Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya

描述（由申请人提供）：男性包皮环切术（MC）是一种有效的，经过研究测试的，以证据为基础的艾滋病毒预防策略，节省成本（1）。随机试验提供了令人信服的证据表明，MC降低男性异性性获得性HIV-1感染的风险约60%（2-4）。早期婴儿男性包皮环切术（EIMC）在预防艾滋病毒和其他性传播感染方面与老年人的MC具有相同的好处，并且更便宜，更安全。我们组建了一支跨学科的研究团队，具有技术，科学和临床能力，可以对EIMC进行高质量的研究。为了提供EIMC服务实施的循证指南，我们提出了一个实施研究，以解决几个突出的运筹学问题。我们的团队成员对博茨瓦纳的EIMC（150名婴儿）进行了一项有前途但相对较新的AccuCirc设备的试点研究，发现它非常安全。AccuCirc器械有可能极大地简化供应链管理，并消除与其他EIMC器械相关的罕见但严重的潜在并发症。然而，在将其列入世卫组织资格预审的EIMC设备清单之前，必须进行更大规模的实地研究。因此，我们建议在AccuCirc器械的安全性和可行性研究中招募600名婴儿（目标1）。此外，必须从供应商的角度识别，理解和克服采用和集成EIMC的障碍，这几乎是一无所知的。我们将通过定性方法探讨供应商提供EIMC服务的角度（目标2）。同样重要的是要彻底了解父母在选择EIMC方面的决策。我们建议通过收集父亲和母亲的定性数据来研究这一点（其中一些人将选择EIMC，其中一些人将拒绝EIMC服务）（目标3）。最后，我们将从我们将提供以家庭为基础和以设施为基础的EIMC服务的集水区的母亲那里收集调查数据。选择EIMC的母亲的数据将与未选择EIMC的母亲的数据进行比较，以确定与吸收相关的因素，包括是否，何时，何地以及由谁提供EIMC服务（目标4）。在供应商和家长中，我们将特别探讨EIMC设备在决策中扮演的角色。这项研究的结果将提供必要的证据，以完善公共卫生和临床实践环境中的EIMC实施战略，并协助肯尼亚卫生部，PEPFAR和其他非洲国家政府扩大EIMC长期预防艾滋病毒的服务提供。

DESCRIPTION (provided by applicant): Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention strategy that is cost-saving (1). Randomized trials provide compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60% (2-4). Early infant male circumcision (EIMC) confers the same benefits of MC in older ages for prevention of HIV and other sexually transmitted infections, and is less expensive and safer. We have assembled a trans-disciplinary research team with the technical, scientific and clinical capacity to conduct high-quality research on EIMC. To provide the evidence-based guidance for implementation of EIMC services, we propose an implementation study to address several salient operations- research questions. Members of our team have conducted a pilot study of the promising, but relatively new AccuCirc device for EIMC (150 infants) in Botswana and found it to be very safe. The AccuCirc device has the potential to greatly simplify supply chain management in addition to eliminating the rare but serious potential complications associated with other EIMC devices. Before it can be included in the WHO's list of prequalified EIMC devices, however, larger field studies must be conducted. Thus, we propose to enroll 600 infants in a safety and feasibility study of the AccuCirc device (Aim 1). Furthermore, it is imperative to identify, understand and overcome barriers to the adoption and integration of EIMC from the perspective of the provider, about which virtually nothing is known. We will explore, through qualitative methods, the perspective of providers with regard to offering and providing EIMC services (Aim 2). Equally important is having a thorough understanding of decision-making among parents with regard to opting for EIMC. We propose to study this through collection of qualitative data among fathers and mothers (some of whom will have opted for EIMC and some of whom will have declined EIMC services) (Aim 3). Lastly, we will gather survey data from mothers in the catchment area where we will be offering home-based and facility-based EIMC services. Data from mothers who opted for EIMC will be compared with those from mothers who did not opt for EIMC to identify factors associated with uptake, including if, when, where and by whom EIMC services were offered (Aim 4). Among providers and parents we will specifically explore what role, if any, the EIMC device plays in decision-making. The findings from this study will provide evidence necessary to refine implementation strategies for EIMC into public health and clinical practice settings and to assist the Kenyan Ministry of Health, PEPFAR and other African governments in the scale-up of EIMC service delivery for long-term HIV prevention.