Integration of Infant Male Circumcision with Community Health Services in Kenya

The Mtoto Msafi Mbili Project

PI: Robert C. Bailey (UIC)
Investigators: Walter Jaoko (UoN), Supriya Mehta (UIC), Fredrick Otieno (NRHS), Sherry Nordstrom (UIC), Dedan Ongong’a (JOOTRH), Walter Obiero (NRHS)
Duration: June 2012 – May 2016
Status: Enrolling
Study Sites:

UNIM Research and Training Centre Kenya Ministry of Health facilities in the Rachuonyo North and Rachuonyo South Districts of Homa Bay County

Sponsor:

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

Purpose:

Early infant male circumcision (EIMC) is little-known and little-practiced in East and southern Africa. EIMC is not part of routine antenatal education and is not normally discussed post-partum nor during immunization visits. Our experience shows that EEIMC is rarely practiced by providers or by parents in Kenya. The proposed study will build on existing evidence and address service and research gaps by employing a community strategy to reach prenatal mothers and their male partners to provide information on EIMC prior to delivery and by offering EIMC services in the community. These approaches directly respond to the two main barriers to EIMC uptake: over half of all deliveries in Kenya occur outside of healthcare facilities, and fathers must be consulted about the EIMC decision.

Significance: The study seeks to determine the relative advantages of two models of EIMC service delivery with cost, acceptability, safety and uptake as outcomes. Both of these models are scalable and can be integrated into existing maternal child health (MCH) care structures under conditions that prevail in many African nations. The study will generate an understanding of barriers to EIMC uptake and determine how service implementation affects these barriers. Results from this study will provide the evidence necessary for the GOK and PEPFAR to move forward with effective scale-up of EIMC services in Kenya and beyond.
Design:

We are conducting a simultaneous, prospective comparison of two models of EIMC service delivery. A standard delivery package (SDP) that includes health facility-based provision of EIMC services with community engagement for client referral will be compared to the standard package plus (SDPplus) that includes community-delivered EIMC services.

Study Population: Mothers aged 16 or over accessing the first oral polio vaccination (OPV-1) for an infant son and their male partners. In addition, we will interview other EIMC stakeholders.
Study Size: A total of 2,286 mothers and 1,794 of these mother’s male partners together with 50 EEIMC stakeholders.
Study Aims:

Aim 1: Using the same monitoring tools as currently applied by the MOH for adult VMMC and EIMC, to assess the effect of two models of EIMC service delivery on EIMC uptake. A standard delivery package (SDP) that includes health facility-based provision of EIMC services with community engagement for client referral will be compared to the standard package plus (SDPplus) that includes community-delivered EIMC services. The outcomes to be compared are: uptake, post-operative review, parental satisfaction, and costs. We will also compare any differences in AE rates between the two packages. Aim 2: To assess barriers and facilitators to EIMC uptake and service delivery among parents and key stakeholders (community health workers, health care providers and Ministry of Health officials) before and after introduction of EIMC services. Ninety six percent of infants in Nyanza Province receive the oral polio I vaccine. We will interview a representative, randomly selected sample of mothers and fathers accessing oral polio I vaccination services for their sons and a convenience sample of community health workers, providers and MOH officials. Information to be collected from parents includes sources and quality of EIMC information received, understanding of EIMC, access to services, reasons for accepting or declining EIMC, satisfaction with services, decision-making processes between mothers and fathers. Providers and MOH staff will be asked about their knowledge and beliefs about EIMC, experience in providing EIMC, challenges of services delivery and methods for increasing uptake.