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临床试验/NCT04499651
NCT04499651终止不适用

Adaptation and Testing of a Navigation Intervention for Hepatitis C and HIV Co-infected Persons Leaving LA County Jail

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Undetectable Hepatitis C RNA

研究概览

简要总结

This study will evaluate the efficacy of navigation for hepatitis C treatment in people living with both HIV and HCV with criminal justice involvement.

详细描述

Hepatitis C (HCV) is the most common chronic, blood-borne infection in the U.S. and, untreated, can result in liver failure and liver cancer. Despite advances in treatment and remarkable improvements in cure rates, very few persons with chronic HCV infection are receiving this treatment, especially among people who use drugs, who are also disproportionately HIV-infected and incarcerated. Existing efforts to ensure linkage to and retention in medical care following release from incarceration among people living with both HIV and HCV are generally insufficient. Increasing treatment engagement following release from incarceration can drastically reduce HCV and HIV in the blood, which can limit transmission to sexual and injection drug use partners.

The goal of this study is to evaluate the effect of a novel navigation intervention to improve HIV/HCV treatment engagement among HIV/HCV co-infected adults with criminal justice involvement. The investigators hypothesize that the navigation intervention is more effective than the current standard-of-care approaches to link this population of adults to HIV/HCV treatment. All participants, regardless of study arm, will complete one baseline interview around the time of study enrollment. Follow-up interviews are done at 3 months and 8 months following enrollment (if enrolled in the community) or after release from jail (if enrolled in the jail).

Blood samples to analyze the HCV RNA will be collected or requested from participants' clinics both for the baseline assessment and the assessment conducted 12 weeks after completion of the HCV treatment course (if the HCV RNA result cannot be obtained at 12 weeks, it will done at the 8-month follow-up interview). HIV RNA will be collected from the clinics.

In addition to the interviews and the HCV/HIV RNA assessments, participants assigned to the intervention arm will engage in a six- or seven-session navigation intervention. Participants will be in the study for about 12 months but no more than 3 years.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •(if recruited in jail)
  • •Diagnosed HIV+/HCV co-infection;
  • •18 years of age or older;
  • •non-cis women;
  • •Fluent in speaking English;
  • •Have an anticipated sentence of no more than 12 months;
  • •Have detectable Hepatitis C viral load
  • •Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County
  • •If recruited outside of jail:
  • •Diagnosed HIV+/HCV co-infection;
  • •18 years of age or older;
  • •non-cis women;
  • •Fluent in speaking English;
  • •Incarceration history within the last 12 months of enrollment;
  • •Have detectable Hepatitis C viral load
  • •Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

排除标准

  • •Inability to give informed consent
  • •CD4 count<200

研究组 & 干预措施

Control

No Intervention

All people who are living with HIV who are currently in custody in the Los Angeles County Jail are provided with Transitional Case Management and may also receive Whole Person Care related services regardless of participation in this study. Participants recruited from clinics who do not enroll in the study will be offered HIV/HCV care that follows the national HIV/HCV care guidelines, as provided by participating study clinics. Participants recruited from non-medical community agencies who do not enroll in the study and do not have a regular provider will receive a referral list of HIV/HCV care facilities that follow the national HIV/HCV care guidelines.

Navigation

Active Comparator

Participants will be paired with a navigator and will complete the following didactic sessions in one-on-one format:

  1. Session 1: Intervention Overview and Basic HIV/HCV Knowledge and Skills Builder
  2. Session 2: Rapport Building
  3. Session 3: Society and Self and the Role of Disclosure
  4. Session 4: Accompaniment 1
  5. Session 5: Goal-Setting, Problem-Solving and a Disclosure Toolkit
  6. Session 6: Accompaniment 2
  7. Session 7: Accompaniment 3 (ONLY if needed)
  8. Weekly check-in calls following Session 2 for six months

干预措施: Navigation (Behavioral)

结局指标

主要结局

Undetectable Hepatitis C RNA

时间窗: 8 months

Undetectable Hepatitis C RNA

Undetectable HIV RNA

时间窗: 8 months

HIV RNA \<40 copies/ml

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Goodman-Meza, MD

Principal Investigator

University of California, Los Angeles

研究点 (1)

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