Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplificat… (NCT05723484) | Clinical Trial Compass
CompletedNot Applicable
Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis
Madagascar, South Africa, Zimbabwe675 participantsStarted 2023-06-01
Plain-language summary
1. To evaluate the performance of a lateral flow POC test, namely the Genital InFlammation Test (GIFT), for identifying women with inflammatory STIs and BV, who are at higher risk of HIV infection and reproductive complications;
2. To evaluate how the GIFT device can be integrated in a feasible, acceptable, and cost-effective way into routine care.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Diagnostic Inclusion Criteria:
* 18-35 years old
* Willing and able to provide informed consent to participate in the study
* Self-reported to be sexually active
* Not pregnant (determined by pregnancy test)
* Accessing family planning service
Integration Inclusion Criteria:
For all: Willing and able to provide informed consent to participate in the study
User experiences/perceptions activity:
* Local or regional policy makers, programmers and other opinion leaders and decision makers
* Healthcare professionals at health facilities
* Women who are eligible for the diagnostic study (including pregnant and menstruating women), but who are not part of the diagnostic study
* 18-35 years old
* Willing and able to provide informed consent to participate in the study
* Self-reported to be sexually active
* Accessing family planning service diagnostic study
Discrete choice experiments:
* Women who are eligible for the diagnostic study (including pregnant and menstruating women), who are either part of, or not part of, the diagnostic study
* 18-35 years old
* Self-reported to be sexually active
* Accessing family planning service diagnostic study
Decision tree classification algorithm:
* Data from diagnostic study participants
Economic evaluation:
* Healthcare professionals at health facilities involved in GIFT device implementation able to complete timesheets
Diagnostic Exclusion Criteria:
* \<18 years or \>35 years
* Refusal by a participant to participate in the study
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimates of sensitivity and specificity for the GIFT device