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Unit 10 HIV Care and ART: A Course for Physicians

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1 Unit 10 HIV Care and ART: A Course for Physicians
Adherence Unit 10 HIV Care and ART: A Course for Physicians This unit provides an overview of factors that challenge and support successful adherence. Unit should take approximately 1 hour, 45 minutes to implement. Step 1: Overview of Learning Objectives (Slides 1 – 2) – 5 minutes Step 2: Adherence Assessment and Support (Slides 3 – 36) – 50 minutes Step 3: Adherence Counseling Role Play (Slide 37) – 45 minutes Step 4: Key Points (Slides 38 – 40) – 5 minutes

2 Learning Objectives Define adherence in ART
Describe the relevance and importance of adherence in ART Identify barriers and factors affecting adherence Demonstrate how to assess client’s adherence success Describe strategies for physicians to use with clients to promote and encourage adherence Step 1: Overview of Unit Learning Objectives (Slides 1 – 2) – 5 minutes Begin by reviewing the unit aim and objectives. The aim of this unit is to explore strategies for promoting and supporting adherence to care and treatment. Ask if participants have any questions before continuing.

3 What is Adherence? Adherence is:
The patient’s active participation in planning care Understanding, consent and partnership in health care delivery between the provider and patient Both adherence to care and adherence to medications Step 2: Adherence Assessment and Support (Slides 3 – 36) – 50 minutes Adherence to ongoing care is as important as adherence to ART. Adherence is a broader term than compliance, which usually reflects the extent to which patients follow the instructions of their health-care providers. Adherence involves entering into and continuing with a program or care plan. It includes going to appointments and tests as scheduled, taking medications as prescribed, modifying lifestyles as needed, and avoiding risk behaviors.

4 In Other Words… Adherence is a client’s behavior coinciding with the prescribed health care regimen as agreed upon through a shared decision making process between the client and the health care provider

5 Adherence vs. Compliance
The term compliance is defined as acting in accordance to a command. In health care, it is often perceived as obeying a provider’s instructions Unlike adherence, compliance is not based upon shared decision-making between the patient and provider The term “adherence” is used to reinforce the idea that the patient is a partner in the health care team with active and informed participation.

6 Why is Adherence Important?
ARV medication adherence is critically important to: Achieve viral suppression Avoid viral resistance Prevent recurrence of OIs A patient’s best chance of ART success is to remain on their first-line regimen of ART For patients on ARV therapy, medication adherence is critically important to treatment success. Near-perfect pill taking is required to achieve viral suppression and to avoid the emergence of viral resistance. When patients skip doses and do not take their medicines regularly, viral resistance can develop and the medicines stop working. Missing doses is a serious common problem for patients on ARV therapy. No conclusive evidence exists to show that the degree of adherence required varies with different classes of agents or different medications in the HAART regimen. The risks of non-adherence are so clear and significant that adherence assessment and support are integral parts of HIV care and treatment programs across the world. Adherence counseling and preparedness must precede ART therapy. ART should be delayed until adherence issues have been addressed.

7 Sub-Optimal Adherence Predisposes to Resistance
Sub-therapeutic drug levels Incomplete viral suppression Generation of resistant HIV strains by selection for mutant viruses This depicts the progression from non-adherence to the resultant development of resistance. When doses are repeatedly missed, drug levels become sub therapeutic. This leads to incomplete viral suppression and the generation of HIV resistant strains. Not only is the patient at risk of failing their current regimen, they are at risk of developing resistance that may reduce the effectiveness of future regimens. Sources: Vanhove G, et al. Patient compliance and drug failure in protease inhibitor monotherapy. JAMA. December 1996;276(24): Montaner JS, et al. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study. JAMA. 1998;279(12): The association between poor adherence and antiretroviral resistance is well-documented1,2 1 Vanhove G, et al. JAMA 2 Montaner JS, et al. JAMA Adherence to Care and Treatment 7

8 Missed Doses & Development of Drug Resistance
Drugs are prescribed at doses that will maintain an effective level of drug in the bloodstream Dose is missed, taken late, or with the wrong type of food: drug level in blood dips While levels are low, resistant viruses will reproduce easily Resistant viruses gain a foothold before person begins taking drugs consistently again Enough drug-resistant viruses may have emerged to cause treatment failure Following drug regimens to the letter (taking pills exactly as they were prescribed) is called adherence (and sometimes also compliance). Unlike treatments used in many other chronic diseases, anti-HIV drug therapy requires an extremely high level of adherence if it is not to fail: as stated earlier, we believe that this requires a level of at least 95%. Increasingly, researchers are recognising that adherence is perhaps the most important factor in successful HIV treatment, and that people taking anti-HIV drugs need support in sticking with their treatment in the long-term.

9 Virologic Control Falls Sharply With Diminished Adherence
(number of pills taken / number of pills prescribed) The best performance was achieved in patients who by self-report and MEMS-caps were found to have >95% adherence, i.e. better than 95% of doses were taken during the 3 months of study. Note that <70% adherence was associated with only 10% of patients achieving a viral load below detection. Source: Paterson, D. L. et. al. Ann Intern Med 2000;133:21-30

10 Adherence to Medication
The accepted definition of successful adherence for most chronic diseases is >80% of pills taken This standard does not apply to HIV disease and antiretroviral therapy Greater than 95% is the goal for ART Early indication of issues with adherence to medication can be seen with initiation of PCP prophylaxis and with cotrimoxazole. OI prophylaxis should be initiated before ART.

11 Benefits of Adherence Through adherence, patients and providers can:
Prevent opportunistic infections Diagnose complications early Improve outcomes of treatment and care Delay emergence of drug resistance Develop a positive patient-provider relationship Ongoing continuous care can detect early opportunistic infections or identify those at risk, can help with support, and improve outcomes.

12 Non-Adherence Factors
Non-adherence is correlated with: Unstable emotional life or psychiatric illness Inability to fit the medication schedule into a daily routine Missed clinic appointments Poor clinician-patient relationship Alcohol and drug abuse Surveys show no clear evidence that adherence is related to socioeconomic status, race, or gender. NEJM :353;

13 Non-Adherence Factors (2)
Lack of patient education Side effects Domestic violence High pill burden Cultural and religious beliefs

14 Five Types of Non-adherers
Consistent Underdoser Regularly neglects to take one of the prescribed doses, such as the midday dose Regularly takes only some of the prescribed medications Consistent Overdoser Regularly takes a drug more often or in larger doses than is prescribed Random Doser Takes the medications when she or he thinks of it Consistent Underdoser: Some patients think that they can avoid side effects by taking less of the prescribed dose, which puts them at risk of not getting enough medication. Consistent Overdoser: Falsely thinks that “more is better.” They may be at higher risk for medication toxicity. Source: Simioni, Jane, “Buddy Training Manual.” This information was pulled from the literature and compiled for an adherence study in the Bronx, NY and for Project PAL in Seattle, WA.

15 Five Types of Non-adherers (2)
Abrupt Overdoser Does not take medications properly and then takes an overdose prior to a clinic visit Doubles up for missed doses Tourist (takes “drug holidays”) Abruptly stops all medications for a few days or weeks Takes one day off per week Abrupt Overdoser: At risk in two ways: When they are not getting enough medication, they are at risk of developing resistance. When their levels are too high, they are risk for toxicity. Source: This information was pulled from the literature and compiled in the “Buddy Training Manual” for an adherence study in the Bronx, NY and for Project PAL in Seattle, WA (“Buddy Training Manual” prepared by Jane Simoni, PhD).

16 Adherence to Care Assessment of adherence to care requires a functioning, integrated administrative infrastructure Adherence-to-care issues are most effectively addressed when coordinated by a designated person Regular and organized interdisciplinary communication is an important adherence-to-care component – different members of the care team have different “pieces of the puzzle” Nurses, pharmacists, counselors, outreach workers Adherence to care can be most efficiently assessed by a designated person such as the clinic supervisor or nurse. Does the patient come to all her appointments? Did the patient pick up medications at the pharmacy as directed? Did the patient complete the tests that were ordered? Interdisciplinary communication is vital in capturing important patient information that will assist in supporting adherence to care. Ongoing multidisciplinary team meetings are a good forum for communicating about a patient’s concerns and issues.

17 Assessing Adherence Health-care providers cannot accurately discern which patients will adhere Providers must formally assess adherence An interdisciplinary assessment approach is most successful Intensive assessment should be conducted during ARV initiation Assessment is a continual process that must be revisited during every patient interaction Studies have shown that health care providers do not identify those who will adhere and those who will not. Successful adherence assessment involves multiple providers. Patients must be asked questions directly regarding missed appointments and pill taking. A patient may be reluctant to disclose a missed medication dose to the clinician who is prescribing them, but may feel more comfortable discussing this with another care provider. Consistent multidisciplinary team meetings are necessary to exchange critical patient information regarding adherence.

18 Assessing Adherence (2)
Assessment requires a supportive and nonjudgmental approach Acknowledge that medication adherence is difficult Assess missed doses Assess barriers to adherence and support strategies It is critically important that providers know the following information about each patient: Are patients taking medications as prescribed? How many doses are missed? What makes it difficult for patients to take medications? Reasons may include side effects, fears about the medications, difficulty getting to the clinic, etc. What helps patients to take medications? Interviews with patients often overestimate adherence. Emphasize to patients that it is important for them to tell the truth, even if the medications are missed or not taken correctly. Patients on ARV medications should know that if they are going to stop medications, they should stop all their ARV medications at once. A respectful, nonjudgmental attitude is vital in framing questions.

19 Assessing Adherence (3)
Examples of questions to assess missed doses: “Many patients taking these medications find it difficult from time to time. What has your experience been?” “How many doses have you missed in the past day? The past week? The past month?” “In an average week, how often do you miss your medications? How often are you late?” Avoid using questions that may be answered either “yes” or “no.” Acknowledge that medication adherence is difficult. At each visit, providers should assess adherence for all medications, not just ARVs.

20 Assessing Adherence (4)
Examples of questions to assess barriers or support strategies: “When is it most difficult to remember your medications?” “It’s not easy to take medicine every day. What things help you to take your pills?” “What kinds of problems make it hard to take your pills?” You may need to prompt patients with questions about specific problems such as side effects, forgetting, etc. Before moving on to the next slides which present barriers to adherence, ask the group to brainstorm what they think some barriers might be. Ask, “What are the challenges or barriers to adhering to a medication regimen?” Record responses on flip chart paper. Then move on to the next slides and compare their responses with the ones provided.

21 Assessing Adherence (5)
Do not assume “once adherent, always adherent” Many things can change over time Patients may tire of taking medications – pill fatigue Family structure may change causing new adherence challenges After clinical improvement occurs, patients may assume they no longer need medications

22 Barriers to Adherence Cultural beliefs or fears about medication
Secrecy and stigma surrounding HIV diagnosis Side effects Difficulty swallowing medicines There are many factors that can create barriers to optimal adherence. These barriers can affect readiness or ability to regularly take medications as prescribed. In Ethiopia, cultural and religious beliefs influence adherence to care and medication very significantly. Fasting and traditional healers can have a significant effect upon adherence.

23 Barriers to Adherence (2)
Inadequate understanding of medicine regimen Competing priorities: work, child care, food access Forgetfulness or lack of support to remember Travel or being away from home

24 Promoting Adherence Care Setting:
Welcoming and comfortable environment Accessible, with co-located services Convenient hours for work, child care Reimbursement for transportation costs Child care or facilities at clinic The best approach towards maintaining adherence varies from patient to patient and setting to setting. Patients should be given motivation to return to the care site and remain in care. A welcoming and comfortable care environment that can offer flexible and creative incentives can motivate patients to become involved in their care.

25 Promoting Adherence (2)
Communication: Ask patients to restate information given Practice active listening Ask open-ended questions to facilitate patient sharing Restate answers to ensure understanding Show concern and respect Be non-judgmental Establishing good communication with patients builds trust and is essential to effective patient care. It can assist in identifying patient problems, needs, and barriers to care. Ask open-ended questions, for example, “Some of my patients find it difficult to take all the medicine. How has that been for you?” Ask participants for examples of other open-ended questions they can ask. Regardless of what a patient tells you, work to project concern and respect in what you say and how you say it.

26 Promoting Adherence (3)
Confidentiality: Explain to all patients upon enrollment Assure that HIV status will not be disclosed without consent Counsel about the importance of discretion regarding other patients Confidentiality is a major issue that affects patients’ adherence to care. This is particularly true due to the stigma and discrimination that disclosure of HIV status may evoke. Mention that disclosure of status to infected children will be discussed in a separate unit.

27 Promoting Adherence (4)
Outreach and Follow-Up: Develop processes to contact patients Plan to address missed appointments Consistently obtain specific patient contact information Document patient’s preferred contact method Patients who miss appointments need to be identified rapidly. Planning ahead for this contingency is a prudent approach and it is important to gather as much contact information for a patient on enrollment as they will permit. Note: Disclosure of HIV status without patient consent is ethically unacceptable.

28 Adherence Readiness Prior to ARV Initiation
ARV initiation is rarely a medical emergency Adherence counseling and preparedness must precede ARV therapy Patients should demonstrate adherence to care Does the patient keep clinic appointments reliably? Practice with OI prophylaxis Ideally, patients should identify an “adherence buddy” for ongoing support Some clinics have a checklist of factors that must be present before ARV initiation. These include the items listed on the slide as well as patient education and the ability to verbalize importance of medications, adherence and side effects. In addition to these factors, there should be general agreement among the multidisciplinary team members about each patient’s readiness to initiate ARV’s. Most patients will qualify for cotrimoxazole prophylaxis by the time they meet criteria for ARV’s. Pill counts can be done and pharmacy records can be checked to assess adherence to CTX prior to ARV initiation. Some clinics require the identification of an “adherence buddy” prior to ARV initiation. This obviously requires disclosure, which some patients may not be willing to do.

29 Strategies to Promote Medication Adherence
Prescribing Medications: Personalized medication regimen for patient’s lifestyle Detailed instructions on how to take medications, including timing, food restrictions, drug interactions Instructions on how to identify and handle adverse effects Streamlined regimens minimizing the number of pills and doses per day Pill boxes Patients who have adequate information regarding their medications and possible side effects are better equipped to handle adverse effects and maintain adherence.

30 Strategies to Promote Medication Adherence (2)
Access to Medication: Ensure easy access to uninterrupted medication supply (avoid “stock outs”) Ensure that patients understand where, when and how to obtain medications Provide on-site pharmacies where possible Assist patients in safeguarding medications Patients should know how to contact provider if out of medications. Educate the patients to communicate with the clinic if they are having any problems getting meds or keeping on schedule.

31 Strategies to Promote Medication Adherence (3)
Counseling and Support: Peer support groups Patient education and counseling Identify barriers to adherence and provide individualized interventions Modified directly observed therapy either in the home by a community based medication partner or at the clinic It is helpful if the patient has a medication partner or “buddy” – a person to whom they have disclosed their HIV status who can help them to keep appointments, provide reminders, assist with refills, offer support, and let the clinic know if there is a problem. This “buddy” could be a peer, friend, family member, or outreach worker who learns about medications along with the patient and takes responsibility for assisting the patient.

32 Strategies to Promote Medication Adherence (4)
Counseling and Support (cont): Medication “reminders” linked to daily activities, timers, beepers, alarm clocks Medication partners or “buddies” Tips on how to remember medications, including daily cues, reminders, partners Observing daily medication at the clinic can be cumbersome, but alternate methods that observe at least one dose a day have been successful in some settings.

33 ART Counseling Team approach, including physician, nurse, pharmacist, laboratory technician and counselor The team provides information to each other to improve quality of care Team ensures confidentiality Involve family members and other care providers Every member of the team should be involved in adherence counseling.

34 Objectives of ART Counseling
Provide information and help patients: Make decisions about antiretroviral therapy Cope with therapy Protect others and maintain positive sexual behavior changes

35 Counseling Patients Before ART
Ensure patients received pre- and post-test counseling Issues to discuss: Financial Adherence Emotional support Information about therapy Disclosure Disclosure should occur on the patient’s timeline based on his or her readiness. Providers need informed consent to disclose HIV status to someone other than the patient.

36 Counseling Patients Before ART (2)
Issues to discuss (cont.): Specific ART drug information Drug adherence Coping with response to ART Sexual behavior change

37 Group Exercise: Adherence Counseling Role Play
Step 3: Group Exercise: Adherence Counseling Role Play (Slide 37) – 45 minutes Introduction: Role-playing adherence counseling teaches participants the importance of empathy, self-awareness, and effective communication for a positive physician-client relationship. Instructions: Refer participants to Worksheet 11.1, Adherence Counseling Role Play. Separate participants into groups of four. Explain that one group member will play a health care professional or counselor, one will play a patient, and two will observe. Ask for a volunteer to read aloud the patient description. Ask another volunteer to read what the health care workers or counselor should explain to the patient. After the role play, the observers in the group should comment on the effectiveness of the teaching and counseling session, and make suggestions for improvement. They should note on a flip chart the issues and challenges encountered in the role play to share with the larger group. Instruct each group to role-play for 15 minutes. After the role plays, the observers should present a summary of their feedback on the role play to the larger group.

38 Key Points Adherence to care and/or treatment is critical for continued viral suppression and improvement in immune function Serious potential consequences can result from non-adherence >95% adherence is necessary to achieve <20% failure rate Benefits of adherence to care include prevention of opportunistic infections, early diagnosis of complications, and development of positive patient-provider relationships Step 4: Key Points (Slides 38 –40) – 5 minutes Summarize the presentation, review the Key Points, and answer final questions.

39 Key Points (2) Antiretroviral (ARV) regimens are complex, may have major side efforts and may pose difficulty with adherence Patient/family education and involvement are critical for successful treatment of HIV infection Physicians should promote and encourage disclosure of HIV status to a patient’s trusted family member and/or friend to help promote successful adherence

40 Key Points (3) A therapeutic alliance between the provider and the patient can promote optimal adherence to both HIV care and ARV regimens Adherence CAN be improved

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