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

项目摘要(摘要) 乌干达Rakai健康科学计划(RHSP)建议建立一个实施科学界-- 对新移民的一种新干预措施的随机对照试验(CRCT) 即将到来的邻居“[Win])，以优化他们与组合艾滋病毒预防(CHP)服务的快速联系。RHSP 数据显示，在迁入后的前36个月内，与居民相比，艾滋病毒阴性的迁入者 感染艾滋病毒的风险增加，移民未充分利用抗逆转录病毒疗法(ART) 增加了继续传播的风险。以理论为基础的双赢干预包括社区 敏感化、以社区为基础的双赢童子军(WINS)和增强的差异化诊所服务 移民。WINS将进行积极的社区监测，以快速识别和欢迎外来移民，提供 向他们提供关于CHP的可获得性和居民的高使用率的信息(以“正常化”吸收)， 利用激励性访谈方法鼓励采用卫生防护方案，让移民获得免费服务， 提供凭证，使他们能够获得优先的诊所服务，并跟踪移民，以评估和 进一步鼓励参与合作伙伴关系。具体目标：目标1：将40名个人配对随机 社区以1：1的比例赢得干预或控制手臂。每条胳膊上年龄在15-49岁的外来移民将 每隔18个月进行一次基线调查和两次跟踪调查。主要终点是#年艾滋病毒发病率 最初是艾滋病毒阴性的外来移民(每臂3,800人)，以及艾滋病毒病毒载量抑制(每臂人~740人)。 卫生保健计划覆盖率和性行为也将进行比较(次要结果)。目标2a：使用 混合方法方法(深度访谈、过程和调查数据)和RE-AIM(覆盖范围、有效性、 采用、执行、维护)以(一)指导必要的临时干预适应；(二)解释 试验结果；以及，(3)将研究转化为未来的行动。目标2b：进行成本研究，以提供 关于可负担性和可持续性的信息。创新和影响：这种新的干预措施将迅速 让弱势的优先移民群体参与进来，以优化共生保健计划和艾滋病毒在乌干达农村地区的影响。

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.