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

PI: Rebeca M. Plank (BWH)
Investigators:

Fredrick O. Otieno (NRHS), Robert C. Bailey (UIC), Edmon O. Obat (NRHS)

Duration: August 2013 – July 2017
Status: Enrolling
Study Sites:

1. UNIM Research and Training Centre
2. Ahero Sub County Hospital

Sponsor:

Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, United States

Purpose:

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, cost-efficient HIV prevention.

Significance:

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, cost-efficient HIV prevention.

Design:

The proposed study uses a mixed-methods approach to answer several questions necessary to close the gap between knowing that EIMC is an efficacious, cost-saving, HIV prevention intervention and knowing how to guide the implementation of this intervention into existing community health systems. This study will include a field study that will provide safety and feasibility data for the AccuCirc. We must understand how providers make decisions about offering and performing EIMC in their daily practice and whether the device used would make an impact on their attitudes and behaviors in creating demand for the service and being willing to provide the service.

Using qualitative methods, we will explore facilitators and barriers among providers trained by our program to perform EIMC. Of equal importance, we must understand how parents make decisions about whether to circumcise a son and how the device for EIMC might influence their decision-making. To understand more about decision-making, we will gather qualitative data from parents who have accepted and from those who have not accepted EIMC for their son. Lastly, we will examine factors associated with uptake of EIMC among mothers living in the area in which we will be offering EIMC (including if, when, where and by whom EIMC services were offered, and how the decision was made as to whether to obtain EIMC services) as part of both home-based and facility-based services.

Study Population: Uncircumcised live born male infants between the ages of 0 and 60 days and resident of Kisumu or Ahero catchment areas. Medical providers trained in AccuCirc and/or Mogen circumcision. Parents of infants eligible for EIMC.
Study Size:

A total of approximately 600 infants will be enrolled, plus approximately 20 staff and 144 parents (mothers and fathers).

Study Aims:

Aim 1: Complete a field evaluation of the AccuCirc device for EIMC in Nyanza Province, Kenya, with a target enrollment of 600 infants, including intensive follow-up of the first 50 infants undergoing EIMC with the AccuCirc device.

Aim 2: Qualitatively assess provider experiences and preferences with regard to EIMC devices and the relationship to future routine provision of EIMC.

Aim 3: Assess parental decision-making about EIMC using qualitative methods, including exploring whether the device for EIMC would influence parental decision-making about circumcision for a son.

Aim 4: Identify factors associated with having a male infant circumcised, including if, when, where and by whom EIMC services were offered to mothers, and the role of devices for EIMC in decision-making, if any.