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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

NCT05723484 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 675

Last updated 2025-08-06

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Macfarlane Burnet Institute for Medical Research and Public Health Ltd

    collaborator OTHER

  • Desmond Tutu HIV Foundation

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Institut Pasteur

    collaborator INDUSTRY

  • Institut Pasteur de Madagascar

    collaborator OTHER

  • Hitotsubashi University

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Jo-Ann Passmore, Professor · University of Cape Town

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Madagascar
  • South Africa
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05723484 on ClinicalTrials.gov