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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carol Bova, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01472354
First received: August 2, 2011
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 Intervention
Hepatitis c
Behavioral: Leap-c group intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility of a HCV Decision-Making Intervention Among HIV-infected Adults

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Decrease in decisional conflict related to HCV treatment 12 weeks post treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Collect data on the study sample at baseline and week 12 to determine whether the intervention decreased decisional conflict.


Secondary Outcome Measures:
  • Proportion of subjects electing HCV treatment 6 months after enrollment in the feasibility study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Collect data on the study sample to determine the proportion of subjects who began HCV treatment 6 months after enrollment in the study.

  • Increase in knowledge related to HCV treatment 12 weeks post treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Collect data at baseline and week 12 to determine whether the intervention improved HCV-related knowledge.

  • Increase in communication between subject and health care provider from baseline to week 12. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Increase in subjects' health related quality of life from baseline to 12 weeks after study enrollment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of symptoms experienced by HCV infected subjects from baseline to week 12 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Severity of symptoms experienced by HCV infected subjects from baseline to week 12 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: October 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472354

Locations
United States, Massachusetts
University of Massachusetts Graduate School of Nursing
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Carol Bova, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01472354     History of Changes
Other Study ID Numbers: S61110000013230, R21NR011132
Study First Received: August 2, 2011
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 15, 2014