Mtoto Msafi Mbili(MM2)

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), Elijah Odoyo June (NRHS), Sherry Nordstrom (UIC), Dedan Ongong’a (JOOTRH), Walter Obiero (NRHS)

Duration:                  June 2012 – May 2015

Status:                  Completed

Study Sites:         UNIM Research and Training Centre

Kenya Ministry of Health facilities in the Rachuonyo North and Rachuonyo South Districts of Nyanza Province

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

Purpose:             Infant male circumcision is little-known and little-practiced in East and southern Africa. IMC is not part of routine antenatal education and is not normally discussed post-partum nor during immunization visits. Our experience shows that IMC is rarely practiced by providers or by parents in Nyanza. 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 IMC prior to delivery and by offering IMC services in the community. These approaches directly respond to the two main barriers to IMC uptake: over half of all deliveries in Kenya occur outside of healthcare facilities, and fathers must be consulted about the IMC decision.

Significance:  The study sought to determine the relative advantages of two models of IMC 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 sought to generate an understanding of barriers to IMC uptake and determine how service implementation affects these barriers.  Results from this study were to provide the evidence necessary for the GOK and PEPFAR to move forward with effective scale-up of IMC services in Kenya and beyond.

Design:   We proposed a simultaneous, prospective comparison of two models of IMC service delivery. A standard delivery package (SDP) that includes health facility-based provision of IMC services with community engagement for client referral was compared to the standard package plus (SDPplus) that includes community-delivered IMC 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 also planned to interview other IMC stakeholders.

Study Size:    A total of 2,286 mothers and 1,794 of these mother’s male partners together with 50 IMC stakeholders.

Study Aims:  Aim 1: Using the same monitoring tools as currently applied by the MOH for adult VMMC and IMC, to assess the effect of two models of IMC service delivery on IMC uptake. A standard delivery package (SDP) that includes health facility-based provision of IMC services with community engagement for client referral will be compared to the standard package plus (SDPplus) that includes community-delivered IMC 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 IMC 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 IMC 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 IMC information received, understanding of IMC, access to services, reasons for accepting or declining IMC, satisfaction with services, decision-making processes between mothers and fathers. Providers and MOH staff will be asked about their knowledge and beliefs about IMC, experience in providing IMC, challenges of services delivery and methods for increasing uptake.

Results:   Of 1,660 mothers interviewed, 1,501 (89%) gave approval to contact the father, and 1,259 fathers (84%) were interviewed. The proportion of babies circumcised was slightly greater in the SDPplus division than the SDP division (27.3% vs 23.7%), but the difference was not significant (p=0.08). In adjusted analyses, however, the prevalence of babies being circumcised was greater in the SDPplus division (aPR=1.23, 95% CI:1.04-1.45) and the factors associated with a baby being circumcised were the mother having received information about EIMC during pregnancy (aPR=4.81, 95% CI: 2.21-3.42), having discussed circumcision with the father if married or cohabiting (aPR=5.39, 95% CI: 3.31-8.80) or being single (aPR=5.67, 95% CI: 3.31-9.69), perceiving herself to be living with HIV (aPR=1.39, 95% CI: 1.15-1.67), or having a post-secondary education (aPR=1.33, 95% CI: 1.04-1.69), and the father being Muslim (aPR=1.85, 95% CI: 1.29-2.65) or circumcised (aPR=1.34, 95% CI: 1.13-1.59). The median age of 2,117 babies circumcised was 8 days (IQR: 1-36), and the median weight was 3.6 kg (IQR: 3.2-4.4). There were 6 moderate adverse events (AEs) (0.28%); 5 severe AEs (0.24%), all involving an injury to the glans penis, requiring hospitalization and corrective surgery; and one death probably related to the procedure. There were no AEs among the 365 procedures performed outside health facilities. Information and education campaigns must reach members of the general population, especially men and fathers, who are influential to the EIMC decision. Serious AEs using the Mogen clamp are rare, but do occur and require efficient, reliable emergency back-up.

Conclusion:   The results of our study have informed the policy guidelines and the EIMC training manual for Kenya. In addition, this project trained most of the clinicians who are currently employed and providing EIMC in selected sub-County and County hospitals in western Kenya.