Simplified Isoniazid Preventive Therapy (SPIRIT) Strategy to Reduce TB Burden

摘要 撒哈拉以南地区艾滋病毒携带者未能使用异烟肼(INH)预防性治疗(IPT) 非洲是当今证据和实践之间最大的实施差距之一 应对艾滋病毒流行。在PLHIV中，结核病是主要的死亡原因，而IPT可使结核病发病率降低40%。 然而，在非洲，只有不到2%的符合条件的个人接受了IPT。鉴于这两个国家指导方针的存在 推荐IPT，以及识别符合IPT条件的人的简单临床算法，仍然是关键 扩大规模的要求是加强在大多数卫生系统中由中层管理人员调解的联系-- 卫生部的政策和诊所之间的关系。在乌干达，地区卫生官员(DHO)是关键的中间人 在政策和执行之间工作的管理人员。我们建议在全国范围内测试多个 针对DHO(我们认为是DHO)的组件“SPIRE”(简化异烟肼预防疗法)干预 批判性传播媒介。SPIRIT基于前面的行为改变模型，部署 易感(协作教学)；启用(INH/B6/Septrin单药组合和从DHO到 供应商)；以及加强(报告协作)组件。对于此次重新提交，我们提供数据以显示 SPIRT在5个DHO及其临床中的可行性研究。DHO参与了迷你- 协作并实施了SPIRIT的关键组件，包括向一线发送双向文本消息 供应商。HIV+成人IPT处方的数量从基线的零增加到8周的300。 目的1：确定精神干预是否增加了IPT的启动。我们将组成20个小组，每5个区 卫生官员随机选择10名精神干预者和10名对照(国家标准)组成一组- 随机试验。主要结果是符合IPT条件的成年人发起IPT的比例。对于第二级 结果，我们将衡量DHO和DHO对知识产权的知识、态度和做法的变化 前线卫生工作者评估干预措施取得成果的机制。 目的：评价精神干预对IPT完成率和结核病发病率的影响。即使是在 干预增加了IPT的使用，量化了患者对IPT的实际使用及其对人群健康的影响 状况(例如结核病的减少)提供了一项重要的影响衡量标准，使决策者能够确定优先事项 这一干预范围更广。将使用两阶段调查抽样方法来确定概率 符合IPT条件的患者样本，通过头发异烟肼水平(直接测量 药片消费量/依从性)和结核病发病率(人口健康衡量标准) 目标3：评估SPIRE的成本和成本效益。使用AIMS中获得的有效性度量 1和2，标准的时间和运动以及成本计算方法，我们将估计以下成本和成本效益 来自目标2的抽样人群的精神与护理标准。感兴趣的结果将包括计划 每项费用：a)开展计划外技术；b)完成计划外技术；以及c)避免结核病病例。

ABSTRACT The failure to use isoniazid (INH) preventative therapy (IPT) in persons living with HIV (PLHIV) in Sub-Saharan Africa represents one of the single biggest implementation gaps between evidence and practice in today's response to the HIV epidemic. In PLHIV, TB is a lead cause of death, and IPT reduces TB incidence by 40%. Yet in Africa, less than 2% of eligible individuals receive IPT. Given the existence of both country guidelines recommending IPT, as well as simple clinical algorithms to identify IPT eligible persons, a remaining critical requirement for scale-up is strengthening the link - mediated by middle management in most health systems - between health ministry policy and clinics. In Uganda, District Health Officers (DHOs) serve as key middle managers working at the nexus between policy and implementation. We propose to test a countrywide multi- component “SPIRIT” (Simplified INH Preventive Therapy) intervention targeting DHOs – whom we view as critical dissemination agents. SPIRIT is based on the PRECEDE model of behavioral change that deploys predisposing (teaching collaborative); enabling (INH/B6/septrin single pill combination and SMS from DHO to provider); and reinforcing (reporting collaborative) components. For this resubmission, we provide data to show feasibility of SPIRT through a pilot study of 5 DHOs and their clinics. The DHOs engaged in the mini- collaborative and implemented key components of SPIRIT including bidirectional text messaging to front line providers. The number of HIV+ adults prescribed IPT increased from zero at baseline to 300 at 8 weeks. Aim 1: Determine if the SPIRIT intervention increases IPT initiation. We will form 20 groups of 5 District Health Officers and randomize 10 to the SPIRIT intervention and 10 to control (country standard) in a cluster- randomized trial. The primary outcome is proportion of IPT-eligible adults initiating IPT. For secondary outcomes, we will measure changes in knowledge, attitudes and practices regarding IPT among DHOs and front line health workers to assess mechanisms through which the intervention achieves outcomes. Aim 2: Evaluate the effect of the SPIRIT intervention on IPT completion and TB incidence. Even if the intervention increases IPT use, quantifying actual use of IPT by patients and effects on population health status (e.g. reduction in TB), provides an important impact measure that can enable policy makers to prioritize this intervention more widely. A two-stage survey sampling approach will be used to identify a probability sample of patients eligible for IPT in which to measure adherence through hair levels of INH (direct measure of pill consumption/adherence) and TB incidence (population health measure) Aim 3: Assess the cost and cost-effectiveness of SPIRIT. Using effectiveness measures obtained in Aims 1 and 2, standard time and motion and costing methods, we will estimate the cost and cost-effectiveness of SPIRIT vs standard of care in our sampled population from Aim 2. Outcomes of interest will include program costs per: a) IPT initiation; b) IPT completion; and c) TB case averted.