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

CompletedOBSERVATIONAL
Enrollment

675

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
STI
Interventions
DEVICE

GIFT Device

The GIFT device - immune-based lateral flow test for reproductive-aged, non-pregnant in resource-limited settings attending sexual reproductive health (family planning) clinics, community health centers, hospitals, and mobile clinics. The test involves the qualitative detection of genital inflammation caused by asymptomatic STIs and BV in self- or clinician-collected lateral vaginal wall swabs, with results available in less than 20 minutes.

Trial Locations (3)

7975

Desmond Tutu Health Foundation, Cape Town

Unknown

Centre Hospitalier Universitaire Gynéco-Obstétrique de Befelatanana, Antananarivo

Chitungwiza Primary Health Care Clinics, Harare

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

OTHER

collaborator

Desmond Tutu HIV Foundation

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

Institut Pasteur

INDUSTRY

collaborator

Institut Pasteur de Madagascar

OTHER

collaborator

Hitotsubashi University

OTHER

lead

University of Cape Town

OTHER

NCT05723484 - 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 | Biotech Hunter | Biotech Hunter