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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse Case Management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hepatitis C Treatment Initiation | Number of days from study enrollment to receipt of the first dose of hepatitis C treatment | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason E Farley, PhD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24988388 | Background | 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. | |
| 25432275 | Background | Patel 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. |
| Label | URL |
|---|---|
| AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C | View source |
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Recruitment took place from July 2016 to February 2018 in an outpatient infectious disease clinic in Baltimore, Maryland
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Usual Care | Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet |
| FG001 | Nurse Case Management | Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention Nurse Case Management: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care | Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet |
| BG001 | Nurse Case Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All eligible participants who were randomized are included. Two participants were excluded (one in each arm) because they were found to be ineligible for study participation after they were randomized. | Posted | Count of Participants | Participants | 60 days |
|
6 months
Data were collected via a monthly medical record review
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Usual Care | Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Starbird | Johns Hopkins University | 9787587909 | Lstarbi1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2017 | Aug 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 23537147 | Background | Cachay 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. |
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Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention
Nurse Case Management: 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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HIV viral load | HIV plasma ribonucleic acid (RNA) not detectable (less than 20 copies/milliliter) | Count of Participants | Participants |
|
| Liver fibrosis level | The fibrosis score is used to describe the amount of inflammation in the liver. A lower score (F0) is more desirable than a higher score (F4): F0: No fibrosis F1: Portal fibrosis without septa F2: Portal fibrosis with few septa F3: Numerous septa without cirrhosis F4: Cirrhosis | Count of Participants | Participants |
|
| Health insurance | Currently enrolled in Medicaid and/or Medicare | Count of Participants | Participants |
|
| Hepatitis C knowledge | Total score on the Brief Hepatitis C Knowledge Scale: A point is given for each correct answer on this true/false scale, with a maximum possible number of points (perfect score) of 19 and a minimum number of points (no questions answered correctly) of 0. | Mean | Standard Deviation | units on a scale |
|
| Alcohol use | Self-reported drinking alcohol in the past 12 months | Count of Participants | Participants |
|
| Injection drug use | Self-reported using drugs intravenously in the past 12 months | Count of Participants | Participants |
|
Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
| OG001 | Nurse Case Management | Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention Nurse Case Management: 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. |
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| Secondary | Time to Hepatitis C Treatment Initiation | Number of days from study enrollment to receipt of the first dose of hepatitis C treatment | ll eligible participants who were randomized are included. Two participants were excluded (one in each arm) because they were found to be ineligible for study participation after they were randomized. | Posted | Mean | Standard Deviation | days | 6 months |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Nurse Case Management | Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention Nurse Case Management: 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. | 2 | 35 | 0 | 35 | 0 | 35 |
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| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |