Integrating molecular and microbiologic surveillance for antimicrobial resistant N. gonorrhoeae for more effective containment in Kisumu, Kenya

The UTAWAKUKI STUDY
Start: July 2019
Status: Data cleaning and analysis ongoing
Design: Surveillance
Study Sites: UNIM Research and Training Centre
Sponsor: United States Department of Defence, Global Emerging Infections Surveillance Program
IRB: Maseno University Ethical Review Committee MUERC/00692/19
Purpose: The objective of this study is to measure the prevalence and types of gonococcal antimicrobial resistance, detecting demographic and clinical factors associated with resistance and differing strain types.
Design: This study is a prospective cross-sectional surveillance study. Subjects are recruited from male patients aged 18 and over with history or exam finding of urethral discharge. We propose to enroll up to 150 men. Among men with urethral discharge, we anticipate 30-50% will test positive for N. gonorrhoeae by culture (n=45 to 75).
Population: Men who are aged 18 years and older with a chief complaint of urethral discharge or findings of urethral discharge on physical examination will be included.
Study Size: Approximately 75 Adult men (≥18 years) presenting with urethral discharge.
Study Aims: Aim 1: Conduct systematic surveillance of N. gonorrhoeae and antimicrobial resistance using traditional microbiologic and molecular approaches in accordance with international recommendations for quality-assured AMR surveillance.
Aim 2: Conduct comprehensive molecular characterization of N. gonorrhoeae phylogeny, sequence type, and antimicrobial resistance type.