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

Summary

Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60%. 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. To provide the evidence-based guidance for implementation of EIMC services, the investigators propose an implementation study to address several salient operations-research questions. Members of the research team have conducted a pilot study of the promising, but relatively new AccuCirc device for EIMC in Botswana and found it to be very safe. The AccuCirc device has the potential to simplify supply chain management in addition to eliminating the rare but serious potential complications associated with other EIMC devices. The investigators propose to enroll 600 infants in a safety and feasibility study of the AccuCirc device. Furthermore, it is imperative to identify, understand and overcome barriers to the adoption and integration of EIMC from the perspective of providers, about which virtually nothing is known. The investigators will explore, through qualitative methods, the perspective of providers with regard to offering and providing EIMC services. Equally important is having a thorough understanding of decision-making among parents with regard to opting for EIMC. The research team proposes to study this through collection of qualitative data among fathers and mothers. Lastly, the investigators will gather observational survey data from mothers in the catchment area and 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. Among providers and parents the researchers 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, other African governments and PEPFAR in the scale-up of EIMC service delivery for long-term HIV prevention.

Conditions

• Male Circumcision

Interventions

DEVICE

AccuCirc

Circumcision with the use of the AccuCirc device.

Sponsors & Collaborators

• University of Illinois at Chicago

  collaborator OTHER

• Nyanza Reproductive Health Society

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Fredrick Otieno, MD · Nyanza Reproductive Health Society

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Day

Max Age

60 Days

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• Kenya

Study Locations