Clinical Trial of Short Course vs. INH for LTBI in Jail

由于囚犯的比例很大，监狱中的结核病是一个严重的问题。 潜伏性结核病感染(LTBI)和发展为活动性疾病的高风险人群。完成 LTBI的治疗在监狱中没有成功，主要是因为囚犯在之前经常被释放 完成6-9个月的标准疗程，每天服用异烟肼(INH)，因为他们的发生率很低 在社区完成治疗。LTBI的有效治疗与治疗时间和时间有关 抗LTBI药物的毒性。LTBI的短期疗法可能会解决这个问题，但它们 还没有得到充分的研究来回答有关副作用、完成率和总成本的问题。 我们提出了一项双臂开放标签随机试验，以测试短程治疗LTBI的疗效。 被监禁的囚犯；4个月内每天服用利福平，而9个月内每周服用两次异烟肼。一个 972名同意和登记的参与者将接受直接观察疗法(DOT) 在监狱里。研究方案包括到结核病诊所的链接，用于DOT出院后，以及密切的临床和实验室 在整个治疗过程中进行监测。参与者将被跟踪，在监狱里和获释后，例如 登记后一年，衡量三个结果：毒性、依从性和成本效益。毒性 将由研究小组分析导致停药的原因，并检查其他预测因素，如 将比较年龄、饮酒以及乙肝和丙型肝炎的依从性，以完成治疗为衡量标准。 将按研究小组和其他预测因素进行检查，包括社会人口统计变量、意向 坚持住有所居、住有所稳。成本效益将按研究小组进行比较并进行计算 使用管理和监测护理的直接成本以及在这一人群中重新开始护理的成本 根据预防结核病病例的成本衡量，再次逮捕率很高。 短期疗程疗法在囚犯群体中治疗LTBI和消除进展风险方面很有希望 到活动性疾病。这项研究将回答有关利福平与异烟肼的安全性问题。 对该方案的治疗完成率和成本-效果的分析将为 监狱中LTBI管理方式的政策变化。

Tuberculosis (TB) in incarcerated populations is a serious problem, due to the large proportion of inmates who are at high risk of having latent tuberculosis infection (LTBI) and developing active disease. Completion of treatment of LTBI has not been successful in jails, mainly because inmates are frequently released before finishing a 6-9 month course of standard therapy with daily isoniazid (INH), and because they have low rates of completing therapy in the community. Effective treatment of LTBI is complicated by length of therapy and toxicity of the drugs used against LTBI. Short-course therapies for LTBI may address this problem but they have not been studied adequately to answer questions about side effects, completion rates, and overall cost. We propose a two arm, open label randomized trial to test the effects of a short-course therapy for LTBI in jailed inmates; rifampin given daily for 4 months as compared to INH given twice weekly for 9 months. A sample of 972 consented and enrolled participants will be administered directly observed therapy (DOT) in jail. The study protocol includes links to the TB Clinic for post-release DOT, and close clinical and laboratory monitoring throughout the course of therapy. Participants will be followed, in jail and after release, for one year after enrollment, to measure three outcomes: toxicity, adherence, and cost-effectiveness. Toxicity leading to stopping drug will be analyzed by study group, and other predictors will be examined, such as age, alcohol use and hepatitis B and C. Adherence, measured by completion of therapy, will be compared by study group, and other predictors will be examined, including sociodemographic variables, intent to adhere, and stability of housing. Cost-effectiveness will be compared by study group and will be calculated using direct costs of administering and monitoring care and costs of re-starting care in this population with a high rate of re-arrest, measured against the cost of prevented cases of TB. Short course regimens are promising in the inmate population to treat LTBI and eliminate risk of progression to active disease. This study will answer questions about the safety of rifampin compared directly to INH. Analysis of completion of therapy and cost-effectiveness of this regimen will provide important information for policy change in the way LTBI is managed in jail.