HIV drug adherence: Special situations

HIV Drug Adherence: Special Situations Catherine Lyons, MSN, NP, MPH Among the highly diverse population of persons living with HIV/AIDS are individuals with particularly challenging life circumstances that can be called "special situations." Substance abuse and homelessness are examples of special situations that require additional consideration when attempting to determine the appropriateness of prescribing complex antiretroviral regimens. When individual cases are examined in the context of relevant models of care and the principles of those models applied, such clinical decisions can be made with the patient. Withholding protease inhibitors from an entire population group, it is argued, is the epitome of practicing bad medicine, Key words: Adherence, antiretroviral therapy, models of care, protease inhibitors Antiretroviral therapy for HIV has become increasingly complex to manage on a day-to-day basis as the new standard of care is to treat with potent combination regimens (Carpenter et al., 1997). These regimens, with numerous pills and sometimes conflicting dosage schedules (e.g., two or three times daily, with and without food), are frequently associated with mild to moderate, although sometimes severe, adverse effects and can have an intimidatingly long list of contraindicated medications. For anyone living with HIV, integrating these regimens into one's life is a challenge. For HIV-positive individuals with competing medical and social issues--such as mental illness, illicit drug use, and/or homelessness--the ability to manage two, three, and even four different antiretroviral medications on a daily basis without missing doses, while juggling other medications and eating times, may appear to be a daunting task. The use and delivery of antiretroviral therapy have additional layers of issues in the context of patients Catherine Lyons, MSN, NP, MPH, is a nurse practitioner in Ward 86 at San Francisco General Hospital.

with "special situations," here defined as nonmainstream living situations or circumstances. Diverse populations of individuals living with HIV/AIDS have unstable lives and need help with rudimentary daily living skills, such as earning a living, planning and eating nutritious meals, finding a regular place to sleep and live, and caring for themselves. Can such individuals take complex protease inhibitor-containing antiretroviral regimens as prescribed? Not surprisingly, that is not a question to which a yes or no answer is correct. With several models of care from which to extract information and guidance, nurse clinicians may be able to establish whether a patient understands the benefits of adhering to complex antiretroviral regimens and the consequences of not adhering, and whether the patient is ready to begin therapy. Based primarily on anecdotal experience, this article explores some of the myriad issues that face patients and practitioners in the decision process associated with HIV drug therapy. "Anecdotal experience" refers to my experiences and those of my colleagues in various urban care settings within the United States serving a population of people with HIV/AIDS who are poor, homeless or marginally housed, and at times struggling with mental illness and/or drag use. This article also draws on my clinical experiences to discuss approaches for determining the best choice of action for patients with special situations. Predictions of nonadherence by a provider, based on patient characteristics, are no better than chance (Meichenbaum & Turk, 1987). Characteristics that may cause higher levels of nonadherence in people with H1V include younger age, depressed mood, and stress (Chesney, 1997). Other factors that influence adherence and nonadherence include characteristics of the regimen, patient-provider relationship, clinic setting or health care delivery setting, and features of HIV disease (Haynes, McKibbon, & Kanani, 1996).

JOURNAL OF THE ASSOCIATION OF NURSES IN AIDS CARE, Vol. 8, Supplement, 1997, 29-36 Copyright 9 1997 Association of Nurses in AIDS Care

30 JANACVol. 8, Supplement, 1997

Prescribing Protease Inhibitors: The Controversy A single question in virtually all clinicians' minds today reflects the heart of the controversy with prescribing protease inhibitor-containing antiretroviral regimens: Are there groups of patients for whom some antiretrovirals are contraindicated--personally, if not medically? This question has been raised ever since the HIV protease inhibitors became available and is exemplified by the following questions: s s

Should we tell drug users who are actively using that they cannot receive protease inhibitors? Should we tell homeless people that they cannot take these medicines?

I believe unequivocally that the answer to these questions is no. Yet, it should be pointed out that some clinicians do categorically withhold protease inhibitors from specific population groups--namely, substance abusers (Sontag & Richardson, 1997). There are long-standing prejudices among some health professionals against drug addicts. They are sometimes viewed as manipulative and morally culpable (O'Connor, Selwyn, & Schoottenfeld, 1994). What if we turn this admittedly controversial issue around and examine it from a different vantage point: Are there individuals for whom some antiretrovirals are contraindicated? I believe the answer to this question is yes. A careful examination of individuals within the context of their daily lives may point to the conclusion that this is, in fact, the case. Using a combination of particularly relevant tenets from several care models, clinicians can better assess whether an individual will adhere to and benefit from the new potent but demanding antiretroviral regimens. As health care practitioners, we must realize that when we see patients, they not only have HIV but also issues of substance abuse, mental illness, homelessness, and other conditions that have an impact. Sometimes, we tend to make assumptions about individuals based on the labels attached to them. The problem, however, may not be the individual but the system. What may be viewed as not adhering or not accessing care may be the lack of appropriate and acceptable care or insurmountable obstacles to accessing case. When

Table 1. HIV Protease Inhibitor Therapy: Barriers to Adherence For all currently approved protease inhibitors Large number of pills to take daily: Minimum = 6 capsules; maximum = 12 capsules Inflexible dosing scheduleto prevent resistance: Even a single missed dose can lead to suboptimal therapeutic blood levels, engendering an environment for the developmentof HIV resistance mutations Unknown drug interactions with street drugs For ritonavir (NorvirTM) Requires refrigeration Has multiple drug interactions, many of which are drugs that HIV patients commonly take (e.g., clarithromycin) Dosing: Twice daily (hid) For indinavir (Crixivan| Requires coordination with food, not with a meal but either l hour before a meal or 2 hours after a meal Requires high fluid intake because of potential for kidney stones Dosing: Every 8 hours (q8h) For saquinavir (Invirase| and nelfinavir (Viracept| Dosing: Three times daily (tid), rather than bid

the system responds to the individuals in the community being served, adherence may be greatly improved. A recent editorial in the Journal of the American Medical Association on the use of protease inhibitors in the homeless suggests that careful evaluation of successful medical interventions within this population can guide us to adapt programs to the needs of individual subgroups (Bangsberg, Tulsky, Hecht, & Moss, 1997). Nevertheless, there are very clear barriers to the demanding prescribed use of, and therefore adherence to, protease inhibitors (see Table 1). These include the large number of pills to take daily, every day, without miss; the dosing schedule of twice or three times daily (bid or tid, respectively) or every 8 hours (q8h); and the coordination with meals. Drug-drug interactions that occur between the protease inhibitors and select medications taken concomitantly are a known barrier to use. The drug interactions that should be considered are not only with prescribed drugs but possibly with street drugs, although this has not been studied. Street drugs include more than intravenous (IV) heroin and IV cocaine and crack. They also include drugs that may be used infrequently or "recreationaUy," such as marijuana, prescription medications (e.g., illicit use of benzodiazipines and narcotics), and drugs such as ecstasy. Access to the potentially life-extending antiretrovi-

Lyons / HIV Drug Adherence 31 Table 2. HarmReductionTenets

Table 3. Considerationsfor Initiating HIV Antiretmviral Therapy

All humans have intrinsic value and dignity. All have rights for comprehensive nonjudgmental medical and social services. Licit/illicit drugs are neither good nor bad; rather, it is the individual's relationship to the drugs (i.e., their impact on the person and the impact of drug use in their life). Users are competent to make choices. Outcomes are in the hands of the patient.

HIV medical history and symptoms HIV markers: Viral load and CD4+ cell count Clinical setting: Patient-providerrelationship Social support Psychiatric diagnosis and therapy Drug/alcohol use Housing Individual psychosocialcharacteristics affectingability to manage a complex medication regimen

SOURCE: Harm Reduction Coalition (1996). ral medications that depend on strict adherence to a regimen must be provided in a creative, flexible, and consumer-centered manner that recognizes the barriers to adherence. Harm reduction is a philosophical approach that emerges out of drug intervention strategies but is applicable to a variety of social and health issues. The goal is to meet individuals and groups from the vantage point of where they are and to work from there to reduce harm at the individual as well as community level.

Harm Reduction Model The harm reduction model is a philosophical care approach that takes a stance of nonjudgment, recognizing and meeting client's needs, and providing userfriendly services (Springer, 1991). This is a helpful model to define what many health care practitioners have, in reality, been doing for many years (with all of their clients, not just those with special situations). The model is especially applicable to providing care to HIV patients with special situations. Table 2 outlines some of the basic tenets of harm reduction. The first tenet listed underscores the element of nonjudgment and the need to respect the client regardless of his or her appearance, demographics, or present circumstances. A second tenet, which can be considered an extension of the first, is that the client not only deserves but has a right to comprehensive and competent medical and social services. The third tenet in this table reflects the relationship of harm reduction to drug intervention strategies. Similarly, the following tenet, a concept of the harm reduction model, states that drug users are competent to make choices, which is fairly radical for some professionals. Health care providers and society in general tend to view drug users as people who are incompetent and who, if they

make choices, will make bad choices. Finally, a primary tenet of harm reduction is that the client can and does directly influence his or her own care outcomes. These concepts are both important and useful in the provision of care to people who are disenfranchised, disparaged, or have not been treated according to their intrinsic value and dignity. In other words, these concepts are particularly relevant to the delivery of care to people who have not been accorded the right to comprehensive, nonjudgmental medical and social services. The harm reduction model is patient centered in its concept of addressing the individual's needs and concerns at the moment. Persons may be infected with HIV and have a CD4+ count of 30 cells/ram 3 and a viral load of 300,000 copies/mL. But if food, shelter, or pain is what the infected individual is concerned about immediately, then those issues must be addressed because they may be a barrier to beginning or using a medication regimen requiring strict adherence. A recent study nicely illustrates this point: Ferrando, Wall, Batki, and Sorensen (1996) showed that lack of attention to psychiatric morbidity in a small group of methadone maintenance patients may have resulted in poor AZT adherence. Table 3 lists the myriad considerations that need to be taken into account when a patient is ready to initiate antiretroviral therapy--that is, medical, care delivery, psychological, social, substance use, and living situation issues.

Enhanced Autonomy Model Another model of care, the enhanced autonomy model, has been recently proposed for physicians. The enhanced autonomy model is contrasted with the paternalistic model of the past, in which the provider determines what is best for the patient (with the inher-

32 JANAC Vol. 8, Supplement, 1997 ent risk of bias by gender, race, socioeconomic status, sexual orientation, and other social identities), and the fully autonomous model of recent years in which the provider is passive and the relationship is entirely patient centered (Quill & Brody, 1996). The enhanced autonomy model falls between these two models and concerns collaboration and a process that is relationship centered. The enhanced autonomy model also contrasts with the independent choice model, which is a fully patient-centered model whereby the provider does not share his or her values or experience and does not make recommendations. All conceivable pieces of information are conveyed to the patient, and that person is then expected to make a decision. Within the enhanced autonomy model, respect for the patient as a person is central, and health care decisions are arrived at via an exchange of information between patient and provider that includes medical information, life circumstances and experiences, and values. All of these models actually provide frameworks for practice styles that many clinicians already use. Relationships with patients should be competence and dialogue based. The process of establishing and maintaining a dialogue is inherently important. Decisions regarding therapies need to be negotiated around an individual's beliefs, lifestyle, abilities, and priorities (Chewning & Sleath, 1996).

Patient-Provider Relationship The dialogue between a provider and a patient has at its core the fact that the provider, as well as the patient, is invested in the outcome. Patient-provider relationships have a second built-in assumption: that the provider is also responsible for relating everything that a patient needs to reach the best outcome (Quill & Brody, 1996). In the context of HIV therapeutic s, this means that the provider is responsible for discussing, explaining, exploring, and assisting in resolving all the steps involved in helping the patient follow an antiretroviral regimen if, in fact, that is what the patient wants to do. The patient-provider relationship is difficult to describe on paper and even more difficult to quantify. It is, however, important to discuss. Language may turn out to be a barrier to the relationship. For example, health care providers may do themselves and their patients a huge disservice when terms such as noncom-

pliant, drug seeking, or difficult are used. These labels immediately place the patient in a category that carries specific expectations, and they may behave according to those expectations. In addition, labels and other language may put the patient at a distance from the provider, simply because the patient may not be open or forthcoming with a provider whom he or she feels is judgmental. As providers, then, we need to be keenly aware of our tendencies to categorize and label patients and equally aware of the language we use with our patients. It is important to remember that when talking about drug users or the homeless or the difficult or the hard to reach, we are not discussing a homogeneous group of people, and each individual will act in a manner inherently his or her own. Their individuality should be recognized, respected, and incorporated into the plan of care. Another issue to consider when addressing these special situations is that of patients' ability to overcome history. People who use drugs, live on the street, and have tended to use emergency rooms as their source of primary care have had very negative experiences with the health care system (Plumb, 1997). Future encounters with a health care provider carry the stigma of that experience; recognizing and countering those experiences become an initial piece of the patientprovider relationship. There needs to be consistency in the patientprovider relationship, and an aura of trust needs to be created over time. After establishing and nurturing a relationship for 4 or 5 years, it would be expected that the provider could offer the patient with a substance abuse problem objective insights into specific situations. For example, the clinician could offer, "This doesn't seem to be working for you. Remember what happened the last time you did that?" It is also important not to put forth an agenda regarding drug use. The problem needs to be identified in the routine list of diagnoses. However, if someone who is on heroin every day comes in for a visit, the health care provider cannot assume that there is a need for immediate treatment for his or her drug abuse. The patient's response about whether there is a problem, the extent of the problem, and what to do about it determine the intervention. The patient's decision then becomes relevant in terms of which medications to prescribe for him or her.

Lyons / HIV Drug Adherence 33 Table 4. Priority of Needs Use multidisciplinaryteam to assess patients' needs and goals Address most pressing needs first Stepwise interventionsto maximizebenefits Acute/emergencymedicaltreatment Food and shelter Drug and/or psychiatrictreatment HIV medicalcare Baseline evaluationand follow-upevaluations Education Pneumocystis carinii pneumoniaand other opportunistic infectionsprophylaxisat appropriatetimes Discussion of antiretroviraloptions Initiation of antiretroviraltreatmentas a process

Prioritizing Needs The needs of the patient must be prioritized, especially when patients have an array of psychosocial issues (see Table 4). First, it is important that the patient is evaluated by a multidisciplinary team. Then, the acute hierarchy of needs must be addressed. In that context, food and shelter are addressed first. HIV medical care then falls toward the end of the list, although that may, in fact, be the provider's primary concem. When addressing HIV medical care, a baseline evaluation is the first priority. Obtaining a baseline evaluation does not mean measuring the patient's T cells and viral load. In addition to a medical and laboratory evaluation, the baseline evaluation must include a complete psychosocial history and an overall picture of the individual's current social situation, such as housing, support, and family. It is also important to obtain a clear sense of the person's understanding of HIV, HIV treatments, and his or her interest, willingness, and ability to manage a complex drug-taking regimen. Today, an assessment of the patient's need for prophylactic interventions for opportunistic infections (OI) is a care priority. Numerous epidemiological surveys have documented that the recent trend in increased survival and prolonged disease-free periods in HIV/AIDS patients is attributable to the increased use of OI prophylaxis (Centers for Disease Control, 1997). Pneumocystis carinii pneumonia (PCP) prophylaxis, generally administered when the patient's CD4+ cell count is below 200 cells/mm3, is relatively simple and makes a tremendous difference in patient morbidity. It should be a very high priority.

9 Finally, the issue of antiretroviral treatment comes to the forefront and constitutes a process. The process involves educating patients about the nature of antiretrovirals, the nature of the regimen, the commitment, and, with the patient, an assessment of the patient's current life situation and ability to adhere to the medication regimen. The role of the provider is not to deny treatment to a patient. Rather, it should be a mutual decision based on a risk-benefit analysis. If someone asks for protease inhibitors, their effectiveness and side effects should be discussed as well as the complex dosing schedule. Patients should be prompted to relate whether they believe they can handle that. The health care provider and patient need to explore the potential and real barriers to adherence together and address them prior to initiating antiretroviral therapy. Treatment, then, becomes a mutual decision-making process, and in cases where provider and patient agree that the patient is not ready or will not be able to adhere to a complex regimen, it is not a question of the provider denying treatment to the patient. The transtheoretical model of change can be extremely useful as a guide in this decision-making process. Table 5 outlines the major steps involved in decision making according to the transtheoretical model of change. In the first, the precontemplative stage, the patient and provider discuss a specific future goal (e.g., prescribing and following an antiretroviral therapy regimen) and the behaviors and/or situations that will likely need changing to reach that goal. A contemplative stage follows, in which specific behavior changes and the consequence of those changes are discussed and considered. Preparation is the immediate predecessor to the action stage, where the patient acquires all the skills and resources needed to effect the behavior change(s). The action stage is followed by a maintenance stage. In the maintenance stage, psychosocial support is provided so that the patient's changed behaviors are reinforced. A builtin relapse stage is especially helPful with changes that are instituted specifically for antiretroviral adherence because missing doses or cutting back on the number of pills is likely to happen at some point. Discussing the chance for relapse with the patient from the start can help the patient feel that the goal is attainable, even if there are missteps along the way.

34 JANAC Vol. 8, Supplement, 1997 Table 5. Harm Reduction as It Fits Into the Transtheoretical Model of Change Stage

Harm Reduction Support

Precontemplative: Not planning to change behavior in next 6 months

Provide comprehensive assessment of behaviors in a nonjudgmental and supportive atmosphere. Develop relationship of mutual trust and respect. Use assessment to point out problems, raise doubts about behaviors, and discuss positive aspects of change. Use continuum of behaviors to identify current level of risk for harm. Discuss the concept of a spectrum of options for change. Promote decision-making techniques. Ascertain and clarify client's tentative goals for change. Reinforce that all decisions are subject to change and can be varied without loss of respect. Analyze risks and rewards of the current behavior and provide information as needed. Clarify goals and discuss incentives to change. Emphasize negative aspects of not changing. Provide skills training specific to the behaviors that the client has identified as acceptable.

Contemplative: Intends to change behavior within next 6 months

Preparation: Seriously planning change within next 30 days Action: Behavior modification meets criterion for a specified minimal amount of time

Maintenance: Behavior change continues for more than 6 months Relapse: Return to previous behavior pattern

Support change efforts. Assist client with self-evaluation process related to desired change and progress toward goals. Vary strategies and ultimate goals as client desire indicates. Reinforce basic premise: "Is this behavior safer/healthier/better than my previous behavior?" Continue support in a nonjudgmental atmosphere. As goals are reached and as behaviors change, reintroduce the continuum to ascertain if client wishes to revise plan and/or set new goals. Remind client that this is not a good/had issue; it is simply part of the process. Reassess client goals and perceived abilities. Help client reset goals as appropriate. Success occurs when any activity that decreases harm in any increment is initiated.

SOURCE: Bradley-Springer (1996). Reprinted with permission. Adapted from information in Denenberg (1993); Grimley, DiClemente, Prochaska, and Prochaska (1995); and Prochaska, Redding, Harlow, Rossi, and Velicer (1994).

Reaching the Harder-to-Reach Populations We can learn from creative community responses to health care needs (E1-Sadr, Medard, & Barthaud, 1996; Robb, 1994). Specific models o f care have been used in the United States to access the harder-to-reach populations, such as people who do not access care regularly or people who perhaps do not keep appointments. One strategy to reach the harder-to-reach populations is the mobile van outreach model, which primarily provides primary and episodic care, links to other services, and routine health maintenance-like practices such as vaccinations. The N e w Haven model program comprises a series of vans that travel around the c i t y - - a l m o s t a caravan (Altice et al., 1996). The caravan begins with the needle exchange van. This is joined by a medical van that follows approximately one block behind the needle exchange van. Yet another van that deals with pregnancy issues may be around the comer. This program is effective, partially because it takes place in a very small city, but it at least provides some interesting

community involvement. Basically, it is a matter o f bringing the program and the provider into the context o f the patient. In some cities, including NeW York and San Francisco, there is a similar model o f care at needle exchange sites. In New York, the Street Side Health Project provides health care and education, treatment o f acute problems such as abscess care and treatment o f upper respiratory infections, and vaccinations (London, Metalios, Russell, Stancliff, & Sturm, 1996). This is a very successful program. The San Francisco needle exchange site also contains a student-run medical clinic (Wlodarczyk, 1996). In addition, there is a similar clinic at the separate w o m e n ' s needle exchange, where there is an effort to maintain a consistent provider to foster the critical element of trust (Knight, 1997). Presumably, a relationship can begin to develop at the site, which is hoped to then move into the setting o f the provider's own office. One interesting and effective program is that of the HIV University, which was begun by Women Organ i z e d to R e s p o n d to L i f e - T h r e a t e n i n g D i s e a s e s

Lyons / HIV Drug Adherence 35

(WORLD). WORLD is a San Francisco-based organization for women infected with HIV. At the HIV University, women meet, create their curriculum, and invite speakers. The women organize and administer the program, which is an extremely empowering experience. Many of the women have had very minimal education, and at the end of the program they receive a formal graduation with diplomas. Therefore, this is not a program of just delivering information to patients, but it is a collaborative effort with patients very actively participating in the process. The assumption of this program is that the more knowledge a person has, the more likely that person will adhere to the medication regimen. This is particularly important in HIV care because patients are being asked to follow a very complicated drug-taking regimen. The daily observed therapy model used for tuberculosis (TB) treatment can be successful, in part, because the dosing is once a day at most (Weis et al., 1994). A similar model for antiretroviral therapy, although intriguing, may not be realistic. Other models also effective in TB screening include incentives such as food vouchers and education (Chaisson, Keruly, McAvinue, Gallant, & Moore, 1996).

Models to Use Preliminary descriptions and evaluations of models of care done in a creative manner, with attention to the needs of the communities and individuals, suggest that we as health care providers can successfully provide state-of-the-art antiretroviral treatment to groups of patients whose situations may suggest otherwise (A1tice et al., 1996; E1-Sadr et al., 1996; London et al., 1996; Robb, 1994; Wlodarczyk, 1996). Clearly, further research is needed to guide us in planning programs and appropriately target our fiscal resources.

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36 JANAC Vol. 8, Supplement, 1997 O'Connor, P. G., Selwyn, P. A., & Schoottenfeld, R. S. (1994). Medical care for injection drug users with human immune deficiency virus infection. New England Journal of Medicine, 331,450-459. Plumb, J. D. (1997). Homelessness: Care, prevention, and public policy. Annals of Internal Medicine, 127, 973-975. Prochaska, J., Redding, C., Harlow, L., Rossi, J., & Velicer, W. (1994). The transtheoretical model of change and HIV prevention: A review. Health Education Quarterly, 21(4), 471-486. Quill, H., & Brody, T. E. (1996). Physician recommendations and patient autonomy: Finding a balance between physician power and patient choice. Annals of Internal Medicine, 125, 763-768. Robb, V. (1994). The hotel project: A community approach to persons with AIDS. Nursing Clinics of North America, 29, 521-531.

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