Feasibility of a Hepatitis C Virus (HCV) Decision-Making Intervention Among HIV-infected Adults (LEAP-C)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01472354 |
Recruitment Status
:
Completed
First Posted
: November 16, 2011
Last Update Posted
: May 30, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis c | Behavioral: Leap-c group intervention | Not Applicable |
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 |
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
|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Massachusetts | |
University of Massachusetts Graduate School of Nursing | |
Worcester, Massachusetts, United States, 01655 |
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 |