Antiretroviral Therapy

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ETHIOPIANS AND AMERICANS IN PARTNERSHIP TO FIGHT HIV/AIDS

Developed by I-TECH with funding from Cooperative Agreement U91HA06801 from the US Department of Health and Human Services. Health Resources and Services Administration (HRSA)

Structured Adherence Counseling Session Guide Edited by: Manuel Kassaye, Ismael Ahmed, Getachew Feleke Addis Ababa, 2015

Acknowledgements I-TECH Ethiopia gratefully acknowledges the expertise and dedication of the HIV Care and Treatment and Nursing Program and particularly I-TECH Head Quarter Teams for their enthusiastic assistance in the production of this guide. I-TECH would also like to express its appreciation for funding received under the US President’s Emergency Plan for AIDS Relief (PEPFAR) in support of training and other HIV-related activities in Ethiopia.  

GLOSSARY OF TERMS Adherence The client’s ability to stick to or maintain an ART regimen. It involves taking medications in the correct amounts, at the correct times, and in the ways they are prescribed. Adherence to treatment care The extent to which a person’s behavior—e.g., taking medication, following a diet, and/or executing lifestyle changes—corresponds with the recommendations of a health care provider. Any deviation from the recommendation (missing part or all of a dose) is non adherence Adherence to care The ability of the client to develop and follow a plan of behavioral and attitudinal change that ultimately serves to empower him/her to improve his/her health and selfmanage an illness. Client HIV/AIDS patient receiving care. Dropped When a client misses appointments over more than three months. Entry into care Visit with an HIV care provider authorized to prescribe ART and enrollment into HIV care following the initial HIV diagnosis. Follow-up An intentional contact following entry into care. This includes formal appointments, telephone contact, and referrals.

Integration Combination of related health care services to facilitate continuity of care, improving convenience for the patient. Integration may be functional or structural. Linkage to care The period starting with the HIV diagnosis and ending with initial enrollment into HIV care and treatment. Lost to follow-up (LTFU) A client who has missed clinic appointments for one month or longer for any reason. Retention in care Ensuring that the client continues to receive appropriate services (from both client and provider perspectives) throughout the continuum of HIV care and support. An intentional contact following entry into care. This includes formal appointments, telephone contact, and referrals. Stopped treatment Situation in which the client and/or the clinician have decided to stop treatment for any reason.

Visit Client contact with a care provider at an HIV clinic.

Preface This guide offers essential information on how to provide information and counseling in antiretroviral therapy (ART) adherence and retention within chronic HIV care, the goal being to improve patient care and strengthen the adherence case-management program in Ethiopia. In order to achieve desired health outcomes with ART, promotion, screening and monitoring of adherence to treatment regimens is critical. Ensuring optimal adherence is the most important task for health care workers working with patients who are on ART, especially those involved in HIV case management: i.e., case managers, adherence supporters, and nurses. In applying a case-management model to HIV counseling and health care, clinicians should support clients in adhering to medication regimens, and proactively identify clients who are not likely to adhere to the complex treatment requirements and are thus at risk of becoming lost to follow-up (LTFU). Ideally, adherence case management should begin before starting the client on ART, and continue throughout the life of the client. Identifying clients at risk for non adherence is critical and is the responsibility of all care providers including dotors,nurses,pharmacists and case managers. When linicians identify clients at risk for non-adherence, they should refer them to case managers for more intensive adherence counseling and follow-up. The tips and guidance for case managers presented in this guide are intended to improve counseling and ART adherence.

INTENDED USERS This guide can be used as a quick reference by case managers, adherence supporters, and health care workers (including pharmacy personnel, health extension workers and social workers).

Table of Contents Acknowledgements......................................................ii Preface..........................................................................iii Introduction.................................................................. 1 Roles and Responsibilities of Case Managers and Adherence Supporters........................................... 2 Functions of HIV Case Management............................ 4 Barriers to Adherence.................................................. 5 Characteristics and Consequences of Poor Adherence............................................................ 6 Strategies to Enhance Adherence................................ 7 Key Factors in Client Empowerment............................10 Key Factors in Improving Client Adherence..................10 Tips for Effective Adherence Counseling......................11 The “5As” of Adherence...............................................12 Maintaining and Sustaining Adherence........................13 Making Referrals...........................................................14 Questions to Ask the Client..........................................14 References....................................................................16 Glossary of Terms.........................................................18

Introduction ART adherence refers to a client’s ability to follow an ART treatment plan. This includes the client’s ability to take medication as prescribed, and to follow dietary restrictions. ART is a lifelong treatment plan for people living with HIV that consists of taking medication at different frequencies each day, and which requires clients to play active roles in their own health care. (The term client is used in place of patient throughout this document.) Adherence is the best predictor of treatment success among clients. Near-perfect adherence is needed for clients to achieve good results, such as decreasing viral loads in the bloodstream, and preventing HIV-related complications. Research has shown that missing doses diminishes the efficacy of ART: According to FHI 360 (formerly Family Health International), “[a] 95 percent adherence rate is associated with controlling HIV replication, which allows an optimal therapeutic response to the medications.” (Family Health International, 2004: P.B-3) ART medication may have temporary and/or permanent side effects for some clients. Usually these side effects are mild; however, it is important to recognize and manage side effects early, since, once clients begin ART, they must continue with it for life. Promoting good adherence is therefore vital to successful health outcomes, especially in resourcelimited settings where therapeutic choices are also limited. 1

Roles and Responsibilities of Case Managers and Adherence Supporters MAIN ROLES AND RESPONSIBILITIES OF CASE MANAGERS  Receive clients—especially those at risk for non-adherence—and initiate HIV/AIDS case management intake.  Assess the holistic needs of clients and families through face-to-face conversation. With the help of the client and family members, prioritize the needs of the client.  Develop with the client a client- and familycentered HIV/AIDS case-management plan that will meet those needs identified as priorities, and focus on services that the client can access to improve adherence.  Help clients navigate the health care system by providing pertinent information, directing them to the right places, and so on.  Refer clients to community organizations that provide care and support, and provide them with information about linkage to such organizations.  Execute client care plans based on the needs identified, and monitor individual progress.  Monitor and formally reassess client progress in treatment adherence. Every three months, evaluate progress made regarding HIV/AIDS case management plans, determine case closure, and document discharge summaries.  Provide health education and counseling to clients, their families and the community. 2

Roles of Adherence Support Coordinator in the MDT Roles of Adherence Support Coordinator in the MDT

Physician Adherence Supporter

Multidisciplinary Team

Pharmacy ART Nurse

Lab Technician

Community Services Catchment Community

PMTCT

MAIN ROLES AND RESPONSIBILITIES OF ADHERENCE SUPPORTERS

 Meet with clients at risk for non-adherence when referred by case managers, and monitor their progress.  Attempt to connect with LTFU clients through phone calls and/or home visits.  Direct or as needed accompany clients to the appropriate departments—e.g., VCT, PMTCT, ART, TB, etc.  Refer clients to the appropriate community organizations for care and support.  Work with case managers and clients to support the development of HIV/AIDS case management plans that will meet those client needs identified as priorities.  Provide emotional support, adherence counseling and education for both clients and their families.

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 In collaboration with case managers, monitor client adherence through regularly scheduled meetings, home visits, and/or reports from home-based caregivers and family members (These are based on FHAPCO’s Guidelines for Implementation of HIV/AIDS Case Management in Ethiopia. Federal HIV/AIDS Prevention and Control Office, Federal Ministry of Health, June 2009.)

FUNCTIONS OF HIV CASE MANAGEMENT Case managers and adherence supporters should, as a matter of routine, perform the following functions:  Maintain accurate medical records, especially for LTFU clients.  Maintain addresses, phone numbers and contact information for clients, families and caregivers.  Conduct home visits with LTFU clients.  Report findings of home assessments, using the appropriate forms, in a timely manner.  Keep lists of deaths and transfer clients up to date.  Keep a list of clients who are facing hardships— i.e., poverty, social isolation, or stigmatization.  Work to reduce the number of LTFU clients by establishing and maintaining regular contact though phone calls and/or home visits.  Identify clients who are unable to successfully 4

maintain adherence to treatment, and take appropriate action regarding their care. (A number of the recommended activities described above were derived from the “Social Worker Assessment Tool” in I-TECH’s Clinical Mentoring Toolkit, (I-TECH, 2008)).

BARRIERS TO ADHERENCE Several barriers to adherence impede progress in controlling HIV. Chief among them are:  Financial constraints, such as the costs of medication, food, or transport.  Secrecy and stigma, as well fear of disclosure as a result of being on ART.  Work schedule travel/migration, may affect access to ART.  Side effects of medication.  Alcoholism and/or other forms of substance abuse (e.g., khat)  Opting for holy water or other traditional medicines.  Misconceptions/misinformation about ART. Research by Mills et al. (2006) identified the following barriers to adherence, particularly in resource-limited settings:  Forgetfulness.  Client suspiciousness toward treatment.  Overly complicated treatment regimens.

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 A decrease in quality of life, or feeling sick, while on medication.  Sleepiness (e.g., clients frequently falling asleep while on medication).  Access to medication.  Depression, which can cause reduced motivation and apathy. Other factors that can interfere with adherence include:  Balancing dietary requirements with those of ART.  Coordinating treatment with work, family, or care giving responsibilities. In addition, some clients feel socially isolated, dislike or distrust their health care provider(s), have no time to refill their prescriptions, or experience other pharmacyrelated problems. The case manager’s job is to counsel the client on how best to develop the coping skills needed to address such concerns.  

Characteristics and Consequences of Poor Adherence

CHARACTERISTICS Poor adherence may encompass any of the following:  Missing one or more doses of a given drug.  Missing entire days of treatment.  Missing appointments.  Not taking medications on time.  Not following dietary instructions. As soon as possible after clients miss doses, fail to take medication correctly, or otherwise have a “slip” of some kind, case managers should meet with them to discuss how they can get back on track. (Safren, 2009:p.8).

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CONSEQUENCES Poor adherence is associated with the development of drug-resistant HIV strains, resulting in treatment failure. Signs of treatment failure include, but are not limited to:  Weight loss.  Development of new opportunistic infections (OI).  A declining CD4 count. Other consequences may include:  Continuous deterioration of the immune system.  Progression of resultant diseases and death.  Emergence of drug-resistant viruses that can be transmitted to partners. Clients should strive for optimal adherence. Clients should know that they must stay in care, even if they are non-adherent for a time. Routine laboratory tests, monitoring of HIV progression, and treatment of nonHIV-related conditions and opportunistic infections are all important to successful health outcomes. Missing more than 5–10% of doses (e.g., more than 3–6 doses a month during a twice-daily treatment regimen) can reduce the effectiveness of medications (I-TECH, 2008).  

STRATEGIES TO ENHANCE ADHERENCE Several strategies have been shown to improve ART adherence. The main activities proved most effective in enhancing adherence are described below. 1. Education and adherence counseling. Ask:  Has the client disclosed his/her HIV status to anyone? What would be the likely repercussions if he/she did disclose?

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 If the client has disclosed his/her diagnosis, whom did he/she tell? Did anything good or bad happen after disclosure?  Does anyone in his/her household know of the diagnosis? Make sure the client understands his/her illness, and that the pills he/she needs to take are essential—especially as the decision is made to begin ART. Educate the client about possible side effects. 2. Recognize and address side effects and toxicities early. 3. Integrate the treatment regimen into the client’s daily routine. 4. Encourage the client to use a medication diary to keep a record of ART adherence. 5. Encourage the client to adopt a “buddy system” (by involving a peer, family member or friend) to help with medications or provide other support 6. Consider the client’s wishes with regard to disclosure. Secrecy and stigma may affect individual decisions whether or not to disclose. If appropriate, encourage the client to disclose his/her HIV status to a trusted friend or family member. Help the client to identify a support system. 7. Where available, suggest the use of electronic devices (e.g., mobile phone, alarms or beepers) to help remind the client when to take medications. Alternatively, work out a written schedule. Using a cueing system. (e.g., having the medication close to something that is part of the daily routine, like a coffee kettle or some other object) may also be a helpful way to help the client remember. Ensure that the client is comfortable with the degree 8

to which such “reminders” may attract attention in public places, especially if the client has not yet made full disclosure. 8. Work with a multidisciplinary team in support of all aspects of ART adherence. 9. Provide reminder devices, such as pillboxes, for clients who believe that they may benefit from their use. 10. Evaluate adherence at each visit; if the client is not sticking to his/her regimen, discuss actions or methods that might help improve adherence. 11. Educate the client about possible side effects and immune reconstitution inflammatory syndrome (IRIS), and prepare for their occurrence. 12. Focus on client concerns and priorities. 13. Identify and address problems or concerns related to beliefs about health, religious practices, the use of holy water or traditional medicines, etc. Adopt a non-judgmental attitude to show support for the client. 14. Emphasize to the client that he/she is in control of his/her medications. Clients who feel in control of their treatment tend to have a better record of adherence. 15. Reinforce to the client that ART treatment is lifelong. 16. Provide more intensive counseling if there is a change in the client’s physical or mental health (see “Questions to Ask the Client”). 17. Educate the client on the basic principles and steps of positive living.

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KEY FACTORS IN CLIENT EMPOWERMENT The factors below are associated with higher rates of adherence; it is important for case managers to be mindful of them (Mills et al. 2006):  Sense of self-worth.  Perception of beneficial health effects of ART.  Acceptance of being HIV-positive.  Understanding of what strict adherence entails.  Access and ability to employ a simple regimen. In order to avoid “pill fatigue” (i.e., tiring of the daily regimen), it is important to provide ongoing counseling to maintain adherence (Minnaar and Bodkin, 2006).   KEY FACTORS IN IMPROVING CLIENT ADHERENCE Case managers and adherence supporters are encouraged to work with other members of the multidisciplinary team so that they remain attuned to the medical status of their clients. Improving viral load and CD4 measures after a few weeks on ART will indicate the effectiveness of adherence counseling. However, rates of adherence tend to decline over time (18 months and longer). It is thus important to continue to check up on client CD4 counts at regular intervals. Programmatically, evaluation of adherence tends to focus on health facility records and client adherence data, such as the number of clients and their rates of ART adherence, and other support data. It is important to triangulate this data as part of any evaluation of adherence (ICAP, Schmitz, 2007). Treatment adherence is best measured quantitatively, using such tools selfreporting and other techniques to validate the data. It is important to consider the following questions:  Do clients keep most of their doctor appointments? 10

 Do they keep their appointments with the case manager? It is always advisable to inform the client’s primary health care provider of any concerns you may have about the client’s adherence to the treatment regimen, as clients are more likely to trust and listen to their primary health care providers.   TIPS FOR EFFECTIVE ADHERENCE COUNSELING 1. Listen to the client; use appropriate body language and eye contact. 2. During each visit, teach the importance of adherence to treatment, drug side effects, the consequences of poor adherence, etc. 3. Provide a comfortable atmosphere for the client to ask questions, and respond to questions and concerns appropriately. Maintain client privacy and confidentiality. 4. Respect the client’s needs, choices and values. 5. Ask questions to identify high-risk behaviors. (Openended questions tend to work best.) 6. Respond to questions, provide information, and correct any false information. 7. Be gently persuasive, but allow the client to make his/her own decisions 8. Reinforce what the client needs to know: emphasize, summarize and repeat key information. Ask the client if he/she has any questions. 9. Never blame the client for failing to adhere; instead, seek ways to inspire improved adherence. Much of the follow-through on adherence is about TRUST. 10. Support the client in developing the resources, support and arrangements they need to ensure adherence. 11

THE “5AS” OF ADHERENCE Another way to think about, and proceed with, supporting adherence is to use the five principles sometimes referred to as the “5As” in adherence counseling:

Assess—Advise—Agree—Assist—Arrange

The 5As approach was first developed in 1996 to guide smoking cessation counseling. It was later adapted for use in other health interventions (Whitlock et al., 2002). This approach has been adapted to suit the context of ART adherence. Case managers should begin discussion before the client starts ART; open discussion should continue throughout the process.

ASSESS Ask about and assess the client’s knowledge, attitudes and concerns about ART and adherence. ADVISE Address the client’s concerns by providing information, counseling and advice on HIV treatment, and review important aspects of care.  Review the ART regimen with the client.  Make sure the client understands the importance of adherence.  Review any dietary recommendations.  Explain limits on alcohol and drug use.  Explain possible side effects to the client.  Provide information on things that can be done to prevent the spread of HIV, such as smoking cessation and safer sex practices. Have the client summarize and repeat key information; reinforce important details. AGREE Make sure the client agrees to the treatment regimen, and is committed to incorporating it into his/her lifestyle. ASSIST Help the client develop the resources/support/ arrangements needed to ensure adherence, including: 12

 Ability to come in for required appointments and scheduled follow-ups.  A home and work situation that permits taking medication as prescribed.  Supportive family and friends.  Disclosure of HIV status to family members and significant others  Adherence support groups (e.g., PLHIV groups, or other local or community associations, if available).

ARRANGE Arrange for follow-up appointments, support and/or referral, as needed. Follow-up appointments, referrals and ongoing supports are needed to maintain adherence.   MAINTAINING AND SUSTAINING ADHERENCE The importance of ART adherence cannot be overemphasized—yet good adherence remains a challenge for many clients. ART case managers, adherence supporters, nurses and health care providers have an important role to play in improving rates of ART adherence.

Key points for health care providers to remember:

 Recognize that adherence to treatment is difficult! If you are to help your client, it is important to understand that difficulty.  ART helps to restore the body’s immune system— but it is not a cure for HIV or AIDS.  Decisions about ART require consideration of multiple issues.  ART requires a high level of adherence to achieve adequate immunologic improvement.  ART can cause side effects that should be closely monitored.  Adherence is a critical component of ART treatment, vital to the successful care and positive treatment outcomes of clients with HIV and AIDS.

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MAKING REFERRALS Good practices for making referrals:  Make sure the referral is appropriate for the client. Know the requirements organizations have before referring clients to them.  Maintain a list of local support organizations available to provide supplementary care and support.  Establish and maintain relationships with support organizations, such as associations of people living with HIV/AIDS (PLHIV).  Follow-up on the status of each referral made.   QUESTIONS TO ASK THE CLIENT DURING A SESSION During one-on-one adherence sessions, some questions may elicit information useful in understanding the individual needs of the client and designing targeted adherence support activities. Be mindful of each client’s social, cultural, religious and educational background. Ask starter questions before moving on to such questions as: 1. How many tablets do you take in the morning? How many at night? 2. Do you know which tablets you need to take, and what they look like? Do you know what they are for? (Check the client’s understanding by asking such questions as: Do you know which ones are for ART? Do you know which medication is meant to treat opportunistic infections, such as tuberculosis?) 3. How are you doing with your timing? What time do you take your medication in the morning? In the evening? 4. How many doses have you missed in the past three days? (Have clients describe this one day at a time, starting with yesterday. Ask if they were late or missed any on that day, then ask them about the two days before that. Next, ask about the past week.) How many doses did you miss over the last seven days? The past month? 5. Do you know what will happen if you miss a dose? 6. Do you have any food or storage restrictions? 7. How do you integrate taking your medication into 14

your daily routine? 8. Have you discussed your HIV status with anyone (family member, friend, etc.)? 9. Who helps you remember to take your medication (i.e., a family member, friend or buddy)? 10. What should you do if you feel sick, or if you vomit after taking your medication? 11. Are you taking any other medications, holy water or traditional medicines? 12. Are you sexually active? Are you or your partner using a condom every time you have sex? 13. Do you have any drug side effects? 14. Do you use/take khat, alcohol or any other substance /drug? 15. Do you think about stopping your treatment? If so, why? Are you feeling better? Tired of taking pills? 16. What will you do if you accidentally or intentionally become pregnant?

AT THE END OF A SESSION Before you conclude your session with the client, ensure that the client has had an opportunity to ask questions or get further clarification. Take the time necessary to explain anything that your client many not have completely understood. Choose from among these questions, as appropriate: 1. Do you know how and when to get your prescriptions filled? 2. Do you know when your next appointment is with your doctor/health care provider or case manager? 3. Are there other things you might need to do to make it easier to follow your treatment plan? 4. Do you have any questions or concerns that we have not yet discussed? Remember that uncovering adherence is an NOTE: When clients posea problem specific with medical questions, important accomplishment, and may notHIV need to be resolved please record them and discuss with clinicians. on the spot. Solutions can evolve in subsequent visits.

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REFERENCES Family Health International (FHI). Adherence Support Worker Training: Participant’s Guide. Prepared by FHI for USAID through the Implementing AIDS Prevention and Care (IMPACT) Project. 2007. Family Health International. Antiretroviral Therapy (ART) Program: Standard Operating Procedures: ART Adherence Counseling. Family Health International. Report prepared for USAID. October 2004. Federal HIV/AIDS Prevention and Control Office, Ministry of Health. Guidelines for Implementation of HIV/AIDS Case Management in Ethiopia. June 2009. Federal Ministry of Health, 2013. Strategic framework to improve adherence to ART and retention to care in Ethiopia. Fiore, MC, Bailey, WC, Cohen, SJ, et al. Treating Tobacco Use and Dependence: Clinical Practice Guideline. Rockville, Maryland, USA: US Department of Health and Human Services, Public Health Service. 2000. http:// www.surgeongeneral.gov/tobacco. Horizon/Population Council. International Center for Reproductive Health. Adherence to Antiretroviral Therapy in Adults: A guide for trainers. Coast Province General Hospital. Mombasa, Kenya: Ministry of Health. 2004. International Center for AIDS Care and Treatment Programs (ICAP). Antiretroviral Therapy Adherence Baseline. Adherence Review. New York. New York, USA: International Center for AIDS Programs at the Columbia University Mailman School of Public Health. 2007. pp. 1–6. International Center for AIDS Care and Treatment Programs (ICAP). Psychosocial Support, Adherence and Measurement (PowerPoint presentation). Kjersti 16

Schmitz for ICAP, New York Clinic. 2007 ICAP Annual Meeting, New York, New York, USA: International Center for AIDS Programs at the Columbia University Mailman School of Public Health. October 5, 2007. International Training and Education Center on HIV (I-TECH). Social Worker Assessment Tools in Clinical Mentoring Toolkit: A Resource for Clinical Mentoring in Resource-constrained Settings: Seattle, Washington, USA: University of Washington. 2008. Mills EJ, Nachenga JB, Bangsberg DR, Singh S, Rachlis B, Wu P, et al. Adherence to HAART: A Systematic Review of Developed and Developing Nation Patient-Reported Barriers and Facilitators. In Ontario HIV Treatment Network. November 2006. Minnar A, Bodkin C. Guide for HIV and AIDS Nursing Care. South Africa: Juta and Company Limited. 2006. Safren, SA. Adherence Counseling for Counselors. Manual: HPTN052/ACTG5175. Contact Information: [email protected]. Accessed July 28, 2009 at: http://www.hptn.org/Web%20Documents/HPTN052/ FINALCOUNESLORADHERENCEMANUAL.pdf.

Weiser S, Wolfe W, Bangsberg D, Thior I, Gilbert P, Makhema J, et al. Barriers to Antiretroviral Adherence for Patients Living with HIV Infection and AIDS in Botswana. InJ Ackuir DeficSyndr. 2003 Nov 1;34(3):281–288. Whitelock EP, Orleans CT, Pender N, Allan J. Evaluating Primary Care Behavioral Counseling Interventions: An Evidence-Based Approach. InAmJ Prev Med. 2002;22:267–284.

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Glossary of Terms Adherence

The client’s ability to stick to or maintain an ART regimen. It involves taking medications in the correct amounts, at the correct times, and in the ways they are prescribed.

Adherence to care

The extent to which a person’s behavior-e.g., taking medication, following a diet, and/or executing lifestyle changes—corresponds with the recommendations of a health care provider.

Adherence to treatment

The ability of the client to develop and follow a plan of behavioral and attitudinal change that ultimately serves to empower him/her to improve his/her health and self-manage an illness.

Client

HIV/AIDS patient receiving care.

Dropped

When a client misses appointments over more than three months.

Entry into care

Visit with an HIV care provider authorized to prescribe ART and enrollment into HIV care following the initial HIV diagnosis.

Follow-up

An intentional contact following entry into care. This includes formal appointments, telephone contact, and referrals.

Integration

Combination of related health care services to facilitate continuity of care, improving convenience for the patient. Integration may be functional or structural.

Linkage to care

The period starting with the HIV diagnosis and ending with initial enrollment into HIV care and treatment.

Lost to follow-up (LTFU)

A client who has missed clinic appointments for one month or longer for any reason.

Retention in care

Ensuring that the client continues to receive appropriate services (from both client and provider perspectives) throughout the continuum of HIV care and support.

Stopped treatment

Situation in which the client and the clinician have decided to stop treatment for any reason.

Visit

Client contact with a care provider at an HIV clinic.

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