence of high rates of STDs especially in minority and poor populations, a fragmented health care system, and dynamic epidemics. Allocation of resources between clinical services, screening, public health outreach, and surveillance is a continual challenge. Furthermore, emerging public health threats, such as bioterrorism and pandemic influenza, pose challenges to more established programs for ongoing public health issues such as STD control. These challenges not only include competition for funding but also competition for experienced staff.

Differential Government Roles in Developing and Implementing STD Policy

The programs and implications of STD prevention policy are different at var- ious levels of government. At the local level, the major focus is on local assess- ment and service provision. Local governments, such as municipal and county governments in the United States, generally provide access to free or low-cost STD services (5). In addition to STD services, they may also provide addi- tional reproductive health care services, such as family planning and adjunc- tive services like partner notification. Often, these services are provided with local health care dollars, supplemented by state funding. In addition, a critical component of local government is implementation of reproductive health edu- cation in public school systems.

At the state level, there are a variety of additional STD prevention functions.

State governments are often involved in providing assurance of service deliv-

ery, both for clinical services and general public health services. In some

states, county health department employees are actually part of the state civil

service systems. Besides providing access to care, state governments provide

overall education guidelines to school systems, including development of cur-

ricula as part of health and science education. State governments also have a

growing role in funding of clinical care services. In some states, Medicaid and

other publicly funded care programs can provide funding to public health serv- ices. An example of this is Minnesota, where a state-wide managed health care system provides support for public health clinics to offer reproductive health services (42). In addition, states are responsible for professional regulation of providers such as nurse practitioners and physicians.

The federal government also has substantial impact on development of STD and reproductive health policy. The federal government expresses STD policy largely through the Centers for Disease Control and Prevention and Prevention (CDC) and, to a lesser degree, through the National Institutes of Health (NIH) and other federal agencies. The CDC supports the development of STD treat- ment guidelines (18), which are widely used for both clinical care and quality assurance, not only in the United States but also throughout the world. The CDC also provides support for national surveillance programs for a variety of sexually transmitted infections. Most of public health surveillance for STDs is passive. However, large periodic national surveys, such as the National Health and Nutrition Evaluation Survey (NHANES) (43) and the National Survey of Family Growth (NSFG) (44), provide opportunities for periodic assessment of broad parts of the population on a cross-sectional basis. The federal govern- ment also supports STD research through a variety of different sources. NIH supports research in basic science of STD, STD vaccine development, as well as targeted STD intervention research programs. NIH research is largely hypothesis-driven. In contrast, CDC research support is often operationally driven, focusing on quality improvement indicators, development of surveil- lance methods and systems, and health process indicators. The federal gov- ernment also has the capability of instituting large national initiatives, such as the syphilis elimination and the chlamydia screening/infertility prevention programs described above. Implementation of federal program initiatives is usually accomplished through appropriation of funding.

Policy Development, Public Health, and the Public Arena

Balancing Individual Liberties and the Public Good

Critical to policy development in public health is understanding the inherent challenge of balancing the overall health needs of the population with individ- ual choice and liberty. At its extreme, public health authority is based in police powers. Practices to prevent infectious disease transmission may conflict with societal privacy norms, notions of personal autonomy or even civil rights. For example, public health entities have the authority to incarcerate an individual who is noncompliant with antituberculosis therapy, or to notify individuals that they have been exposed to a sexually transmitted or other communicable disease. Use of such authority is essentially abrogating privacy and intruding on personal autonomy. In a democratic society, a cost-benefit calculation would determine that the public good often outweighs privacy and freedom liberties.

Community Influence

Community support is essential for the development of public health policies.

Thus, another way of looking at policy development is informing, educating,

and empowering communities, processes that are dependent on both the assessment and communication public health functions. Mobilization of com- munity partnerships is integral to policy development because such partners are the basis for political support. Political support is dependant essentially on the electoral process. If policy makers recognize community support and con- sensus for a public health initiative, political will to support those initiatives is greatly increased.

Potential advocates for STD policy can result in coalitions of grass-roots organizations and political organizations that may not be intuitively obvious.

For example, women’s groups have traditionally coalesced around issues of specific interest, such as infertility prevention, maternal-fetal health, and reproductive health. These issues can catalyze a natural alliance between the women’s caucus in the congressional leadership and STD prevention interests.

Grass-roots community organizing, following the models of nongovernmental organizations seen in international settings and developing countries, have been effective in influencing legislators when addressing the needs of particu- lar populations. Probably the best example of community organizing has been in the area of HIV treatment and prevention. Early in the epidemic, commu- nity groups, especially those in the gay community, were especially effective in humanizing those affected by the disease. They also focused on legislative action, resulting in a treatment programs such as those funded by the Ryan White Care Act, and prevention and research programs.

Advocacy partnerships vary widely, depending on the specific objective.

For example, two of the major advocacy groups for STD control are the American Social Health Association (ASHA) and the National Coalition of STD Directors (NCSD). Each has a different audience. ASHA largely focuses on consumers (patients) and provides resources and information, especially on chronic viral infections such as genital herpes and genital HPV infection.

ASHA also advocates in the general public sector on the overall medical and economic impact of STDs. NCSD represents State public health programs and has typically collaborated with traditional public health advocates, such as the American Public Health Association and associations of county health officials. NCSD educates policy makers about a variety of issues related to STD prevention and control including funding for surveillance, public health infrastructure, and STD core support services.

One of the best partnership examples was the syphilis elimination program initiated in the late 1990s (45–49). This effort was fueled by substantial con- cern, in both the African American community and the public health commu- nity, over the increased rates of syphilis in heterosexual African Americans.

Previous syphilis control programs were hampered by poor access to margin- alized populations. In the African-American community, these problems were complicated by the historical legacy of discrimination and the Tuskegee syphilis study. Partnership with the affected community was seen as critical to success.

The National Plan to Eliminate Syphilis from the United States was released

in 1999 (50). A key feature of this program was recognizing the need to inter-

act with community partners. These partners included public health advocacy

groups, health providers, grass-roots community organizations and supportive

churches. The program start-up had many trust-building initiatives, including

open discussion of past discrimination and of the Tuskegee study. One overall

objective, which was achieved, was to provide support to enable and empower community members to deal with syphilis as a health problem and not as a stigmatizing issue. Achievement would not have been possible without devel- oping successful partnerships. Tools for developing partnerships, which are translatable to multiple settings are available at the CDC Syphilis Elimination web site (51).

Communicating Policy with Senior Officials

Policy messages need to be effectively communicated to politicians in order to effect change. At times, these communications can be based on cost effective- ness arguments and savings for the health care system. At other times, policy communication may be emergently necessary due to political embarrassment.

For example, in 1997–1998, a syphilis epidemic in Baltimore (52,53) embar- rassed local political leaders, which in turn resulted in the rapid provision of resources (54). Effective utilization of these resources by health care person- nel resulted in an extremely positive relationship between health department staff and the political process, which in turn enhanced future funding levels.

A common error made by many scientists and public health officials is over- looking the political realm. Political decision making is an art form. A brief- ing for policy makers should be concise and is typically provided in the form of a briefing paper, a talking points memo, and a very short presentation. Talking points memos are short, one-page documents that present the policy question, the stakeholder constituencies, and the pros and cons of policy options, clos- ing with a recommendation and justification.

Economic Influences on Policy Making: Cost-Effectiveness

The cost and cost-effectiveness of public health programs is an area of increas- ing interest, and there is a growing amount of cost-effectiveness data for many STD diagnostic and therapeutic interventions, especially chlamydia screening (55–57). Such analyses are critically important when addressing policy makers, because effective prevention often requires investment of financial resources.

STD interventions are usually less expensive than interventions typically used in general medical practice. For example, the annual costs of medical interven- tions for conditions such as end-stage renal disease, advanced coronary artery disease, and HIV treatment are between $30,000 and $60,000 per year.

Cost-effectiveness data need to be carefully evaluated. For example, cost effectiveness should be used as a tool only when the savings are seen as preven- tion of subsequent medical costs, Quality-Adjusted Life-Years (QALY), or Disability-Adjusted Life Years (DALY), all of which are internationally recog- nized normalization approaches. Some authorities recommend using full cost analyses, including indirect costs (e.g., lost income, overall societal benefit). See Chapter 21 in this book for more discussion about cost effectiveness analysis.

Managed care organizations (MCOs) have historically looked closely at cost-

effectiveness of care and can be another potential source of support for STD

advocacy. Vertically integrated MCOs, where the organization provides and

pays for all medical and prevention services, are natural test beds for evaluat-

ing public health prevention interventions that result in later cost savings. In

these systems, a single payer, which is also the provider, is responsible for the

prevention services, medical services, hospital care, and all associated services.

Therefore, cost savings realized by prevention result in increased revenue at the bottom line for the provider through decreased complication rates and a decreased need for treatment services. For example, large, vertically-integrated MCOs such as the Kaiser Permanente groups and Group Health of Puget Sound have been especially active in developing cost-effectiveness models for many diseases, including STD prevention initiatives (42,58–61). This model contrasts with the typical care reimbursement system in the United States, where invest- ment in prevention services by either a hospital or health department results in savings not for the provider of these services but rather for the organization that pays for care (e.g., Medicare, Medicaid, other insurers). In this latter system, there is no feedback loop to compensate or reward for increased prevention.

Public Health Policy and the Prevention Cost Paradox

One of the most important issues facing prevention analysts is the cost para- dox. The United States is largely structured for health care on a payment scheme. Therefore, payment is provided for clinical services rendered, not for morbidity that is prevented or population-level health promotion. This results in a clinical paradox (62). For example, it is often difficult to garner adequate funding for prevention initiatives; however, practitioners are well aware of the large sums of money spent on complications of preventable diseases, resulting in both practical and ethical dilemmas. The practical issues are that prevention programs are very difficult to tangibly assess, especially for the layperson and the policy maker. Furthermore, it is very difficult—medically, ethically, and politically—to refuse to provide care to sick individuals, even at the terminal phase of illness. Solutions to this problem have been evasive. One solution is a vertically integrated managed care system, such as Kaiser Permanente, in which clinical care and preventive care are all funded through the same finan- cial source, as described above. In such a situation, there is a direct incentive to reduce overall costs, not just costs on the prevention side.

Case Study: Effective Intervention without Implementation—The Failure of Translational Follow-Through

Although there has been substantial research on behavioral interventions, there has been little investment in implementation. One of the best examples in this area is Project RESPECT. Project RESPECT was a large multi-center behav- ioral intervention project which was conducted by CDC from1992 to 1995 in five STD clinics (63,64). Project RESPECT conclusively showed that behav- ioral intervention in an STD clinic (high risk) setting can yield benefits, both in terms of behaviors such as increased condom use and decreased STD rates.

Despite this demonstrated effectiveness, the Project RESPECT intervention was never implemented in the vast majority of STD clinics. This occurred for a number of reasons. First, the demonstration project clearly indicated the need for increased support and training of staff and improved infrastructure.

Second, in underfunded programs, if managers are presented a choice between

allocating funds for treating symptomatic STDs or investing in behavioral

counseling, treating symptomatic patients is always prioritized. Finally, the

savings from preventing HIV and other STDs primarily accrue to the health

insurers, not to the prevention agencies.

Case Study: Chlamydia and Infertility Prevention—Successful Screening Intervention for Women, but Not for Men

An example of both the advantages and disadvantages of the legislative process is the development of the chlamydia control and prevention initiatives.

The major morbidity of chlamydia was well-appreciated to be the develop- ment of pelvic inflammatory disease and subsequent infertility. Therefore, as chlamydia screening initiatives were developed, it became very clear that women should be their initial targets, primarily to prevent development of these subsequent complications. Chlamydia prevention was marketed to legis- lators in the 1980s as an infertility and neonatal infection prevention program.

Although this approach resulted in broad-based political support, it was lim- ited by its failure to support screening of men or partner management.

Although a number of venues have begun to implement chlamydia screening of men (e.g., correctional centers, job core centers, adolescent clinics, STD clinic) (65), no federal programs currently support male screening.

Using Science to Instruct Policy

Framing the Issue for Success Case Study from the United Kingdom

How an issue is framed can significantly impact its ability to be successfully addressed through policy. One of the best examples of using data to successfully inform policy and effective advocacy was development of the National Strategy for Sexual Health and HIV in the United Kingdom in 2001 (66). Concern over increased pregnancy and STD rates in the United Kingdom prompted a Parliamentary Commission of Inquiry in 2002 (67). The Commission recom- mended greater investment in STD services, increased support of National Health Service (NHS) STD interventions, and implementation of a national chlamydia screening program.

This initiative has had broad-based support (68,69). The Commission’s report to Parliament largely focused on improving sexual health rather than on sexual

improving health care and social care for people living with HIV, and reducing the stigma associated with HIV and sexually transmitted infections (STIs). The linking of STI care to HIV care resulted in substantial support from the HIV advocacy community for improved care services. The sexual health plan included specific clinical provision issues, such as providing more patient-friendly services at the NHS facilities. The plan also addressed social issues, including improved sex education, prevention initiatives, overall reduction of social inequality, and specific outreach to vulnerable groups such as homosexual men, injecting drug users, and immigrants. The Commission was able to assess the problems with input from stakeholders and based on that assessment, develop an acceptable strategy that promoted sexual health and expanded clinical services.

Policy Controversies in the United States

The United States has the highest rate of teenage pregnancy among other devel-

oped countries, and nearly one million of these are terminated annually through

therapeutic abortion (70). Although the abortion rate has dropped significantly

over the past decade, it is still much higher than that seen in other developed countries.

Despite the large number of unwanted pregnancies and high STD rates, one of the most contentious policy issues in the United States has been sex educa- tion for adolescents. The foci of the two primary competing programs are

include the biology of reproduction. However, abstinence-only education pro- grams place great emphasis on the adverse impacts of sexual intercourse prior to marriage (72–74), and contraception and condom use as prevention strate- gies are not included. In contrast, comprehensive sex education includes all forms of disease prevention, such as delayed onset of sexual intercourse, abstinence, health promotion, and appropriate use and benefits of contracep- tion and condoms (75).

In addition, service delivery access, in general, presents real and substantive problems. Over 45 million persons in the United States currently lack health insurance. Although there have been significant advances in providing access to services for children and young adults, there are still important gaps, espe- cially for adolescents, older males, and women who are not pregnant or do not have dependents. When teens and young adults do choose to seek reproductive health services, they face substantial structural barriers. Without parental con- sent, they frequently cannot access insurance for which they are eligible, pay- ment, and/or transportation. For those covered under a parent’s insurance plan, confidentiality may be an important barrier to seeking care because the service delivery and payment notifications that are typically mailed out to the sub- scriber.

Case Study: The Efficacy of Condoms—Interpretation of Empirical Data

An important intersection of policy and science revolves around the issue of condom promotion as a major form of STD prevention. Despite a long history of being recommended and used both for contraception and STD control, con- doms actually lack formally and rigorously obtained clinical data demonstrat- ing effectiveness (76,77). The absence of such studies is largely related to the fact that condom efficacy is difficult to study, especially since study designs would require that all individuals at a minimum be counseled about standard public health practice, which includes condom use. Thus, it is unethical to con- duct a trial where individuals are exposed to sexually transmitted infections without recommending use of a condom. Therefore, indirect methodologies have to be used, resulting in problems with selection and reporting bias. Even under these constraints, however, there are increasing data that condoms are effective in reducing risk of transmission of HIV, gonorrhea, herpes, and chlamydia (77). In addition, there are ecological data from large country-level programs as in Thailand, where national campaigns to increase condom use resulted concurrently in structural interventions (i.e., 100% condom use regu- lations in brothels, development of alternative recreational activities for army personnel), destigmatization of HIV in public discourse, and substantial (over 90%) decreases in STDs (78,79). The 100% condom campaign has been pro- moted extensively by the Thai Ministry of Health, and more recently, by other countries in Southeast Asia, such as Cambodia and Vietnam (80,81).

In 2000, the NIH held a consensus conference to assess the data on condom

efficacy (76). The motivations for this conference were largely driven by an

emerging political debate in the late 1990s which argued that, since there were no data from randomized clinical trials on condom efficacy, they should not be promoted as an effective means to prevent STDs (76). Based on review of the published literature, the conference concluded that apart from HIV and gonorrhea, there was little efficacy data to demonstrate condom effectiveness for most STDs. Some organizations focused on the absence of data as justifi- cation for discouraging the recommendation of condom use in high-risk situ- ations (82). The dearth of data also provided justification for Congress to enact subsequent legislation that directed the FDA (83) to mandate labeling on con- dom packaging that indicated both the “overall effectiveness” and the “lack of effectiveness” in preventing STDs, including condom efficacy for specific STDs. This mandate represented a changed emphasis from the FDA regula- tions in place since 1987 which required that condom packages include lan- guage emphasizing the effectiveness of condoms against STDs when used properly. The explicit goal of the new mandate was to inform consumers about the limitations of the device (84).

In response, there was a large surge in research to evaluate condom efficacy using more methodologically sound designs (73). Innovative clinical trial designs evaluated data seen in patients from sexual partnerships (85, 86). Other studies used sophisticated retrospective analyses of previous data sets, like those collected for such purposes as STD vaccine trials (87). A recent prospective study showed that condom use reduces male to female transmission of human papillomavirus (HPV) (88), an area of great interest to policy makers. The grow- ing body of scientific evidence showing that condoms reduce the transmission risk of most STDs, including human papillomavirus (89), more firmly supports recommendations regarding the importance of condoms in STD/HIV prevention among individuals who choose to be sexually active (18). See Chapter 10 in this book for more extensive discussion of the latest studies on male condoms.

Case Study: Abstinence-Only Sex Education

Abstinence-only education has been the primary sex education policy of the federal government in the United States since the mid-1990s (90). Funded through the 1996 Social Security Act, Title V, Section 510 (88) as well as Special Projects of Regional and National Significance (SPRANS) as part of block grants starting in 2005 (91), abstinence-only education programs must adhere to the following guidance:

A. Have as its exclusive purpose teaching the social, psychological, and health gains to be realized by abstaining from sexual activity

B. Teach abstinence from sexual activity outside marriage as the expected standard for all school-age children

C. Teach that abstinence from sexual activity is the only certain way to avoid out-of-wedlock pregnancy, STDs, and other associated health problems D. Teach that a mutually faithful, monogamous relationship in the context of

marriage is the expected standard of sexual activity

E. Teach that sexual activity outside the context of marriage is likely to have harmful psychological and physical effects

F. Teach that bearing children out-of-wedlock is likely to have harmful con- sequences for the child, the child’s parents, and society

G. Teach young people how to reject sexual advances and how alcohol and

drug use increases vulnerability to sexual advances

H. Teach the importance of attaining self-sufficiency before engaging in sex- ual activity

Abstinence–only sex education is by definition not comprehensive. Yet, it is important to note that national surveys have shown that over 88% of American adults have had vaginal sexual intercourse prior to marriage (92). Though almost all adults (94%) and teens (92%) believe it is important that society give a strong message that teens delay sex until after high school (93), most believe that the abstinence-only approach will not prevent STDs or unwanted pregnancies (94). Most also think teens who are sexually active should have access to birth control (94).

Study results from abstinence-only approaches must be carefully examined before conclusions are drawn. For example, data from large nationally based prospective surveys of adolescents have shown that abstinence-only programs and the use of virginity pledges delayed the onset of coital debut by six months (95). However, although these programs delayed the onset of coitus, when it did occur, the virginity pledgers were less likely to use contraception and con- doms than others, resulting in increased risk for pregnancy and STDs. When analyzed over time, the cumulative STD and pregnancy rates in the virginity pledge groups were similar to those of the nonabstinent group, and in some subsets, were actually higher. Findings were stable across both socioeconomic and ethnic lines. These data suggest that lack of comprehensive sex education, which affords the young individual the tools to use for protection in case sex- ual intercourse occurs unexpectedly or in an unplanned fashion, reduces the STD and pregnancy prevention benefits of abstinence programs. The few stud- ies to date that have reported positive results from abstinence-only programs have had significant methodological limitations (e.g., measuring short-term behaviors, small sample sizes, use of nonstandard statistical data, use of self- reported vs. laboratory-confirmed STIs) (73,75).

Therefore, in this case, the emphasis of the national public health policy on abstinence-only education for youth is discordant with the practices and attitudes of the vast majority of the American population as well as the existing science.

In contrast to this approach, peer-reviewed research on abstinence-only education and comprehensive sex education (72,73) has led many prestigious organiza- tions to recommend a different policy direction. For example, the Institute of Medicine (96), the American Academy of Pediatrics (97), and the American Psychological Association (98) have all concluded that sex education for ado- lescents needs to offer comprehensive approaches to optimize prevention (including abstinence), and that abstinence-only programs leave adolescents vulnerable and unarmed with the tools they need to prevent harmful outcomes.

Science, Policy Making, and Politics in STD Prevention and Reproductive Health: Tensions and Promise

The Institute of Medicine concluded that health policy making should be

driven by public health concerns and based on scientific knowledge (1). Yet,

politics clearly influences the way science, policy making and public health

practice converge, especially in the field of reproductive health. The contro-

versies in the United States about emergency contraception, condoms, and

abstinence education exemplify the influence of politics on how public health

problems are addressed. Similar observations can be made in the field of global warming where environmental scientists have recently argued the importance of distinguishing policy from politics as a way to ensure that sci- ence instructs policy without political bias. Science, they would argue, cannot resolve political differences since scientific results can be interpreted to sup- port different political agendas (8,99). Rather, scientists might more usefully and more objectively link their results to policy. In other words, scientific inquiry should not only show results but should also offer policy options based on those results. Using science to justify a political agenda after that agenda has been defined removes the objectivity of the science (99).

Policy making as a core function of public health plays a critical role in effec- tive STD prevention. If policy options are not informed by science, political agendas may weaken the effectiveness of STD prevention efforts. At the same time, one cannot ignore the influence of politics on policy makers. Partnerships between the public and private sectors can constructively fuel the political arena within which policy is developed. To maximize STD prevention efforts, STD prevention scientists, public health practitioners, health care providers and the general public must recognize the complementary but different roles of science, policy and politics in formulating effective public health programs.

Acknowledgments: The author acknowledges support from NIH grant K13-

AI01633. Ms. Lin Rucker provided invaluable assistance in preparing the manuscript. I also acknowledge the review and constructive comments from Dr. Stephen Teret of Johns Hopkins Bloomberg School of Public Health and an anonymous reviewer.

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