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、经过研究检验的、基于证据的艾滋病预防策略，可以节省成本(1)。随机试验提供了令人信服的证据，表明MC可将男性通过异性恋获得的HIV-1感染风险降低约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男性包皮环切术具有同样的好处，而且费用更低，更安全。我们已经组建了一支具有技术、科学和临床能力的跨学科研究团队，可以开展高质量的EIMC研究。为了为EIMC服务的实施提供循证指导，我们提出了一项实施研究，以解决几个突出的运营研究问题。我们的团队成员已经对博茨瓦纳用于EIMC（150名婴儿）的AccuCirc设备进行了一项有前途但相对较新的试点研究，发现它非常安全。AccuCirc设备除了消除与其他EIMC设备相关的罕见但严重的潜在并发症外，还具有极大简化供应链管理的潜力。然而，在将其列入世卫组织的资格预审EIMC设备清单之前，必须进行更大规模的实地研究。因此，我们建议招募600名婴儿参与AccuCirc装置的安全性和可行性研究（Aim 1）。此外，必须从提供者的角度确定、理解和克服采用和整合EIMC的障碍，而这些障碍实际上是一无所知的。我们将通过定性方法，探讨供应商在提供和提供EIMC服务方面的观点（目标2）。同样重要的是要彻底了解家长选择EIMC的决策。我们建议通过收集父亲和母亲（其中一些人将选择EIMC，其中一些人将拒绝EIMC服务）的定性数据来研究这一点（目标3）。最后，我们将从集水区的母亲那里收集调查数据，我们将提供基于家庭和基于设施的EIMC服务。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，以确定与接受相关的因素，包括是否，何时，何地以及由谁提供EIMC服务（目标4）。在提供者和家长中，我们将特别探讨EIMC设备在决策中发挥的作用（如果有的话）。这项研究的结果将提供必要的证据，以完善EIMC在公共卫生和临床实践环境中的实施战略，并协助肯尼亚卫生部、总统防治艾滋病紧急救援计划和其他非洲政府扩大EIMC服务的提供，以长期预防艾滋病毒。

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.