TY - JOUR
T1 - Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis
T2 - study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation Test (GIFT)
AU - Ramboarina, Stephanie
AU - Crucitti, Tania
AU - Gill, Katherine
AU - Bekker, Linda Gail
AU - Harding-Esch, Emma Michele
AU - van de Wijgert, Janneke H H M
AU - Huynh, Bich-Tram
AU - Fortas, Camille
AU - Harimanana, Aina
AU - Mayouya Gamana, Théodora
AU - Randremanana, Rindra Vatosoa
AU - Mangahasimbola, Reziky
AU - Dziva Chikwari, Chido
AU - Kranzer, Katharina
AU - Mackworth-Young, Constance R S
AU - Bernays, Sarah
AU - Thomas, Nicola
AU - Anderson, David
AU - Tanko, Fatime Ramla
AU - Manhanzva, Monalisa
AU - Lurie, Micaela
AU - Khumalo, Fezile
AU - Sinanovic, Edina
AU - Honda, Ayako
AU - Pidwell, Tanya
AU - Francis, Suzanna C
AU - Masson, Lindi
AU - Passmore, Jo-Anne
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2024.
PY - 2024/5/1
Y1 - 2024/5/1
N2 - Introduction A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care 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 and analysis We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational 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 the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent 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. Ethics and dissemination Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications. The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046). Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).
AB - Introduction A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care 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 and analysis We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational 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 the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent 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. Ethics and dissemination Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications. The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046). Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).
KW - Adult
KW - Biomarkers/analysis
KW - Cross-Sectional Studies
KW - Cytokines/metabolism
KW - Feasibility Studies
KW - Female
KW - Humans
KW - Interleukin-1alpha/metabolism
KW - Interleukin-1beta/analysis
KW - Multicenter Studies as Topic
KW - Observational Studies as Topic
KW - Point-of-Care Testing
KW - Prospective Studies
KW - Sexually Transmitted Diseases/diagnosis
KW - South Africa
KW - Vaginosis, Bacterial/diagnosis
KW - Zimbabwe
U2 - 10.1136/bmjopen-2024-084918
DO - 10.1136/bmjopen-2024-084918
M3 - Article
C2 - 38692732
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e084918
ER -