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

尽管有证据表明，电子保健方法可以有效地减少艾滋病毒的风险， 这些要求不符合扩大公共卫生规模的既定战略，这是一个悬而未决的问题， 如何将这些计划付诸实践。本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计划的新战略。继续努力！ (KIU!)是一个被证明可以降低男男性行为者（YMSM）感染艾滋病毒风险的在线项目， 包括由于行为而导致HIV风险升高的YMSM（即，无避孕套性行为、物质使用）， 人口统计学（即，种族/少数民族）。对行为和生物医学有效的有力证据 结果让KIU！一个理想的电子健康干预的实施科学。吸取的经验教训将为 目前正在进行疗效测试的许多艾滋病毒电子健康计划的实施途径。 通过与社区组织（CBO），卫生部门， 疾病预防控制中心和研究人员，我们已经确定了两个务实的实施战略，我们将评估， 比较：策略1：社区组织申请，并被选中，资金提供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，由中心化的工作人员招募参与者 在全国范围内通过在线广告活动和管理参与。运送艾滋病毒/性传播感染检测包 直接到YMSM，并在艾滋病毒阴性测试结果的文件，参与者交付KIU！ 目的1：比较两种实施策略，使用集群随机试验。75个县， 将大的YMSM群体以2：1的比例随机分配至策略1（CBO）或策略2（DTC）。阿秋！将交付 在每个县两年。在本项整群随机试验中，随机化单位为县， 从YMSM参与者、社区组织和技术收集的实施和有效性结果数据 卖主。我们的主要成果是公共卫生影响（定义为达到X有效性）和每 感染得以避免我们还将收集和报告作为次要结果的多个指标的范围， 有效性和执行。 目标2：检查解释实施结果可变性的采用特征。 我们将对统一实施框架中的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CFIR特征数据 通过行政数据、调查和与主要利益攸关方的电话访谈。 我们还将探索KIU的维护/维护！在研究完成时。社区组织将 提供材料，方便申请外部资金继续提供邱！经研究后 完成，包括一个影响工具，以估计当地的影响和成本。通过专家咨询， 检查DTC模式的持续维持模式。

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.