HIVCare2CureNCT02707991
Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection
A study testing Nurse Case Management in people with HIV and Hepatitis C, Chronic, run by Johns Hopkins University at 1 site in United States.
Trial summary
Effective all-oral medications are finally available to cure hepatitis C virus, which affects more than 4 million Americans and one-in-four people living with HIV. However, many barriers exist that prevent people with HIV/HCV co-infection from getting this curative treatment, including low knowledge, competing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C, Chronic
- What is being tested?
- Nurse Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- HIV infection
- Chronic hepatitis C infection
- Did not attend a hepatitis C specialty appointment in the past year
- Able to speak English
- Current patient at the John G. Bartlett Specialty Practice at Johns Hopkins Hospital (at least 1 visit in the past year)
Who cannot join
- Pregnancy
- Emergency medical care needed
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse Case Management to Improve Linkage to Hepatitis C Care and Treatment Initiation in HIV Co-infection: A Randomized Controlled Trial
Effective all-oral medications are finally available to cure hepatitis C virus, which affects more than 4 million Americans and one-in-four people living with HIV. However, many barriers exist that prevent people with HIV/HCV co-infection from getting this curative treatment, including low knowledge, competing demands, and drug interactions with HIV medications.
This study evaluates if a hepatitis C nurse case management intervention in an HIV primary care clinic will improve patient attendance to hepatitis C care and help people start hepatitis C treatment earlier. Half of the participants will receive brief case management with a nurse, while the other half will receive usual clinic care.
Read the detailed description
Hepatitis C virus (HCV) is a leading cause of liver cancer and HCV-related liver disease is among the most common causes of non-AIDS related death among people living with HIV (PLWH). One quarter of PLWH in the U.S. are co-infected with HCV, which leads to a 3-fold increase in progression to end stage liver disease and liver cancer. HCV can be cured, but less than half of PLWH with chronic HCV in the U.S. have linked to HCV care, and about 7% initiated treatment. Poor treatment initiation rates historically have been due to low efficacy among PLWH, but HCV care now is at a turning point. The investigators have the ability to substantially decrease HCV-related morbidity and mortality in PLWH with the availability of effective all-oral treatment. As patients are funneled into HCV care, improving the process of linkage to care and treatment preparation related to HIV medication modifications necessary for current HCV regimens is essential to maximize the lifesaving potential of available therapies among PLWH.
There are several barriers to linkage to HCV care and treatment. HCV is a "silent epidemic" often presenting no symptoms for 20 years. Knowledge about HCV and its available therapies is also low and lags behind new advancements in HCV treatment. Competing work, school and caregiving demands has also historically led to low motivation to engage in HCV care. For PLWH who are linked to HCV care, drug interactions between new HCV therapies and HIV treatment regimens introduce a new barrier to HCV treatment initiation. Up to 88% of PLWH will need to switch their HIV treatment regimen to avoid contraindicated drug interactions. The April 8, 2015 Guidelines for the Use of Antiretroviral Agents in HIV-1-infected Adults and Adolescents emphasize the need to modify HIV regimens to treat HCV in many PLWH. But modifying HIV treatment regimens can have severe negative consequences, including decreased quality of life, increased symptom burden, and loss of viral suppression.
Interventions that both increase HCV knowledge and support HIV treatment modifications in the setting of drug interactions are needed to improve linkage to HCV care and decrease time to treatment initiation. In similar settings and populations, nurse case management interventions have been shown to improve these outcomes. However, few of these interventions have been rigorously tested in the context of HCV.
This study is a randomized, single-blinded controlled trial to test whether a nurse case management intervention will improve the HCV treatment cascade among PLWH in an HIV primary care setting compared to usual care.
Specifically, this study aims to:
- Test whether a nurse case management intervention will increase linkage to the Viral Hepatitis Clinic among persons with HIV/HCV co-infection compared to usual care; Hypothesis: A higher proportion of those who are randomized to the intervention arm will attend the Viral Hepatitis Clinic within 60 days of randomization compared to those who receive usual care.
- Determine if a nurse case management intervention will decrease time to HCV treatment initiation among persons with HIV/HCV co-infection compared to usual care; Hypothesis: Those who are randomized to the intervention arm will have a decreased time to HCV treatment initiation from the point of randomization compared to those who receive usual care.
- Describe the characteristics associated with uptake of HCV care among people living with HIV, controlling for covariates; Research question 2.1: What patient-level characteristics are associated with increased uptake of HCV care?; Research question 2.2: Compared to the known historical barriers to engaging in HCV care, what factors continue to be associated with uptake of HCV care in the new paradigm of HCV treatment for people living with HIV?
- Conditions
- HIV, Hepatitis C, Chronic
- Being tested
- Nurse Case Management
- Keywords
- Continuity of Patient Care, Treatment Cascade
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Case ManagementBehavioural
Also called Care Coordination
Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No intervention | Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet |
| Nurse Case Management | Experimental | Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention Receives: Behavioral: Nurse Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Linked to Care
This will be assessed based on the number of participants who attend an appointment at the Viral Hepatitis Clinic within 60 days of enrolling in the study. A participant is considered "linked to care" if he/she attends an appointment at the clinic. A participant is considered "not linked to care" if he/she does not attend an appointment at the clinic. Whether a participant linked to care will be determined by looking at the medical record, where all attended appointments are documented. If no attended appointment is documented, this will be considered non-attendance/not linked to care.
Measured: 60 days
Secondary outcomes (1)
Time to Hepatitis C Treatment Initiation
Number of days from study enrollment to receipt of the first dose of hepatitis C treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason E Farley, PhD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707991
- Sponsor's protocol ID
- IRB00081068
- Acronym
- Care2Cure
- Status last verified
- Jan 2019
- First submitted
- 9 Mar 2016
- Last updated
- 2 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014.
PubMed 24988388Patel N, Nasiri M, Koroglu A, Amin R, McGuey L, McNutt LA, Roman M, Miller C. Prevalence of drug-drug interactions upon addition of simeprevir- or sofosbuvir-containing treatment to medication profiles of patients with HIV and hepatitis C coinfection. AIDS Res Hum Retroviruses. 2015 Feb;31(2):189-97. doi: 10.1089/AID.2014.0215. Epub 2015 Jan 6.
PubMed 25432275Cachay ER, Hill L, Ballard C, Colwell B, Torriani F, Wyles D, Mathews WC. Increasing Hepatitis C treatment uptake among HIV-infected patients using an HIV primary care model. AIDS Res Ther. 2013 Mar 28;10(1):9. doi: 10.1186/1742-6405-10-9.
PubMed 23537147Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012 Feb 21;156(4):271-8. doi: 10.7326/0003-4819-156-4-201202210-00004.
PubMed 22351712Lo Re V 3rd, Kallan MJ, Tate JP, Localio AR, Lim JK, Goetz MB, Klein MB, Rimland D, Rodriguez-Barradas MC, Butt AA, Gibert CL, Brown ST, Park L, Dubrow R, Reddy KR, Kostman JR, Strom BL, Justice AC. Hepatic decompensation in antiretroviral-treated patients co-infected with HIV and hepatitis C virus compared with hepatitis C virus-monoinfected patients: a cohort study. Ann Intern Med. 2014 Mar 18;160(6):369-79. doi: 10.7326/M13-1829.
PubMed 24723077Thomas DL. Cure of hepatitis C virus infection without interferon alfa: scientific basis and current clinical evidence. Top Antivir Med. 2014 Jan;21(5):152-6.
PubMed 24531555Mehta SH, Genberg BL, Astemborski J, Kavasery R, Kirk GD, Vlahov D, Strathdee SA, Thomas DL. Limited uptake of hepatitis C treatment among injection drug users. J Community Health. 2008 Jun;33(3):126-33. doi: 10.1007/s10900-007-9083-3.
PubMed 18165889Afdhal NH, Zeuzem S, Schooley RT, Thomas DL, Ward JW, Litwin AH, Razavi H, Castera L, Poynard T, Muir A, Mehta SH, Dee L, Graham C, Church DR, Talal AH, Sulkowski MS, Jacobson IM; New Paradigm of HCV Therapy Meeting Participants. The new paradigm of hepatitis C therapy: integration of oral therapies into best practices. J Viral Hepat. 2013 Nov;20(11):745-60. doi: 10.1111/jvh.12173.
PubMed 24168254Harris M, Rhodes T. Hepatitis C treatment access and uptake for people who inject drugs: a review mapping the role of social factors. Harm Reduct J. 2013 May 7;10:7. doi: 10.1186/1477-7517-10-7.
PubMed 23651646Swan D, Long J, Carr O, Flanagan J, Irish H, Keating S, Keaveney M, Lambert J, McCormick PA, McKiernan S, Moloney J, Perry N, Cullen W. Barriers to and facilitators of hepatitis C testing, management, and treatment among current and former injecting drug users: a qualitative exploration. AIDS Patient Care STDS. 2010 Dec;24(12):753-62. doi: 10.1089/apc.2010.0142.
PubMed 21138381Munoz-Plaza CE, Strauss S, Astone-Twerell J, Jarlais DD, Gwadz M, Hagan H, Osborne A, Rosenblum A. Exploring drug users' attitudes and decisions regarding hepatitis C (HCV) treatment in the U.S. Int J Drug Policy. 2008 Feb;19(1):71-8. doi: 10.1016/j.drugpo.2007.02.003. Epub 2007 Aug 6.
PubMed 18312822Fusfeld L, Aggarwal J, Dougher C, Vera-Llonch M, Bubb S, Donepudi M, Goss TF. Assessment of motivating factors associated with the initiation and completion of treatment for chronic hepatitis C virus (HCV) infection. BMC Infect Dis. 2013 May 23;13:234. doi: 10.1186/1471-2334-13-234.
PubMed 23701894Wagner G, Osilla KC, Garnett J, Ghosh-Dastidar B, Bhatti L, Witt M, Goetz MB. Provider and patient correlates of provider decisions to recommend HCV treatment to HIV co-infected patients. J Int Assoc Physicians AIDS Care (Chic). 2012 Jul-Aug;11(4):245-51. doi: 10.1177/1545109712444163. Epub 2012 May 7.
PubMed 22564797Rockstroh JK. Optimal therapy of HIV/HCV co-infected patients with direct acting antivirals. Liver Int. 2015 Jan;35 Suppl 1:51-5. doi: 10.1111/liv.12721.
PubMed 25529087Chen EY, North CS, Fatunde O, Bernstein I, Salari S, Day B, Jain MK. Knowledge and attitudes about hepatitis C virus (HCV) infection and its treatment in HCV mono-infected and HCV/HIV co-infected adults. J Viral Hepat. 2013 Oct;20(10):708-14. doi: 10.1111/jvh.12095. Epub 2013 Apr 1.
PubMed 24010645
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Case Management to Improve Linkage to Hepatitis C Care and Treatment Initiation in HIV Co-infection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02707991
- Acronym / sponsor ID
- Care2Cure / IRB00081068
- Conditions
- HIV, Hepatitis C, Chronic
- Keywords
- Continuity of Patient Care, Treatment Cascade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Posted 2 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective all-oral medications are finally available to cure hepatitis C virus, which affects more than 4 million Americans and one-in-four people living with HIV. However, many barriers exist that prevent people with HIV/HCV co-infection from getting this curative treatment, including low knowledge, competing demands, and drug interactions with HIV medications.
This study evaluates if a hepatitis C nurse case management intervention in an HIV primary care clinic will improve patient attendance to hepatitis C care and help people start hepatitis C treatment earlier. Half of the participants will receive brief case management with a nurse, while the other half will receive usual clinic care.
Detailed description
Hepatitis C virus (HCV) is a leading cause of liver cancer and HCV-related liver disease is among the most common causes of non-AIDS related death among people living with HIV (PLWH). One quarter of PLWH in the U.S. are co-infected with HCV, which leads to a 3-fold increase in progression to end stage liver disease and liver cancer. HCV can be cured, but less than half of PLWH with chronic HCV in the U.S. have linked to HCV care, and about 7% initiated treatment. Poor treatment initiation rates historically have been due to low efficacy among PLWH, but HCV care now is at a turning point. The investigators have the ability to substantially decrease HCV-related morbidity and mortality in PLWH with the availability of effective all-oral treatment. As patients are funneled into HCV care, improving the process of linkage to care and treatment preparation related to HIV medication modifications necessary for current HCV regimens is essential to maximize the lifesaving potential of available therapies among PLWH.
There are several barriers to linkage to HCV care and treatment. HCV is a "silent epidemic" often presenting no symptoms for 20 years. Knowledge about HCV and its available therapies is also low and lags behind new advancements in HCV treatment. Competing work, school and caregiving demands has also historically led to low motivation to engage in HCV care. For PLWH who are linked to HCV care, drug interactions between new HCV therapies and HIV treatment regimens introduce a new barrier to HCV treatment initiation. Up to 88% of PLWH will need to switch their HIV treatment regimen to avoid contraindicated drug interactions. The April 8, 2015 Guidelines for the Use of Antiretroviral Agents in HIV-1-infected Adults and Adolescents emphasize the need to modify HIV regimens to treat HCV in many PLWH. But modifying HIV treatment regimens can have severe negative consequences, including decreased quality of life, increased symptom burden, and loss of viral suppression.
Interventions that both increase HCV knowledge and support HIV treatment modifications in the setting of drug interactions are needed to improve linkage to HCV care and decrease time to treatment initiation. In similar settings and populations, nurse case management interventions have been shown to improve these outcomes. However, few of these interventions have been rigorously tested in the context of HCV.
This study is a randomized, single-blinded controlled trial to test whether a nurse case management intervention will improve the HCV treatment cascade among PLWH in an HIV primary care setting compared to usual care.
Specifically, this study aims to:
- Test whether a nurse case management intervention will increase linkage to the Viral Hepatitis Clinic among persons with HIV/HCV co-infection compared to usual care; Hypothesis: A higher proportion of those who are randomized to the intervention arm will attend the Viral Hepatitis Clinic within 60 days of randomization compared to those who receive usual care.
- Determine if a nurse case management intervention will decrease time to HCV treatment initiation among persons with HIV/HCV co-infection compared to usual care; Hypothesis: Those who are randomized to the intervention arm will have a decreased time to HCV treatment initiation from the point of randomization compared to those who receive usual care.
- Describe the characteristics associated with uptake of HCV care among people living with HIV, controlling for covariates; Research question 2.1: What patient-level characteristics are associated with increased uptake of HCV care?; Research question 2.2: Compared to the known historical barriers to engaging in HCV care, what factors continue to be associated with uptake of HCV care in the new paradigm of HCV treatment for people living with HIV?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | No intervention | –Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet |
| Nurse Case Management | Experimental | Behavioral: Nurse Case ManagementNurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infection
- Chronic hepatitis C infection
- Did not attend a hepatitis C specialty appointment in the past year
- Able to speak English
- Current patient at the John G. Bartlett Specialty Practice at Johns Hopkins Hospital (at least 1 visit in the past year)
Key exclusion criteria (3 listed)
- Pregnancy
- Emergency medical care needed
- Unable to provide informed consent
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 |
|---|---|---|
| Nurse Case ManagementAlso: Care CoordinationParticipants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention. | Behavioural | Nurse Case Management |
Primary outcome
Number of Participants Linked to Care
Time frame: 60 days
This will be assessed based on the number of participants who attend an appointment at the Viral Hepatitis Clinic within 60 days of enrolling in the study. A participant is considered "linked to care" if he/she attends an appointment at the clinic. A participant is considered "not linked to care" if he/she does not attend an appointment at the clinic. Whether a participant linked to care will be determined by looking at the medical record, where all attended appointments are documented. If no attended appointment is documented, this will be considered non-attendance/not linked to care.
1 secondary outcome
Time to Hepatitis C Treatment Initiation
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24988388Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014.
- Background: PubMed 25432275Patel N, Nasiri M, Koroglu A, Amin R, McGuey L, McNutt LA, Roman M, Miller C. Prevalence of drug-drug interactions upon addition of simeprevir- or sofosbuvir-containing treatment to medication profiles of patients with HIV and hepatitis C coinfection. AIDS Res Hum Retroviruses. 2015 Feb;31(2):189-97. doi: 10.1089/AID.2014.0215. Epub 2015 Jan 6.
- Background: PubMed 23537147Cachay ER, Hill L, Ballard C, Colwell B, Torriani F, Wyles D, Mathews WC. Increasing Hepatitis C treatment uptake among HIV-infected patients using an HIV primary care model. AIDS Res Ther. 2013 Mar 28;10(1):9. doi: 10.1186/1742-6405-10-9.
- Background: PubMed 22351712Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012 Feb 21;156(4):271-8. doi: 10.7326/0003-4819-156-4-201202210-00004.
- Background: PubMed 24723077Lo Re V 3rd, Kallan MJ, Tate JP, Localio AR, Lim JK, Goetz MB, Klein MB, Rimland D, Rodriguez-Barradas MC, Butt AA, Gibert CL, Brown ST, Park L, Dubrow R, Reddy KR, Kostman JR, Strom BL, Justice AC. Hepatic decompensation in antiretroviral-treated patients co-infected with HIV and hepatitis C virus compared with hepatitis C virus-monoinfected patients: a cohort study. Ann Intern Med. 2014 Mar 18;160(6):369-79. doi: 10.7326/M13-1829.
- Background: PubMed 24531555Thomas DL. Cure of hepatitis C virus infection without interferon alfa: scientific basis and current clinical evidence. Top Antivir Med. 2014 Jan;21(5):152-6.
- Background: PubMed 18165889Mehta SH, Genberg BL, Astemborski J, Kavasery R, Kirk GD, Vlahov D, Strathdee SA, Thomas DL. Limited uptake of hepatitis C treatment among injection drug users. J Community Health. 2008 Jun;33(3):126-33. doi: 10.1007/s10900-007-9083-3.
- Background: PubMed 24168254Afdhal NH, Zeuzem S, Schooley RT, Thomas DL, Ward JW, Litwin AH, Razavi H, Castera L, Poynard T, Muir A, Mehta SH, Dee L, Graham C, Church DR, Talal AH, Sulkowski MS, Jacobson IM; New Paradigm of HCV Therapy Meeting Participants. The new paradigm of hepatitis C therapy: integration of oral therapies into best practices. J Viral Hepat. 2013 Nov;20(11):745-60. doi: 10.1111/jvh.12173.
- Background: PubMed 23651646Harris M, Rhodes T. Hepatitis C treatment access and uptake for people who inject drugs: a review mapping the role of social factors. Harm Reduct J. 2013 May 7;10:7. doi: 10.1186/1477-7517-10-7.
- Background: PubMed 21138381Swan D, Long J, Carr O, Flanagan J, Irish H, Keating S, Keaveney M, Lambert J, McCormick PA, McKiernan S, Moloney J, Perry N, Cullen W. Barriers to and facilitators of hepatitis C testing, management, and treatment among current and former injecting drug users: a qualitative exploration. AIDS Patient Care STDS. 2010 Dec;24(12):753-62. doi: 10.1089/apc.2010.0142.
- Background: PubMed 18312822Munoz-Plaza CE, Strauss S, Astone-Twerell J, Jarlais DD, Gwadz M, Hagan H, Osborne A, Rosenblum A. Exploring drug users' attitudes and decisions regarding hepatitis C (HCV) treatment in the U.S. Int J Drug Policy. 2008 Feb;19(1):71-8. doi: 10.1016/j.drugpo.2007.02.003. Epub 2007 Aug 6.
- Background: PubMed 23701894Fusfeld L, Aggarwal J, Dougher C, Vera-Llonch M, Bubb S, Donepudi M, Goss TF. Assessment of motivating factors associated with the initiation and completion of treatment for chronic hepatitis C virus (HCV) infection. BMC Infect Dis. 2013 May 23;13:234. doi: 10.1186/1471-2334-13-234.
- AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis CLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jason E Farley, PhD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Case Management in people with HIV and Hepatitis C, Chronic, run by Johns Hopkins University 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 5 inclusion and 3 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 2 May 2019. 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?
Yes. Results are posted in the registry (first posted 2 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Linked to Care (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707991, which also lists 25 linked publications.
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 2 May 2019.