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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98104
- University of Washington
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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")
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Community Pharmacy Program Successful Linkage
時間枠:6 months
|
The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Initiation of HCV Treatment
時間枠:6 months
|
The number/percent who initiate medications for HCV.
|
6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Substance Use
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:9 months
|
The number/percent who complete treatment for HCV, defined as having received all planned medication doses.
|
9 months
|
Sustained Virologic Response (SVR12)
時間枠:12 months
|
SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.
|
12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Judith I Tsui, MD, MPH、University of Washington
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00010476
- R34DA047660 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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