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

肯尼亚 Nyanza 的 AccuCirc 对早期婴儿男性包皮环切术的评估

• 批准号: 9198088
• 负责人: Robert Converse Bailey
• 金额: $ 62.49万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-11-25 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9198088
• 关键词: Evaluation; AccuCirc; Early; Infant; Male

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.

描述（由申请人提供）：男性包皮环切术（MC）是一种有效的，研究测试的，基于证据的艾滋病毒预防策略，可节省成本（1）。随机试验提供了令人信服的证据，表明MC会降低男性出现的异性恋HIV-1感染的风险约为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的年龄较大的年龄较大的年龄中也赋予了MC相同的好处，并且更便宜且更安全。我们已经组建了一个跨学科研究团队，具有对EIMC进行高质量研究的技术，科学和临床能力。为了提供基于证据的EIMC服务实施指南，我们提出了一项实施研究，以解决几个显着的操作 - 研究问题。我们团队的成员对博茨瓦纳的EIMC（150名婴儿）进行了有希望但相对较新的ACCUCIRC设备的试点研究，发现它非常安全。除了消除与其他EIMC设备相关的罕见但严重的潜在并发症之外，Accucirc设备有可能极大地简化供应链管理。在将其包括在WHO预先资格的EIMC设备列表中之前，必须进行较大的现场研究。因此，我们建议在Accucirc设备的安全性和可行性研究中注册600名婴儿（AIM 1）。此外，必须从提供商的角度识别，理解和克服EIMC采用和整合的障碍，几乎什么都不知道。我们将通过定性方法探索提供者在提供和提供EIMC服务方面的观点（AIM 2）。同样重要的是，在选择EIMC方面对父母的决策有透彻的理解。我们建议通过在父亲和母亲之间收集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）（AIM 3）。最后，我们将从集水区的母亲那里收集调查数据，在那里我们将提供基于家庭和基于设施的EIMC服务。将选择EIMC的母亲的数据与不选择EIMC的母亲的母亲进行比较，以识别与摄取相关的因素，包括是否提供EIMC服务的何时，何时，何地，何处和由何处提供EIMC服务（AIM 4）。在提供者和父母中，我们将特别探讨EIMC设备在决策中扮演什么角色。这项研究的发现将提供必要的证据，以完善EIMC进入公共卫生和临床实践环境的实施策略，并协助肯尼亚卫生部，PEPFAR和其他非洲政府对EIMC预防HIV预防的EIMC服务提供。