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

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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.