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 range18 Years – 35 Years
SexFEMALE
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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
…
What they're measuring
1
Estimates of sensitivity and specificity for the GIFT device