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eHealth方法可以有效降低艾滋病毒风险，但他们的实施 要求不符合已建立的公共卫生策略的规模，将其提出了一个公开的问题 如何将这些程序付诸实践。该提案的总体目标是通过 制定和评估实施eHealth HIV预防计划的新型策略。继续努力吧！ （Kiu！）是一项在线计划，旨在降低与男性发生性关系（YMSM）的年轻男性的艾滋病毒风险， 包括YMSM在艾滋病毒升高的风险中，由于行为（即无避孕套性，使用物质）和 人口统计学（即种族/族裔少数民族）。对行为和生物医学有效性的有力证据 成果使Kiu！实施科学的理想eHealth干预措施。经验教训将设定 实施当前正在进行效率测试的许多HIV EHEADH计划的途径。 通过与社区组织（CBO），卫生部门的形成性研究， CDC和研究人员我们已经确定了两种务实的实施策略，我们将评估和 比较：策略1：CBO申请并被选为提供Kiu的资金！通过当前的艾滋病毒 测试程序。策略2是“直接面向消费者”（DTC）模型，集中式员工招募参与者 通过在线广告活动和管理参与到全国范围内。 HIV/STI测试套件已发货 直接到YMSM，并在记录HIV阴性测试结果后，参与者将交付KIU！ 目标1：使用群集随机试验比较两种实施策略。 75个县 大型YMSM种群将被随机2：1与策略1（CBO）或策略2（DTC）。 kiu！将交付 在每项两年中。在此集群随机试验中，随机化的单位是该县， 从YMSM参与者，CBO和技术收集的实施和有效性结果数据 小贩。我们的主要结果是公共卫生影响（定义为X X效率）和每 / 感染避免了。我们还将作为次要结果收集和报告多个覆盖范围的指标， 有效性和实施。 目标2：检查解释实施结果变异性的采用特征。 我们将对实施的合并框架对域进行混合方法研究 研究（CFIR）解释实施成功的变异性。将收集有关CFIR特征的数据 通过行政数据，对主要利益相关者进行调查和电话访谈。 我们还将探索KIU的维护/维持！研究完成时。 CBO会 提供材料，以促进申请外部资金继续提供Kiu！研究后 完成，包括估计当地影响和成本的影响工具。通过专家咨询，我们将 检查模型是否持续维持DTC模型。