Transcript Hepatitis C Treatment Decision

Hepatitis C Treatment Decisionmaking among HIV/HCV Co-infected
Adults: A Tale of Two Studies
Outline
0 Discuss the clinical problem of HCV in HIV-infected
patients
0 Summarize the qualitative descriptive study
0 Describe the intervention study (feasibility)
0 Discuss the research challenges
0 Open discussion
The Clinical Problem
0 Patients with HIV living longer
0 Liver-related deaths have increased 4-fold
0 Hepatitis C virus (HCV) infection is one of the major
problems
0 Estimates suggest that 40% - 50% have HCV coinfection
0 Treatment for HCV has improved; but it is not without
significant side effects
0 There are still many patients who have not been
treated for HCV
Study 1:
HCV treatment experiences and decision-making
among patients living with HIV infection
(NINR: R15 NR008341)
0 Purpose: Develop a clear understanding of HIV-
infected patients’ decision-making experiences with
HCV treatment
0 Develop a model to guide the development of an
intervention to support HCV treatment efforts
0 Method: Qualitative descriptive study
0 Interviews conducted before treatment, 8-12 weeks into
treatment, and at treatment completion)
0 Participants who chose not to be treated were interviewed
only once
Study #1:
Inclusion & Measures
0 Inclusion:
0 18 years or older
0 HIV-infected
0 Chronic HCV (detectable HCV VL)
0 Measures
0 Interview Guide
0 Demographics
0 Clinical
0 Symptoms (HIV-SEI) (α= 0.86)
0 Mental Wellbeing(MHI-5) (α= 0.89)
0 Sample
0 N = 39 participants
0 n= 16 HCV treated
0 n= 23 non-treated
Participants
Characteristic
N
%
Gender
Male
Female
21
18
53.8
46.2
Race/Ethnicity
White (non-Hispanic)
Hispanic
African American
19
14
6
48.7
35.9
15.4
Participants
Mean (SD)
Median
Range
Age
45 (5.0)
45
34-56 years
Length of time with HIV
in months
141 (37.2)
(11.8 years)
180
(15 years)
24-288 months
(2-24 years)
CD4 cell count
439 (239.9)
406
19-1056
(11.4% <200)
Participants
Characteristic
N
%
History of Substance Abuse
Yes
No
37
2
94.9
5.1
Active Substance Abuse
Yes
No
6
33
15.4
84.6
Problematic Substances (multiple options possible)
Heroin
Cocaine
Alcohol
Crack
33
30
29
17
84.6
76.9
75.0
43.6
Participants
Characteristic
N
%
Any Mental Illness
Yes
No
34
5
87.2
12.8
Depression
Yes
No
26
13
67.7
33.3
Ever Hospitalized to Treat Mental Illness
Yes
No
10
29
25.6
74.4
History of Suicide Attempt
Yes
No
13
26
33.3
67.7
Taking Mental Health Medications
Yes
No
25
14
64.1
35.9
Participants
Characteristic
N
%
HCV Genotype 1
23
59.0
Participants
Characteristic
HIV Illness Stage
Asymptomatic
Symptomatic
AIDS
On Antiretroviral Therapy
Yes
No
N
%
17
8
14
43.6
20.5
35.9
31
8
79.5
20.5
Results
0 For those who decided to be treated:
0 HCV evaluation and treatment process was conducted
smoothly
0 Successful treatment was facilitated by monitoring for
depression, substance abuse relapse, side effects and
providing considerable support
0 Among the 16 treated participants – only 1 relapse
0 For those who were undecided about treatment:
0 There were a lot of barriers to making an “active”
decision about treatment
0 Many just kept “holding off and not making a decision”
Results
0 6 major themes emerged that were further
categorized into either treatment barriers or
treatment facilitators
0 Treatment Barriers
0 Treatment fears
0 Side effects, liver biopsy, relapse, needle use
0 Vicarious experiences
0 Treatment Facilitators
0 Experience will illness management
0 Patient-provider relationships
0 Gaining sober time
0 Facing treatment head-on
Data Example: Fear
0 “ I’m afraid to put my foot through the door
because the fears that you are going to get sick
from those side effects… then if I look back 6
months, 6 years, saying all that time I was halfstepping, wasting time, and I could have gone
through the door….I just stay standing in that
same place because of that fear that people
never talk about”
Data Example: Fear of needles
0 “Last time I did heroin it was like 10
months ago, and I decided to become
sober – then I built up a fear of needles.
I've gotten to the point where I don’t
even want to touch a needle – it makes
me sick to my stomach…”
Data Example: Vicarious
experiences
0 “ I’m scared of that stuff. I watched [my
partner]; he went through hell; some
days no appetite, he never could sleep,
insomnia was a big thing”
Data example: Facing
treatment head on
0“ I heard horror stories about the
biopsy, the side effects, the effect on
me emotionally, but eventually I goit’s my turn – I ‘m going in like a
soldier.”
Intervention Needed to:
1. REDUCE BARRIERS (fear of side effects, liver bx, needle use, relapse and negative vicarious
experiences)
2. ENHANCE FACILITATORS (prior illness management experiences, positive patientprovider relationships, gaining sober time, facing treatment head-on)
HIV +
Chronic
HCV
HCV treatment
Evaluation
Treatment not
indicated
Close monitoring
Expert clinical care
Expert counseling
Family/friend, peer support
Continue to monitor
Our Thoughts
0 We could adapt a model that we had used successfully
to help women with HIV adjust to chronic illness
(Positive Life Skills Group)
0 Guided by Lazarus & Folkman’s theory of appraisal
centered coping
0 If we could re-frame negative meaning (or appraisal of
illness) plus add social support then we may be able
to improve participants’ active decision-making about
HCV treatment
LEAP-C Group Intervention
Antecedents
Personal
Characteristics
Illness Factors
Resources (or
lack thereof)
Mediating Processes
Appraisal of Illness
Social Support
Outcomes
Effective DecisionMaking
Improved HCV
knowledge
Less decisional
conflict
Improved PatientProvider
Communication
Improved HRQOL
Study #2: Learning Experiencing and
Preparing for Hepatitis C Treatment
(LEAP-C) (NINR R21 NR011132)
0 The purpose of this study was to examine the
feasibility and preliminary efficacy of a group
intervention that:
1. Addresses the barriers to HCV treatment decisionmaking found in the first study
2. Incorporates the facilitators found in the first study
3. Reframes the negative meaning associated with HCV
treatment
4. Provides social support
5. Enhances knowledge about HCV and treatment
6. Enhances patient-provider communication
Study #2:The Aims
0 Feasibility of recruiting and retaining a sample of HIV/HCV
co-infected adults to complete a protocol that involves
randomization into a 4-week group intervention or usual
care and completion of two data collection interviews
(baseline and week 12) and one telephone interview (6
months)
0 Establish the preliminary effects size of the LEAP-C group
intervention on HCV knowledge, decisional conflict,
patient-provider communication, HRQOL, symptom
experience and decision-making engagement
0 Describe the components of the intervention and the usual
care that are most useful for helping HIV/HCV co-infected
patients engage in decision-making about HCV treatment
Methods
0 RCT (feasibility) with qualitative interviews conducted
post data collection with a subset of intervention and
control participants
0 Data collection completed before randomization and at
week 12 (face to face interviews) and brief telephone
interview about decision at 6 months
0 Sample: As recommended by Browne (1995) and Kieser &
Wassmer (1996) a feasibility study with 10-20 participants
per arm is adequate for estimation of variance for planning
a larger clinical trial of up to 250 participants.
0 Therefore, we planned on a sample size of 40 study
participants meeting the inclusion criteria
Inclusion Criteria
0 HIV/HCV co-infected age 18 years of age or older
0 Detectable HCV viral load
0 Willing to be randomized to a 4-week group
intervention or standard of care
0 Absence of severe cognitive impairment (MMSE >23)
0 English Speaking
0 No previous HCV treatment
0 Absence of “medical” contraindications to HCV
treatment
0 Plan to remain within the study region for 6 months
LEAP-C Intervention
Cognitive Re-Framing intervention
0 Four weekly sessions of 90 minutes each lead by a
professional group interventionist
0 Week one –introduction to group process, sobriety and
confidentiality; Identifying barriers and facilitators to HCV
treatment
0 Week two –HCV, HCV treatment, preparing for treatment,
readiness, adherence, managing side effects
0 Week Three – peer educators – living through HCV treatment;
managing substance abuse and mental illness
0 Week Four –working with health care providers,
communication and group debriefing
0 Groups are small (4-6 each) and gender – specific
0 Peer educators with HIV/HCV who have completed
treatment will meet with the group participants
Usual Care
0 Appointment is scheduled with a HCV provider to
receive an initial evaluation and education session
0 Follow up appointments scheduled at the discretion of
that provider (and tracked)
0 Tracking sheet capture the number of appointments and
time spent in those appointments
Measures
0
0
0
0
0
0
0
0
0
0
0
0
0
0
HCV Knowledge Scale
Decisional Conflict Scale (CDS)
Patient-Provider communication scale
Engagement with health care provider scale
Hepatitis Quality of Life Questionnaire version 2
HIV Symptom Experience Inventory
Meaning of Illness Questionnaire
Duke UNC social support questionnaire
Mini Mental Status Exam
Health Care Relationship Trust Scale
Personal characteristics
Illness Factors
Substance abuse history form
Mental illness history form
Participants (N = 39)
Characteristic
N
%
Gender
Male
Female
28
11
71.8
28.2
Race/Ethnicity
White (non-Hispanic)
Hispanic
African American
24
12
3
61.5
30.8
7.7
Participants
Mean (SD)
Median
Range
Age
49.1 (6.5)
49.0
34-59 years
Length of time with HIV
in months
184.9 (81.1)
(15.4 years)
192.0
12-348 months
CD4 cell count
403.0 (240.0)
337.0
34-1103
Participants
Characteristic
HIV Illness Stage
Asymptomatic
Symptomatic
AIDS
On Antiretroviral Therapy
Yes
No
N
%
3
4
32
7.7
10.3
82.0
36
3
92.3
7.7
Participants
Characteristic
Undetectable HIV VL
N
%
30
76.9
Participants
Characteristic
N
%
HCV Genotype 1
24
61.5
ALT > 42
23
59.0
Participants
Characteristic
N
%
History of Substance Abuse
Yes
No
37
2
94.9
5.1
Active Substance Abuse
Yes
No
27
12
69.2
30.8
Problematic Substances (multiple options possible)
Heroin
Cocaine
Alcohol
Crack
30
27
20
20
76.9
69.2
51.3
51.3
Participants
Characteristic
N
%
Any Mental Illness
Yes
No
33
6
84.6
15.4
Depression
Anxiety
PTSD
Bipolar
Schizophrenia
32
28
10
8
4
82.1
71.8
25.6
20.5
10.3
Ever Hospitalized to Treat Mental Illness
Yes
No
12
27
30.8
69.2
History of Suicide Attempt
Yes
No
9
30
23.1
76.9
Taking Mental Health Medications
Yes
No
22
17
56.4
43. 6
Work Status
Not Working
35
89.7
Differences between Study
Samples
0 More study participants in Study #2 (LEAP-C):
0 Are male (71.8% vs. 53.8%)
0 Have AIDS (82% vs. 35.9%)
0 Active substance use (69.2% vs. 15.4%)
0 Note: equal number of substance users (94.9% in both)
0 Fewer study participants in Study #2 (LEAP-C):
0 Are African American (7.7% vs. 15.4%)
0 Work (64.1% vs. 89.7%)
Challenges Encountered
0 Recruitment difficulties
0 Misunderstanding by providers
0 Recruiting into groups by gender
0 Lag time issue
0 Unique patient population
0 Who would have suspected that identifying patients with two
viral infections and who have “still” not been treated for one
of the infections (although most successfully treated for HIV)
would = a significantly marginalized population of patients
0 Changes in treatment – resulting in an historical effect:
0 Newer directly acting agents hold significant promise – so
most providers/patients holding off on treatment unless no
other option
0 IL28B identification
Conclusions: Lessons Learned
0 The best of times………The results of the first study showed
tremendous promise that we could develop an
intervention that could help patient make an informed
decision about HCV treatment
0 The worst of times………LEAP-C results are pending but
the feasibility of recruiting this very “hard to reach”
population makes conducting a full-scale clinical trial
extremely difficult
0 LEAP-C also revealed that there are “sub-populations”
within our already vulnerable populations that need
special attention, care and advocacy
0 Is there a way to work on decision-making with this
population that is brief and simple and episodic?
The Study Team
0
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0
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Tobey Burwick, LICSW
Sybil Crawford, PhD
Akwasi Duah, MS, RN
Kristopher Fennie, PhD, MPH
Carol Jaffarian, MS, RN
Lisa Ogawa, PhD, RN
Maritza Quinones
Susan Sullivan-Bolyai
Mireya Wessolossky, MD
Ann B. Williams, EdD, RN, FAAN
Peer Educators
References
0 Bova, C., Ogawa, L. F., & Sullivan-Bolyai, S. (2010). Hepatitis C
treatment experiences and decision making among patients
living with HIV infection. JANAC, 21, 63-74.
0 Ogawa, L., & Bova, C. (2009). Substance use experiences and
hepatitis C treatment decision-making among HIV/HCV coinfected adults. Substance Use & Misuse, 44, 915-933.
0 Bova, C., Burwick, TN, & Quinones, M. (2008). Improving
women’s adjustment to HIV infection: Results of the Positive Life
Skills Workshop Project. JANAC, 19, 58-65.
0 Bova, C., Jaffarian, C., Himlan, P., Mangini, L. & Ogawa, L. (2008).
The symptom experience of HIV/HCV co-infected adults. JANAC,
19, 170-180.
Thank you!
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