BridgeMD
New treatment option for Gonorrhea Infection
Official title A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
ClinicalTrials.gov ID: NCT07569900
What this study is testing
- What it's testing
- The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Age \> 16 years
- Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures
- Female gender
- Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)
- Subject can complete the required testing on the allocated testing day
You likely can't join if
- Subject 15 years of age or younger
- Male gender
- Female currently menstruating
- Subject is unable or unwilling to provide informed consent
- Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance
- Subject is unable to provide paired samples for reference testing
See the full eligibility criteria
- Age \> 16 years
- Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures
- Female gender
- Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)
- Subject can complete the required testing on the allocated testing day
- Subject can speak, read, and write English
- Subject's demographic information, risk factors, and symptoms are available and can be recorded on case report forms
- Subject agrees to comply with study procedures and sample collection for both the investigational device and the reference method
- Subject is willing to participate in the study site's standard-of-care Gonorrhea counselling and testing program and receive standard-of-care test results, as required and applicable
- Subject is indicated for sexually transmitted infection testing for one or more of the following reasons:
- At risk of Gonorrhea, such as recent unprotected intercourse, multiple or new partners within \< 60 days, known exposure to an infected partner, or prior STI history
- Having signs and/or symptoms suggestive of Gonorrhea (e.g., urethral, vaginal, rectal, or pharyngeal discharge; dysuria; pelvic or lower-abdominal pain; sore throat; or rectal discomfort)
- Undergoing routine or opportunistic STI screening, including family-planning, antenatal, or sexual-health clinic visits
- Undergoing re-testing (test-of-cure) \> 7 days after completion of Gonorrhea treatment and clinically stable
- Undergoing co-testing for other STIs where Gonorrhea testing is part of a broader diagnostic panel
- Subject 15 years of age or younger
- Male gender
- Female currently menstruating
- Subject is unable or unwilling to provide informed consent
- Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance
- Subject is unable to provide paired samples for reference testing
- Subject requires urgent antimicrobial treatment before specimen collection
- Subject received systemic or topical antibiotics active against Gonorrhea within the previous 7 days
- Subject used topical intravaginal or rectal antiseptics within 48 hours prior to study sampling
- Previously enrolled for the same infection episode
- Anatomical or clinical contraindication to study sampling (e.g., severe cervical pathology)
- Recent urogenital procedure (e.g., cystoscopy, lavage) \< 72 hours before study sampling
- Subject belongs to a protected group excluded by local ethics (e.g., incarcerated persons), unless explicitly approved by the EC/IRB
- Any condition that, in the opinion of trained personnel or study staff, would make the participant unsuitable or unsafe for enrolment, interfere with completion of assessments, consent, or questionnaires, or bias study...
- Subject is participating in another treatment clinical study within 30 days that could interfere with study results
The study team makes the final eligibility decision.
Where it's taking place
- Johannesburg, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
- Cape Town, Western Cape, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Johannesburg, Gauteng, South Africa; Durban, KwaZulu-Natal, South Africa; Cape Town, Western Cape, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.