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New rapid test could transform gonorrhea detection for pregnant women

NCT ID NCT07530406

Diagnosis Sponsor: Foundation for Professional Development (Pty) Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, quick test for gonorrhea in pregnant women and women with symptoms in South Africa. About 1,239 women will provide samples to see if the new test works as well as standard lab methods. The goal is to make diagnosis faster and easier, especially in clinics with limited resources.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,239 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

1. Pregnant women 2. Symptomatic women 3. Healthcare workers (HCWs) population Systems Usability Score Survey \& TFA Acceptability Survey * HCWs using the NG LFA during month 3 of the study. Focus Group Discussions (FGD) * HCWs actively involved in conducting the study Focus Group Discussions (FGD) - Non-Study Participants * HCWs working at the study site but NOT directly involved in the NG LFA study procedures

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gonorrhea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neisseria gonorrheae infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 1. Nontyatyambo CHC 2. Empilweni Gompo CHC 3. Duncan Village Day Hospital 4. Grey Gateway Clinic 5. Ndevana Clinic

    RECRUITING

    East London, Eastern Cape, 5247, South Africa

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Other studies related to the condition(s) this trial covers.