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

NCT ID: NCT01472354

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-11-30

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.

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.

Conditions

Hepatitis c

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care referral to specialist

Subjects are referred for education, counseling and evaluation for HCV treatment to a specialty health care provider

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Leap-c group intervention

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

LEAP-C

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Carol Bova

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Massachusetts Graduate School of Nursing

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

R21NR011132

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S61110000013230

Identifier Type: -

Identifier Source: org_study_id