A new paradigm for HIV care: ethical and clinical considerations.

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Commentary

A New Paradigm for HIV Care: Ethical and Clinical Considerations A B S T R A C T Although dramatic advances in clinical treatment have greatly improved the lives of many people with HIV/AIDS, many other patients do not have information about or access to these treatments because of health care providers’ presumptive judgments about patients’ ability to adhere to medical regimens. The authors contend that with sufficient support and education most patients, even those with difficult social and medical problems, can be helped to initiate and maintain HIV treatment in accordance with current clinical standards. This commentary delineates a new paradigm for HIV care in which patients and providers collaborate on individualized plans to establish patients’ readiness for treatment, ensure maintenance of treatment, and make use of the social services necessary to accomplish these goals. Providers have an ethical responsibility to do everything possible to see that patients who might benefit from new HIV treatments have a fair opportunity to do so, and health systems have a responsibility to facilitate this process. Substantial progress toward meeting these responsibilities can be made within the current health care environment. (Am J Public Health. 2001;91:690–694)

Sonja Noring, MA, Nancy Neveloff Dubler, LLB, Guthrie Birkhead, MD, MPH, and Bruce Agins, MD, MPH In recent years, the use of combination therapies including protease inhibitors has proven to be a dramatic advance in the treatment of HIV/AIDS, allowing longer and healthier lives for many people.1–3 These scientific advances, together with substantially increased public-sector funding for HIV/ AIDS treatment in most regions, clearer standards of HIV care, and greater HIV expertise among health care providers, should be expected to substantially improve the quality of clinical care for the large majority of people with HIV/AIDS. However, clinical benefits have not been evenly distributed. Reports have suggested that individuals and entire categories of HIV patients have sometimes been deprived of information about or access to new HIV therapies because of presumptive judgments about their ability to adhere to medical regimens.4–8 Most often, these are people with difficult social and medical problems: substance users, inmates, the homeless, and the mentally ill, groups representing a substantial proportion of those living with HIV. The problem of unequal access to HIV therapies exposes 3 critical issues in HIV/AIDS care that are echoed in many other health care arenas: the difficulties of designing treatment regimens for patients with complex socioeconomic and medical needs; barriers to appropriate care that stem from organizational structure, staff training, and policy; and pervasive problems of treatment maintenance. The ethical, medical, and public health imperatives of the HIV/AIDS epidemic require that these issues be directly addressed.

Critical Issues in HIV Treatment Socially and economically disadvantaged populations are disproportionately affected by HIV infection. The additional problem of inequitable access to HIV treatment poses a compelling ethical obligation to examine the ways 690

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in which treatment decisions are made. As Paul Farmer has written, “The advent of truly effective therapies only brings into starker relief the centrality of social inequalities, when unequal access to these therapies heightens the inequalities of infection.”9(p14) In other words, “the better the therapy, the more injustice meted out to those not treated.”9(p267) Combination HIV therapies, known as highly active antiretroviral therapies (HAART), are indeed better therapy. They can increase the length and quality of life and reduce viral load, thus decreasing the likelihood of HIV transmission. HIV-related hospitalizations and death rates have declined since the widespread introduction of these therapies in the past several years.10 However, combination HIV therapies are complex as well as costly. Regimens may involve multiple doses of 8 or more different medications with precise scheduling and nutritional requirements. Side effects, patient responsiveness to treatment, disease progression, and drug interactions all mandate frequent clinical monitoring. Medical benefits are highly dependent on strict maintenance of treatment regimens,11(p2) for which most patients need substantial education and continuing encouragement. Low levels of adherence—that is, discontinuities or cessation of some components of treatment—can compromise the effectiveness of medications and could result in individual and perhaps widespread drug resistance,3,12–15 similar to the problem of multiSonja Noring, Guthrie Birkhead, and Bruce Agins are with the New York State Department of Health AIDS Institute, New York, NY. Guthrie Birkhead is also with the Department of Epidemiology, School of Public Health, University at Albany, Albany, NY. Nancy Neveloff Dubler is with the Division of Bioethics, Montefiore Medical Center, Bronx, NY. Requests for reprints should be sent to Sonja Noring, MA, 267 W 89th St (5B), New York, NY 10024 (e-mail: [email protected]). This commentary was accepted January 5, 2001.

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drug resistance in the treatment of tuberculosis. Thus, while there is a clinical responsibility to provide the most effective care, there is also a public health obligation to ensure treatment maintenance. Even for people with HIV who do not have additional social and medical complications, successful initiation and maintenance of HAART regimens requires a paradigm for provider–patient interaction fundamentally different from those of the past and from those

dictated by current health care delivery systems that are burdened with other priorities. HIV therapies demand coordinated, consistent primary and specialty health services, together with access to social and support services, through an ongoing relationship with a trusted team of providers. The reality is that many people cannot afford and do not obtain basic health care. Increasing numbers are underinsured or uninsured.16 Less time is now allocated to patient

TABLE 1—Principles of HIV Care 1. Knowledge of HIV status

2. Access to health care services

3. Access to HIV treatment information

4. Patient–provider collaboration

5. Special populations

6. HIV treatment support services

7. Access to HIV treatment

8. Responsibility to individual and public health

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The first step in gaining access to HIV treatment is learning one’s HIV status. All health care providers and all social service, religious, and community organizations have a public responsibility to widely and strongly encourage HIV counseling and testing. Every person with HIV should have access to basic health care services as well as to HIV specialists as needed. Health care providers have an ethical obligation to inform every person with HIV about all potentially beneficial treatments. Information is broadly defined to include a full explanation of the requirements of treatment regimens and the benefits and risks of initiating or delaying treatment. Determining an HIV treatment plan should be a collaborative process. Patients have a responsibility to be active in shaping treatment decisions that fit their circumstances and to maintain regimens. Providers have a responsibility to work with patients to explore treatment options and to identify and reduce barriers to care. Providers are responsible for facilitating the most appropriate treatment plan when patients are unable to fully participate in treatment decisions (e.g., children or the mentally ill) or when patients do not have control over their participation in services to support treatment (e.g., prison inmates, immigrants, or others in institutional settings). Every patient with HIV should have access to support services that will enhance readiness to begin therapy and provide the maximum opportunity for effective maintenance of the treatment regimen. Providers should be informed about factors that enhance treatment maintenance and available support services. No one should be denied access to HIV treatment because of membership in any group, HIV risk behaviors, or past medication experience, factors that do not reliably predict the ability to maintain a new treatment regimen. Providers have an ethical obligation to offer all medically appropriate HIV treatments when a patient is most likely to benefit. Physicians are responsible for considering HIV treatment decisions in light of the potential for both individual and public health risk from inadequate HIV therapy. A decision to postpone or discontinue HIV therapy does not decrease a physician’s obligation to provide a full range of HIV care to a patient and to continually reconsider treatment options.

interactions with increasingly interchangeable physicians and other providers. Agencies and medical offices are asked to streamline operations in the interest of minimizing costs. The commercialization of modern medicine and the escalating pace of scientific discovery and translation into clinical care have put new types of pressure on all health care providers. This commentary describes a new paradigm for HIV treatment that attempts to address these critical issues in an ethically and financially responsible way.

Workgroup on Ethical Issues in Access to HIV Treatment To examine how new HIV therapies can be made available to all who might benefit, the New York State AIDS Advisory Council convened the Workgroup on Ethical Issues in Access to HIV Treatment with a mandate to develop guidelines for providers, policymakers, and administrators. The report of the workgroup detailed 8 principles (Table 1) and 33 recommendations to help ensure equitable access while preserving the discretion of physicians to determine what is medically appropriate and how to best engage patients in sustained collaboration on treatment decisions.17 The workgroup began by addressing the language of physician–patient interactions, rejecting terms such as “compliance” and “adherence” in favor of terms that recognize the need for patients to be “active participants in the process of evolving an effective treatment plan and committed to maintaining it.” Since effective treatment involves personal responsibility as well as professional skill, the workgroup suggested using the term “treatment maintenance.”17(pp6,9),18 It was the view of the workgroup that denying patients access to information about HAART or to the therapies themselves without making a diligent effort to enable patients to use these therapies constitutes an ethically unacceptable standard of care. Specifically, presumptive judgments about the likelihood of treatment maintenance should not be used to restrict access to HIV treatment education or therapies. Rather, providers have an obligation to help patients whose ability to maintain a treatment regimen is in doubt make use of services that could enable them to succeed. Recognizing that HAART is forcing a reevaluation of contemporary patient– provider relationships, which are often ill suited to this enabling function, the workgroup outlined a new patient care paradigm for HIV therapies. The practice of ascribing to patients a real or potential “failure” to maintain treatment regimens not only may reflect presumptive American Journal of Public Health

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judgments about patients but also may obscure organizational and staff training issues that affect the ability of providers to offer the type of comprehensive care that HIV treatment demands. While the intent of the workgroup was to define the parameters of ethical HIV treatment, it is hoped that the difficulties of following these guidelines in less than ideal clinical settings will contribute to the debate about ways to integrate ethical, medical, public health, economic, and political concerns in health care systems. The new paradigm for HIV care detailed by the workgroup may serve as an instrument of inquiry about the delivery of complex care in contemporary health care environments, with substantial implications for the treatment of other diseases.

likely to benefit. This process must begin with a dedicated effort on the part of every health care provider to urge patients to learn their HIV status. Assessing patients’ readiness for treatment and preparing patients to initiate treatment are parts of a continuing and most likely incremental process. It cannot be undertaken unilaterally by providers and imposed on patients. Discussions about medically appropriate treatment options, education about the requirements of drug regimens, and decisions to undertake a course of therapy are the work of both providers and patients, who are partners in determining a health care plan. Providers should take an active role in exploring potential obstacles to initiating treatment and helping patients gain access to and use ancillary services that would make treatment possible.

A New Paradigm Treatment Maintenance Barriers to care are numerous and often subtle in many if not all health care models. Effective communication between physicians and patients, the foundation for effective treatment, involves difficult elements: language skills, cultural empathy, trust, respect for traditional beliefs, and understanding of the particular perspectives of race, ethnicity, gender, age, and sexual orientation. These concerns have particular importance for HIV treatment, given the disproportionate impact of HIV infection among people of color, substance users, and gay men, with rising rates among women and adolescents. In the new paradigm of provider–patient interaction formulated by the workgroup, traditional values such as trust in the provider and belief in the benefits of therapy are integrated with new strategies for patient education and therapeutic partnerships. The paradigm consists of 3 interrelated components: treatment readiness, treatment maintenance, and support services. The paradigm is further characterized by several assumptions: that the provider–patient relationship is necessarily collaborative and ongoing, that the process is patient-centered (i.e., the patient participates in and helps to define all elements of the treatment plan), and that trained providers must work as a team to provide effective treatment.

Treatment Readiness The first component, treatment readiness, encompasses education of patients about treatment options and includes patients’ understanding of and commitment to the requirements of an appropriate regimen. The process of establishing treatment readiness builds on the premise that every patient should have access to HIV medications at the point at which that person would be most 692

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The second component, treatment maintenance, requires effective integration of a realistic medication schedule into the patient’s life so that doses are taken appropriately and the regimen is continued. Patients who might benefit from HIV treatment but who have other major problems, such as intravenous drug use, mental illness, incarceration, or homelessness, are often categorically assumed to be inappropriate candidates for long-term relationships with providers and to be unable to maintain treatment regimens. A closer look at the general problem of treatment maintenance, however, offers clues for clinical practice in HIV/ AIDS. In the general population, the proportion of patients who maintain treatment regimens ranges from 25% to 75%. On average, only 50% to 60% of patients complete a course of any type of treatment. Similarly, the proportion who maintain antiretroviral HIV therapy ranges from 25% to 85%. In one national sample, 57% of subjects maintained antiretroviral treatment regimens at a 100% level over the 7 days before the interview.11(p4) Many factors may affect HIV treatment maintenance. Those assumed to be significant, such as demographic factors, past records of nonadherence, and even a physician’s previous experience with a patient, are, in fact, poor predictors of a patient’s ability to maintain a new treatment plan.19–24 Although in a small number of studies demographic variables are cited, the most common factors associated with poor treatment maintenance are side effects, forgetfulness, lack of access to health care and medications, untreated alcohol and intravenous drug use, and inadequate integration of the treatment regimen into the patient’s lifestyle. In general, adherence for any individual varies with the context, especially the qual-

ity of the provider–patient interaction. Even within populations such as the homeless and intravenous drug users, cooperative relationships with providers and subjective elements within those relationships, such as a patient’s beliefs about his or her medical condition and the potential benefits of treatment, are the critical factors with positive impact on maintenance of a medication schedule. Social support and peer interaction are also important in maintaining treatment regimens.11(pp4–6) The workgroup’s conclusions were consistent with those in a review of HAART adherence literature in which Webster and Barr stated, “Physicians should not automatically assume a future of poor adherence by their patients on the basis of demographic and behavioral characteristics.”11(pp15–16) Instead, providers are urged to view the development of each treatment plan as a distinct process to be customized according to individual needs and circumstances. This process demands not only physician involvement but also an integrated effort by all types of health care personnel and members of the patient’s social network whenever possible.

Support Services The final component, support services, may allow many people assumed to be incapable of maintaining treatment plans to succeed. A broad menu of services should be developed and used. Support strategies implemented within the HIV treatment setting might include teams of trained providers regularly repeating and reinforcing messages; forums; pill organizers; buddy systems; and other teaching aids. In addition, the help of peers, family members, counselors, and others with confidential knowledge of the patient’s HIV status could be enlisted. External support services include provision of housing, drug treatment, mental health programs, regular meals, cooking facilities, medication supplies and storage, health insurance, legal services, child care, flexible work schedules, and social service programs. Some populations, such as children, adolescents, pregnant women, inmates, the disabled, and immigrants, may have additional specific needs that require appropriate services.17

Extent of Provider Responsibility Providers should make concerted efforts to provide comprehensive HIV treatment education and patient preparation, enlist competent support services, and engage the patient in a long-term productive relationship. However, circumstances may render a patient temporarily, intermittently, or chroniMay 2001, Vol. 91, No. 5

cally incapable of engaging in a working relationship with a provider or maintaining a treatment regimen. Lack of a stable living environment, privacy, or control over daily schedules (e.g., in prisons and other institutions) can make treatment maintenance exceedingly difficult, although not impossible. Despite sincere efforts by providers, there will also be patients who cannot or do not wish to initiate or maintain a course of treatment. There will be situations in which patients and providers cannot establish the relationship necessary for effective care. There will also be patients who demand medically inappropriate therapies. What, then, is the extent of provider responsibility? The workgroup recognized that a physician may sometimes be in a position in which the best medical decision is to temporarily withhold treatment from a patient. Consistent with the need to ensure access to treatment and yet safeguard medical standards, a physician in this position would be obligated to reassess the patient’s status regularly and to continue to encourage treatment readiness. The physician should provide a full explanation for any decision to withhold therapies, including the potential for drug resistance from missed doses of medication, and should offer to refer the patient to another health care provider. Finally, health systems should be restructured so that physicians and other health care providers can be considerably more aggressive in developing patients’ readiness for treatment, arranging access to services that promote readiness and treatment maintenance, and offering alternative treatment plans if the optimal therapy is determined to be inappropriate or ineffective. Providers have a responsibility to do everything possible to see that patients who might benefit from new HIV treatments have a fair opportunity to do so. Health systems have a responsibility to facilitate this process.

Discussion It does not take a careful reading to observe that this model presents a challenge to most current health care systems. Often providers do not have the time, resources, or skills to effectively assess a patient’s comprehensive needs and design a coordinated response. In much of the world the funds for HIV medications, to say nothing of treatment education and support services, are simply not available. Health care rationing and inequitable access have been common throughout history. Whether health care is considered a right or a privilege, every society struggles with problems of unequal access, as it must struggle with the result: unequal health outcomes. May 2001, Vol. 91, No. 5

Medications and comprehensive care are expensive, but hospitalization, decreased productivity, drug resistance, and the consequences of social and family disintegration through illness and death are also costly. Although we cannot attempt a cost–benefit analysis here, we contend that ethically and clinically, the advent of a widely promulgated new standard of HIV care with medications that can extend and improve lives dictates that every effort be made to ensure access for all who might benefit. Further, these efforts need not wait for large-scale socioeconomic and political change. What needs to be done can realistically be done now. Although the paradigm presented here is a fundamental break with the assumptions of power and authority in traditional physician– patient relationships, basic concepts such as patient education, team collaboration, and integrated care have been emerging for some time. HIV therapies have forced them further into the spotlight, since, clearly, providing access to HIV therapies cannot mean simply writing a prescription, and providing HIV treatment education cannot mean simply handing someone a brochure. The chronic nature of HIV disease and frequent advances in treatment have prompted many HIV treatment providers to forge highly collaborative relationships with patients, even as they have spurred many patients to become knowledgeable about clinical research and treatment options. These developments should be encouraged. Since HIV treatment is substantially supported by public funds, changes in public policy could have profound effects on the effectiveness of treatment. Given the many types of existing financial resources for HIV treatment in New York and many other states, efforts could be focused on deficiencies in staff training and program organization. Serious social, behavioral, economic, and other medical problems need not preclude highquality HIV care. To fairly distribute the benefits of HIV treatment research, health systems should acknowledge that health is tied to other forms of well-being, and they should accommodate the integration of social and supportive services into routine health care. Workable treatment plans are not standard issue.They require individualized crafting and the ongoing concerned attention of all parties.18 This holistic approach should be incorporated into planning by funding agencies and organizations. For patients and providers to become partners in decision making about HIV treatment, providers must acquire better skills in working with patients and with other providers. Clinicians who have not already adapted to the needs of comprehensive HIV care will be asked to make fundamental changes in the way they care for patients, expanding their

roles beyond the traditional exclusive concern with medical issues. Whether alone or as part of a team, physicians and nurse practitioners may need to assess many aspects of a patient’s life and help coordinate services to enable the patient to initiate and maintain treatment. The public health interest in this new paradigm is substantial. Improved treatment has not changed the fact that HIV infection rates are steady and are increasing among some groups.25,26 There are recent indications that the rate of decline in HIV deaths and serious illness has slowed. In small studies conducted to date, evidence of resistance to HIV medications among newly infected patients is mounting.12 Drug resistance compromises an individual’s chances for optimal HIV care and long-term quality of life and may eventually pose a widespread public health threat from resistant HIV strains. Officials at the National Institutes of Health caution, “The transmission of drug-resistant strains of HIV-1 underscores the importance of intensifying education and modifying behavior to prevent transmission, recent advances in the therapy of HIV-1 infection aside.”12 In addition to HIV prevention, public health has several treatment-related tasks: to encourage and fund patient and provider education about HIV therapies; to ensure that support services are available and that referral networks facilitate their use; and to monitor access to HAART and other HIV treatment services and promote their equitable distribution. In these goals, public health concerns intersect with legal interests in preventing group-based discrimination in access and avoidable harm to individuals or communities.17 Specific efforts to address these imperatives have begun. Team models for developing patient readiness and encouraging treatment maintenance are being used in some settings in New York and elsewhere. In 1998 the New York State Department of Health AIDS Institute, using state and federal funds, initiated 11 treatment adherence demonstration projects to define resources and strategies for interventions that can be replicated across the state to improve HIV treatment maintenance.27 Federal and state HIV care guidelines and professional education activities promote clinical HIV expertise, treatment maintenance, and uniform standards of care.2,28,29 Pharmaceutical companies are working to produce newer drugs with simplified regimens and fewer side effects. The report of the New York State AIDS Advisory Council Workgroup on Ethical Issues in Access to HIV Treatment offers recommendations for implementing the new paradigm for HIV treatment described here.17 On the other hand, advocacy of this patient care paradigm is contrary to some preAmerican Journal of Public Health

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vailing trends. Physician–patient relationships in general have eroded steadily over the last several decades and promise to undergo still more dramatic revision with wider use of the Internet and greater evolution in settings for health care delivery.Yet even the advent of simpler HIV drug treatments will not diminish the need for some form of individualized, patientcentered care that integrates medical and social services. Public health, medical, and ethical dictates are increasingly convergent with regard to HIV disease, tuberculosis, sexually transmitted disease, intravenous drug use, tobacco and alcohol addictions, and other illnesses. None permit quick fixes. Prevention and equitable access to comprehensive treatment are emerging as the common central themes.

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Contributors N. Neveloff Dubler and G. Birkhead were co-chairs of the NewYork State AIDS Advisory Council’s Workgroup on Ethical Issues in Access to HIV Treatment, which formulated the principles and recommendations for HIV care on which this article is based. All authors participated in the work of this group and together generated the discussion of implications presented in this article. S. Noring, editor and writer at the AIDS Institute, wrote the paper. All authors contributed substantially to its revision.

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