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Hepatitis C Pharmacy-based Strategy for Injectors (HepPSI)

31 oktober 2022 uppdaterad av: Judith I. Tsui, University of Washington

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

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

40

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • University of Washington

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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")

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Community Pharmacy Program Successful Linkage
Tidsram: 6 months
The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Initiation of HCV Treatment
Tidsram: 6 months
The number/percent who initiate medications for HCV.
6 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Substance Use
Tidsram: 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).
6 months
HIV Drug Risk Behaviors
Tidsram: 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).
6 months
HIV Sex Risk Behaviors
Tidsram: 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).
6 months
Utilization of Other Community Pharmacy Services
Tidsram: 6 months
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
Tidsram: 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.
6 months
Completion of HCV Treatment
Tidsram: 9 months
The number/percent who complete treatment for HCV, defined as having received all planned medication doses.
9 months
Sustained Virologic Response (SVR12)
Tidsram: 12 months
SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Washington

Samarbetspartners

National Institute on Drug Abuse (NIDA)

Utredare

  • Huvudutredare: Judith I Tsui, MD, MPH, University of Washington

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 november 2020

Primärt slutförande (Förväntat)

30 juni 2023

Avslutad studie (Förväntat)

30 juni 2023

Studieregistreringsdatum

Först inskickad

24 november 2020

Först inskickad som uppfyllde QC-kriterierna

4 januari 2021

Första postat (Faktisk)

7 januari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 november 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 oktober 2022

Senast verifierad

1 oktober 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00010476
  • R34DA047660 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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