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临床试验/NCT04428346
NCT04428346Unknown不适用

A Pilot Two-arm, Individual-level, Randomised Controlled Trial to Assess the Effect of an Intervention Integrating Contingency Management (Financial Incentives) to Enhance Hepatitis C Treatment Uptake Following Dried Blood Spot Hepatitis C RNA Testing Among People With Recent Injecting Drug Use Attending Needle and Syringe Programs

Kirby Institute0 个研究点目标入组 400 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
主要终点
The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing

研究概览

简要总结

A pilot two-arm, individual-level, randomised controlled trial to assess the effect of an intervention integrating contingency management (financial incentives) to enhance hepatitis C treatment uptake following dried blood spot hepatitis C RNA testing among people with recent injecting drug use attending needle and syringe programs: the AMPLIFY study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

Participants will be randomised with a computerised random number generator (or random number table) with block randomisation to assist with keeping participant balance between study arms with a small sample size.

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

  • Participants have voluntarily signed the informed consent form
  • 18 years of age or older
  • Recent injecting drug use (previous six months)

排除标准

  • Inability or unwillingness to provide informed consent

结局指标

主要结局

The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing

时间窗: 6 months

Data will be presented in percentages and mean (SD) or median values (interquartile range), as appropriate. Chi square test or Fisher's exact test will be utilised, as appropriate, to examine between group differences.

次要结局

  • Feasibility of recruitment through a peer-based referral incentivization scheme(6 months)
  • Time to HCV treatment initiation(6 months)
  • Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire(6 months)
  • Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake(6 months)
  • Time to HCV treatment completion(6 months)
  • Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

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