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

实施有效的电子健康艾滋病毒预防计划的两种策略的务实试验

• 批准号: 10176599
• 负责人: Brian Mustanski
• 金额: $ 151.01万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-20 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10176599
• 关键词: AIDS prevention; Address; Adopted; Adoption; Advertising; Behavior; Behavioral; Businesses; Caring; Centers for Disease Control and Prevention (U.S.); Characteristics; Cluster randomized trial; Communities; Consolidated Framework for Implementation Research; Consultations; County; Data; Decision Making; Diagnostic Reagent Kits; Documentation; Effectiveness; Epidemic; Equipoise; Evidence based intervention; Funding; Goals; HIV; HIV Seronegativity; HIV risk; HIV/STD; Health; Human immunodeficiency virus test; Incidence; Infection; Intervention; Investments; Lead; Leadership; Maintenance; Measures; Modeling; NIH Office of AIDS Research; Outcome; Participant; Pathway interactions; Patient Recruitments; Population; Populations at Risk; Predictive Factor; Prevention program; Provider; Public Health; Randomized; Reporting; Research; Research Design; Research Methodology; Research Personnel; Risk; Risk Reduction; Ships; Surveys; Technology; Telephone Interviews; Test Result; Testing; Training; United States National Institutes of Health; Unsafe Sex; Vendor; arm; base; cost; demographics; design; disparity reduction; eHealth; effectiveness implementation study; effectiveness outcome; efficacy testing; ethnic minority population; implementation intervention; implementation outcomes; implementation research; implementation science; implementation strategy; improved; innovation; novel strategies; pragmatic trial; prevention service; preventive intervention; primary outcome; programs; racial and ethnic; response; scale up; secondary outcome; substance use; success; tool; young men who have sex with men

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.

尽管有证据表明电子卫生保健方法可以有效降低艾滋病毒风险，但其实施 要求不符合扩大公共卫生规模的既定战略——这使其成为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策略。 (KIU!) 是一个在线计划，被证明可以降低男男性行为者的艾滋病毒风险 (YMSM)， 包括 YMSM 由于行为（即无套性行为、药物滥用）而面临较高的 HIV 风险，以及 人口统计（即少数种族/族裔）的行为和生物医学有效性的有力证据。 结果使 KIU! 成为科学实施的理想电子卫生干预措施。 目前正在进行功效测试的许多艾滋病毒电子卫生项目的实施途径。 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，我们已经确定了两种务实的实施策略，我们将对其进行评估和 比较： 策略 1：CBO 申请并被选中提供资金以通过其当前的 HIV 项目提供 KIU！ 策略 2 是“直接面向消费者”(DTC) 模式，集中工作人员招募参与者。 通过在线广告活动在全国范围内运送艾滋病毒/性传播感染检测试剂盒。 直接向 YMSM 提交，在记录 HIV 阴性检测结果后，参与者将获得 KIU！ 目标 1：使用 75 个县的整群随机试验来比较两种实施策略。 大量 YMSM 人群将被随机分配到策略 1 (CBO) 或策略 2 (DTC)！ 在这个整群随机试验中，随机化的单位是县，其中 从 YMSM 参与者、CBO 和技术收集的实施和有效性结果数据 我们的主要结果是公共卫生影响（定义为达到 X 有效性）和单位成本。 我们还将收集并报告多个影响范围指标， 有效性和执行力。 目标 2：检查实施结果中可变性所解释的采用特征。 我们将对综合实施框架中的领域进行混合方法研究 将收集有关 CFIR 特征的数据来解释实施成功的可变性。 通过行政数据、调查以及对主要利益相关者的电话采访。 研究完成后，我们还将探讨 KIU 的维护/维持！ 提供材料以方便申请外部资助以在学习后继续提供KIU！ 完成，包括通过专家咨询来估计当地影响和成本的影响工具。 检查 DTC 模型持续维持的模型。