Transforming the Cascade Of Hepatitis C Care
Transforming the Cascade of Hepatitis C Care
Several factors are barriers to effective Hepatitis C care: 1) The majority of Hepatitis C Virus (HCV)-positive patients (45-85 percent) are unaware that they are infected; 2) Only a small minority of those in need of treatment receive it; 3) Members of minorities and older patients are even less likely to receive needed care; and 4) Until recently, even those who were treated had a low chance of clearing the virus or achieving cure; 5) It is possible that older attitudes and expectation of futility might continue to persist among patients and provider in primary care settings.
Community Health Centers are often the most culturally appropriate and accessible choices, particularly for underserved populations, with the benefit of ongoing trust and relationships with patients. Therefore, these can be ideal places to deliver complex HCV care if they possess the needed expertise. However, most community-based primary care and community health centers lack access to Hepatitis C evaluation and treatment services, leading to a major public health problem.
Thus, investigators propose to implement and evaluate a pragmatic trial to implement and evaluate a multi-disciplinary model for HCV treatment at Currently, the treatment initiation rates at each of these sites is estimated as less than 10%. The investigators hypothesize that our project will increase the rate of participation in all the steps of the HCV care cascade and ultimately lead to more than doubled rates of treatment uptake
연구 개요
상태
정황
상세 설명
Primary Objective:
Determine uptake, effectiveness and safety of IFN-free, DAAs among "real world" patients, including those with multiple comorbidities, in the primary care setting.
Secondary Objective(s):
- Demonstrate the transformation of the cascade of Hepatitis C Care at 3 primary care clinics in terms of changes from baseline in rates for rates of access to HCV care including HCV screening, evaluation, treatment consideration, treatment uptake, completion, loss to follow-up, and treatment success rate.
- Advance understanding of hepatitis C related decision-making in the era of Interferon (IFN)-free Direct acting agents (DAAs) by examining the context, needs, motivators, barriers, and preferences among patients and providers to the delivery of hepatitis C treatment at primary care clinics
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15232
- UPMC Shadyside Family Health Center
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers
Exclusion Criteria:
- Criteria for automatic specialty referral (exclusion from treatment at community health centers) Child Turcotte Pugh Class B or C Any history of decompensated liver disease or hepatocellular carcinoma Evidence of renal disease (GFR <50) or coexisting autoimmune condition HIV of hepatitis B co-infection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period.
기간: three years
|
measure percentage of patients moving through the cascade of care to cure of condition (SVR 12)
|
three years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rates of Hepatitis C Virus (HCV) screening
기간: three years
|
Percentage of at risk patients in the practice who have a completed HCV antibody test
|
three years
|
|
Rate of Chronic Hepatitis C evaluation
기간: three years
|
Percentage of patients with a positive HCV antibody test who have a HCV polymerase chain reaction (PCR) viral load completed
|
three years
|
|
Rate of treatment consideration
기간: three years
|
Percentage of consented patients with a positive HCV viral load who have a clinical evaluation and assessment of psychosocial readiness for treatment documented in the medical record
|
three years
|
|
Rate of treatment uptake
기간: three years
|
Percentage of patients recommended for treatment who begin medical treatment
|
three years
|
|
Rate of treatment completion
기간: three years
|
Percentage of patients that began treatment who complete the recommended course of therapy
|
three years
|
|
Rate of patients lost to follow up
기간: three years
|
Percent of consented patients with a positive HCV viral load who are lost to follow up
|
three years
|
|
Hepatitis C capacity building among family medicine physicians (provider practice and perceived confidence):
기간: three years
|
Endpoints related to HCV capacity building among family medicine physicians: Evaluate comfort and skill among family physicians to evaluate and treat HCV infection as measured on a qualitative survey of physicians
|
three years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- PRO16040427
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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