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

扩大 HPTN 074：越南吸毒者抗逆转录病毒治疗循证干预的整群随机实施试验

• 批准号: 10430161
• 负责人: VIVIAN F. GO
• 金额: $ 91.09万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10430161
• 关键词: Address; Anti-Retroviral Agents; Caring; Characteristics; Climate; Confidence Intervals; Counseling; Data; Decision Making; Development; Effectiveness; Ensure; Environment; Evidence based intervention; HIV; HIV Infections; HIV diagnosis; HIV prevention trials network; Health; Human immunodeficiency virus test; Indonesia; Injecting drug user; Intervention; Left; Level of Evidence; Measures; Morbidity - disease rate; Newly Diagnosed; Outcome Assessment; Patient Self-Report; Penetration; Persons; Population; Positioning Attribute; Process; Provider; Randomized; Readiness; Resource-limited setting; Site; System; Target Populations; Testing; Ukraine; Vietnam; Viral; Vulnerable Populations; antiretroviral therapy; arm; base; care systems; cost; cost effective; cost effectiveness; cost efficient; cost-effectiveness ratio; effectiveness outcome; evidence base; experience; flexibility; implementation barriers; implementation cost; implementation evaluation; implementation intervention; implementation outcomes; implementation process; implementation strategy; implementation trial; improved; incremental cost-effectiveness; intervention mapping; medication-assisted treatment; microcosting; mortality; primary outcome; psychosocial; scale up; stakeholder perspectives; standard of care; substance use treatment; success; theories; transmission process; treatment response; trial comparing; uptake

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.

项目总结 注射毒品的艾滋病毒感染者(PWID)不太可能从事艾滋病毒护理和使用抗逆转录病毒药物 治疗(ART)比其他人群的艾滋病毒感染者更多。在艾滋病毒预防试验网络(HPTN)074中， 将系统导航和心理社会咨询(SNAP)相结合的综合干预非常有效 在艾滋病毒-艾滋病患者中增加抗逆转录病毒药物的摄入量、病毒抑制和药物辅助治疗(MAT)的摄入量 受感染的PWID。值得注意的是，Snap还降低了死亡率。不幸的是，Snap，就像许多基于证据的 干预措施(EBI)可能无法在人口层面充分发挥其潜力，如果 这一弱势群体没有得到解决。在本研究中，我们建议比较两种实现 Snap的策略-两者都基于干预映射的概念。干预映射是一种 整合理论、证据和利益相关者观点以选择包的形式化多步骤流程 制定实施战略，解决实施EBI的障碍。量身定制的干预地图 通过结合特定地点的障碍评估和当地定制来扩展干预地图 实施战略。我们的具体目标是：1)将定制干预映射(TIM)与 标准实施图(IM)，以在越南全国42个艾滋病毒检测地点扩大规模；2) 衡量在越南实施Snap的TIM与IM的增量成本；以及3)探索 在每个研究ARM中实施Snap的高性能和低性能艾滋病毒测试点的主要特征。在……里面 目的1，我们将进行一项双臂、实用、整群随机对照试验，比较IM、 通过干预映射确定的标准、统一大小适合所有多方面实施包，以及 TIM是一个量身定做的实施方案，在中央和地方两级使用干预映射。这个 主要结果包括SNAP干预的保真度(实施)和ART摄取(有效性)。 次要实施成果包括渗透率、可接受性和成本；次要效果 结果包括病毒抑制和MAT摄取。主要成本效益成果(目标2)将是 增量成本效益比，表示为每增加一次抗逆转录病毒药物治疗的增量成本， 将TIM与IM进行比较。在试验结束后，我们将探索高性能和低性能的特点 艾滋病毒检测地点(目标3)，使用定性和定量数据。这项研究将为 全球实施HPTN 074干预、SNAP以及其他EBI。重要的是，这一指导将 不取决于TIM相对于IM的优越性，而是以积极或消极的方式提供信息 比较一下。有了这些信息和指导，HPTN 074的成功将在全球范围内复制。

项目成果

The case for prioritizing implementation strategy fidelity measurement: benefits and challenges.

• DOI: 10.1093/tbm/ibab138
• 发表时间: 2022-02-16
• 期刊: Translational behavioral medicine
• 影响因子: 3.6
• 作者: Akiba CF;Powell BJ;Pence BW;Nguyen MXB;Golin C;Go V
• 通讯作者: Go V