A Novel Point-Of-Care Cytokine Biomarker Lateral Flow Test for the Screening for Sexually Transmitted Infections and Bacterial Vaginosis: Study Protocol of a Multi-Centre Multi-Disciplinary Prospective Clinical Study to Evaluate the Performance and Feasibility of the Genital Inflammation Test (GIFT)

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Abstract Background A prototype lateral flow device detecting cytokine biomarkers IL-1α and IL-1β has been developed as a Point-of-Care (POC) test – called the Genital InFlammation Test (GIFT) - for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe, and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care. Methods We will conduct a prospective, multidisciplinary, multi-centre, and cross-sectional clinical study comprising two distinct components: a biomedical (“diagnostic study”) and a qualitative, modelling, and economic (“an integration into care study”) part. The diagnostic study aims to evaluate GIFT’s performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for evaluation of cytokine concentrations (enzyme-linked immunosorbent assay), STIs (nucleic acid amplification tests), BV (Nugent Score), and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms. Discussion The study will improve our understanding of key factors contributing to the successful implementation of a novel screening device for STI and BV in low-and middle-income countries, including providing first-in-field performance for this novel POC test for screening of vaginal inflammation and the interplay between common STIs and the vaginal microbiome. Trial registration The study is registered in the Clinicaltrials.gov public registry (NCT05723484).

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