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NCT05723484: GIFT

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

Completed Last updated 6 August 2025
What this trial tests

trial testing GIFT Device in STI in 675 participants. Completed in 31 December 2023.

Timeline
1 June 2023
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorUniversity of Cape Town
StatusCompleted
Study typeOBSERVATIONAL
Enrollment675
Start date1 June 2023
Primary completion31 December 2023
Estimated completion31 December 2023
Sites3 locations across Madagascar, Zimbabwe, South Africa

Drugs / interventions tested

Conditions studied

Sponsor

University of Cape Town

Who can join

Adults 18 to 35, female only, with STI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Ge
    Ramboarina S, Crucitti T, Gill K, Bekker LG, et al · · 2024 · cited 4× · PMID 38692732 · DOI 10.1136/bmjopen-2024-084918
  2. 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 Infl
    Ramboarina S, Crucitti T, Gill K, Bekker L, et al · · 2023 · DOI 10.21203/rs.3.rs-3675671/v1

Verify or expand the search:

Other recruiting trials for STI

Currently open trials in the same condition.

Other University of Cape Town trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05723484.

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