MENTAL HEALTH

Adherence to ART Guideline

Introduction

Mental Health Guidelines Committee, September 2006

RECOMMENDATION
  • Patients with mental health disorders should be considered candidates for antiretroviral therapy (ART) if they meet the medical eligibility criteria for ART and demonstrate readiness to begin therapy. Clinicians should determine treatment readiness on a case-by-case basis, weighing such factors as whether the patient attends the majority of his/her appointments and whether he/she expresses an interest in receiving ART.

Patients with mental health disorders should be considered candidates for ART if they meet the medical eligibility criteria for ART and demonstrate readiness to begin therapy. Whether a patient is ready to begin therapy needs to be determined on a case-by-case basis; however, factors such as whether the patient attends the majority of his/her appointments and expresses interest in receiving ARV treatment will help to determine whether the patient is ready.

Achievement of the benefits of ART requires careful adherence to regimens that may be complex and/or cause unpleasant side effects. Non-adherence to ART may result not only in reduced treatment efficacy but also in the selection of drug-resistant HIV strains and increased progression to AIDS and death [1,2]. Because the exact level of adherence that is necessary to prevent the emergence of drug-resistant virus or to delay disease progression to AIDS and death is unknown, near-perfect adherence (>90% to 95%) remains the goal for all HIV-infected patients [3,4], including those with mental health disorders or a history of mental health disorders.

Appropriate identification and treatment, or referral for treatment, of underlying mental health disorders will facilitate optimal adherence among this patient population. Depression, the most studied mental health disorder, has been shown to be predictive of poor adherence [5,6]. However, an improvement of depressive symptoms should result in improved adherence [7].

KEY POINT
  • The most effective means of promoting adherence in patients with mental health disorders is through adequate stabilization of their mental health symptoms and integration of mental health treatment into the comprehensive treatment plan.
References:
  1. Bangsberg DR, Hecht FM, Charlebois ED, et al. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS 2000;14:357-366.
  2. Montaner JSG, Reiss P, Cooper D, et al. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients. JAMA 1998;279:930-937.
  3. Bangsberg DR, Perry S, Charlebois ED, et al. Non-adherence to highly active antiretroviral therapy predicts progressions to AIDS. AIDS2001;15:1181-1183.
  4. Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: Risk factors for virologic failure and adverse drug reactions.  Ann Intern Med 1999;131:81-87.
  5. Gordillo V, del Amo J, Soriano V, et al. Sociodemographic and psychological variables influencing adherence to antiretroviral therapy. AIDS1999;13:1763-1769.
  6. Avants SK, Margolin A, Warburton LA, et al. Predictors of nonadherence to HIV-related medication regimens during methadone stabilization. Am J Addict 2001;10:69-78.
  7. Starace F, Ammassari A, Trotta MP, et al. Depression is a risk factor for suboptimal adherence to highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2002;3(Suppl 3):S136-S139.

Coordination of Care

September 2007

RECOMMENDATIONS
  • Primary care clinicians should refer patients to licensed mental health providers when:
    • Initial mental health treatment by the primary care clinician is ineffective
    • Complex mental status evaluations become necessary or a patient’s behavior jeopardizes effective treatment
    • The patient has co-occurring mental health and substance use disorders
  • Primary care clinicians and mental health care providers should collaborate to develop a step-by-step treatment plan. The treatment plan should delineate the frequency of follow-up visits with both providers as well as the frequency of team meetings to reevaluate effectiveness of the overall medical and mental health treatment.
  • Primary care clinicians should initially consult with a psychiatrist when managing patients with mental health disorders who refuse mental health care. Throughout the patient’s care, the clinician should communicate with a psychiatrist or a licensed mental health professional who can provide consultation.
  • Primary care clinicians should notify the mental health care provider when there is a change in medical or mental health treatment.

The care for HIV-infected patients with mental health disorders should be a collaborative effort involving patients, primary care clinicians, and mental health providers. Extra attention and involvement of the care team may be required to ensure that these patients adhere to their ARV regimens. When patients are also taking psychotropic medications, adherence may be more difficult, which can make coordination of care even more critical. When necessary, case managers, substance use counselors, relatives, pharmacies, insurance companies, and domestic violence service providers should also be involved.

Regular communication between primary care clinicians and the mental health provider(s) offers a chance to discuss techniques for approaching patients with mental health disorders. For patients who have established a therapeutic alliance with their mental health provider, a meeting involving the patient, the primary care clinician, and the mental health provider can help “transfer” the trust from the mental health provider to the primary care clinician. The same strategy can be used to transfer the trust from the primary care clinician to the mental health provider. This can help the patient feel that the care team takes a genuine interest in the his/her health.

When patients with mental health disorders do not agree to mental health evaluation and treatment by a mental health professional, the primary clinician should establish a “silent partnership” with a licensed mental health professional who can help the primary clinician develop a treatment strategy for the patient. Because psychiatrists are physicians and are familiar with medical illnesses and their treatment, initial consultation with a psychiatrist would be ideal for the primary care clinician to establish the patient’s overall care. A licensed mental health professional may play the primary role as silent partner thereafter. Importantly, however, initiation of or changes in psychotropic
medications should be performed in consultation with a psychiatrist  when necessary.

A mental health patient who is enrolled in a methadone treatment program should be educated about drug-drug interactions because he/she may develop opiate withdrawal symptoms after initiating ARV treatment or other medications. The patient should also be asked to notify the medical staff at the drug treatment program that he/she is initiating ARV treatment. If symptoms occur, adjustment of  methadone dose may need to be made with ongoing coordination between the primary care clinician and the patient’s methadone program.

Predictors and Barriers

September 2006

Predictors

Predictors of adherence that have been consistently identified among persons with HIV infection with and without mental health disorders include the following:

  • Social stability and support
  • Beliefs and knowledge about medications
  • Confidence in their ability to adhere successfully to an ARV regimen
  • A regimen that works (“fits”) with their daily activities [1-3]
  • A strong and trusting patient-provider relationship
KEY POINT
  • Patients with mental health disorders may have learned skills related to adherence to psychiatric medications that they can use to help them adhere to HIV treatment.

Barriers

Adherence to medication regimens, including ARV treatment, has been shown to be affected by mental health and psychosocial factors. Mental health factors that may affect adherence include:

  • Substance use disorders
  • Affective disorders, such as bipolar disorder and depression
  • Anxiety disorders, such as generalized anxiety disorder, panic disorder, post-traumatic stress disorder (PTSD)
  • Fluctuations in mental health status or impairments in cognitive function, which may interfere with a patient’s ability to follow directions
  • Personality characteristics, such as pessimism, apathy, and poor coping styles

Although mental health disorders and/or history of substance use disorders are not contraindications for initiation of treatment, these factors may make adherence more challenging. Active substance or alcohol use is one of the few relatively consistent predictors of poor adherence [4,5]. Patients with severe affective disorders have also been found to have lower rates of adherence. However, it is noteworthy that, at least in one large study, patients with schizophrenia were found to be as adherent to ARV therapy as those without a serious mental health disorder [6].

Psychosocial factors that may affect adherence include:

  • Lack of social support
  • Homelessness
  • Family instability
  • Domestic violence
  • Poor self-image and fears of stigma

Among homeless individuals, adherence may be compromised when they experience increased housing instability or stay in settings not conducive to adherence, such as moving from a residential hotel to a shelter, not having a secure place to keep medications, or not having a refrigerator for certain medications [7].

References:
  1. Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: The AACTG adherence instruments. AIDS Care 2000;12:255-266.
  2. Safren SA, Otto MW, Worth JL, et al. Two strategies to increase adherence to HIV antiretroviral medication: Life-steps and medication monitoring.Behav Res Ther 2001;39:1151-1162.
  3. Kalichman SC, Ramachandran B, Catz S. Adherence to combination antiretroviral therapies in HIV patients of low health literacy. J Gen Intern Med1999;14:267-273.
  4. Haubrich RH, Little SJ, Currier JS, et al. The value of patient-reported adherence to antiretroviral therapy in predicting virologic and immunologic response. AIDS 1999;13:1099-1107.
  5. Arnsten JH, Demas PA , Grant RW, et al. Impact of active drug use on antiretroviral therapy adherence and viral suppression in HIV-infected drug users. J Gen Intern Med 2002;17:377-381.
  6. Walkup JT, Sambamoorthi U, Crystal S. Use of newer antiretroviral treatments among HIV-infected Medicaid beneficiaries with serious mental illness.  J Clin Psychiatry 2004;65:1180-1189.
  7. Community Health Advisory and Information Network. Report 2004-1: Service Gaps and Utilization in the Continuum of Care in NYC. New York: HIV Health and Human Services Planning Council. Available at: http://www.nyhiv.org/pdfs/chain/CHAIN%202004-1%20Report_Service%20Gaps%20and%20Utilization%20in%20the%20Continuum%20of%20Care%20in%20New%20York%20City.pdf

Identifying and Addressing Potential Barriers

September 2006

RECOMMENDATIONS
  • Clinicians should carefully assess each patient to evaluate his/her ability to adhere to ART.
  • Clinicians should identify and address potential barriers to adherence before initiating ART. If clinicians elect to defer ART while addressing potentially modifiable barriers to adherence, they should discuss this decision with the patient and document it in the medical record.
  • Clinicians should discuss the following with patients before initiating ART:
    • Clinician and patient treatment goals
    • Patient’s concerns about treatment and ability to adhere
    • Potential side effects of ARV therapy and potential interactions with psychotropic and other medications, as well as how the side effects and interactions will be managed should they occur
  • Clinicians should use translator or sign language services when language barriers exist.
  • Primary care clinicians should refer patients with mental health disorders to specialized adherence services when adherence barriers cannot be resolved, particularly if the patient has AIDS or is at risk for advanced progression of HIV.

Determination of a patient’s ability to adhere and promotion of adherence are processes that begin before patients actually start taking medications. Identification and management of potential barriers to adherence before initiating ART in HIV-infected patients with mental health disorders are critical (see Table 1). Clinicians may choose to defer ART while addressing potentially modifiable barriers to adherence. In patients with advanced AIDS, it may be appropriate to initiate ART, even if barriers to adherence are present. In these cases, referrals to specialized adherence programs should be made for intensified adherence support (see NYSDOH Linkage, Retention and Treatment Adherence Initiative).

An initial step in the identification and management of barriers to adherence involves a discussion with the patient about his/her treatment goals. Discussions about treatment goals involve the patient in the decision of when to initiate therapy. The clinician should not assume that the patient’s goals are the same as the clinician’s goals. For example, the clinician’s main goal may be viral load suppression, whereas the patient’s main goal may be to look healthier. Discussion points may include the following:

  • If the clinician and patient have different goals, how can they bridge the difference?
  • How realistic are the patient’s goals?
  • Which symptoms might impede him/her in achieving his/her goals?

After discussing treatment goals, the clinician should give the patient the opportunity to discuss his/her concerns about treatment readiness: How hopeful is the patient about adherence to both HIV and psychotropic medications? Some patients may fear the consequences of initiating ART. For example, the patient may be afraid of:

  • The stigma associated with receiving ART
  • Losing government benefits if his/her medical status improves
  • Giving up psychological or material benefits associated with the “sick role”
  • Returning to an anxious state of uncertainty about the length of time that the medications will be effective

By expressing interest in the patient’s concerns and goals, the clinician may both strengthen the patient-provider relationship as well as provide means for supporting HIV treatment adherence. For example, a patient with a history of trauma might be too anxious to put a potentially toxic medication into his/her body. The patient’s commitment to HIV care may be strengthened by the clinician showing an active interest in learning about the patient’s anxiety and related social concerns:

  • Who in the patient’s life is aware and supportive of his/her mental health problems?
  • What kind of experience has he/she had with mental health professionals and psychiatric medications?
  • Does the patient have health beliefs or cultural beliefs about western medicine that are causing additional anxiety about taking medication?

When assessing readiness for treatment in patients with mental health disorders, the factors in Table 1 should be considered as potential barriers.

Table 1: Assessment and Approaches to Potential Barriers to Care
Questions Assessment Possible Approaches
Stage of acceptance Is the patient in denial? Educational approaches; motivational interviewing; medication education support group; consider referral for counseling
Mental health Is there an untreated mental health disorder? Treat the underlying mental health symptoms; refer for treatment; “silent partner” with mental health provider
Cognitive functions Does the patient understand instructions? See Cognitive Disorders Guideline; see “Communication Strategies for Clinicians Treating Patients With Mental Health and/or Substance Use Disorders” (below); see Cognitive-Behavioral Strategies
Language barriers Do the clinician and patient speak the same native language? Is the patient deaf or does the patient have a hearing impairment? Translator or sign language interpreter; someone who does not know the patient may be preferable
Substance use Is there active substance use or inadequate substance use treatment? See Substance Use guidelines
Presence or severity of particular symptoms Are any of the following symptoms present? Helplessness; hopelessness; negativity; lack of motivation; apathy; low energy and easy fatigue; stigma and shame about HIV or mental health disorders; low self-esteem; depression; and inadequate coping styles, especially under stress [1,2]. Treatment adherence support program; screen for common mental health disorders; if symptoms are due to a personality disorder, see Personality Disorders; consider full mental health evaluation
Support network and social stability What is the degree of support from family and friends? Is there lack of social stability (e.g., housing problems, legal issues)? Are children or other dependents in the home? Is there domestic violence? With patient’s consent, consider involving family, friends, HIV social service organization, case management services
History of abuse or violence Does the patient have PTSD symptoms? See Trauma and Post-Traumatic Stress Disorder
Medication concerns Has the patient had poor past experiences handling side effects? Would the regimen “fit” with the patient’s daily routine? Is there a risk of drug-drug interactions? Consider regimen that accommodates lifestyle; avoid regimens with possible side effects that would likely lead to poor adherence

The more disorganized and chaotic a patient’s life is, the more important improved treatment-setting characteristics and supportive services become:

To optimizing the treatment-setting, offer the following:

  • Assurances of confidentiality
  • Incentives to keep appointments, such as food and travel vouchers
  • More frequent follow-up monitoring
  • A comfortable, private, and welcoming clinic setting

Improved waiting time in the clinic, particularly for patients with personality disorders, who often have poor coping skills and a very low tolerance for frustration. Clinicians may consider arranging these patients’ appointments at the beginning of the day or arranging a special “slot” because patients who feel shamed and stigmatized may feel too uncomfortable to wait in an area with other patients. Patients experiencing uncontrollable muscle movement or who have difficulty sitting still for any reason may be disruptive to the waiting area.

Refer patients as needed:

  • To adherence support groups and adherence research projects
  • For food and nutritional supplements
  • To case-management services for assistance in obtaining financial support, housing, and childcare and help with managing the cost or coverage of drugs, medical care, and transportation for traveling to appointments
  • To various services, such as outpatient mental health clinics, HIV adult day programs, psychiatric day programs, mental health residential programs, nutritional programs, stress-management services, and professionally or peer-led support groups

Designated AIDS centers, HIV/AIDS social service organizations, and select pharmacies offer educational programs and support groups designed to help patients with medication adherence. Some programs may target particular issues related to adherence. For example, some target their services to patients who are starting their first ARV regimen (see NYSDOH Linkage, Retention and Treatment Adherence Initiative for resources).

References:
  1. Chesney MA. New antiretroviral therapies: Adherence challenges and strategies. Evolving HIV Treatments: Advances and the Challenge to Adherence, 37th ICAAC Symposium, Toronto, Canada, September 1997.
  2. Singh N, Squier C, Sivek C, et al. Determinants of compliance with antiretroviral therapy in patients with human immunodeficiency virus: prospective assessment with implications for enhancing compliance. AIDS Care 1996:8:261-269.

Initiating, Measuring, and Monitoring ART Adherence

September 2006

RECOMMENDATIONS
  • Clinicians should assess adherence at every routine monitoring visit by verifying that patients are taking the correct medications, correct number of pills per dose, and correct number of doses per day.
  • Clinicians should use finite time intervals when inquiring about and quantifying the patient’s self-report. Clinicians should calculate an average response rate based on information obtained at multiple visits to determine a more accurate estimate of adherence.
  • Clinicians should reassess potential barriers to adherence at least every 3 to 4 months and whenever adherence problems are identified.
  • When clinicians find it necessary to speak with the patient’s friends or family to assess adherence, permission should be obtained from the patient and the patient should be involved in these discussions.

Measurement of adherence is challenging in both clinical and research settings and usually relies on any one or a combination of the following methods:

  • Self-report
  • Pill counts
  • Pharmacy records
  • Electronic pill bottle monitors
  • Therapeutic drug monitoring
  • Computer-assisted self-interview (CASI) assessment

The advantages and disadvantages of each method are discussed in the appendix, Advantages and Disadvantages of Adherence Measures.

When adherence is assessed, finite time intervals should be used. For example, the clinician should ask about the number of doses taken and missed in the past day or past week. Despite its tendency to overestimate adherence, self-report remains the most practical measure in most clinical settings and is most likely to facilitate discussion between patients and providers about the reasons for non-adherence. Self-report is most valid when patients are asked about the number of missed doses within a short time frame (1-7 days), but some studies have found that asking about adherence within the past month is also valid [1,2].

In addition to the usual means of assessing adherence, primary care clinicians may need to involve input from licensed mental health providers, case managers, friends, and/or family members of patients with active mental health disorders. When clinicians find it necessary to speak with the patient’s friends or family to assess adherence, permission should be obtained from the patient and the patient should be involved in these discussions.

As ongoing adherence to treatment is monitored, the factors described in Table 1: Assessment and Approaches to Potential Barriers to Care should be considered.

References:
  1. Walsh JC. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS 2002;16:269-277.
  2. Giordano TP, Guzman D, Clark R, et al. Measuring adherence to antiretroviral therapy in a diverse population using a visual analogue scale. HIV Clin Trials 2004;5:74-79.

Strategies to Improve Adherence

September 2006

Patient-Provider Interaction Strategies

RECOMMENDATIONS
  • Clinicians should encourage patients to state in their own words what they understand about treatment instructions and to ask questions when additional information is needed.
  • Clinicians should encourage patients to be honest by responding in a nonjudgmental, supportive manner when patients report non-adherence.

Factors such as the clinician’s language, eye contact, ability to listen, communication skills, and consultation style can foster or hinder collaboration with the patient. Factors that facilitate the relationship include the provision of understandable information, openness to questions, sensitivity and respect for the patient, interest and trust in the patient, and ongoing availability.

KEY POINT
  • A strong patient-provider relationship, including trust and engagement with the provider, has been associated with improved ARV adherence [1].

Below are communication strategies for the enhancement of adherence in patients with mental health and/or substance use disorders. Interventions work best when they are practical, initiated promptly, and individualized to the patient’s characteristics and needs.

Communication strategies: 

  • Proceed slowly; repeat key points; have patients repeat back instructions in their own words
  • Teach science in simple terms
  • Allow honest reporting of non-adherence
  • Use translator or sign language services when language barriers exist
  • Use pictures and/or written material

When a patient reports non-adherence, the clinician should respond in a way that enhances an open and honest partnership. Clinicians can be supportive by acknowledging that treatment for multiple disorders is challenging because of the increased pill burden and added responsibility and stress of adhering to more than one regimen. Being actively supportive by welcoming the patient’s honesty will mitigate any shame that the patient may feel about his/her poor adherence. The clinician might say, “Everyone has difficulty taking medications. The fact that you sometimes remember to take your pills is great. It will help us understand the best way for you take your pills regularly. So, let’s review when you do remember and when you don’t.”

Health Education Strategies

RECOMMENDATION
  • Clinicians should provide adherence information in an organized manner, both orally and in written form, with easy-to-understand brief statements.

Health educational strategies are most effective when the patient receives information, both orally and in written form, that is well organized and easy to understand. Clinicians should convey education points through the use of brief statements. Important educational topics for clinicians and patients to discuss are given below.

Health education points for enhancing adherence:

  • The treatment regimen and treatment options
  • Drug side effects, with special attention to psychiatric side effects—how to address or avoid
  • Drug-drug interactions—how to determine whether interactions are occurring and what to do about them; which drugs do not have any known risks for or lack of likelihood for drug-drug interactions with prescribed and alternative medications, methadone, recreational drugs, and/or alcohol
  • The importance of treating comorbid disorders, such as mental health and substance use disorders
  • The possible impact of HIV on mental health symptoms

Educational tools can be helpful; yet these should complement and enhance the direct communication and not replace it. These tools need to be tailored to the patient (using lay language or, when applicable, native language). 

Motivational Strategies

Motivational strategies can help to address attitudinal barriers and may include providing psychosocial support and involving family members, partners, and social and community organizations.

A therapeutic treatment style that may be used when exploring issues of ambivalence and conflict regarding adherence is motivational interviewing. Through use of motivational interviewing, the clinician attempts to stimulate change by identifying discrepancies in the patient’s current behavior and the patient’s goals of healthier behaviors. When the patient begins to understand how the consequences of current behavior conflict with personal values, the clinician reflects the discordance back to the patient, until the patient realizes that change is necessary and makes the decision to commit to change. This approach encourages patients to describe their behaviors and develop their own solutions.

For patients who have difficulty tolerating direct communication or who may not be able to identify their own needs, use of motivational interviewing may not be suitable. Direct persuasion and aggressive confrontation are not part of motivational interviewing. With this approach, clinicians do not give advice or directives.

Principles of Motivational Interviewing

Clinicians should understand the underlying principles of motivational interviewing before using it. The four key components of motivational interviewing are shown in Table 2.

Table 2: Key Components of Motivational Interviewing
Component Involves
Expressing empathy Understanding and being aware of and sensitive to the feelings, thoughts, and experiences of another. Accomplished through reflective listening.
Supporting self-efficacy Supporting the patient with the sense that an individual can identify and meet one’s needs and goals.
Avoiding argumentation and rolling with resistance Listening to the patient’s resistance to change. Working collaboratively with the patient to develop his/her input regarding the treatment plan.
Discovering discrepancies Helping patients identify discrepancies between their current behavior and desired future behavior.

Expressing empathy: To gain a better understanding of the patient’s perspective, the clinician actively listens without being judgmental. Through this reflective listening, the clinician may find that the patient is not ready or willing to stop engaging in a particular behavior or to adopt a new behavior. In this case, the initial focus is on building therapeutic rapport and supporting the patient, instead of verbally suggesting change.

Supporting self-efficacy: Self-efficacy refers to a person’s belief in his/her ability to successfully carry out a specific task. The clinician should support the patient’s belief in his/her ability to change by giving the patient examples of positive change and emphasizing the importance of taking responsibility. When the patient feels strong support from the clinician, his/her sense of self-efficacy is enhanced.

Avoiding argumentation and rolling with resistance: Motivational interviewing differs from other approaches to behavior change in that it does not label patients (e.g., “non-compliant” or “difficult”). When faced with a patient’s resistance, it is important for the clinician to allow the resistance to be expressed. Through this process, the clinician reflects the patient’s questions and concerns back to the patient, so that the patient may further examine the possible alternatives to this resistance. The patient then becomes the source of the positive actions that could be taken, does not feel defeated in sharing his/her concerns, and is able to take the risk to express feelings.

Discovering discrepancies: Once patient-provider rapport has been established, the goal is to discover and amplify discrepancies between present and past behavior and future goals. This is achieved through examination of the consequences of continuing an unhealthy behavior and often involves discussing the advantages of adopting a new behavior. The patient will then be able to present the argument for change and begin to realize the need for change.

Motivational Interviewing Approach

The acronym OARS outlines the basic approach to interactions in motivational interviewing:

Open-ended questions invite patients to provide more information than yes or no and will encourage them to explore their own motivators for change. This strategy lets the patient know that the clinician is interested in his/her situation, while allowing the clinician to obtain needed information and insight into the patient’s issues.

Affirmations provide opportunities for clinicians to recognize the patients’ strengths.

Reflective listening helps the clinician identify areas of ambivalence. Reflective listening is often challenging because the clinician may need to form assumptions about the meaning of the patients’ statements in order to articulate them back to the patient. It is particularly important to reflect back any statements that indicate that the patient is motivated to change.

Simple reflections acknowledge the patient’s statements about disagreements, feelings, or perceptions.

Double-sided reflections acknowledge both what the patient has said and the ambivalence.

Amplified reflections reveal the patient’s ambivalence in a slightly exaggerated form.

Summaries will emphasize the main points of the discussion and should capture both sides of the patient’s ambivalence. The summary can also be used to shift focus or direction when the patient is expressing impassible resistance. After the clinician summarizes, he/she should invite the patient to make any corrections.

More resources on motivational interviewing are available from the Motivational Interviewing Network of Trainers (MINT).

Cognitive-Behavioral Strategies

Cognitive-behavioral strategies can be used when mild memory difficulties are present or when the individual feels overwhelmed by the pill-taking challenge. Practical strategies include the following:

  • Simplifying regimens: decrease dosing frequency, decrease number of pills
  • Personalizing drug schedules: tailor treatment to lifestyle, link medications to daily activities
  • Using reminders: written instructions or illustrations, pill boxes, timers, diaries, phone calls from family or friends
  • Using available pharmacy services: pharmacies may call patients to remind them about need for refills, deliver medications, provide professional regimen reviews

If memory deficits are pronounced, after evaluation by a neurologist, the assistance of relatives, home health aides, or visiting nurses should be sought. Before initiating treatment or when switching regimens, a practice run without active medication can help a client feel confident about his/her ability to adhere to ARV therapy.

For more information regarding cognitive impairment among HIV-infected patients, see Cognitive Disorders Guideline.

Directly Observed Therapy

Some medical programs and HIV/AIDS social service organizations have programs that provide ARV directly observed therapy (DOT) for outpatients (see the appendix, Advantages and Disadvantages of Adherence Measures). Although shown to be effective in several non-randomized trials [2,3], published data are limited that compare the efficacy of DOT with other modalities for successful treatment of HIV disease. DOT and modified DOT (MDOT) may facilitate adherence through direct supervision of pill-taking. These programs may also include psychoeducational and social service components, as well as behavioral reinforcements. DOT and MDOT may be the only effective means of ensuring treatment adherence in some patients with severe and persistent mental health illness, those with dual mental health and substance use disorders, and those who are living in unstable and disorganized social conditions.

References:
  1. Bakken S, Holzemer WL, Brown MA, et al. Relationships between perception of engagement with health care provider and demographic characteristics, health status, and adherence to therapeutic regimen in persons with HIV/AIDS. AIDS Patient Care STDs 2000;14:189-197.
  2. Stenzel MS, McKenzie M, Adelson-Mitty J, et al. Enhancing adherence to HAART: A pilot program of modified directly observed therapy. AIDS Reader 2001;11:317-328.
  3. Babudieri S, Aceti A, D’Offizi GP, et al. Directly observed therapy to treat HIV infection in prisoners. JAMA 2000;284:179-180.

Strategies to Improve Adherence: Appendix: Advantages and Disadvantages of Adherence Measures

September 2006

Method Advantages Disadvantages
Directly observed therapy
  • 100% adherence, in theory
  • Ideal method for institutional settings (prisons, nursing homes, residential treatment programs, etc.)
  • Labor intensive
  • Not practical for complex regimens with multiple doses and/or dietary restrictions
  • May compromise confidentiality
Electronic monitoring
  • Best correlation with virologic outcomes
  • Allows more detailed view of non-adherence patterns
  • Most accurate measure
  • Expensive and generally reserved for clinical trials
  • Precludes use of pillbox
  • Fails if multiple medications are kept in a single bottle or if multiple doses are taken out at one time
  • Requires carrying the container
  • Subject to “pocket doses” (removing more than one dose at a time)
  • Does not guarantee that the patient took the medication
Hematologic monitoring using either complete blood counts or expanded chemistry panels
  • Confirms patient reporting
  • Only effective for certain drugs: zidovudine, stavudine (increased MCV); indinavir (increased bilirubin)
  • Not always reliable
Modified directly observed therapy (observation of most but not all medication doses)
  • 100% adherence, in theory
  • Ideal method for ambulatory settings
  • Labor intensive
  • Concern for development of resistance if plan not followed
Pharmacy refill monitoring
  • Easy, minimal time commitment
  • Timely refilling of prescriptions correlates well with adherence
  • Most successful when limited to patient using one pharmacist
  • Is a useful adjunct to self-report
  • Effective in understanding adherence behavior in large populations
  • Patients may use more than one pharmacy
  • Does not equate with medication-taking
Pill counts
  • Useful adjunct to self-report
  • Unannounced pill counts may be more accurate
  • Direct costs minimal
  • Tends to overestimate adherence because of “pill dumping” before visit
  • Casts provider in the role of medication monitor and not ally or advocate
  • Indirect costs a concern due to time constraints
  • Does not prove that patient actually took medication
Provider estimation
  • Most poorly correlated with actual adherence
Self-report
  • Easily obtained using patient interview or questionnaire (report of non-adherence is more reliable than report of adherence)
  • Inexpensive
  • Overestimates adherence
  • Correlation is dependent on patient’s relationship with staff
  • Individuals may give providers what they perceive as socially desirable, “right” responses
Therapeutic drug monitoring
  • Low drug levels confirm non-adherence, but therapeutic drug levels do not confirm adherence
  • Pharmacokinetic levels for most drugs have not been well-established
  • Only confirms the pre-measurement adherence, long-term adherence still unknown
Viral load
  • Can correlate with adherence
  • Although poor adherence is associated with virologic failure, not all individuals with virologic failure will be poor adherence
  • Does not necessarily indicate non-adherence
  • May overestimate adherence
  • Virologic failure can be indicative of drug resistance

All Recommendations

Mental Health Guidelines Committee, September 2006

ALL RECOMMENDATIONS: ADHERENCE TO ANTIRETROVIRAL THERAPY AMONG HIV-INFECTED PATIENTS WITH MENTAL HEALTH DISORDERS
Introduction 
  • Patients with mental health disorders should be considered candidates for ART if they meet the medical eligibility criteria for ART and demonstrate readiness to begin therapy. Clinicians should determine treatment readiness on a case-by-case basis, weighing such factors as whether the patient attends the majority of his/her appointments and whether he/she expresses an interest in receiving ART.
Coordination of Care 
  • Primary care clinicians should refer patients to licensed mental health providers when:
    • Initial mental health treatment by the primary care clinician is ineffective
    • Complex mental status evaluations become necessary or a patient’s behavior jeopardizes effective treatment
    • The patient has co-occurring mental health and substance use disorders
  • Primary care clinicians and mental health care providers should collaborate to develop a step-by-step treatment plan. The treatment plan should delineate the frequency of follow-up visits with both providers as well as the frequency of team meetings to reevaluate effectiveness of the overall medical and mental health treatment.
  • Primary care clinicians should initially consult with a psychiatrist when managing patients with mental health disorders who refuse mental health care. Throughout the patient’s care, the clinician should communicate with a psychiatrist or a licensed mental health professional who can provide consultation.
  • Primary care clinicians should notify the mental health care provider when there is a change in medical or mental health treatment.
Identifying and Addressing Potential Barriers to Adherence
  • Clinicians should carefully assess each patient to evaluate his/her ability to adhere to ART.
  • Clinicians should identify and address potential barriers to adherence before initiating ART. If clinicians elect to defer HAART while addressing potentially modifiable barriers to adherence, they should discuss this decision with the patient and document it in the medical record.
  • Clinicians should discuss the following with patients before initiating ART:
    • Clinician and patient treatment goals
    • Patient’s concerns about treatment and ability to adhere
    • Potential side effects of ARV therapy and potential interactions with psychotropic and other medications, as well as how the side effects and interactions will be managed should they occur
  • Clinicians should use translator or sign language services when language barriers exist.
  • Primary care clinicians should refer patients with mental health disorders to specialized adherence services when adherence barriers cannot be resolved, particularly if the patient has AIDS or is at risk for advanced progression of HIV.
Initiating, Measuring, and Monitoring Adherence to ART 
  • Clinicians should assess adherence at every routine monitoring visit by verifying that patients are taking the correct medications, correct number of pills per dose, and correct number of doses per day.
  • Clinicians should use finite time intervals when inquiring about and quantifying the patient’s self-report. Clinicians should calculate an average response rate based on information obtained at multiple visits to determine a more accurate estimate of adherence.
  • Clinicians should reassess potential barriers to adherence at least every 3 to 4 months and whenever adherence problems are identified.
  • When clinicians find it necessary to speak with the patient’s friends or family to assess adherence, permission should be obtained from the patient and the patient should be involved in these discussions.
Strategies to Improve Adherence 
  • Clinicians should encourage patients to state in their own words what they understand about treatment instructions and to ask questions when additional information is needed.
  • Clinicians should encourage patients to be honest by responding in a nonjudgmental, supportive manner when patients report non-adherence.
  • Clinicians should provide adherence information in an organized manner, both orally and in written form, with easy-to-understand brief statements.