Hepatitis cLEAP-CNCT01472354
Feasibility of a Hepatitis C Virus (HCV) Decision-Making Intervention Among HIV-infected Adults
A study testing Leap-c group intervention in people with Hepatitis c, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis c
- What is being tested?
- Leap-c group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Non-English Speaking
- Children under age 18
- HCV mono-infected adults
- HIV/HCV co-infected adults who have received any HCV treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Graduate School of Nursing
Worcester, Massachusetts, 01655
About this study
Official title: 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.
Read the 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
- Being tested
- Leap-c group intervention
- Keywords
- HIV, Hepatitis C, Decision-Making, chronic
- Medical subject headings
- Hepatitis C, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leap-c group interventionBehavioural
Also called LEAP-C
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Leap-c group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Secondary outcomes (6)
Proportion of subjects electing HCV treatment 6 months after enrollment in the feasibility study.
Collect data on the study sample to determine the proportion of subjects who began HCV treatment 6 months after enrollment in the study.
Measured: 6 months
Increase in knowledge related to HCV treatment 12 weeks post treatment
Collect data at baseline and week 12 to determine whether the intervention improved HCV-related knowledge.
Measured: Up to 12 weeks
Increase in communication between subject and health care provider from baseline to week 12.
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.
Measured: Up to 12 weeks
Increase in subjects' health related quality of life from baseline to 12 weeks after study enrollment
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.
Measured: Up to 12 weeks
Number of symptoms experienced by HCV infected subjects from baseline to week 12
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.
Measured: Up to 12 weeks
Severity of symptoms experienced by HCV infected subjects from baseline to week 12
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis cStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Carol Bova, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472354
- Sponsor's protocol ID
- S61110000013230
- Other IDs
- R21NR011132
- Acronym
- LEAP-C
- Status last verified
- May 2013
- First submitted
- 2 Aug 2011
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a HCV Decision-Making Intervention Among HIV-infected Adults
- ClinicalTrials.gov ID
- NCT01472354
- Acronym / sponsor ID
- LEAP-C / S61110000013230
- Conditions
- Hepatitis c
- Keywords
- HIV, Hepatitis C, Decision-Making, chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Leap-c group intervention4-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Non-English Speaking
- Children under age 18
- HCV mono-infected adults
- HIV/HCV co-infected adults who have received any HCV treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leap-c group interventionAlso: LEAP-C4-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 | Behavioural | LEAP-C Group Intervention |
Primary outcome
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.
6 secondary outcomes
Proportion of subjects electing HCV treatment 6 months after enrollment in the feasibility study.
Time frame: 6 months
Increase in knowledge related to HCV treatment 12 weeks post treatment
Time frame: Up to 12 weeks
Increase in communication between subject and health care provider from baseline to week 12.
Time frame: 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
Number of symptoms experienced by HCV infected subjects from baseline to week 12
Time frame: Up to 12 weeks
Severity of symptoms experienced by HCV infected subjects from baseline to week 12
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leap-c group intervention in people with Hepatitis c, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in decisional conflict related to HCV treatment 12 weeks post treatment (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.