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

May 29, 2013 updated by: Carol Bova, University of Massachusetts, Worcester

Feasibility of a HCV Decision-Making Intervention Among HIV-infected Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • LEAP-C

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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