- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01472354
Feasibility of a Hepatitis C Virus (HCV) Decision-Making Intervention Among HIV-infected Adults (LEAP-C)
Feasibility of a HCV Decision-Making Intervention Among HIV-infected Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts Graduate School of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
Up to 12 weeks
|
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.
|
Up to 12 weeks
|
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.
|
Up to 12 weeks
|
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.
|
Up to 12 weeks
|
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.
|
Up to 12 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S61110000013230
- R21NR011132 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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