Hepatitis C
Conditions
Brief summary
The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).
Detailed description
Non-blinded, randomized controlled trial. In-depth qualitative interviews assess attitudes and barriers to treatment. In Phase 1, potential participants will be pulled from a convenience sample at a Portland clinic providing care for the urban area. An initial target sample of 100 Hepatitis C positive participants will be enrolled for DBS validation. Power will be reassessed based on feedback from receiver operating curve model and additional participants enrolled up to a total of 100 Hepatitis C Positive participants, if necessary. A total of 500 potential participants can be screened expecting 1 in every 4 participants will be positive HCV. In Phase 2, rural peer care coordinators (PCCs) and research assistants recruit up to 200 PWUD participants from high-needs rural Oregon counties. Study staff specifically target untreated populations recruited from local syringe exchange programs and direct community outreach (e.g. community barbeques, parks, homeless shelters, food pantries, etc.). Participants are encouraged to refer others for study screening. A subset of up to 40 study participants will complete in-depth qualitative interviews regarding their experiences of hepatitis C treatment.
Interventions
OTHERTele-HCV
Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
OTHERCommunity Linkage to Care
Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
Sponsors
Comagine Health
HIV Alliance
Oregon Health Authority
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. live in the study area 2. have injected drugs or report recreational opioid use without injection in the last 90 days 3. are age 18 or greater 4. have chronic active, untreated hepatitis C (defined as positive HCV RNA) 5. are seeking treatment for hepatitis C infection. 6. are able to communicate in English (this is due to the fact that less than 5% of the population in which we are targeting will be non-English speaking; see Non-English Speaking Subjects for additional information). 7. are enrolled in health insurance
Exclusion criteria
1. Have decompensated cirrhosis, defined as Child-Turcotte-Pugh (CTP) score of 7 or greater, or CTP B cirrhosis. CTP scoring is a composite of laboratory metrics (bilirubin, albumin, PT/INR) and clinical findings, including: 1. increased abdominal or lower extremity swelling 2. confusion consistent with hepatic encephalopathy 2. Are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Response | 12 weeks post treatment | Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Initiation | 4 weeks | Number of participants who initiated Hepatitis-C Virus (HCV)treatment at 4 weeks post study enrollment. |
| Treatment Completion | 36 weeks post treatment | HCV treatment completion, filled final prescription. 90% of HCV pills taken |
| Engagement in Harm Reduction Resources | Baseline, 12 weeks, and 36 Weeks | Participants complete surveys to assess whether or not they are regularly engaging in substance use and harm reduction resources in the community. Surveys conducted a Baseline, 12 weeks, and 36 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tele-HCV Treatment Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation. | 100 |
| Community Linkage to Care Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider. | 103 |
| Total | 203 |
Baseline characteristics
| Characteristic | Tele-HCV Treatment | Total | Community Linkage to Care |
|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 11.5 | 41.6 years STANDARD_DEVIATION 11.2 | 42.2 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 11 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 192 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 89 Participants | 179 Participants | 90 Participants |
| Region of Enrollment United States | 100 participants | 203 participants | 103 participants |
| Sex: Female, Male Female | 42 Participants | 77 Participants | 35 Participants |
| Sex: Female, Male Male | 58 Participants | 126 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 100 | 2 / 103 |
| other Total, other adverse events | 2 / 100 | 2 / 103 |
| serious Total, serious adverse events | 1 / 100 | 4 / 103 |
Outcome results
Primary
Viral Response
Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.
Time frame: 12 weeks post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-HCV Treatment | Viral Response | 63 Participants |
| Community Linkage to Care | Viral Response | 16 Participants |
Secondary
Engagement in Harm Reduction Resources
Participants complete surveys to assess whether or not they are regularly engaging in substance use and harm reduction resources in the community. Surveys conducted a Baseline, 12 weeks, and 36 weeks.
Time frame: Baseline, 12 weeks, and 36 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tele-HCV Treatment | Engagement in Harm Reduction Resources | 12 Weeks | 88 Participants |
| Tele-HCV Treatment | Engagement in Harm Reduction Resources | 36 Weeks | 61 Participants |
| Tele-HCV Treatment | Engagement in Harm Reduction Resources | Baseline | 100 Participants |
| Community Linkage to Care | Engagement in Harm Reduction Resources | Baseline | 103 Participants |
| Community Linkage to Care | Engagement in Harm Reduction Resources | 12 Weeks | 83 Participants |
| Community Linkage to Care | Engagement in Harm Reduction Resources | 36 Weeks | 68 Participants |
Secondary
Treatment Completion
HCV treatment completion, filled final prescription. 90% of HCV pills taken
Time frame: 36 weeks post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-HCV Treatment | Treatment Completion | 46 Participants |
| Community Linkage to Care | Treatment Completion | 9 Participants |
Secondary
Treatment Initiation
Number of participants who initiated Hepatitis-C Virus (HCV)treatment at 4 weeks post study enrollment.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-HCV Treatment | Treatment Initiation | 85 Participants |
| Community Linkage to Care | Treatment Initiation | 13 Participants |