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

NCT01472354 | Completed

• 2 other identifiers: S61110000013230R21NR011132
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis c

Keywords

HIV; Hepatitis C; Decision-Making; chronic

Outcome Measures

Primary Outcomes (1)

• Decrease in decisional conflict related to HCV treatment 12 weeks post treatment

  Collect data on the study sample at baseline and week 12 to determine whether the intervention decreased decisional conflict.

  Up to 12 weeks

Secondary Outcomes (6)

• Proportion of subjects electing HCV treatment 6 months after enrollment in the feasibility study.

  6 months

• Increase in knowledge related to HCV treatment 12 weeks post treatment

  Up to 12 weeks

• Increase in communication between subject and health care provider from baseline to week 12.

  Up to 12 weeks

• Increase in subjects' health related quality of life from baseline to 12 weeks after study enrollment

  Up to 12 weeks

• Number of symptoms experienced by HCV infected subjects from baseline to week 12

  Up to 12 weeks

Study Arms (2)

Standard of care referral to specialist

NO INTERVENTION

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

LEAP-C Group Intervention

EXPERIMENTAL

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

Interventions

Leap-c group intervention 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

Also known as: LEAP-C

LEAP-C Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Non-English Speaking
• Children under age 18
• HCV mono-infected adults
• HIV/HCV co-infected adults who have received any HCV treatment

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Massachusetts Graduate School of Nursing

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Hepatitis C; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

US (1)