A pragmatic trial of two strategies for implementing an effective eHealth HIV prevention program

尽管有证据表明电子健康方法可以有效地降低艾滋病毒风险，但它们的实施 要求不符合公共卫生扩大的既定战略--这是一个悬而未决的问题，如 如何将这些计划付诸实践。这项提案的总体目标是通过以下方式满足这一需求 制定和评估实施电子健康艾滋病毒预防方案的新战略。坚持下去! (Kiu！)是否有一项在线计划被证明可以降低男男性接触者(YMSM)感染艾滋病毒的风险， 包括因行为(即无安全套的性行为、吸毒)而艾滋病毒风险升高的男男性同性恋者和 人口统计数据(即，种族/少数民族)。对行为和生物医学有效的有力证据 结果造就了Kiu！实施科学的理想电子健康干预。吸取的经验教训将使 目前正在进行疗效测试的许多艾滋病毒电子健康方案的实施途径。 通过与社区组织(CBO)、卫生部门、 CDC和研究人员我们已经确定了两个务实的实施战略，我们将对其进行评估和 比较：战略1：CBO申请并被选中资金，以提供KiU！通过他们目前的艾滋病毒 测试程序。策略2是一种“直接面向消费者”(DTC)模式，集中的员工招募参与者 在全国范围内通过在线广告活动和管理参与度。HIV/STI检测试剂盒已发货 直接交给基督教青年会，在记录HIV阴性测试结果后，参与者将被交付KiU！ 目的1：使用整群随机试验比较两种实施策略。75个县有 大规模YMSM人群将以2：1随机分为策略1(CBO)或策略2(DTC)。乔！将被交付 在每个县都呆了两年。在这个整群随机试验中，随机单位是县，有 从YMSM参与者、CBO和技术收集的实施和有效性结果数据 供应商。我们的主要成果是对公共健康的影响(定义为REACH X有效性)和单位成本 感染得以避免。我们还将收集和报告覆盖范围的多个指标作为次要结果， 有效性和实施性。 目标2：审查可解释执行结果的可变性的采用特征。 我们将从综合实施框架中对领域进行混合方法研究 研究(CFIR)，以解释实施成功的可变性。将收集有关CFIR特征的数据 通过行政数据，以及对主要利益攸关方的调查和电话采访。 我们还将探讨KiU的维护/维持！在研究完成时。CBOS将 提供材料，以方便申请外部资金，继续提供KiU！在学习之后 完成工作，包括评估当地影响和成本的影响工具。通过专家咨询，我们将 审查持续维持DTC模型的模型。

Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements do not fit within established strategies for public health scale up—leaving it an open question as to how to bring these programs into practice. The overarching goal of this proposal is to address this need by developing and evaluating novel strategies for implementing eHealth HIV prevention programs. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM), including YMSM at elevated HIV risk due to behaviors (i.e., condomless sex, substance use) and demographics (i.e., racial/ethnic minorities). Strong evidence of effectiveness on behavioral and biomedical outcomes makes KIU! an ideal eHealth intervention for implementation science. Lessons learned will set the pathway for implementation of the many HIV eHealth programs currently undergoing efficacy testing. Through formative research with community-based organizations (CBOs), health departments, the CDC, and researchers we have identified two pragmatic implementation strategies that we will evaluate and compare: Strategy 1: CBOs apply for, and are selected for, funding to deliver KIU! through their current HIV testing programs. Strategy 2 is a “direct-to-consumer” (DTC) model where centralized staff recruit participants nationally through online advertising campaigns and manage engagement. HIV/STI testing kits are shipped directly to YMSM and, upon documentation of an HIV negative test result, participants are delivered KIU! Aim 1: Compare two implementation strategies using a cluster randomized trial. 75 counties with large YMSM populations will be randomized 2:1 to strategy 1 (CBO) or strategy 2 (DTC). KIU! will be delivered in each county for two years. In this cluster randomized trial, the unit of randomization is the county, with implementation and effectiveness outcome data collected from YMSM participants, CBOs, and the technology vendor. Our primary outcomes are public health impact (defined as reach X effectiveness) and cost per infection averted. We will also collect and report as secondary outcomes multiple metrics of reach, effectiveness, and implementation. Aim 2: Examine adoption characteristics that explain variability in implementation outcomes. We will conduct mixed-methods research on the domains from the consolidated framework for implementation research (CFIR) to explain variability in implementation success. Data on CFIR characteristics will be collected through administrative data, and surveys and telephone interviews with key stakeholders. We will also explore maintenance/sustainment of KIU! at the completion of the study. CBOs will be provided with materials to facilitate applying for external funding to continue to provide KIU! after study completion, including an Impact Tool to estimate local impact and costs. Through expert consultation we will examine models for ongoing sustainment of the DTC model.