strategies for improving adherence to ...pra category i credit(s)tm. physicians should claim only...

STRATEGIES FOR IMPROVING ADHERENCE TO LIFELONG ANTIRETROVIRAL TREATMENT

MALLIKA MOOTOO, MDPEDIATRICIAN AND CLINICAL LEAD,POSITIVELY UNITEDTO SUPPORT HUMANITY (PUSH PROJECT)GUYANA

NOVEMBER 7,2019

CME Disclosures: Planning Committee And Speaker

Speaker: The following speaker has nothing to disclose in relation to this activity Mallika Mootoo, MD

Howard UniversityCME Accreditation

Sponsor Accreditation: Howard University Collegeof Medicine is accredited by the Accreditation Council

for Continuing Medical Education to provide continuingmedical education for physicians.

Credits for Physicians: Howard University Collegeof Medicine, Office of Continuing Medical Education,

designates this live activity for a maximum of 1.0 AMAPRA Category I Credit(s)TM . Physicians should claim

only the credit commensurate with the extent of their participation in the activity.

Goulda A. Downer, PHD, RD, LN, CNS – Principal Investigator/Project Director

CME Disclosures: Planning Committee And Speaker

AETC-Capitol Region Telehealth ProjectPlanning Committee: The following committee members have nothing to disclose in relation to this activity:

Goulda A. Downer, PhD, FAND, RD, LN, CNS Dr. Walter P. Bland, Assistant Dean, CMEJohn I. McNeil, MDDenise Bailey, M.EDMarjorie Douglas

Speaker: The following speaker has nothing to disclose in relation to this activity: Mallika Mootoo, MD

Howard University CME Accreditation Requirements For Internet Viewers

Intended Audience: Health service providers: Physicians, Physician Assistants, Nurse Practitioners, Pharmacists,

Dentists, Nurses, Social Workers, Case Managers and other Clinical Personnel.

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GILEAD SCIENCES INC. FUNDING AND DISCLOSURE

“Supported by grant funding from Gilead Sciences, Inc. Gilead Sciences, Inc. has had no input into the development or content of these materials.”

STRATEGIES FOR IMPROVING ADHERENCE TO LIFELONG ANTIRETROVIRAL TREATMENT

LEARNING OBJECTIVES

By the end of this session participants will be able to:

1. Define adherence to ART

2. Recognize the importance of adherence to the 90-90-90 goals

3. Identify barriers to ART adherence in adult and pediatric populations

4. Propose solutions to ART adherence in the Caribbean

WHAT IS ADHERENCE?

ADHERENCE

ØAdherence is defined as the "extent to which a client's behavior coincides with the prescribed health care regimen as agreed through a shared decision-making process between the client and the health care provider" (KITSO Manual, 2004; Carter, 2004).

ØAdherence is an attachment or commitment to a person, cause, or belief.

GLOBAL SUMMARY - 2018

https://www.kff.org/global-health-policy/fact-sheet/the-global-hivaids-epidemic/

GLOBAL SUMMARY

https://www.kff.org/global-health-policy/fact-sheet/the-global-hivaids-epidemic/

CARIBBEAN SUMMARY

Ø In 2018, 72% of people living with HIV in the Caribbean were aware of their HIV status. Of those who were aware:

o 77% were accessing antiretroviral treatment (ART)

o Of those on treatment, 74% were virally suppressed

ØThe annual number of new HIV infections among adults in the Caribbean declined by 18% between 2010 and 2017, and deaths from AIDS-related illness fell by 23%.

HTTPS://WWW.AVERT.ORG/PROFESSIONALS/HIV-AROUND-WORLD/LATIN-AMERICA/OVERVIEWHTTPS://BARBADOSTODAY.BB/2018/12/01/WORLD-AIDS-DAY-2018-MESSAGE-FROM-UNAIDS/

STATUS OF THE HIV EPIDEMIC

A BRIEF REVIEW-THE CARIBBEAN:90-90-90 TARGETS

WHAT IS 90-90-90 TARGETS?

ØThe Joint United Nations Programme on HIV/AIDS (UNAIDS) and partners launched the 90–90–90 targets in 2014.

ØThe aim was to diagnose 90% of all HIV-positive persons, provide antiretroviral therapy (ART) for 90% of those diagnosed, and achieve viral suppression for 90% of those treated by 2020.

90-90-90

STATUS OF 90-90-90

18

90-90-90- BY GENDER

Men

WHERE THE CARIBBEAN STANDS IN 90-90-90

WHY IS ADHERENCE IMPORTANT TO 90-90-90 GOALS?

ØAdherence to ART is essential to ensure viral suppression in HIV patients.

Ø Poor adherence will result in sub therapeutic plasma ARV drug concentrations, which can lead to the development of drug resistance to one or more drugs in a given regimen.

Ø Suboptimal adherence can also limit the options for future effective drug regimens and increase the risk of secondary transmission of drug-resistant virus.

CARIBBEAN ADHERENCE

ØData is limited, although UNAIDS reports overall viral suppression to be 40% in the Caribbean.

Ø In the Caribbean viral suppression ranges from 17% of people on treatment in Jamaica to 43% in Cuba, Dominican Republic and Suriname.

ØKey populations (i.e. LGBT, Sex workers)and young people often face barriers to accessing treatment.

HTTPS://WWW.AVERT.ORG/PROFESSIONALS/HIV-AROUND-WORLD/LATIN-AMERICA/OVERVIEW

RESEARCH ON CARIBBEAN ADHERENCE

Ø In a study conducted among persons from living with HIV in Antigua and Barbuda, Grenada and Trinidad and Tobago,394 respondents, 69.5% were currently taking ART

Ø Of these, 70.1% took 95% to 100% of their prescribed pills

Ø One in 20 took more pills than prescribed, all of whom were prescribed fewer or equal to the median pill number

Ø Factors independently associated with adherence were use of a counselling service, revelation of HIV status without consent, alcohol consumption and side effects

Ø Drug resistance to ART was reported by 6% of users. HTTPS://WESTINDIES.SCIELO.ORG/SCIELO.PHP?PID=S0043-31442011000300005&SCRIPT=SCI_ARTTEXT&TLNG=PT

RESEARCH ON CARIBBEAN ADHERENCEØ Barrow and Barrow (2013) indicated that, once persons have accessed treatment, results are

more positive, with 75% retained in care and 94% of them with viral load suppression.

Ø However, there is some suggestion that “medical fatigue” may be an emerging factor affecting coverage rates.

Ø Data from the HIV treatment database (Barrow 2013) in Jamaica also suggest that attrition rates at 1 year in care are between 10% and 31%.

Ø Many persons diagnosed as HIV positive may not present to treatment programs.

Ø Members of the general public may be less receptive to starting lifelong ART when they show no signs of disease, in contrast, for example, to mothers-to-be who are generally highly motivated to protect their unborn children.

HTTPS://JOURNALS.SAGEPUB.COM/DOI/FULL/10.1177/2325957413511113

ADHERENCE

ØAdherence is dynamic in nature – previously adherent patients can become non-adherent

ØAdherence should be measured at every visit even in patients who are experiencing treatment success

ØAll missed doses should be addressed in a non-judgemental manner

ØEducation on non-adherence and resistance to ARVs is essential before initiation and during treatment.

CASE STUDY #1

Ø JR 43-year-old � patient

ØDiagnosed HIV+ in 2004 at a private medical clinic

ØART Htx: LSN 2005-2018o Atripla: 2018

o TLD: 2019

ØReferred to a Faith-based care and treatment site 2018

ØLabs: Viral Load: 28,910, CD4: 23 c/ul / 1%, Hepatitis C: positive,

ALT: 115, ALT :66, Creatinine :12.9

PATIENT’S BACKGROUND

TREATMENT

ØTreated for OI’s

ØStarted on Atripla, Septrin, Fluconazole, IPT and weekly Azithromycin

ØCondition deteriorated ( weight loss, recurrent candida)

INTERVENTIONS

ØCase discussion with medical team: Possible resistance to Atripla after unmonitored treatment with LSN

ØAdherence counseling done non-adherence denied

ØChange regimen to INSTI based regimen

ØEngage partner in treatment support

PATIENT FOLLOW-UP CARE

ØAfter 2 months weight loss continued, oral candidiasis still present

ØNon-Adherence denied

ØDecision made with partner to hospitalize JR for one week

ØClinic Nurse did DOTS with patient during hospitalization

ØCandida improved and appetite increased

ØCounseling was done daily during hospitalization

INTERVENTIONS TO IMPROVE ADHERENCE

ØOn discharge from hospital a strategy to improve adherence was implemented:

Ø JR’s son would do Directly Observed Treatment Support (DOTS) with his mother and would take her pill box to the clinic to be filled weekly.

Ø JR’s partner would call her every day to ensure that she had taken her pills

ØThe nursing staff at the clinic would use What’s App to contact JR daily to offer encouragement and support.

ØAt every clinic visit counseling was done

CASE 1 - OUTCOME

ØAugust 2019 VL:<20 copies.

Ø JR continues to gain weight and is enjoying a better quality of life.

ØBoth her partner and son are engaged in her care.

ØAdherence counseling continues at every visit.

BARRIERS TO ADHERENCE

ØLack of support and encouragement

ØStigma of HIV

ØNegative perception of medications/ART

ØComplicated regimens/Pill Burden

STRATEGIES USED TO IMPROVE ADHERENCE

ØFamily Involvement

ØCounseling at every visit

ØHospitalization

ØDOTS

ØPill box

ØDaily calls/messages by clinic staff to encourage

ADHERENCE IS COMPLEX AND MULTI-FACTORIAL

ADHERENCE ASSESSMENT

ØPotential barriers to adherence should be assessed and discussed before therapy is initiated or changed.

ØSocial, behavioral and medical factors that may influence adherence should be assessed.

ØDiscuss potential adverse effects of ARVs.

ØAssess for acceptance of diagnosis.

ADHERENCE ISSUES SPECIFIC TO CHILDREN

ØDependence on Caregiver

o Caregiver’s understanding of ARVs, adherence and resistance

o Caregiver’s dedication

ØPalatability of formulations

ØLimited availability of once daily regimens

ØLack of Disclosure

BARRIERS TO ART ADHERENCE

ØNon-Disclosure to partner/family

ØNew partner

ØChange in schedule

ØTravel

ØToxicities

ØDepression

ØAlcohol/substance abuse

ØPill burden

ØForgetfulness

ASSESSING AND COUNSELING IN ADHERENCE TO ART

METHODS OF MEASURING ADHERENCE (1)

Ø Self-reporting

Ø Pill counts

Ø Pharmacy records

Ø Provider estimate

Ø Pill identification test

Ø Electronic devices—MEMS

Ø Biological markers—Viral load

Ø Measuring medicine levels—TDM

METHODS OF MEASURING ADHERENCE (2)

Method Advantages Disadvantages Potential Bias

Physician’s assessment

§Simple, cheap, requires no structured tool

§Subjective, inaccurate: estimates affected by doctor-patient relationship

§No particular bias§Study showed correct est. in only 40%

Patient self-report § Simple, cheap, qualitative assessment possible

§Subjective, inaccurate: poor patient recall, lack of candor

§ Overestimates adherence

§ Most widely used currently

Pill counts § Simple, cheap, objective

§Pill dumping, pill sharing, timing of doses unknown, bottles needed

§ Overestimates adherence

METHODS OF MEASURING ADHERENCE (3)

Method Advantages Disadvantages Potential BiasPharmacy refill records

§Objective §Pill dumping, pill sharing, timing of doses unknown; good records, patient tracking, and overtime needed

§Overestimates adherence

Drug level monitoring

§Objective §Expensive, requires lab, invasive, unknown timing of doses; PK profile of population needed

§Can over- or underestimate depending on behavior immediately prior to test; genetic variations in drug metabolism

Electronic drug monitoring (EDM)

§Objective, data on timing of doses, monitoring over longer periods

§Pill dumping, pill sharing, timing of doses unknown

§Underestimates adherence; taking out multiple doses for later use

ADHERENCE COUNSELING: MULTIDISCIPLINARY TEAM

Same message from all!

Adherence message for the

client/patient

DoctorsAdherence

nurse

Pharmacist Family and friends

Counselor Social worker

Source: Horizons/Population Council, International Centre for Reproductive Health, and Coast Provincial General Hospital, Mombasa, Kenya. 2004. Adherence to Antiretroviral Therapy in Adults: A Guide for Trainers. Nairobi: Population Council.

ADHERENCE COUNSELING: PURPOSE

ØHelp clients/patients develop an understanding of their treatment and its challenges.

ØPrepare clients/patients to initiate treatment.

ØProvide ongoing support for clients/patients to adhere to treatment over the long term.

ØHelp clients/patients develop good treatment-taking behavior.

ØHelp clients/patients set goals for their treatment.

ADHERENCE COUNSELING: NATURE

ØNeeds to occur before and be ongoing throughout treatment period sessions.

Ø Involves highly personal and intimate matters and behavior.ØRequires recognition of barriers to and challenges of

adherence. ØNeeds reinforcement or constructive intervention as

appropriate.ØAvoids negative-messaging, judgmental attitudes, and “pill

policing.ӯEncourages participation by family and friends.

SLEPTIN

AWAYFROM HOME

RAN OUT OF PILLS

FELT ILL FELT BETTER

PILLS DO NOT HELP

FEAR SIDE EFFECTS

DID NOT WANT

OTHERS TO SEE

FAMILY SAID NO TO MEDICATION FORGOT or

TOO BUSY

DID NOT UNDERSTAND

INSTRUCTIONS

MISSED DOSES

WHAT TO DO?

TAKING PILL HOLIDAYS

UNABLE TO CARE FOR

SELF

• No double dose

• Within 3 hours, take the missed dose

• If >3 hours, go for the next

COUNSELING FOR ADHERENCE PROBLEMS

WENT FOR PRAYERS AND GOT CURED

RECAP ON ADHERENCE TO ART

Ø Excellent adherence is key to successful ART programs.Ø The consequences of poor adherence are poor health

outcomes and increased health care costs.Ø Adherence is a dynamic process that needs to be followed

up.Ø Client/patient-tailored innovative interventions are required

and must fit into the sociocultural context of each setting.Ø Family, friends, and community are key factors in improving

adherence.Ø A multidisciplinary approach toward adherence is needed.

STRATEGIES AND INTERVENTIONS for ADHERENCE

INITIAL STRATEGIES TO IMPROVE ADHERENCE

Ø Establish trust and identify mutually acceptable goals for care.

Ø Client must be involved in the decision for the need of treatment and adherence.

Ø Identify depression, substance abuse, or other mental health issues in the client and/or the caregiver that may affect adherence. o Evaluate and initiate treatment for

mental health issues before starting ARV drugs, if possible.

Ø Identify a support person/team.Ø Educate the patient/family /support

person about the role of adherence to ARVs in treatment in outcomes.

Ø Educate on the relationship between partial adherence and resistance and the potential impact on future drug regimen choices.

Ø Develop a treatment plan that the patient and family understand and to which they feel committed.

STRATEGIES TO IMPROVE ADHERENCE

ØSimplify the regimen

ØDecrease pill burden

ØChoose the regimen with the fewest AEs

ØChoose the more palatable formulations for children

ØConsider drug-drug interactions with other medications

STRATEGIES TO IMPROVE ADHERENCE

Ø Have more than one member of the multidisciplinary team monitor adherence at each visit and in between visits by telephone, text, what’s app as needed.

Ø Provide ongoing support, encouragement, and understanding of the difficulties associated with maintaining adherence to daily medication regimens.

Ø Provide ongoing patient education of medication, HIV. Ø Use reward system to encourage children, stickers, lucky-dip, Ø Encourage use of pill boxes, reminders, mobile apps, alarms, and timers.Ø Provide access to support groups or peer groups for caregivers and patients.Ø Consider DOT at home, in the clinic, or in certain circumstances, such as

during a brief inpatient hospitalization.

ASSESSING EFFECTS OF INTERVENTIONS

ØOnce an intervention is implemented, it must be assessed to see if it has yielded the desired outcome.

ØThe HCP should assess 1-2 weeks after intervention was discussedo Was it implemented

o Did adherence improve

ØMonitor improvement in adherence with VL.

ASSESSING EFFECTS OF INTERVENTIONS

Ø If still non-adherent

o Work with patient and team to find another strategy that may work better.

ØVL still detectable but adherent

o Consider resistance testing.

CASE STUDY # 2

ØCO is a 3 ½-year-old � child born to a HIV+ mother.

ØMother attended PMTCT clinic during pregnancy.

ØChild’s DNA-PCR test HIV- at birth and 4 months

ØMother and child defaulted from care in 6th month.

ØReturned to care when child was 21 months.

ØChild malnourished, with oral candidiasis, muscle wasting.

ØHIV +

PATIENT’S BACKGROUND

TREATMENT

ØMother counseled on child’s diagnosis and on ART for child

ØEncouraged to bring child’s father for testing.

ØChild started on ART: Lamivudine, Abacavir and Lopinavir/ritonavir.

ØBaseline VL: 5,642,820; CD4:157/2% o Weight: 9.1kg

PATIENT FOLLOW-UP (THREE MONTHS)

Ø Three months later:

o Father has not come for testing.

o Calls to fathers alleged number proved futile.

o Child’s physical condition not improving.

o VL:3,562,298.

o Adherence counseling with clinic nurse reveals child is vomiting with LPV/r.

o LPV/r stopped NVP started.

PATIENT FOLLOW-UP ( SIX MONTHS)

ØSix months later:

o Father still hasn’t come to clinic VL: 1.

o Child’s condition very slightly improved.

o ,970,565.

o Mother is counseled by counselor, nurse and physician, she reveals that father does not know her nor child’s status.

o She does not give the medication if father is at home.

o Father is the sole bread winner in the family, she is scared he may leave if he knows the truth.

INTERVENTIONS

ØClinical Team works together with mother to encourage father to come for testing and counseling.

ØMother discloses to father in presence of social worker and nurse.

ØFather tests HIV+.

ØFather and mother are counseled.

INTERVENTIONS

ØChild still not gaining weight after more than 12 months on ART.

ØPediatric Nurse counsels’ mother regarding medication regimen, dosage delivery mode.

ØMother does not like giving the child the medication, because seeing him take them reminds her that she infected the child.

ØMother is referred for counseling.

ØPediatric Nurse does DOTS for child.

ØChild does not take medication willingly. Nurse employs reward system (stickers, fruit, candy) to encourage child.

INTERVENTIONS

ØDOTS is continued for 6 months VL:1,196,650.

ØCase discussion with medical team: Possible NVP resistance

ØRegimen change to INSTI.

ØOne month after regimen change weight gain and increased appetite and activity is noticed.

ØThree months later: weight gain continues, child is able to attend nursery school. Both mother and child have pill boxes filled weekly. Father has started ART.

BARRIERS TO ADHERENCE

ØMother’s Guilt

ØSide Effects of ART

ØViral Load

STRATEGIES USED TO IMPROVE ADHERENCE

ØAssisted Disclosure to partner

ØMultidisciplinary Approach to counseling for mother

ØRegimen Change

ØDOTS/Pill box

ØFamily centered care and treatment

SUMMARY

ØOur patients face multiple barriers to adherence, and no single intervention will be sufficient to ensure that the high levels of adherence needed for virological suppression are sustained.

ØFor better adherence and higher rates of viral suppression, health providers should consider a more structured multidisciplinary approach that first identifies patients at risk of poor adherence and then seeks to establish the support that is needed to overcome the most important barriers to adherence.

REFERENCES

1. Joint United Nations Programme on HIV/AIDS, Joint United Nations Programme on HIV/Aids. 90-90-90: an ambitious treatment target to help end the AIDS epidemic. Geneva: UNAIDS (2014).

2. Patient-Reported Barriers to Adherence to Antiretroviral Therapy: A Systematic Review and Meta-Analysis

Zara Shubber, Edward J. Mills, Jean B. Nachega et al

3. Adherence to antiretroviral therapy and factors affecting low medication adherence among incident HIV-infected individuals during 2009–2016: A nationwide study

Jungmee Kim, Eunyoung Lee,

4.Predictors of non-adherence to antiretroviral therapy among HIV infected patients in northern Tanzania

Seleman Khamis Semvua , Catherine Orrell, Blandina Theophil Mmbaga,Hadija Hamis Semvua,John A. Bartlett, Andrew A. Boulle

5.Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection : AidsInfo.

6. Evaluating Adherence to Antiretroviral Therapy and Managing the suboptimally adherent patient

https://www.infectiousdiseaseadvisor.com › ... › Infectious Diseases

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