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

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;To evaluate how the GIFT device can be integrated in a feasible, acceptable, and cost-effective way into routine care.

Diagnostic Inclusion Criteria:18-35 years oldWilling and able to provide informed consent to participate in the studySelf-reported to be sexually activeNot pregnant (determined by pregnancy test)Accessing family planning serviceIntegration Inclusion Criteria:For all: Willing and able to provide informed consent to participate in the studyUser experiences/perceptions activity:Local or regional policy makers, programmers and other opinion leaders and decision makersHealthcare professionals at health facilitiesWomen who are eligible for the diagnostic study (including pregnant and menstruating women), but who are not part of the diagnostic study18-35 years oldWilling and able to provide informed consent to participate in the studySelf-reported to be sexually activeAccessing family planning service diagnostic studyDiscrete 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 study18-35 years oldSelf-reported to be sexually activeAccessing family planning service diagnostic studyDecision tree classification algorithm:Data from diagnostic study participantsEconomic evaluation:Healthcare professionals at health facilities involved in GIFT device implementation able to complete timesheetsDiagnostic Exclusion Criteria:<18 years or >35 yearsRefusal by a participant to participate in the studyTreatment for any STI/BV in the past 30 daysPregnancyEnrolled in a study which does not allow co-enrolment in other studiesIntegration Exclusion Criteria:For all: Not willing or able to provide informed consent to participate in the studyUser experiences/perceptions activity:Non-relevant policy makersHealthcare professionals at health facilities not included in diagnostic studyWomen who are:Part of the diagnostic study<18 years or >35 yearsTreated for any STI/BV in the past 30 daysPregnantEnrolled in a study which does not allow co-enrolment in other studiesDiscrete choice experiments:Women who are:<18 years or >35 yearsTreated for any STI/BV in the past 30 daysPregnantEnrolled in a study which does not allow co-enrolment in other studiesDecision tree classification algorithm:Participants for whom there are no diagnostic study dataEconomic evaluation:Healthcare professionals not at study sites, not involved in GIFT device implementation, and/or not able to complete timesheets