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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA047660 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Community Pharmacy Program Successful Linkage | The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of HCV Treatment | The number/percent who initiate medications for HCV. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| HIV Drug Risk Behaviors |
Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited at various community sites in Seattle where HCV screening occurs, including syringe exchange programs, addiction treatment programs (a methadone clinic and primary care-based buprenorphine program), homeless shelters, urban drop-in shelters and low-income housing sites.
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| Name | Affiliation | Role |
|---|---|---|
| Judith I Tsui, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38261893 | Derived | Tsui JI, Gojic AJ, Pierce KA, Tung EL, Connolly NC, Radick AC, Hunt RR, Sandvold R, Taber K, Ninburg M, Kubiniec RH, Scott JD, Hansen RN, Stekler JD, Austin EJ, Williams EC, Glick SN. Pilot study of a community pharmacist led program to treat hepatitis C virus among people who inject drugs. Drug Alcohol Depend Rep. 2023 Dec 23;10:100213. doi: 10.1016/j.dadr.2023.100213. eCollection 2024 Mar. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Group | Person who injects drugs, with documented positive hepatitis c virus test results. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Person who injects drugs, with documented positive hepatitis c virus test results.
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Group | Person who injects drugs, with documented positive hepatitis c virus test results. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Community Pharmacy Program Successful Linkage | The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation. | Posted | Count of Participants | Participants | 6 months |
|
|
2 years
Definitions for adverse event and serious adverse event used to collected adverse event information for this trial does not differ from the clinicaltrials.gov definitions. No event frequency threshold was implemented for this trial, and therefore, all events were reports
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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 | Observational Group | Person who injects drugs, with documented positive hepatitis c virus test results. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judith Tsui | University of Washington | 206-744-1835 | tsuij@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2022 | Mar 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2022 | Mar 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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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).
| 6 months |
| 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). | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| Completion of HCV Treatment | The number/percent who complete treatment for HCV, defined as having received all planned medication doses. | 9 months |
| Sustained Virologic Response (SVR12) | SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion. | 12 months |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Initiation of HCV Treatment | The number/percent who initiate medications for HCV. | Not Posted | 6 months | Participants |
| 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). | Not Posted | 6 months | Participants |
| 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). | Not Posted | 6 months | Participants |
| 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). | Not Posted | 6 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Completion of HCV Treatment | The number/percent who complete treatment for HCV, defined as having received all planned medication doses. | Not Posted | 9 months | Participants |
| Other Pre-specified | Sustained Virologic Response (SVR12) | SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion. | Not Posted | 12 months | Participants |
| 1 |
| 40 |
| 2 |
| 40 |
| 0 |
| 40 |
| Death | Cardiac disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |