Hepatitis C Treatment Decision-making among HIV/HCV Co-infected Adults: A Tale

of Two Studies

It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair, we had everything before us, we had nothing before us…..

Charles Dickens, A Tale of Two CitiesEnglish novelist (1812 - 1870)

Carol Bova PhD, RN

UMass Worcester

UCLA: School of Nursing

February 23, 2012

Outline

0Discuss the clinical problem of HCV in HIV-infected patients

0Summarize the qualitative descriptive study0Describe the intervention study (feasibility)0Discuss the research challenges 0Open discussion

The Clinical Problem

0Patients with HIV living longer0Liver-related deaths have increased 4-fold0Hepatitis C virus (HCV) infection is one of the major

problems0Estimates suggest that 40% - 50% have HCV co-

infection0Treatment for HCV has improved; but it is not without

significant side effects0There 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)

0Purpose: Develop a clear understanding of HIV-infected patients’ decision-making experiences with HCV treatment0 Develop a model to guide the development of an

intervention to support HCV treatment efforts0Method: Qualitative descriptive study

0 Interviews conducted before treatment, 8-12 weeks into treatment, and at treatment completion)0Participants who chose not to be treated were interviewed

only once

Study #1:Inclusion & Measures

0 Inclusion:0 18 years or older0 HIV-infected0 Chronic HCV (detectable HCV VL)

0 Measures0 Interview Guide0Demographics0 Clinical 0 Symptoms (HIV-SEI) (α= 0.86)0Mental Wellbeing(MHI-5) (α= 0.89)

0 Sample0 N = 39 participants

0 n= 16 HCV treated0 n= 23 non-treated

Participants

Characteristic N %

Gender Male Female

2118

53.846.2

Race/Ethnicity White (non-Hispanic) Hispanic African American

1914 6

48.735.915.4

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

633

15.484.6

Problematic Substances (multiple options possible) Heroin Cocaine Alcohol Crack

33302917

84.676.975.043.6

ParticipantsCharacteristic N %Any Mental Illness Yes No

34 5

87.212.8

Depression Yes No

2613

67.733.3

Ever Hospitalized to Treat Mental Illness Yes No

1029

25.674.4

History of Suicide Attempt Yes No

1326

33.367.7

Taking Mental Health Medications Yes No

2514

64.135.9

Participants

Characteristic N %

HCV Genotype 1

23 59.0

Participants

Characteristic N %

HIV Illness Stage Asymptomatic Symptomatic AIDS

17 814

43.620.535.9

On Antiretroviral Therapy Yes No

31 8

79.520.5

Results

0For 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 relapse0For 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”

Results06 major themes emerged that were further

categorized into either treatment barriers or treatment facilitators0 Treatment Barriers

0Treatment fears0 Side effects, liver biopsy, relapse, needle use

0Vicarious experiences0 Treatment Facilitators

0Experience will illness management0Patient-provider relationships0Gaining sober time0Facing 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 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

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 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 treatmentClose monitoring

Expert clinical careExpert counseling

Family/friend, peer support

Treatment not indicated

Continue to monitor

Our Thoughts

0We could adapt a model that we had used successfully to help women with HIV adjust to chronic illness (Positive Life Skills Group)

0Guided 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 Characte

risticsIllness Factors

Resources (or lack thereof)

Mediating

Processes

Appraisal of

IllnessSocial

Support

OutcomesEffective Decision-Making

Improved HCV

knowledgeLess

decisional conflict

Improved Patient-Provider

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 thefeasibility and preliminary efficacy of a group intervention that:1. Addresses the barriers to HCV treatment decision-making

found in the first study2. Incorporates the facilitators found in the first study3. Reframes the negative meaning associated with HCV

treatment4. Provides social support 5. Enhances knowledge about HCV and treatment6. 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

0HIV/HCV co-infected age 18 years of age or older0Detectable HCV viral load0Willing to be randomized to a 4-week group

intervention or standard of care0Absence of severe cognitive impairment (MMSE >23)0English Speaking0No previous HCV treatment0Absence of “medical” contraindications to HCV

treatment0Plan to remain within the study region for 6 months

LEAP-C InterventionCognitive Re-Framing intervention

0 Four weekly sessions of 90 minutes each lead by a professional group interventionist

0Week one –introduction to group process, sobriety and confidentiality; Identifying barriers and facilitators to HCV treatment

0Week two –HCV, HCV treatment, preparing for treatment, readiness, adherence, managing side effects

0Week Three – peer educators – living through HCV treatment; managing substance abuse and mental illness

0Week Four –working with health care providers, communication and group debriefing

0 Groups are small (4-6 each) and gender – specific0 Peer educators with HIV/HCV who have completed treatment

will meet with the group participants

Usual Care

0Appointment is scheduled with a HCV provider to receive an initial evaluation and education session0 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

Measures0 HCV Knowledge Scale0 Decisional Conflict Scale (CDS)0 Patient-Provider communication scale0 Engagement with health care provider scale0 Hepatitis Quality of Life Questionnaire version 20 HIV Symptom Experience Inventory0 Meaning of Illness Questionnaire0 Duke UNC social support questionnaire0 Mini Mental Status Exam 0 Health Care Relationship Trust Scale0 Personal characteristics0 Illness Factors0 Substance abuse history form0 Mental illness history form

Participants (N = 39)

Characteristic N %

Gender Male Female

2811

71.828.2

Race/Ethnicity White (non-Hispanic) Hispanic African American

2412 3

61.530.8 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 N %

HIV Illness Stage Asymptomatic Symptomatic AIDS

3432

7.710.382.0

On Antiretroviral Therapy Yes No

36 3

92.3 7.7

Participants

Characteristic N %

Undetectable HIV VL 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

2712

69.230.8

Problematic Substances (multiple options possible) Heroin Cocaine Alcohol Crack

30272020

76.969.251.351.3

ParticipantsCharacteristic N %Any Mental Illness Yes No

33 6

84.615.4

DepressionAnxietyPTSDBipolarSchizophrenia

322810 8 4

82.171.825.620.510.3

Ever Hospitalized to Treat Mental Illness Yes No

1227

30.869.2

History of Suicide Attempt Yes No

930

23.176.9

Taking Mental Health Medications Yes No

Work Status Not Working

2217

35

56.443. 6

89.7

Differences between Study Samples

0More 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%)

0Note: equal number of substance users (94.9% in both)

0Fewer study participants in Study #2 (LEAP-C):0 Are African American (7.7% vs. 15.4%)0 Work (64.1% vs. 89.7%)

Challenges Encountered0 Recruitment difficulties0 Misunderstanding by providers0 Recruiting into groups by gender

0 Lag time issue0 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 Team0 Tobey Burwick, LICSW0 Sybil Crawford, PhD0 Akwasi Duah, MS, RN0 Kristopher Fennie, PhD, MPH0 Carol Jaffarian, MS, RN0 Lisa Ogawa, PhD, RN0 Maritza Quinones 0 Susan Sullivan-Bolyai 0 Mireya Wessolossky, MD0 Ann B. Williams, EdD, RN, FAAN0 Peer Educators

References0 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 co-infected 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!carol.bova@umassmed.edu