Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response (SVR) in the community linkage arm
研究概览
简要总结
Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease. However, despite availability of effective treatment, people who experience incarceration are often unable to access this curative therapy, and are often not readily engaged in medical care upon release. This perpetuates transmission and progression of disease in an incredibly high risk, marginalized population. Therefore, in order to effectively eliminate HCV, it is imperative that the epidemic of HCV in prisons is addressed, and that models of care are established for treatment of HCV in incarcerated individuals, both during and after incarceration.
As such, the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison. This care is provided in conjunction with collocated services to prevent HCV reinfection, including opioid agonist therapy. This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals, while simultaneously treating opioid use disorder and preventing HCV reinfection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years old
- •Able and willing to sign informed consent
- •For the community linkage arm: Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
- •For the community linkage arm: ineligible for treatment through the prison/jail without a known sentence longer than 9 months, as of consent date
- •For the in-prison arm: Achievement of SVR through the previous standard of care treatment through the DOC
排除标准
- •Decompensated cirrhosis (Child-Pugh B or C)
- •Pregnant or breastfeeding women
- •For community linkage arm: Prior treatment with a direct acting antiviral regimen
- •For community linkage arm: Any co-medications that are contraindicated or not recommended for concomitant use with glecaprevir-pibrentasvir
- •Poor venous access not allowing screening laboratory collection
- •Have any condition that the investigator considers a contraindication to study participation
研究组 & 干预措施
Community Linkage - Rapid Initiation Arm
The rapid initiation group will receive HCV medication immediately upon release from prison/jail.
干预措施: Glecaprevir/pibrentasvir (Drug)
Community Linkage - Clinic-Based Initiation Arm
The group will receive medication after attending first ANCHOR clinic visit.
干预措施: Glecaprevir/pibrentasvir (Drug)
结局指标
主要结局
Sustained Virologic Response (SVR) in the community linkage arm
时间窗: 6 months after treatment
Absence of plasma HCV RNA levels 70 days or greater after completing direct acting antiviral therapy.
次要结局
- OAT uptake Rates(12 months)
- Retrospective rates of SVR in the In prison arm(6 months after treatment)
- Treatment Initiation Rates(6 months)
- HCV Reinfection Rates(24 months)
- Comparison between Rapid Initiation and Clinic-base Initiation(24 months)
研究者
Elana Rosenthal
Assistant Professor
University of Maryland, Baltimore