RCT to reduce HIV acquisition and viral load among migrants, Rakai, Uganda

项目概要（摘要） 乌干达 Rakai 健康科学计划 (RHSP) 提议建立一个实施科学社区 - 针对新移民个体的新型干预措施的随机对照试验（CRCT）（“欢迎进来- 即将到来的邻居”[WIN]），以优化其与艾滋病毒综合预防 (CHP) 服务的快速联系。右心室SP 数据显示，在迁入后的前 36 个月内，与居民相比，HIV 阴性的迁入者 感染艾滋病毒的风险增加，而艾滋病毒移民未充分利用抗逆转录病毒疗法 (ART) 增加继续传播的风险。基于理论的 WIN 干预包括社区 宣传、基于社区的 WIN 侦察员 (WIN) 以及增强的、差异化的诊所服务 移民。 WIN 将进行积极的社区监测，以快速识别和欢迎移民，提供 向他们提供有关热电联产的可用性和居民高使用率的信息（以“正常化”使用）， 利用动机性访谈方法鼓励采用 CHP，向移民推荐免费服务， 提供优惠券，使他们能够获得优先诊所服务，并对移民进行后续评估和 进一步鼓励参与热电联产。具体目标： 目标 1：随机分配 40 个单独匹配的个体 社区与 WIN 干预或控制臂的比例为 1:1。每支年龄在 15 岁至 49 岁之间的移民将 每隔 18 个月进行一次基线调查和 2 次后续调查。主要终点是艾滋病毒发病率 最初为 HIV 阴性的移民（每组 n 约 3,800 人），以及 HIV 病毒载量抑制（每组 n 约 740 人）。 还将比较 CHP 覆盖率和性行为（次要结果）。目标 2a：使用 混合方法方法（深度访谈、流程和调查数据）和 RE-AIM（覆盖面、有效性、 采用、实施、维护）以 (i) 根据需要指导临时干预措施的调整； (二) 解释 试验结果； (iii) 将研究转化为未来的行动。目标 2b：进行成本研究以提供 有关负担能力和可持续性的信息。创新和影响：这种新颖的干预措施将迅速 让脆弱的重点移民群体参与其中，以优化乌干达农村地区的卫生防护中心和艾滋病毒影响。

PROJECT SUMMARY (ABSTRACT) The Rakai Health Sciences Program (RHSP), Uganda, proposes an implementation science community- randomized controlled trial (CRCT) of a novel intervention to newly in-migrated individuals (“Welcome In- coming Neighbor” [WIN]), to optimize their rapid linkage to combination HIV prevention (CHP) services. RHSP data show that within the first 36 months after in-migration, compared to residents, HIV-negative in-migrants are at increased risk of HIV acquisition and HIV+ in-migrants underutilize antiretroviral therapy (ART) increasing the risk of onward transmission. The theory-based WIN intervention includes community sensitization, community-based WIN scouts (WINs), and enhanced, differentiated clinic services for in- migrants. WINs will conduct active community surveillance to rapidly identify and welcome in-migrants, provide them with information about the availability of CHP and high rates of use by residents (to “normalize” uptake), utilize a motivational interviewing approach to encourage CHP adoption, refer in-migrants to free services, provide vouchers enabling them to receive priority clinic services, and follow-up in-migrants to assess and further encourage engagement in CHP. Specific Aims: Aim 1: To randomize 40 individually matched communities in a 1:1 ratio to the WIN intervention or control arm. In-migrants aged 15-49 in each arm will undergo a baseline and 2 follow-up surveys at ~18-month intervals. Primary end points are HIV incidence in initially HIV-negative in-migrants (n ~3,800 py per arm), and viral load suppression in HIV+ (n ~740 per arm). CHP coverage rates and sexual behaviors will also be compared (secondary outcomes). Aim 2a: To use a mixed methods approach (in-depth interviews, process & survey data) and RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) to (i) guide interim intervention adaptation as necessary; (ii) interpret trial results; and, (iii) translate the research into future action. Aim 2b: To conduct cost studies to provide information on affordability and sustainability. Innovation and Impact: This novel intervention will rapidly engage a vulnerable priority population of in-migrants, to optimize CHP and HIV impact in rural Uganda.