Transcript Adapting an evidence-based adherence intervention to China

Adapting and pilot testing an
evidence-based ARV adherence
intervention for China
Ann B. Williams, Honghong Wang, Xianhong Li, Kris Fennie, Jane Burgess
UCLA School of Nursing & Xiangya School of Nursing
Los Angeles, California, U.S.A. & Changsha, Hunan, China
HIV/AIDS Medication Adherence
Challenges
• Lifetime duration of treatment
• Frequent (& serious) adverse drug effects
• AIDS stigma
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Adherence required…
…and adherence achieved
• In order to achieve the
optimal virologic,
immunologic, and clinical
outcomes possible with
HAART, the level of
adherence required is
over 90%. (Bartlett, 2002;
Paterson et al., 2000; Singh et al.,
• Only 6% of patients report
full adherence, with a
mean level of 56%
adherence. (Murphy et al., 2003)
• Adherence may be the
variable determining
HAART failure or success.
(Knobel et al., 1999)
1999)
• While patients report a
preference for once-a-day
• This is the equivalent of
dosing, research suggests
missing 1 dose per month
adherence rates are no
on a once-a-day regimen.
better for QD dosing. (Stone
et al., 2004)
3
Emerging Resistance
PROBABILITY
OF SELECTING FOR
RESISTANT STRAINS
MOST DANGEROUS PLACE:
PARTIAL SUPPRESSION
0%
100%
SUPPRESSION OF VIRAL REPLICATION
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Viral
Resistance
PATIENT
ADHERENCE
Systemic drug
concentration
Effective
drug potency
Intracellular
drug
concentration
Viral
Virulence
PRESERVATION
OF IMMUNE
FUNCTION
Rate
AND
of viral
DELAY IN
replication
DEISEASE
PROGRESSION
Host
Factors
Pharmacokinetics
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Background: ATHENA Intervention
• A home-based
adherence
intervention delivered
by a nurse and peer
educator team.
• Demonstrated
efficacy in the
northeastern U.S. in a
randomized controlled
trial.
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Clinician
Characteristics
Patient
Characteristics
Adherence
Regimen
Characteristics
Illness
Characteristics
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A focus limited to personal behavior
change leads to a programmatic
emphasis on individual responsibility for
health, at the cost of an examination of
individual response-ability, or the
capacity of the individual for responding
to his or her personal needs or the
challenges posed by the environment.
Meredith Minkler
Health education,
health promotion and
the open society: An
historical perspective.
HEQ, 16: 17-30, 1989 8
Social
Context
Patient
Characteristics
Clinician
Characteristics
Adherence
Regimen
Characteristics
Illness
Characteristics
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Intervention
•Home visit by a peer counsellor and a
nurse
• Once a week, first 3 months
• Bi-weekly, months 4-6
• Once a month, months 7-12
• Visits last 15 minutes to one hour
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Results
Selected characteristics of ATHENA participants at baseline*
Total
N=171
%
Gender
Total
N=171
%
Substance Use1
Male
88
51.5
Current
Female
82
48.0
Past history
1
0.5
Native Am
3
1.8
African-Am
59
34.5
Caucasian
72
42.1
Hispanic
32
18.7
Other
4
Declined
1
Transgendered
Race/Ethnicity
54
32
155
91
1Does
not include EtOH;
includes marijuana
Median
(N)
Age
46.8
(171)
2.3
Viral Load
400
(171)
0.6
CD4
354
(170)
*These characteristics did not differ significantly between the
intervention and control groups.
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Results
Subjects with ≥ 90% adherence
Control
Intervention
45
40
Percent
35
30
25
20
15
10
5
0
33
79
42%
33
82
40%
Baseline
18
68
27%
24
64
38%
3
14
64
22%
24
66
36%
14
60
23%
6
19
60
32%
9
12
54
22%
19
61
31%
12
9
37
24%
16
44
36%
15
Months
A greater proportion of subjects in the intervention group had adherence
greater than 90% at each time point compared to the control group. The
difference over time is significant (Extended Mantel-Haenszel Test: 5.80,
p=.02)
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Summary Results
• The intervention group maintained a higher
proportion of subjects with adherence
greater than 90% over time compared to the
control group (p=.02).
• A statistically significant intervention effect
on viral load or CD4+ count was not seen.
• There was an statistically signifcant
association between >90% adherence and an
undetectable viral load over time (p<.03).
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Conclusions
• Home visits from a nurse and peer
counselor significantly improved
medication adherence compared to
usual care.
• The proportion of individuals with
medication adherence >90% was
unacceptably low in both control and
experimental groups.
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ATHENA to Ai Sheng Nuo
Reaching around the Globe
Nurses working together to help patients take lifesaving medication
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Purpose
• To adapt the ATHENA intervention to the
social and cultural context of Hunan
Province
• To conduct a pilot test of the adapted
intervention
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HIV/AIDS in Hunan Province
• HIV/AIDS cases reported through 2010: 10,794
• Patients are:
– Rural
– Poor
– High prevalence of IDU (40% of PLWHA)
Reported HIV infections and AIDS cases in
Hunan Province
1600
1400
1200
Number of HIV
Infections
Number of
AIDS Cases
1000
800
600
400
200
0
1992
1995
1998
2001
2004
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HIV/AIDS in Hunan Province
• Free treatment (ARVs) is
available
• Medication adherence is
a challenge
• Evidence-based
interventions to support
adherence are limited
and were developed for
use in different social,
cultural, and economic
environments.
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Adaptation Framework
• The ADAPT-ITT Model
– 8 sequential steps
– Qualitative and quantitative data
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Step 1: Assessment
• Cross sectional survey
– 7 China CARES sites
– 308 respondents
• 20% reported <90% adherence
• Associated with current heroin use
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Step 1: Assessment
• Qualitative data
– Stigma
– Family relationships and responsibility
– Guilt
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Step 2: Choosing ATHENA
• Freirian philosophy
– Well suited to Chinese
culture
– Emphasizes
community context
– Known in China
Process
Action
Reflection
Action
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Step 3 and 4
Administration
• Demonstrating the
intervention
• Reviewing original
manuals
• Consider applicability
to Hunan context
Production
• Identify core elements
– Peer educators
– Dialogue
– Reflection
• Produce plan for
adaptation
– Emphasis on family
– Group activities
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Step 5: Expert review
• PLWHA, families, and HCWs reviewed proposed
intervention
• Concerns: Risk for disclosure & stigma
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Step 6: Integration
ATHENA to Ai Sheng Nuo
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Love, Life, Promise
• Ai Sheng Nuo
– Family emphasis
– Decreased frequency
of home visits
– More structured
patient education
– Option for group
activities
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Step 7: Training & developing manual
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Step 8: Pilot testing
Methods
• Randomized controlled pilot
– July 2010 – August 2012
• Randomized to intervention or control
– Intervention: Monthly visits and interim phone
contact plus standard clinic support
– Control: Standard clinic support
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Study Sites: Hunan Province
• 11th largest province of China,
situated in the southeast.
• Commercial sex work and
injection drug use are highly
prevalent.
• Two clinical sites, in Hengyang
City and Changsha.
• Comprehensive evaluation and
ARV when indicated.
• However, mental health
screening and treatment are
not routinely available.
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Pilot study: Subjects
Eligibility
• Living with HIV/AIDS
• Attending one of the two clinical sites
• Self-reporting adherence <90% to
prescribed ARVs or to pre-ARV
medications (TMP-SMX, multi vitamins)
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Pilot study: Measures
• A 7-day visual analogue scale
• Social Support Rating Scale
• Center for Epidemiological Studies
Depression Scale (Chinese)
• HIV/AIDS Related Stigma Scale.
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Pilot study: Data collection
• Data were collected in structured face-toface interviews conducted at the time of a
regularly scheduled clinical visit.
• Information regarding ARV regimen,
treatment duration, time of diagnosis, CD4
count and HIV-RNA from medical record
review.
• Baseline, 6 months, 12 months
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Results: Subjects
N = 114
ARV status at baseline
• 57 reporting <90% adherence to pre-ARV meds
• 57 reporting <90% adherence to ARV
Presumed HIV transmission routes
–
–
–
–
–
36%
40%
11%
2%
11%
IDU
Heterosexual contact
MTM sexual contact
Transfusion
Unclear
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Results: Subjects
Male:
Female:
Age
< 30
30 – 45
> 45
Married
High school or college
Stably Employed
82 (72%)
32 (28%)
32 (28%)
57 (50%)
25 (22%)
59 (52%)
46 (40%)
32 (28%)
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Results: Subjects
• Past or current drug abuse
35 (31%)
• Has disclosed HIV status
84 (75%)
• 2 years or less since diagnosis
90 (82%)
• CD4 <350 cells/mm3
87 (98%)
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Results: Subjects
• ARV regimens
•
•
•
•
AZT + 3TC + NVP or EFV
D4T + 3TC + NVP or EFV
AZT + LPV/r + 3TC
LPV/r + TDF + 3TC
36
Depressive symptoms at baseline
• 66% scored 16 or greater on the CESD-C
• Those in the ARV prep treatment stage were
more likely to report significant depressive
symptomatology than those for whom ARV
had already been prescribed.
(OR = 2.84, 95% CI 1.26, 6.38; p = 0.01)
37
Factors independently associated
with depressive symptoms
• History of drug use
OR 4.10 (1.11, 15.15) p=.03
• High perception of stigma
1.06 (1.02, 1.09) p=.001
• Lack of stable employment
3.23 (1.01, 10.00) p=.05
• Lack of social support
1.10 (1.03, 1.19) p=.02
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Results
Subjects with > 90% adherence
Percent
Control
Intervention
100
90
80
70
60
50
40
30
20
10
0
Baseline
6
12
Months
A greater proportion of subjects in the intervention group had adherence
greater than 90% at both time points compared to the control group. The
difference over time is significant (Extended Mantel-Haenszel Test: 8.8,
p=.003)
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Pilot Test
• Biological measures:
– No difference between groups:
• Quantitative HIV-RNA
• CD4 counts
– Results of ARV resistance studies
• No resistance at baseline by standard genotype
• Ultra Deep Sequencing ongoing
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Other findings
• Adherence barriers identified:
– Medication side effects
– Fear of disclosure
– Knowledge deficits
– Poor family relationships
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Conclusions
• Structured approach facilitates adaptation of
evidence based interventions.
• In spite of significant cultural differences,
adaptation is possible.
• Key barriers to ARV adherence appear to be
universal.
• Strategies to improve adherence may differ
somewhat, but home based interventions are
effective.
42
Future Directions
• Logistics: Mobile communication
technology.
• Content: address mental health issues,
especially depression.
• Cost of intervention.
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