Transcript Hepatitis C Treatment Decision
Hepatitis C Treatment Decision making among HIV/HCV Co-infected Adults: A Tale of Two Studies
Outline
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Discuss the clinical problem of HCV in HIV-infected patients
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Summarize the qualitative descriptive study
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Describe the intervention study (feasibility)
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Discuss the research challenges
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Open discussion
The Clinical Problem
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Patients with HIV living longer Liver-related deaths have increased 4-fold Hepatitis C virus (HCV) infection is one of the major problems Estimates suggest that 40% - 50% have HCV co infection Treatment for HCV has improved; but it is not without significant side effects 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)
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Purpose: Develop a clear understanding of HIV infected patients’ decision-making experiences with HCV treatment
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Develop a model to guide the development of an intervention to support HCV treatment efforts Method: Qualitative descriptive study
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Interviews conducted before treatment, 8-12 weeks into treatment, and at treatment completion)
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Participants who chose not to be treated were interviewed only once
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Study #1: Inclusion & Measures
Inclusion:
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18 years or older
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HIV-infected Chronic HCV (detectable HCV VL) Measures
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Interview Guide
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Demographics Clinical Symptoms (HIV-SEI) (α= 0.86) Mental Wellbeing(MHI-5) (α= 0.89) Sample
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N = 39 participants
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n= 16 HCV treated
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n= 23 non-treated
Characteristic Gender Male Female Race/Ethnicity White (non-Hispanic) Hispanic African American
Participants
N 21 18 19 14 6 % 53.8
46.2
48.7
35.9
15.4
Participants
Age Mean (SD)
45
(5.0) Median 45 Range 34-56 years Length of time with HIV in months 141 (37.2)
(11.8 years)
CD4 cell count
439
(239.9) 180 (15 years) 24-288 months (2-24 years) 406 19-1056
(11.4% <200)
Participants
Characteristic History of Substance Abuse Yes No Active Substance Abuse Yes No Problematic Substances (multiple options possible) Heroin Cocaine Alcohol Crack N 37 2 6 33 33 30 29 17 %
94.9
5.1
15.4
84.6
84.6
76.9
75.0
43.6
Participants
Characteristic
Any Mental Illness
Yes No
Depression
Yes No
Ever Hospitalized to Treat Mental Illness
Yes No
History of Suicide Attempt
Yes No
Taking Mental Health Medications
Yes No N 34 5 26 13 10 29 13 26 25 14 %
87.2
12.8
67.7
33.3
25.6
74.4
33.3
67.7
64.1
35.9
Participants
Characteristic HCV Genotype 1 N 23 %
59.0
Participants
Characteristic HIV Illness Stage Asymptomatic Symptomatic AIDS On Antiretroviral Therapy Yes No N 17 8 14 31 8 %
43.6
20.5
35.9
79.5
20.5
Results
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For those who decided to be treated:
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HCV evaluation and treatment process was conducted smoothly Successful treatment was facilitated by monitoring for depression, substance abuse relapse, side effects and providing considerable support
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Among the 16 treated participants – only 1 relapse For those who were undecided about treatment:
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There were a lot of barriers to making an “active” decision about treatment Many just kept “holding off and not making a decision”
Results
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6 major themes emerged that were further categorized into either treatment barriers or treatment facilitators
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Treatment Barriers
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Treatment fears
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Side effects, liver biopsy, relapse, needle use
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Vicarious experiences Treatment Facilitators
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Experience will illness management
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Patient-provider relationships
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Gaining sober time
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Facing treatment head-on
Data Example: Fear
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“ 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 half stepping, 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
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“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
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“ 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
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“ I heard horror stories about the biopsy, the side effects, the effect on me emotionally, but eventually I go it’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 patient provider relationships, gaining sober time, facing treatment head-on) HIV + Chronic HCV Evaluation HCV treatment Close monitoring Expert clinical care Expert counseling Family/friend, peer support Treatment not indicated Continue to monitor
Our Thoughts
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We could adapt a model that we had used successfully to help women with HIV adjust to chronic illness (Positive Life Skills Group)
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Guided by Lazarus & Folkman’s theory of appraisal centered coping
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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 Decision Making Improved HCV knowledge Less decisional conflict Improved Patient Provider Communication Improved HRQOL
Study #2: Learning Experiencing and Preparing for Hepatitis C Treatment (LEAP-C)
(NINR R21 NR011132)
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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 decision making found in the first study 2.
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Incorporates the facilitators found in the first study Reframes the negative meaning associated with HCV treatment Provides social support Enhances knowledge about HCV and treatment Enhances patient-provider communication
Study #2:The Aims
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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) 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 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
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RCT (feasibility) with qualitative interviews conducted post data collection with a subset of intervention and control participants Data collection completed before randomization and at week 12 (face to face interviews) and brief telephone interview about decision at 6 months 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.
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Therefore, we planned on a sample size of 40 study participants meeting the inclusion criteria
Inclusion Criteria
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HIV/HCV co-infected age 18 years of age or older Detectable HCV viral load Willing to be randomized to a 4-week group intervention or standard of care Absence of severe cognitive impairment (MMSE >23) English Speaking No previous HCV treatment Absence of “medical” contraindications to HCV treatment Plan to remain within the study region for 6 months
LEAP-C Intervention
Cognitive Re-Framing intervention 0 0 0
Four weekly sessions of 90 minutes each lead by a professional group interventionist
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Week one –introduction to group process, sobriety and confidentiality; Identifying barriers and facilitators to HCV treatment
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Week two –HCV, HCV treatment, preparing for treatment, readiness, adherence, managing side effects Week Three – peer educators – living through HCV treatment; managing substance abuse and mental illness Week Four –working with health care providers, communication and group debriefing Groups are small (4-6 each) and gender – specific Peer educators with HIV/HCV who have completed treatment will meet with the group participants
Usual Care
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Appointment is scheduled with a HCV provider to receive an initial evaluation and education session
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Follow up appointments scheduled at the discretion of that provider (and tracked) Tracking sheet capture the number of appointments and time spent in those appointments
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Measures
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 Gender Male Female Race/Ethnicity White (non-Hispanic) Hispanic African American N 28 11 24 12 3 % 71.8
28.2
61.5
30.8
7.7
Participants
Age Mean (SD) 49.1 (6.5) Median 49.0
Length of time with HIV in months 184.9 (81.1) (15.4 years) CD4 cell count 192.0
403.0 (240.0) 337.0
Range 34-59 years 12-348 months 34-1103
Participants
Characteristic HIV Illness Stage Asymptomatic Symptomatic AIDS On Antiretroviral Therapy Yes No N 3 4 32 36 3 % 7.7
10.3
82.0
92.3
7.7
Participants
Characteristic Undetectable HIV VL N 30 %
76.9
Participants
Characteristic HCV Genotype 1 ALT > 42 N 24 23 %
61.5
59.0
Participants
Characteristic History of Substance Abuse Yes No Active Substance Abuse Yes No Problematic Substances (multiple options possible) Heroin Cocaine Alcohol Crack N 37 2 27 12 30 27 20 20 %
94.9
5.1
69.2
30.8
76.9
69.2
51.3
51.3
Participants
Characteristic
Any Mental Illness
Yes No
Depression Anxiety PTSD Bipolar Schizophrenia Ever Hospitalized to Treat Mental Illness
Yes No
History of Suicide Attempt
Yes No
Taking Mental Health Medications
Yes No
Work Status
Not Working N 12 27 9 30 33 6 32 28 10 8 4 22 17 35 %
84.6
15.4
82.1
71.8
25.6
20.5
10.3
30.8
69.2
23.1
76.9
56.4
43. 6 89.7
Differences between Study Samples
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More study participants in Study #2 (LEAP-C):
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Are male (71.8% vs. 53.8%) Have AIDS (82% vs. 35.9%) Active substance use (69.2% vs. 15.4%)
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Note: equal number of substance users (94.9% in both)
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Fewer study participants in Study #2 (LEAP-C):
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Are African American (7.7% vs. 15.4%) Work (64.1% vs. 89.7%)
Challenges Encountered
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Recruitment difficulties Misunderstanding by providers Recruiting into groups by gender
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Lag time issue Unique patient population
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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 Changes in treatment – resulting in an historical effect:
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Newer directly acting agents hold significant promise – so most providers/patients holding off on treatment unless no other option
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IL28B identification
Conclusions: Lessons Learned
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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 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 LEAP-C also revealed that there are “sub-populations” within our already vulnerable populations that need special attention, care and advocacy Is there a way to work on decision-making with this population that is brief and simple and episodic?
The Study Team
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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
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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.
Ogawa, L., & Bova, C. (2009). Substance use experiences and hepatitis C treatment decision-making among HIV/HCV co infected adults. Substance Use & Misuse, 44, 915-933.
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.
Bova, C., Jaffarian, C., Himlan, P., Mangini, L. & Ogawa, L. (2008). The symptom experience of HIV/HCV co-infected adults. JANAC, 19, 170-180.