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临床试验/NCT03740906
NCT03740906已完成不适用

Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting (The SHARP-P Study)

Kirby Institute1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2019年9月6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
202
试验地点
1
主要终点
To evaluate the incidence of HCV reinfection following successful DAA therapy among people with chronic HCV infection and recent injecting drug use in the prison setting.

研究概览

简要总结

SHARP-P is an observational cohort study investigating the effect of direct-acting antiviral (DAA) therapy and reinfection in people with chronic hepatitis C virus (HCV) and recent injecting drug use. A prospective, observational cohort design will be used to enrol patients from correctional centres in New South Wales, Australia.

Participants will be prescribed a direct-acting HCV medication as per the standard of care. The on treatment phase will vary dependent on the type of a direct-acting antiviral prescribed as per the standard of care. Once patients have completed their treatment course they will be followed up every 3 months for up to 3 years following the end of treatment phase.

The study will aim to evaluate the incidence of HCV reinfection following successful DAA treatment over the three years of follow up. The study will also evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) with direct-acting anti-viral HCV therapy.

详细描述

In Australia, hepatitis C virus (HCV)-related morbidity and mortality have doubled in the past decade, with health care costs of $220 million per annum associated with approximately 200,000 chronically infected cases. The majority of new (90%) and existing (80%) cases of HCV infection occur among people who inject drugs (PWID).

As there is a close relationship between imprisonment, injecting drug use, and HCV, in any given year, almost 20,000 of those with chronic HCV in Australia spend time in prison, including approximately 8,000 in New South Wales (NSW). These individuals are likely to represent the most marginalised and 'hard-to-access' subgroup of the affected population. In addition, the prison environment is a key venue for ongoing transmission. Amongst PWID in the prison setting the report of any injecting drug use decreased from 71% prior to prison entry to 27% following imprisonment. However, among people who reported injecting drug use, the proportion reporting sharing a needle/syringe increased from 29% prior to prison entry to 73%. In the community, 15-20% of current PWID report recent (last month) receptive needle/syringe sharing.

In prison, where there is no access to formal needle and syringe programs, sharing injecting equipment can be normative with inmates' accounts of injecting practice revealing few ways that they can minimise HCV risk. Establishing effective disease prevention in the prison context is challenging, as prisons are unique in physical structure, and prisoners form a distinct micro-society with their own rules and regulations. Many health problems amongst prisoners arise directly from conditions of imprisonment such as overcrowding, uncontrolled exposure to violence and illicit drugs, lack of purposeful activity, separation from family networks and emotional deprivation.

The existing strategies for HCV prevention in NSW prisons are delivered by Justice Health & Forensic Mental Health and Corrective Services. Justice Health & Forensic Mental Health provides a targeted screening program for blood-borne virus infection with pre- and post-test counselling, and opioid substitution treatment (OST) for those who are opioid dependent. Corrective Services provides bleach (or the quaternary amine disinfectant, Fincol) to clean used syringes. NSP is not available.

Despite these efforts, in the Hepatitis C Incidence and Transmission Study in prisons (HITS-p; n=590) led by CI-Lloyd, half of the cohort (49%) of PWID reported injecting drug use during follow-up in prison and 31% reported sharing injecting equipment. HCV incidence was 14.1/100 p-yrs (95% CI: 9.96, 19.3). There was no apparent protective effect of bleach cleansing or OST, highlighting the additional challenges of HCV prevention in the custodial setting.

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

  • Participants have voluntarily signed the informed consent form.
  • Be ≥18 years of age on day of signing informed consent form.
  • Have chronic HCV infection.
  • Report of recent injecting drug use (within the previous 6 months).
  • Eligible for DAA therapy as per the PBS
  • HIV-1 infected participants enrolled in the study must meet the following additional criteria:
  • Have HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
  • Be on HIV Antiretroviral Therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the intended DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/) OR be naive to treatment with any antiretroviral therapy (ART) with a baseline CD4 count of >200 and have no plans to initiate ART treatment while participating in this study and through to at least Follow-up Week 4.

排除标准

  • The participant will be excluded from participating in the study if the subject is unable or unwilling to provide informed consent or abide by the requirements of the study.

结局指标

主要结局

To evaluate the incidence of HCV reinfection following successful DAA therapy among people with chronic HCV infection and recent injecting drug use in the prison setting.

时间窗: 3 years

次要结局

  • To evaluate the proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following DAA HCV therapy among PWID with chronic HCV infection and recent injecting drug use(2.5 years)
  • To evaluate the proportion of participants who complete treatment(3 years)
  • To evaluate the proportion of participants with undetectable HCV RNA at the end of treatment(3 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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