Performance, Acceptability, and Usability of a Novel Rapid Lateral Flow Test for Detecting Neisseria Gonorrhoeae in Pregnant and Symptomatic Women Attending Clinics in South Africa.

Recruiting now

Conditions studied: Neisseria Gonorrheae Infection

In brief

Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women. However, a study in Zimbabwe reported a lower sensitivity of 65% among pregnant women attending antenatal care (ANC). This discrepancy raises important questions about the test's performance in pregnant women in the East London ANC population. Physiological changes during pregnancy may influence test accuracy, highlighting the need for further investigation in this specific population and setting. This study aims to evaluate the performance, acceptability, and usability of the NG LFA among pregnant and symptomatic women attending clinics in East London. Participants will provide clinical samples that are tested using both the NG LFA and standard laboratory methods to assess diagnostic accuracy, including sensitivity and specificity. The study will specifically determine whether pregnancy affects the test's performance and whether the LFA is reliable for routine use in ANC clinics. Confirming its accuracy could enable wider implementation, improving case detection, treatment rates, and reducing the burden of gonorrhea in the community. In addition to evaluating performance, the study will investigate the feasibility of self-collected samples. Self-collection offers privacy, convenience, and may increase participation in testing, particularly for women who prefer this method. It may also reduce the workload for healthcare providers, especially in resource-limited settings. The study will compare the accuracy of self-collected samples with clinician-collected samples to determine whether self-collection is a viable option in ANC and symptomatic populations. The findings will provide crucial evidence to guide implementation of the NG LFA in primary care and ANC clinics, supporting timely diagnosis and treatment. If successful, this approach could strengthen gonorrhea screening programs, enhance patient-centered care, and contribute to better sexual and reproductive health outcomes for women in South Africa.

Key facts

Study ID: NCT07530406
Run by: Foundation for Professional Development (Pty) Ltd
People needed: 1239
Starts: 2025-09-11
Expected to finish: 2026-06-30
Last updated by the study team: 2026-04-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

ANC population
Women age ≥18 years
Pregnant women
Attending a study site for antenatal care
Willingness to participate and signed informed consent form (ICF)

You may not qualify if…

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 is running

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 (enrolling)

Full record on ClinicalTrials.gov

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