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