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- Klinische proef NCT04698629
Hepatitis C Pharmacy-based Strategy for Injectors (HepPSI)
Pilot Study of a Community-Pharmacy Model to Expand Access to Medications to Treat and Prevent Hepatitis C, Opioid Use Disorders, Overdose and HIV Among Persons Who Inject Drugs
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- University of Washington
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- >18 years old
- Reports injecting drugs with 90 days of screening
- Positive HCV test documented (screening antibody test or viral load test)
- Not currently taking medications to treat HCV, and never previously treated with direct-acting antivirals (DAAs) for HCV
- Willing to undergo evaluation for HCV through a community pharmacy program and work with Patient Navigators
- Provides release of information (ROI) to access community pharmacy program records and/or other HCV treatment providers
Exclusion Criteria:
- People who plan to leave the Seattle area within 6 months
- Who do not wish to be treated for their HCV infection
- Who are known to be pregnant
- Who report impending incarceration that would disrupt clinical care
- Who are not comfortable reading and speaking English
- Who report being HIV-positive
- Who report having end-stage renal disease or require dialysis treatments
- 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")
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Community Pharmacy Program Successful Linkage
Tijdsspanne: 6 months
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The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Initiation of HCV Treatment
Tijdsspanne: 6 months
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The number/percent who initiate medications for HCV.
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6 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Substance Use
Tijdsspanne: 6 months
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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).
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6 months
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HIV Drug Risk Behaviors
Tijdsspanne: 6 months
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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).
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6 months
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HIV Sex Risk Behaviors
Tijdsspanne: 6 months
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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).
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6 months
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Utilization of Other Community Pharmacy Services
Tijdsspanne: 6 months
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The number/percent who receive of other medications (naloxone, PrEP, and medications to treat OUD) via the community pharmacy program.
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6 months
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Participant Satisfaction and Referral to the Community Pharmacy Program
Tijdsspanne: 6 months
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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.
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6 months
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Completion of HCV Treatment
Tijdsspanne: 9 months
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The number/percent who complete treatment for HCV, defined as having received all planned medication doses.
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9 months
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Sustained Virologic Response (SVR12)
Tijdsspanne: 12 months
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SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.
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12 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Judith I Tsui, MD, MPH, University of Washington
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00010476
- R34DA047660 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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