跳至主要内容
临床试验/NCT03564639
NCT03564639已完成不适用

Hepatitis C Reinfection in an Injection Drug Using Population in Kenya: A Follow-up to the TLC-IDU Hepatitis C V Supplement Study.

Yale University1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Examine usage of needle exchange programs

研究概览

简要总结

The goal of this research project is to build upon the Testing and Linkage to Care for Injecting Drug Users (TLC-IDU) parent study and describe post-cure HCV reinfection in a population of people who inject drugs (PWIDs) in Kenya.

详细描述

In addition to describing reinfection in a substance using cohort, we will identify individual predictors of HCV reinfection in Kenya, as well as identifying individual utilization intervention approaches and dosing that reduce reinfection risk and treatment cite level risk factors (frequency of visits, community vs hospital location etc.). Determining the risk factors specific to reinfection and understanding the impact of concurrent harm reduction interventions will guide service delivery and implementation of HCV elimination strategies in Kenya and throughout the region.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Live in Nairobi or coastal Mombasa (Coast Province including Malindi), Kenya;
  • Are injection drug users (IDUs) that ever injected any non-prescribed drugs; and able and willing to provide informed consent.
  • Participates are in the parent study;
  • Complete treatment protocol; and achieve a sustained virologic response (SVR).

排除标准

  • Not in the above inclusion criteria.

结局指标

主要结局

Examine usage of needle exchange programs

时间窗: 12 months

Brief questionnaire on services used

Evaluate psychoeducational counseling

时间窗: 12 months

Brief questionnaire on knowledge, attitude and beliefs of each participant.

HCV Reinfection

时间窗: 6-18 months post sustained virologic response (SVR) to HCV treatment.

The reinfection of patients with hepatitis C after completion of a previous HCV infection treatment.

Examine usage of methadone maintenance

时间窗: 12 months

Brief questionnaire on services used

次要结局

  • HCV reinfection referrals for treatment at Kenyetta National Hospital(9-16 months post treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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