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Feasibility of a Hepatitis C Virus (HCV) Decision-Making Intervention Among HIV-infected Adults (LEAP-C)

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ClinicalTrials.gov Identifier: NCT01472354
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : May 30, 2013
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Carol Bova, University of Massachusetts, Worcester

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the LEAP-C (learning, experiencing and preparing for hepatitis C treatment) study is to see if a brief (4-week) small group intervention will help people with HIV/HCV co-infection make an informed decision about Hepatitis C treatment.

Condition or disease Intervention/treatment Phase
Hepatitis c Behavioral: Leap-c group intervention Not Applicable

Detailed Description:
Chronic Hepatitis C Virus (HCV) infection is a major problem for Human Immunodeficiency Virus (HIV)-infected patients. Without HCV treatment, increasing numbers of HIV positive patients will die either from end stage liver disease or from HIV-related complications because of the inability to use antiretroviral agents due their hepatotoxicity. Major advances in understanding HCV treatment in this population have occurred within the past several years. Yet, only a small proportion of co-infected patients receive HCV treatment (approximately 15%). Moreover, few studies have explored patient decision-making related to HCV treatment in HIV co-infected patients. The major gap in our knowledge is how best to support patients as they engage in the HCV treatment decision making process with their health care provider. Therefore, the purpose of this phase II study is to test the feasibility of conducting a theoretically-derived group intervention with HIV/HCV co-infected adults to support active engagement in HCV treatment decision-making. The primary aims are to: (1) determine the feasibility of recruiting and retaining a sample of HIV/HCV co-infected adults to complete a protocol that involves randomization into the 4-week HCV Positive Life Skills group intervention or usual care and completion of two data collection interviews (at baseline and week 12), (2) establish the preliminary effect size of the HCV Positive Life Skills group intervention on HCV knowledge, decisional conflict, patient-provider communication, health-related quality of life, symptom experience and engagement with health care providers, (3) explore the capacity of the group intervention to influence HCV knowledge, decisional conflict, patient-provider communication, engagement with health care providers, health related quality of life and symptom experience and (4) describe the components of the intervention and usual care (through qualitative interviews) that are most useful for helping HIV/HCV co-infected patients engage in decision-making about HCV treatment. A mixed method approach will be used. 50 HIV/HCV co-infected participants will be randomized equally to receive either the group intervention or usual care. Then qualitative interviews, using qualitative descriptive methods, will be conducted with 10-12 participants to identify the most salient parts of the intervention and usual care that support effective decision-making about HCV treatment. The investigators will also compare the time spent with both groups, identify variability in the control condition, describe the number of subjects who start HCV treatment and further refine the intervention manual and intervention fidelity procedures in preparation for a full scale multi-site randomized clinical trial.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of a HCV Decision-Making Intervention Among HIV-infected Adults
Study Start Date : October 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard of care referral to specialist
Subjects are referred for education, counseling and evaluation for HCV treatment to a specialty health care provider
Experimental: LEAP-C Group Intervention
4-week group intervention to help HIV/HCV co-infected patients reframe negative appraisals associated with HCV treatment to decrease decisional conflict, increase HCV knowledge, improve communication
 Behavioral: Leap-c group intervention
4-week group intervention to help HIV/HCV co-infected patients reframe negative appraisals associated with hCV treatment, increase HCV knowledge, increase skills related to working with health care providers
Other Name: LEAP-C


Outcome Measures
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Primary Outcome Measures :
  1. Decrease in decisional conflict related to HCV treatment 12 weeks post treatment [ Time Frame: Up to 12 weeks ]
    Collect data on the study sample at baseline and week 12 to determine whether the intervention decreased decisional conflict.


Secondary Outcome Measures :
  1. Proportion of subjects electing HCV treatment 6 months after enrollment in the feasibility study. [ Time Frame: 6 months ]
    Collect data on the study sample to determine the proportion of subjects who began HCV treatment 6 months after enrollment in the study.

  2. Increase in knowledge related to HCV treatment 12 weeks post treatment [ Time Frame: Up to 12 weeks ]
    Collect data at baseline and week 12 to determine whether the intervention improved HCV-related knowledge.

  3. Increase in communication between subject and health care provider from baseline to week 12. [ Time Frame: Up to 12 weeks ]
    Collect data on the study sample at baseline and week 12 to determine whether the intervention has improved the subjects' perception of communication with their health care provider.

  4. Increase in subjects' health related quality of life from baseline to 12 weeks after study enrollment [ Time Frame: Up to 12 weeks ]
    Collect data on the study sample at baseline and week 12 to determine whether the intervention has improved subjects' perception of health related quality of life.

  5. Number of symptoms experienced by HCV infected subjects from baseline to week 12 [ Time Frame: Up to 12 weeks ]
    Collect data on the study sample at baseline and week 12 to determine whether the intervention has decreased the number of symptoms experienced by the research subjects.

  6. Severity of symptoms experienced by HCV infected subjects from baseline to week 12 [ Time Frame: Up to 12 weeks ]
    Collect data on the study sample at baseline and week 12 to determine whether the intervention has decreased the severity of symptoms experienced by the research subjects.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Men and Women (18 years of age or older) who have both HIV and chronic Hepatitis C (they need to have a detectable Hepatitis C viral load)

HIV/HCV co-infected adults who have NEVER started treatment

HIV/HCV co-infected adults who DO NOT have a MEDICAL reason that would make it dangerous to treat their hepatitis C (for example, severe cirrhosis already)

HIV/HCV co-infected adults who would be willing to be RANDOMIZED into a group session or standard of care (one on one care with a HCV provider)

Exclusion Criteria:

Non-English Speaking

Children under age 18

HCV mono-infected adults

HIV/HCV co-infected adults who have received any HCV treatment

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472354


Locations
United States, Massachusetts
University of Massachusetts Graduate School of Nursing
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institute of Nursing Research (NINR)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Carol Bova, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01472354     History of Changes
Other Study ID Numbers: S61110000013230
R21NR011132 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Carol Bova, University of Massachusetts, Worcester:
HIV
Hepatitis C
Decision-Making
chronic

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections