A Pilot Trial of Directly Observed Anti HCV Therapy Supported With Contingency Management in a Population on Opiate Substitute Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Tayside
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- The number of patients reaching a sustained virological response in the pharmacist -led arm, as compared with the current treatment pathway for patients receiving opiate substitution therapy
研究概览
简要总结
DOT-C is a cluster randomised trial of a pharmacist-led, directly observed anti HCV therapy pathway versus the conventional care pathway within community pharmacies. The primary trial outcome is to evaluate the effect of pharmacist-led anti-HCV directly observed therapy on the proportion of patients reaching a sustained virological response.
详细描述
DOT-C is a cluster randomised trial of a pharmacist-led, directly observed anti HCV therapy pathway versus the conventional care pathway within 8 community pharmacies. Patients attending an individual pharmacy are the cluster. Pharmacies who are participating in the trial will be allocated to the pharmacist-led pathway or the conventional care pathway. The pilot trial aims to recruit 40 patients into the both the pharmacist-led and the conventional care pathways.
Approximately 2,000 patients are prescribed OST within the Tayside region of North East Scotland. Around 85% of these patients receive daily or regular supervision of their OST consumption through one of the 92 community pharmacies. It is expected that at least 40% of these patients will be infected with HCV and that around 40% of infections will be with Genotype 1 virus. The 8 pharmacies acting as cluster sites for this trial have around 400 patients attending for supervised OST administration.
Design: This is a cluster randomised trial of directly observed anti HCV therapy versus conventional care in HCV positive patients, who are in a pharmacist delivered OST program, where the patients attending an individual pharmacist are the cluster. Pharmacies participating in the trial will be allocated to conventional care pathway or the DOT pathway.
Entry into the trial will be following a positive HCV test at which stage the patient will be allocated to a pathway, dependent on the pharmacy they are attending. The pathways are:
- Pharmacy DOT
- Conventional care pathway
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV PCR positive to genotype 1
- •On Opioid Substitution Therapy dispensed and with supervised administration by pharmacist
排除标准
- •HCV PCR positive to any genotype other than genotype 1
- •Evidence of current or previous decompensated liver disease
- •HIV infection
- •HBsAg positive with detectable HBV DNA
- •Aggressive or violent behaviour
- •Inability to provide informed consent
- •Pregnancy or breast feeding
研究组 & 干预措施
Pharmacist-Led Pathway
Assessment & Treatment of HCV infection with oral antivirals in a community pharmacy pathway
干预措施: Assessment & Treatment of HCV infection with oral antivirals (Procedure)
Conventional Care Pathway
Assessment & Treatment of HCV infection with oral antivirals in a conventional care pathway
干预措施: Assessment & Treatment of HCV infection with oral antivirals (Procedure)
结局指标
主要结局
The number of patients reaching a sustained virological response in the pharmacist -led arm, as compared with the current treatment pathway for patients receiving opiate substitution therapy
时间窗: Sustained Virological response will be assessed at 12 weeks post completion of therapy
Participants who complete the pathway and undertake a test for viral clearance
次要结局
- Cost effectiveness of the pharmacist DOT pathway as compared with the conventional care pathway(One Year post trial completion)
- Comparison of rate of HCV testing rates in pharmacist pathway compared with current pathway(Sustained Virological response will be assessed at 12 weeks post completion of therapy)