Rapid gonorrhoea test for pregnant and symptomatic women in East London, South Africa
Official title: Evaluation of Performance, Acceptability, and Usability of a Novel Lateral Flow Assay for Point-of-Care Detection of Neisseria Gonorrhoeae Infection Among Pregnant and Symptomatic Women in South Africa
Run by Foundation for Professional Development (Pty) Ltd · NCT07530406 · Data updated 2026-11-12
This project will test a quick point-of-care gonorrhoea test to see if it accurately detects infection in pregnant and symptomatic women attending clinics in East London, South Africa.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1239 (estimated) |
| Sponsor | Foundation for Professional Development (Pty) Ltd Academic / other |
| Locations | 1 site (East London, Eastern Cape) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT07530406 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (≥18) who are pregnant and attending antenatal care or non-pregnant women with symptoms of vaginal discharge, willing to consent and able to provide required specimens, and without recent antimicrobial or vaginal product use.
✕Probably not a fit
People who recently used antibiotics or vaginal products, cannot provide specimens, are under 18, or do not fit the pregnancy or symptom criteria are unlikely to benefit from this study's testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares a novel rapid lateral flow assay (LFA) for Neisseria gonorrhoeae against standard laboratory methods, including NAAT, in women attending five clinics in East London, Eastern Cape. Adult participants will provide genital samples that are tested on-site with the LFA and in parallel by laboratory reference tests to determine sensitivity and specificity. The study will also collect acceptability and usability feedback from participants and clinic staff to understand practical implementation in antenatal and symptomatic care settings. Analyses will examine whether pregnancy-related physiological factors influence LFA performance compared with prior regional results.
Why it matters
Potential benefit: If accurate, the rapid LFA could enable same-visit diagnosis and treatment in low-resource clinics, reducing delays, pregnancy complications, and onward transmission.
How similar studies have gone: Prior field studies showed mixed results—about 80% sensitivity in asymptomatic women in East London but 65% sensitivity in pregnant women in Zimbabwe—so the approach is promising but not yet consistently validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: ANC population * Women age ≥18 years * Pregnant women * Attending a study site for antenatal care * Willingness to participate and signed informed consent form (ICF) Exclusion Criteria: * Self-reported use of antimicrobial therapy within 21 days preceding enrolment * Use of vaginal douche or vaginal product in the previous 24 hours * Unable to provide specimens for testing * A medical condition, serious illness, or other condition that could interfer with study procedures or jeopardise participant safety Symptomatic population Inclusion - * Non pregnant women age ≥18 years * Diagnosis of VDS. Diagnosis of VDS will be based on self-reported presence ofsymptoms consistent with VDS, such as increased or abnormal vaginal discharge * Willingness to participate and sign ICF Exclusion - * Self-reported use of antimicrobial therapy within 21 days preceding enrolment * Use of vaginal douche or vaginal product in the previous 24 hours * Unable to provide specimens for testing * A medical condition, serious illness, or other condition that could interfere with study procedures or jeopardise participant safety
Where it's running
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1. Nontyatyambo CHC 2. Empilweni Gompo CHC 3. Duncan Village Day Hospital 4. Grey Gateway Clinic 5. Ndevana Clinic
East London, Eastern Cape, South Africa Recruiting
Study contacts
- Principal investigator: Mandisa M Mdingi, Master of Public Health — Foundation for Professional Development
- Study coordinator: Mandisa M Mdingi, Master of Public Health
- Email: mandisam@founadtion.co.za
- Phone: +27 73 706 9068
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Point-of-care STI testing to speed treatment in pregnant patients
This study tests whether rapid point-of-care STI tests in pregnant women at Grady Memorial Hospital can speed up treatment for syphilis, chlamydia, gonorrhea, and trichomonas compared with standard lab testing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.