Assessing Your Clients for Adherence:

A Real World Approach

Sharon Mannheimer, MD

Harlem Hospital Center

Treatment Adherence Network Meeting

February 27, 2001

Adherence

• A complex behavioral process • involving progression through

various stages • working toward the goal of

maintaining 100% adherence with all doses all of the time

• ultimate goal of improved quality of life and survival

It is difficult to identify who will and won’t adhere to

medications

• No test available

• No single patient characteristic 100% predictive

• Physicians are poor predictors

Assessing for adherence

• complex

• involves assessing clients’ progression toward full adherence to therapy

• as well as assessing for a variety of barriers known to be associated with poorer adherence

Steps Toward Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take and adhere to ART

3. Maintenance of adherent behavior

Adherence Behavior: Theoretical models

• Theoretical models can provide a framework for assessing for behaviors such as adherence– Health Belief Model– Prochaska’s Transtheoretical Model of

Change (TTM or TMC)– Information, Motivation and Behavioral

Skills (IMB)

Assessing Clients’ Progression Toward

Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take ART

3. Maintenance of adherent behavior

Assessing for Acceptance of ART

1. Ask the patient – e.g., “Do you feel that you can take HIV

medications two times a day, every day?”

2. Assess for barriers to acceptance– recent HIV diagnosis– denial of diagnosis– lack of knowledge – lack of trust in provider – lack of trust in medications– beliefs

A O R p value

Acceptance

TRUST in Physician Scale 0.08 <0.0001 MISTRUST Medications 0.30 <0.001

* There is an 8% increase in adherence for each unit increase in the 11-55 item Trust in Physician Scale

Acceptance of and Adherence to ARTImportance of Trust

Altice, et al. 4th Conf. onRetrovirus and OIs, 1997

Assessing Clients’ Progression Toward

Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take ART

3. Maintenance of adherent behavior

Assessing client’s ability to take & adhere to ART

Assess for:

1. Barriers to adherence

2. Motivation for adherence

3. Skills needed for adherence

Assessing Barriers to Adherence:

Adherence barriers can be classified as being related to:

• Patient characteristics• Provider• Treatment regimen• Clinic/office characteristics• Disease characteristics

Patient characteristics associated with

lower adherence levels• Demographics

– African American race

• Social/environmental:– Lack of insurance or access– Active substance use – Homelessness – Poor social support– Doubt efficacy of medication– Confidentiality concerns

Patient characteristics -2 • Lack of Knowledge

– HIV treatment regimen – CD4– Resistance

• Psychological factors• beliefs:

– Poor self-efficacy– 2 aspects of the Health Belief Model [Becker 1974]:

1) having greater perceived benefits from therapy

2) having fewer perceived barriers to treatment

Race and Adherence

• Lower adherence rates noted among African Americans in several studies– Ostrow. 8th CROI 2001; Mannheimer, XIII Int’l AIDS Conf. 2000;

Gifford, JAIDS 2000; Kleeberger, XIII Int’l AIDS Conf. 2000; Singh, Clin Infect Dis1999; Wenger, 6th CROI 1999; Muma, AIDS Care 1995; Moore, NEJM 1994; Besch, Int’l AIDS Conf. 1992

• independent of education and drug use history in some studies

• Nonwhite race may be a marker for other factors such as low literacy

Substance Use (SU) and Adherence

Mannheimer, et al, HATS data 2/01, updated from Durban N= 164

p = .005

0

10

20

30

40

50

60

70

80

90

100

Active SU No active SU

Mean AdherenceLevel, %

Substance Use & Adherence - 2HATS data 2/01

• Active substance users were:– less likely to report 100% adherence (p = 0.06)

– less likely to report > 90% adherence (p < .04)

– less likely to believe that ART was helpful in fighting HIV (fewer perceived benefits) (p = .03)

– more likely to report stressful life events

(p = .02)

Active Substance Use and HIV RNA

(HATS data 2/01, N = 164)

p < .05

05

101520253035404550

Active SU No active SU

% with nondetectable(<400) HIV RNA

Social support and adherenceGifford, et al. JAIDS 2000

N = 133

0

10

20

30

40

50

60

70

<80% 80-99% 100%

% of pts reportingthey had support forusing medications

Adherence OR p value

SOCIAL ISOLATION 0.08 0.0001

SIDE EFFECTS 0.09 0.0001

COMPLEXITYof Antiretroviral Regimen 0.33 0.01

Barriers to Adherence to ART

Altice, et al. 4th Conf. onRetrovirus and OIs, 1997

Psychological factors• Depression

(Singh 1996, Broers 1994, Burack 1993)

• Active psychiatric illness (Paterson Ann Intern Med 2000)

• Stress(Gifford 2000, Singh 1996)

• Poor coping skills (Singh 1996)

• HIV “burnout”(Ostrow 8th CROI 2001)

Provider-related barriers to adherence

• Mistrust of provider

• Provider’s interpersonal skills

• Provider’s experience/expertise

(N=886)

Predictors of Adherence Montessori, et al (CROI 2000)

Variable AOR CI

Male 1.96 1.28 - 3.01Increased age (@10 yr) 1.33 1.2 - 1.57AIDS at baseline 2.28 1.44 - 3.61Physician experience 1.45 1.20 - 1.74 (per 100 pts)History IDU 0.50 0.36 - 0.71

Medication-related barriers to adherence

• fit with lifestyle

• complexity / pill burden

• dose frequency

• side effects

• duration

Correlation With How Well Regimen Fits Patients’ Daily Life*

(N = 1910)70

60

50

40

30

20

10

0

% of PatientsAdherent to

Therapy†

*P < .001.† Patients who reported no missed doses in the past week.

Wenger et al., 6th Conf. on Retroviruses and OIs; 1999

Not at all well

A little bit

Somewhat

Very well

Extremely well

Patients responded that

regimen fits in:

Fit with daily activities and Adherence

Gifford, et al. JAIDS 2000N = 133

0

10

20

30

40

50

60

70

<80% 80-99% 100%

% reporting thatregimen fits well withdaily activities

Perceived fit and HIV RNAGifford JAIDS 2000

Patients having a good perceived fit of their regimens with their routine and daily activities (“high regimen convenience scores”) had lower viral loads (1.04 log copies/mL lower) than persons having “low regimen convenience scores”

Virologic response by pill burden

Bartlettt J. XIII IAC, Durban, 2000. Abstract 4998

Number of antiretroviral pills prescribed per day

90

80

70

60

50

40

30

20

10

05 10 15 20

Pat

ien

ts w

ith

pla

sma

HIV

RN

A

50

co

pie

s/m

l at

48 w

eeks

(%

)

PI

NRTI

NNRTI

(r=–0.57, P=0.0085)

Size of symbol is directly proportional to weight of the data point in the analysis.

Disease-related barriers to adherence

Health Status– AIDS, h/o OI

• (Samet 1992, Singh 1996)

– symptomatic • (Eldred 1997a)

Clinical setting-related barriers to adherence

• long waiting times

• inconvenient clinic hours

• unfriendly staff

• lengthy delays between contact and appointments

• substantial travel costs

Cramer 1991; Cuneo, Clin Chest Med 1989; Haynes 1979

Motivation

• Belief in efficacy of pills– greater perceived benefits from treatment

(Balestra 1996, Eldred 1997, Ferris 1996, Mossar 1993, Muma 1995, Samet 1992, Smith 1997)

• Self-efficacy– Gifford JAIDS 2000; Eldred 1997; Muma AIDS

Care 1995

• Support – Morse 1991

Assess for Behavioral skills helpful with adherence

• Pill taking - difficulty swallowing pills

• keeping to a schedule

• forgetfulness

• use of pillbox

Assessing Clients’ Progression Toward

Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take ART

3. Maintenance of adherent behavior

Adherence Scores Over Time Mannheimer, XIII int’l AIDS conf., 2000

data from 2 large CPCRA clinical trials of ART (N = 732)

0

10

20

30

40

50

60

70

80

1 mo 4 mo 8 mo 12 mo

follow-up visit

10080-1000-80

P < .001 for difference between mos 1 and 4 and mos 1 and 8

Consistency of 100% adherenceand virologic outcome

Mannheimer et al., data from participants in 2 CPCRA ART clinical trials

N = 205

0

10

20

30

40

50

60

70

80

90

0 1 2 3 4

%non-detectable

Number of follow-up visits with self-reported 100% adherence

Assessing for Maintenance of Adherence in the field

• Self-report– nonjudgmental– give permission to “miss”

• Important to assess at every follow-up visit/encounter if possible

• high risk of relapse even if in “maintenance”

• Frequent follow-up

Assessing for consistency of adherence

• Assess Stage of Behavioral Change (Precontemplation, Contemplation, Preparation, Action, Maintenance)– e.g. for Maintenance:

“Have you been taking medications against the HIV/AIDS virus regularly for the last 6 months?”

Correlation of Stage of Behavioral Change

with HIV RNA

N= 1 N=4 N=45 N=34 N=76 p< .001

0

20

40

60

80

100

120

I II III IV V

% of pts withundetectabe HIV RNA(<400 copies/mL)

Summary• Assessing for adherence is complex• Adherence should be assessed

frequently• Involves assessing for:

– acceptance of treatment– barriers to adherence– motivation and behavioral skills for

adherence– stage of behavioral change

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