Scaling up HPTN 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam

项目摘要 注射毒品的艾滋病毒感染者（PWID）不太可能参与艾滋病毒护理和使用抗逆转录病毒药物 抗逆转录病毒疗法（ART）比其他艾滋病毒感染者群体。在艾滋病毒预防试验网络（HPTN）074中， 结合系统导航和心理社会咨询（SNaP）的综合干预非常有效 在增加艾滋病毒感染者的抗逆转录病毒治疗、病毒抑制和药物辅助治疗（MAT）方面， 感染的PWID值得注意的是，SNaP也降低了死亡率。不幸的是，SNaP，像许多基于证据的 如果在执行方面存在障碍， 这些弱势群体没有得到解决。在这项研究中，我们建议比较两种实现方式， SNAP的战略-两者都是基于干预映射的概念。干预映射是一种 正式的多步骤流程，结合理论、证据和利益相关者的观点来选择方案包 解决EBI实施障碍的实施策略。定制干预映射 通过结合特定地点的障碍评估和当地定制的 执行战略。我们的具体目标是：1）比较定制的干预映射（TIM）， 在越南全国42个艾滋病毒检测点推广SNaP标准实施图; 2） 衡量越南实施SNaP的TIM与IM相比的增量成本;以及3）探索 在每个研究组中，SNaP实施的高性能和低性能HIV检测点的关键特征。 目的1，我们将进行一项两组、务实、分组随机对照实施试验，比较IM， 通过干预绘图确定的标准、一刀切的多方面实施方案，以及 TIM是在中央和地方两级利用干预绘图专门制定的一揽子实施方案。的 主要结果包括SNaP干预的保真度（实施）和ART吸收（有效性）。 次要实施结果包括渗透率、可接受性和成本;次要有效性 结果包括病毒抑制和MAT摄取。主要成本效益结果（目标2）将是 增量成本-效果比，表示为每增加一次抗逆转录病毒治疗的增量成本， 比较TIM和IM。在试验完成后，我们将探讨高性能和低性能的特点， 使用定性和定量数据的艾滋病毒检测点（目标3）。这项研究将为 HPTN 074干预措施、SNaP以及其他EBI的全球实施。重要的是，该指南将 不依赖于TIM相对于IM的优效性，但将提供积极或消极的信息 对比有了这些信息和指导，HPTN 074的成功将在全球范围内复制。

PROJECT SUMMARY HIV-infected people who inject drugs (PWID) are less likely to engage in HIV care and use antiretroviral therapy (ART) than other groups of HIV-infected people. In HIV Prevention Trials Network (HPTN) 074, an integrated intervention combining systems navigation and psychosocial counseling (SNaP) was highly effective in increasing ART uptake, viral suppression, and medication-assisted treatment (MAT) uptake among HIV- infected PWID. Remarkably, SNaP also reduced mortality. Unfortunately, SNaP, like many evidence-based interventions (EBI), may fail to achieve its full potential at the population level if barriers to implementation with this vulnerable population are not addressed. In this study, we propose to compare two implementation strategies for SNaP—both are based on the concept of Intervention Mapping. Intervention Mapping is a formalized multistep process incorporating theory, evidence, and stakeholder perspectives to select a package of implementation strategies that addresses barriers to EBI implementation. Tailored Intervention Mapping expands upon Intervention Mapping by incorporating site-specific barrier assessment and locally tailored implementation strategies. Our specific aims are: 1) To compare tailored Intervention Mapping (TIM) to standard Implementation Mapping (IM) to scale-up SNaP in 42 HIV test sites throughout Vietnam; 2) To measure the incremental costs of TIM compared to IM for SNaP implementation in Vietnam; and 3) To explore the key characteristics of high and low performing HIV test sites for SNaP implementation in each study arm. In Aim 1, we will conduct a two-arm, pragmatic, cluster randomized controlled implementation trial comparing IM, a standard, one-size fits all multi-faceted implementation package identified through Intervention Mapping, and TIM, a tailored implementation package using Intervention Mapping at both central and local levels. The primary outcomes include fidelity of the SNaP intervention (implementation) and ART uptake (effectiveness). Secondary implementation outcomes include penetration, acceptability, and cost; secondary effectiveness outcomes include viral suppression and MAT uptake. The primary cost-effectiveness outcome (Aim 2) will be the incremental cost-effectiveness ratio, expressed as the incremental cost per incremental ART uptake, comparing TIM to IM. Upon completion of the trial, we will explore characteristics of high and low performing HIV test sites (Aim 3) using both qualitative and quantitative data. This study will provide guidance for the global implementation of the HPTN 074 intervention, SNaP, as well as other EBI. Importantly, this guidance will not depend on the superiority of TIM relative to IM, but will be informative with a positive or a negative comparison. With this information and guidance, the success of HPTN 074 will be replicable worldwide.