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

Study Objectives:

The aim of this study is to conduct an analysis of T. pallidum genomes in swabs obtained from symptomatic individuals with suspected syphilis in South Africa and Botswana.

Study objectives

Primary objectives

1. To determine the distribution of T. pallidum clades, sequence types and antimicrobial resistance-associated variants through molecular epidemiological analysis of specimens collected from different populations in South Africa and Botswana.
2. To ensure geographic inclusivity of South Africa and Botswana in the syphilis genome global database (GISAID) in support of vaccine development efforts.

Secondary objectives:

1. To determine microbiological aetiology of genital ulcer disease through molecular detection of the most common pathogens in symptomatic individuals across South Africa and Botswana.
2. To compare performance of different tests (rapid syphilis test, laboratory-based serology, and PCR) for diagnosis of syphilis in symptomatic individuals in South Africa and Botswana, and in the context of HIV infection.

Study Design: This is a cross-sectional study of swabs obtained from individuals presenting with genital ulcer disease or condylomata lata at participating healthcare facilities.

Study Population:

The study will recruit men and women at participating primary healthcare facilities. Individuals are eligible for participation if they meet the following criteria:

• Adult age (≥18 years).
• Clinical diagnosis of genital ulcer disease or condylomata lata
• Willingness to participate and signed informed consent
• Good comprehension of English or Setswana

Sample Size:

The study plans to recruit 500 individuals between all study sites in this study to obtain 100 T. pallidum genomes for genomic analysis; the sample size of 500 is based on an estimated 20% prevalence of T. pallidum as aetiological cause of genital ulcer disease [17,18]. From the general perspective, 100 T. pallidum genomes would provide a meaningful contribution to the global database and provides for sufficient sample size to conduct molecular epidemiological analysis of T. pallidum clade and sequence type distribution across South African and Botswana.

Individuals presenting at participating healthcare facilities with a clinical diagnosis of genital ulcer disease or condylomata lata will be asked to participate. To minimize the impact of the study to patients and clinical care provision, the questionnaire has been kept as short as possible while swab collection will take limited time and effort during routine physical examination.

Study duration: 24 months

Sponsor: Open Philanthropy