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: 9981750
• 负责人: VIVIAN F. GO
• 金额: $ 99.15万
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9981750
• 关键词: Address; Alcohol or Other Drugs use; Anti-Retroviral Agents; Caring; Characteristics; Climate; Confidence Intervals; Counseling; Data; Decision Making; Development; Effectiveness; Ensure; Environment; Evaluation; 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; Outcome Assessment; Patient Self-Report; Penetration; Population; Positioning Attribute; Process; Provider; Randomized; Readiness; Resources; 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; evidence base; experience; flexibility; implementation strategy; implementation trial; improved; incremental cost-effectiveness; medication-assisted treatment; microcosting; mortality; primary outcome; psychosocial; scale up; standard of care; 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.

项目概要 注射吸毒者 (PWID) 的艾滋病毒感染者不太可能参与艾滋病毒护理和使用抗逆转录病毒药物 在艾滋病毒预防试验网络 (HPTN) 074 中，艾滋病毒感染者的治疗 (ART) 优于其他群体。 结合系统导航和心理社会咨询（SNaP）的综合干预非常有效 提高 HIV 感染者对 ART 的接受、病毒抑制和药物辅助治疗 (MAT) 的接受 值得注意的是，SNaP 也降低了死亡率，不幸的是，SNaP 与许多基于证据的药物一样。 如果实施干预措施（EBI）存在障碍，则可能无法在人口层面充分发挥其潜力 在本研究中，我们建议比较两种实施方式。 SNaP 的策略——两者都基于干预映射的概念。 结合理论、证据和利益相关者观点的正式多步骤流程来选择软件包 解决 EBI 实施障碍的实施策略。 通过结合特定地点的障碍评估和本地定制，扩展了干预映射 我们的具体目标是： 1) 将定制干预映射 (TIM) 与 标准实施规划 (IM)，以在越南 42 个 HIV 检测点扩大 SNaP 2)； 衡量在越南实施 SNaP 时 TIM 与 IM 的增量成本；以及 3) 探索； 每个研究组中实施 SNaP 的高绩效和低绩效 HIV 检测点的关键特征。 目标 1，我们将进行一项双臂、务实、整群随机对照实施试验，比较 IM、 一个标准的、一刀切的方法，适合通过干预映射确定的所有多方面实施包，以及 TIM，在中央和地方层面使用干预映射进行定制的一揽子实施。 主要结果包括 SNaP 干预的保真度（实施）和 ART 的采用（有效性）。 次要实施结果包括渗透率、可接受性和次要有效性； 结果包括病毒抑制和 MAT 吸收 主要成本效益结果（目标 2）是。 增量成本效益比，表示为每次增量 ART 吸收的增量成本， 试验完成后，我们将比较 TIM 和 IM。 HIV 检测点（目标 3）使用定性和定量数据，本研究将为艾滋病毒检测点（目标 3）提供指导。 HPTN 074 干预措施、SNaP 以及其他 EBI 的全球实施 重要的是，本指南将。 不依赖于 TIM 相对于 IM 的优越性，但会提供积极或消极的信息 有了这些信息和指导，HPTN 074 的成功将在全球范围内复制。