Enhanced Provision of Male Circumcision for HIV Prevention, Rakai, Uganda

描述(申请人提供)：撒哈拉以南非洲60%的人口和85%的乌干达人居住在农村地区，那里迫切需要增加男性包皮环切术(MC)的覆盖率。Rakai健康科学计划(RHSP)进行了MC预防艾滋病毒/性传播感染的随机试验，对PEPFAR资助的MC服务进行了实施科学研究，并监测了参加50个Rakai社区队列研究(RCCS)的14,000名农村人口的MC摄取率和有效性。在2007-2011年年中，我们在5个静态设施中执行了18,000个服务MC；最近，我们还在一个移动MC营地试行MC供应。然而，在农村信用社人群中，MC在非穆斯林男性中的覆盖率仍然不高，约为28%，并且MC在年轻、低风险男性中的接受率不成比例。我们建议进行以下实施科学研究。目的1.利用增强的信息传递、有针对性的外展、任务转移、任务分担和流动营地，增加农村地区，特别是高风险男性的MC接受率，并比较静态诊所和流动营地的MC接受率、覆盖面、客户的社会人口学/行为特征和成本效益。我们预计在3年内总共有27,000名MC接受者。我们假设，与我们之前的服务相比，增强的消息传递/外展将增加高风险男性对MC的整体接受，流动MC营地将增加高风险男性的接受度，并且在农村环境中比静态服务更具成本效益，MC在农村社区的流行率将增加到60%。目的2.早期婴儿MC(EIMC)比成人MC更简单、更安全、更便宜，并能对HIV流行产生长期影响。EIMC的可持续扩大需要将任务转移到非内科医生。我们将进行一项随机研究，比较目前正在进行成人MC手术的临床医生(CoS)和目前没有获得执行该程序许可的护士-助产士(NMW)提供的EIMC的可接受性和安全性。我们将首先在局麻下使用Mogen钳对EIMC人员进行培训，然后每只手臂招收500名2个月大的婴儿。我们假设，由NMW执行的EIMC的可接受性和安全性将与CoS相当。结果将与政策制定者分享，用于未来的项目开发。目的3.评估MC的人群流行率及其对农村合作医疗人群中HIV发病率的影响(几乎完全由其他赠款支持)，并使用边际结构模型进行因果推断，估计避免一次HIV感染所需的MC数量和避免的每一次HIV感染的成本。随机模拟模型将用于预测在10年内避免的感染和节省的成本。拟议的研究将为快速扩大MC(目标1)和EIMC服务(目标2)提供一个模式，以帮助指导非洲农村的方案。MC对艾滋病毒发病率、成本效益和改进模型的影响(目标3)将提供关于通过MC预防艾滋病毒人群的数据，用于政策和方案的制定。 与公共卫生的相关性：拟议的研究将为撒哈拉以南非洲农村地区利用移动服务、增强的信息/外联、任务转移和任务分担(目标1)迅速扩大MC提供一个模式。早期婴儿母婴传播(EIMC)可对艾滋病毒流行产生长期影响，但可持续的EIMC服务需要将任务转移给非医生，特别是在怀孕和产后与父母有接触的护士-助产士(目标2)。在人口层面评估MC的流行情况及其对艾滋病毒发病率的影响(目标3)，将为成本效益分析和改进建模提供数据，以加强政策和方案的制定。

DESCRIPTION (provided by applicant): 60% of the sub-Saharan African population and 85% of Ugandans reside in rural areas, where there is an urgent need to increase coverage of male circumcision (MC). The Rakai Health Sciences Program (RHSP) has conducted randomized trials of MC for HIV/STI prevention, implementation science research on PEPFAR- funded MC services, and has monitored MC uptake and effectiveness in a rural population of 14,000 persons enrolled in a 50 village Rakai Community Cohort Study (RCCS). Between 2007-mid 2011, we performed >18,000 service MCs in 5 static facilities; recently, we also piloted MC provision in a mobile MC camp. However, MC coverage among non-Muslim men in the RCCS population remains modest at ~28%, and MC acceptance occurs disproportionately among younger, lower risk men. We propose the following implementation science research. Aim 1. To increase MC uptake in a rural setting, particularly in higher risk men, using enhanced messaging, targeted outreach, task shifting, task sharing and mobile camps, and to compare MC uptake, coverage, and client sociodemographic/behavioral characteristics and cost-effectiveness in static clinics versus mobile camps. We project ~27,000 MC acceptors overall within 3 years. We hypothesize that the enhanced messaging/outreach will increase overall MC uptake by higher risk men compared to our prior services, that mobile MC camps will increase acceptance by higher risk men and be more cost-effective than static services in this rural setting, and that MC prevalence in RCCS will increase to 60%. Aim 2. Early infant MC (EIMC) is simpler, safer and cheaper than adult MC, and can have a long-term impact on the HIV epidemic. Sustainable scale-up of EIMC requires task shifting to non-physicians. We will conduct a randomized study of the acceptability and safety of EIMC provided by clinical officers (COs) who currently perform adult MC, compared with nurse-midwives (NMWs) who are not currently licensed to perform the procedure. We will first train personnel in EIMC using the Mogen clamp under local anesthesia, and then enroll 500 infants aged <2 months per arm. We hypothesize that the acceptability and safety of EIMC performed by NMWs will be comparable to COs. Outcomes will be shared with policy makers for future program development. Aim 3. To assess the population prevalence of MC and its impact on HIV incidence in the RCCS population (supported almost completely by other grants), and estimate the number of MCs required to avert one HIV infection and costs per HIV infection averted, using marginal structural models for causal inference. A stochastic simulation model will be used to project infections averted and cost savings over 10 years. The proposed studies will provide a model for rapid MC scale up (Aim 1), and EIMC services (Aim 2) to help guide programs in rural Africa. The impact of MC on HIV incidence, cost-effectiveness and enhanced modeling (Aim 3) will provide data on population prevention of HIV through MC, for policy and program development. PUBLIC HEALTH RELEVANCE: The proposed studies will provide a model for rapid MC scale up in rural sub-Saharan Africa using mobile services with enhanced messaging/outreach, task shifting and task sharing (Aim 1). Early infant MC (EIMC) can have a long-term impact on the HIV epidemic, but sustainable EIMC services require task shifting to non- physicians, particularly nurse-midwives who have contact with parents during pregnancy and postpartum (Aim 2). The assessment of the prevalence of MC and its impact on HIV incidence at the population level (Aim 3), will provide data for cost-effectiveness analyses and enhanced modeling, to enhance policy and program development.