adapting and pilot testing an evidence-based arv adherence intervention for china ann b. williams,...
TRANSCRIPT
Adapting and pilot testing an evidence-based ARV adherence
intervention for ChinaAnn B. Williams, Honghong Wang, Xianhong Li, Kris Fennie, Jane Burgess
UCLA School of Nursing & Xiangya School of NursingLos Angeles, California, U.S.A. & Changsha, Hunan, China
2
HIV/AIDS Medication Adherence Challenges
• Lifetime duration of treatment
• Frequent (& serious) adverse drug effects
• AIDS stigma
3
Adherence required…
• 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.,
1999)
• This is the equivalent of missing 1 dose per month on a once-a-day regimen.
• 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)
• While patients report a preference for once-a-day dosing, research suggests adherence rates are no better for QD dosing. (Stone et al., 2004)
…and adherence achieved
4
Emerging Resistance
PROBABILITYOF SELECTING FORRESISTANT STRAINS
SUPPRESSION OF VIRAL REPLICATION
0% 100%
MOST DANGEROUS PLACE:PARTIAL SUPPRESSION
5
PATIENTADHERENCE
Systemic drugconcentration
Pharmacokinetics
ViralResistance
Effectivedrug potency
Intracellulardrug
concentration
Rateof viral
replication
PRESERVATIONOF IMMUNEFUNCTION
ANDDELAY INDEISEASE
PROGRESSION
HostFactors
ViralVirulence
6
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.
7
ClinicianCharacteristics
Adherence
IllnessCharacteristics
PatientCharacteristics
RegimenCharacteristics
8
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
9
ClinicianCharacteristics
Adherence
IllnessCharacteristics
PatientCharacteristics
RegimenCharacteristics
SocialContext
10
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
11
Results
TotalN=171
%
Gender
Male 88 51.5
Female 82 48.0
Transgendered 1 0.5
Race/Ethnicity
Native Am 3 1.8
African-Am 59 34.5
Caucasian 72 42.1
Hispanic 32 18.7
Other 4 2.3
Declined 1 0.6
Median (N)
Age 46.8 (171)
Viral Load 400 (171)
CD4 354 (170)
Selected characteristics of ATHENA participants at baseline*
*These characteristics did not differ significantly between the intervention and control groups.
TotalN=171
%
Substance Use1
Current 54 32
Past history 155 911Does not include EtOH; includes marijuana
12
ResultsSubjects with ≥ 90% adherence
0
5
10
15
20
25
30
35
40
45
Baseline 3 6 9 12 15
Months
Pe
rce
nt
Control Intervention
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)
33 79 42%
33 8240%
12 54 22%
9 37 24%
19 6131%
16 44 36%
19 60 32%
24 66 36%
24 6438%
18 68 27%
14 64 22%
14 60 23%
13
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).
14
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.
15
ATHENA to Ai Sheng NuoReaching around the Globe
Nurses working together to help patients take lifesaving medication
16
Purpose
• To adapt the ATHENA intervention to the social and cultural context of Hunan Province
• To conduct a pilot test of the adapted intervention
17
• 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
0
200
400
600
800
1000
1200
1400
1600
1992 1995 1998 2001 2004
Number of HIVInfectionsNumber ofAIDS Cases
HIV/AIDS in Hunan Province
18
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.
19
Adaptation Framework
• The ADAPT-ITT Model
– 8 sequential steps– Qualitative and quantitative data
20
Step 1: Assessment
• Cross sectional survey– 7 China CARES sites– 308 respondents
• 20% reported <90% adherence• Associated with current heroin use
21
Step 1: Assessment
• Qualitative data
– Stigma– Family relationships and responsibility– Guilt
22
Step 2: Choosing ATHENA
• Freirian philosophy – Well suited to Chinese
culture– Emphasizes
community context– Known in China
Process
Action
Reflection
Action
23
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
24
Step 5: Expert review
• PLWHA, families, and HCWs reviewed proposed intervention
• Concerns: Risk for disclosure & stigma
25
Step 6: IntegrationATHENA to Ai Sheng Nuo
26
Love, Life, Promise
• Ai Sheng Nuo– Family emphasis– Decreased frequency
of home visits– More structured
patient education– Option for group
activities
27
Step 7: Training & developing manual
28
Step 8: Pilot testingMethods
• 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
29
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.
30
Pilot study: SubjectsEligibility
• 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)
31
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.
32
Pilot study: Data collection
• Data were collected in structured face-to-face 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
33
Results: SubjectsN = 114
ARV status at baseline• 57 reporting <90% adherence to pre-ARV meds• 57 reporting <90% adherence to ARV
Presumed HIV transmission routes– 36% IDU– 40% Heterosexual contact– 11% MTM sexual contact– 2% Transfusion– 11% Unclear
34
Results: Subjects
Male: 82 (72%)
Female: 32 (28%)
Age
< 30 32 (28%)
30 – 45 57 (50%)
> 45 25 (22%)
Married 59 (52%)
High school or college 46 (40%)
Stably Employed 32 (28%)
35
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%)
36
Results: Subjects
• ARV regimens
• AZT + 3TC + NVP or EFV• D4T + 3TC + NVP or EFV• AZT + LPV/r + 3TC• LPV/r + TDF + 3TC
37
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)
38
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
39
ResultsSubjects with > 90% adherence
0
10
20
30
4050
60
70
80
90
100
Baseline 6 12
Months
Pe
rce
nt
Control Intervention
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)
40
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
41
Other findings
• Adherence barriers identified:– Medication side effects– Fear of disclosure– Knowledge deficits– Poor family relationships
42
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.
43
Future Directions
• Logistics: Mobile communication technology.
• Content: address mental health issues, especially depression.
• Cost of intervention.