Principal Investigator: Chelsea Morroni, MPH, MPhil, PhD, MBChB, DTM&H, DFSRH

Study Objectives:

1. To determine the aetiology of GUD in patients presenting with genital ulceration
2. To determine risk factors for specific causes of GUD
3. To determine the prevalence of azithromycin resistance amongst cases of syphilis
4. To undertake whole genome sequencing on organisms identified in cases of GUD and describe the genomic diversity present in target countries.
5. To determine the prevalence of other sexually transmitted infections in individuals with GUD
6. To describe the knowledge, attitudes and practice  regarding self-collection and self -testing for STIs and of partner notification among persons with genital ulcer disease and genital discharge attending outpatient STI clinics.
7. Generate a biobank to allow future validation of new near-patient and/or point of care diagnostic tests for genital ulcer disease

Study Design:

This is a multi-country cross-sectional study investigating the aetiology of GUD across several LMICs. Participants will be recruited through local clinics. For the purpose of the study we will collect clinical and demographic data alongside samples for laboratory testing. All participants will receive treatment in line with local STI treatment guidelines

Study Population and Size:

Men and women, aged 18 years or older, presenting to health services with GUD. In each country we aim to recruit a minimum of 200 GUD cases aiming for an approximately even split by gender.

Assuming that HSV is the most common cause of GUD this sample size provides adequate power to detect a prevalence of HSV of 60% in each country/gender sub-group. Across the overall study population (1000 individuals) we will have adequate power to detect causes of GUD that account for as little as 10% +/- 2.5% of all GUD. For this sub-study we will aim to enrol a total of 24 individuals at each country site aiming for 12 men and 12 women per-site.

Study duration: 18 Months

Study Results: Study is on-going and no results yet.

Sponsor: Welcome Sanger Institute