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: 8676654
• 负责人: Rebeca Milanesi Plank
• 金额: $ 54.93万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8676654
• 关键词: AIDS prevention; Address; Adoption; Adult; Affect; Africa South of the Sahara; African; Age; Area; Benefits and Risks; Botswana; Catchment Area; Clinical; Collection; Country; Data; Decision Making; Devices; Enrollment; Evaluation; Fathers; Feasibility Studies; Future; Government; HIV-1; Health; Health Personnel; Home environment; Individual; Infant; Infection; Kenya; Local anesthesia; Male Adolescents; Male Circumcision; Manuals; Mothers; Neonatal; Operations Research; Parents; Pilot Projects; Play; Prevention strategy; Procedures; Provider; Province; Public Health; Public Health Practice; Publications; Publishing; Qualitative Methods; Questionnaires; Recruitment Activity; Research; Risk; Role; Safety; Services; Sexually Transmitted Diseases; Son; Surveys; Testing; Time; Training; United States Food and Drug Administration; World Health Organization; base; clinical practice; comparison group; cost; evidence base; experience; field study; follow-up; male; member; men; parental influence; preference; programs; public health relevance; randomized trial; research study; safety study; scale up; uptake

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、经过研究测试、循证的艾滋病毒预防策略，并且节省成本 (1)。随机试验提供了令人信服的证据，表明 MC 可以将男性异性获得 HIV-1 感染的风险降低约 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相同的益处，而且更便宜、更安全。我们组建了一支具有技术、科学和临床能力的跨学科研究团队，对 EIMC 进行高质量的研究。为了为 EIMC 服务的实施提供基于证据的指导，我们提出了一项实施研究来解决几个突出的运筹学问题。我们团队的成员对博茨瓦纳的 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 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，还有可能大大简化供应链管理。然而，在将其纳入 WHO 的 EIMC 设备资格预审清单之前，必须进行更大规模的实地研究。因此，我们建议招募 600 名婴儿参加 AccuCirc 设备的安全性和可行性研究（目标 1）。此外，必须从提供商的角度识别、理解和克服采用和集成 EIMC 的障碍，而对此几乎一无所知。我们将通过定性方法探讨提供商对于提供和提供 EIMC 服务的看法（目标 2）。同样重要的是充分了解家长关于选择 EIMC 的决策。我们建议通过收集父亲和母亲的定性数据（其中一些人选择 EIMC，一些人拒绝 EIMC 服务）来研究这一问题（目标 3）。最后，我们将收集学区母亲的调查数据，我们将在该地区提供基于家庭和设施的 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）。在医疗服务提供者和家长中，我们将专门探讨 EIMC 设备在决策中发挥的作用（如果有的话）。这项研究的结果将为将 EIMC 的实施策略细化到公共卫生和临床实践环境中提供必要的证据，并协助肯尼亚卫生部、PEPFAR 和其他非洲政府扩大 EIMC 服务的提供，以实现长期艾滋病毒预防。