Rapid gonorrhoea test for pregnant and symptomatic women in East London, South Africa
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
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 |
|---|---|
| Enrollment | 1239 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Foundation for Professional Development (Pty) Ltd Academic / other |
| Locations | 1 site (East London, Eastern Cape) |
| Trial ID | NCT07530406 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
East London, Eastern Cape
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.