Congenital and Maternal Point of Care Rapid Testing for Syphilis Study, Uganda

NCT07173764 | Not Yet Recruiting

• 1 other identifier: 2025.0124
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Syphilis is an infection which affects about 1 in 25 pregnant women in Uganda. If the infection is not diagnosed and treated this can be a risk to the mother and unborn baby's health. This study aims to see whether a new test for syphilis infection in mothers and babies which can give a result in 10 minutes is as good as the standard tests that are done in the laboratory and take hours or days to provide results.

Conditions

Syphilis; Syphilis, Congenital

Keywords

syphilis; point of care test

Outcome Measures

Primary Outcomes (1)

• Primary outcomes

  Correlation of binary non-treponemal IgM and IgG results for the Chembio DPP Syphilis TnT with RPR positivity. Correlation of binary treponemal IgM and IgG results for the Chembio DPP Syphilis TnT with Treponemal Antibody (TPAB) positivity. Correlation of binary IgA and IgM results for the Chembio DPP Syphilis CS and Chembio DPP Syphilis TnT to the RPR results in mother and baby to confirm the diagnosis of congenital syphilis in the neonate.

  At enrolment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mothers delivering at Kawempe National Referral Hospital with a positive syphilis rapid diagnostic test during their current pregnancy.

You may qualify if:

• Mothers delivering at Kawempe National Referral Hospital with a positive syphilis rapid diagnostic test during their current pregnancy.

You may not qualify if:

• Mothers who are unable to give written informed consent.
• Mothers with evidence of neurological symptoms compatible with neurological syphilis.
• Mothers who are aged less than 14 years. Emancipated and mature minors are allowed to consent for research per Ugandan law.11
• Mothers, who in the view of the study team, are unable to adhere to required study procedures

Sponsors & Collaborators

• St George's, University of London: lead
• Johns Hopkins University: collaborator
• MU-JHU CARE: collaborator

Study Sites (1)

Kawempe National Referral Hospital

Kampala, Uganda

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Syphilis; Syphilis, Congenital

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)