HCV-ACCELERATE Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Linkage to Care
研究概览
简要总结
The overarching goal of this study is to develop a peer-based care coordination intervention for individuals with Hepatitis C Virus (HCV) who were recently released from correctional settings to promote linkage to and retention in HCV care. The investigators will assess the existing barriers and facilitators of HCV treatment initiation, HCV treatment completion, and sustained virologic response among individuals recently released from a U.S. jail or prisons in a randomized control trial. This study will assess the feasibility and process measures of a peer-enhanced HCV care coordination intervention among recently incarcerated individuals.
详细描述
The proposed 2-year study will be a block stratified, randomized controlled trial. Once consented and enrolled, participants will be randomly assigned to either the peer-enhanced intervention or referred to standard clinical care. The investigators will enroll 80 former inmates with chronic HCV who have been released from incarceration within the past 6 months. It is expected that enrollment will be completed by the fourth quarter of the first year. This will allow sufficient time for HCV treatment uptake, completion, determination of Sustained Virologic Response (SVR), and assessment of reinfection. Individual participant follow-up will be 3 months on average for treatment, 3 months for SVR, and 3 months to assess for reinfection.
Elucidating the barriers and facilitators in the re-entry care cascade (as well as how they may be overcome) will be critical in designing sustainable models of care for HCV-infected former inmates. The investigators hypothesize that a peer-enhanced strategy will be more effective than standard referral in improving linkage to, and retention in, HCV care among individuals recently released from correctional settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
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
- •currently incarcerated or recently released from a U.S. jail or prison (6 months)
- •Chronic HCV with documented detectable viral load
- •18 years old
- •Fluent in English or Spanish
- •Resident of the Upstate area of South Carolina
排除标准
- •Unable to sign informed consent
- •Life expectancy of less than 1 year
- •Plans to relocate from the Upstate area of South Carolina in the next 6 months
研究组 & 干预措施
Standard of care
If randomized to the standard of care intervention, the participant will only receive passive referral to HCV-care.
干预措施: Standard of care (Behavioral)
Peer-enhanced intervention
Those randomized to the peer-enhanced intervention group will be contacted by a peer mentor within 72 hours of enrollment to discuss the early release period, readiness for HCV treatment, and identify ancillary needs. Individuals randomized to this arm will be provided a study cell phone.
干预措施: Peer mentor (Behavioral)
结局指标
主要结局
Linkage to Care
时间窗: 6 months
Linkage to care is defined as having a visit with an HCV treatment provider after release. Electronic Medical record (EMR) data will be extrapolated to evaluate this outcome. Results will be summarized by study arm using descriptive statistics.
次要结局
- Hepatitis C Virus (HCV) Reinfection(12 months after treatment completion)
- Sustained Virologic Response (SVR)(3 months after treatment completion)
- Time to HCV Treatment Initiation(Up to 3 months after linkage to care)
- Time to HCV Treatment completion(Up to 3 months after treatment initiation)
- Reincarceration Rate(Up to 24 weeks (~6 months))
- Emergency Department (ED) Utilization(Up to 24 weeks (~6 months))
- Hospitalizations(Up to 24 weeks (~6 months))
- Number of Participants with Detectable Hepatitis C Virus (HCV) Reinfection(12 months after treatment completion)
- Time to HCV Treatment Initiation(up to 3 months after linkage to care)
- Time to HCV Treatment completion(up to 3 months after treatment initiation)
- Reincarceration Rate(Up to 24 weeks (~ 6 months))
- Emergency Department (ED) Utilization(Up to 24 weeks (~ 6 months))
- Hospitalization Rate(Up to 24 weeks (~ 6 months))