Hepatitis C
Conditions
Keywords
Hepatitis C, Community Pharmacy, Direct Acting Antivirals, Patient Navigator
Brief summary
The aim of this study is evaluate the acceptability/usage of a newly implemented model of delivery of care, namely a community-pharmacy program, to provide access to medications to treat hepatitis C (HCV), and prevent overdose and HIV, for persons who inject drugs (PWID) with HCV who are in need of treatment. Adults will be enrolled who test positive for HCV at community sites and who agree to linkage to the community-pharmacy program through the use of patient navigators. The primary outcome of the study will be the measure of the number/% of participants who are successfully linked to the community-pharmacy program and assess HCV treatment initiation, completion, and cure. In addition, other outcomes including receipt of other medications (e.g. Naloxone, pre-exposure prophylaxis (PrEP), and medications for opioid use disorders), and self-reported substance use and HIV risk behaviors will also be measured.
Detailed description
Single-arm, prospective observational study of 40 adult persons who inject drugs (PWID) who screen positive for hepatitis C virus (HCV) with a reactive antibody test at community sites who are offered facilitated linkage to community-pharmacy program through patient navigators. Individuals who are eligible and enroll will complete a baseline survey to assess sociodemographics, substance use, HIV risk behaviors, and awareness of and interest in HCV treatment. After the survey, the participants will be linked to the community-pharmacy program, via the patient navigator, where treatment for HCV and opioid use disorder (OUD), as well as pre-exposure prophylaxis (PrEP), Naloxone and vaccinations, will be offered to participants. After 6 months, participants will complete a follow-up survey, which will include questions on: whether an evaluation for HCV occurred at the community pharmacy, whether HCV treatment was initiated since baseline visit, substance use, HIV risk behaviors, receipt of medications to treat HCV, opioid use disorder, Naloxone and PrEP receipt, medication adherence, and injecting network.
Interventions
None listed
Sponsors
National Institute on Drug Abuse (NIDA)
University of Washington
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years old 2. Reports injecting drugs with 90 days of screening 3. Positive HCV test documented (screening antibody test or viral load test) 4. Not currently taking medications to treat HCV, and never previously treated with direct-acting antivirals (DAAs) for HCV 5. Willing to undergo evaluation for HCV through a community pharmacy program and work with Patient Navigators 6. Provides release of information (ROI) to access community pharmacy program records and/or other HCV treatment providers
Exclusion criteria
1. People who plan to leave the Seattle area within 6 months 2. Who do not wish to be treated for their HCV infection 3. Who are known to be pregnant 4. Who report impending incarceration that would disrupt clinical care 5. Who are not comfortable reading and speaking English 6. Who report being HIV-positive 7. Who report having end-stage renal disease or require dialysis treatments 8. Who report prior enrolled in (i.e. completed at least the initial intake appointment) the Kelley-Ross pharmacy program for hepatitis C treatment (One Step Hep C Free)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Community Pharmacy Program Successful Linkage | 6 months | The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of HCV Treatment | 6 months | The number/percent who initiate medications for HCV. |
Other
| Measure | Time frame | Description |
|---|---|---|
| HIV Sex Risk Behaviors | 6 months | Compare at baseline and 6-month follow-up the number of episodes of unprotected vaginal or anal sex within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS). |
| Utilization of Other Community Pharmacy Services | 6 months | The number/percent who receive of other medications (naloxone, PrEP, and medications to treat OUD) via the community pharmacy program. |
| HIV Drug Risk Behaviors | 6 months | Compare at baseline and 6-month follow-up the number of injecting episodes using shared needle/syringe within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS). |
| Completion of HCV Treatment | 9 months | The number/percent who complete treatment for HCV, defined as having received all planned medication doses. |
| Sustained Virologic Response (SVR12) | 12 months | SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion. |
| Participant Satisfaction and Referral to the Community Pharmacy Program | 6 months | Self-reported participant Likert scale surveys of satisfaction and willingness to refer an injecting partner to the community pharmacy for treatment; 1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree with the level of satisfaction/likelihood of referral to services. |
| Substance Use | 6 months | Compare at baseline and 6-month follow-up the number of days of drug use within the past 30 days via self-report using the modified Addition Severity Index (ASI). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from community sites that serve PWID in the Seattle area: a non-profit organization with a syringe services program, an opioid treatment program, and several emergency housing units. Potential participants were identified and referred by local providers within their respective site organizations or self-referred after seeing informational flyers at study sites. The first participant was enrolled on 11/05/2020, and the last participant was enrolled on 10/28/2021.
Participants by arm
| Arm | Count |
|---|---|
| Observational Group Person who injects drugs, with documented positive hepatitis c virus test results. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Observational Group |
|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex/Gender, Customized Man | 24 Participants |
| Sex/Gender, Customized Non-binary or Transgender man or woman | 4 Participants |
| Sex/Gender, Customized Woman | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 2 / 40 |
Outcome results
Primary
Community Pharmacy Program Successful Linkage
The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational Group | Community Pharmacy Program Successful Linkage | 38 Participants |
Secondary
Initiation of HCV Treatment
The number/percent who initiate medications for HCV.
Time frame: 6 months
Other Pre-specified
Completion of HCV Treatment
The number/percent who complete treatment for HCV, defined as having received all planned medication doses.
Time frame: 9 months
Other Pre-specified
HIV Drug Risk Behaviors
Compare at baseline and 6-month follow-up the number of injecting episodes using shared needle/syringe within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).
Time frame: 6 months
Other Pre-specified
HIV Sex Risk Behaviors
Compare at baseline and 6-month follow-up the number of episodes of unprotected vaginal or anal sex within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).
Time frame: 6 months
Other Pre-specified
Participant Satisfaction and Referral to the Community Pharmacy Program
Self-reported participant Likert scale surveys of satisfaction and willingness to refer an injecting partner to the community pharmacy for treatment; 1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree with the level of satisfaction/likelihood of referral to services.
Time frame: 6 months
Other Pre-specified
Substance Use
Compare at baseline and 6-month follow-up the number of days of drug use within the past 30 days via self-report using the modified Addition Severity Index (ASI).
Time frame: 6 months
Other Pre-specified
Sustained Virologic Response (SVR12)
SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.
Time frame: 12 months
Other Pre-specified
Utilization of Other Community Pharmacy Services
The number/percent who receive of other medications (naloxone, PrEP, and medications to treat OUD) via the community pharmacy program.
Time frame: 6 months