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Genital Inflammation Test (GIFT) for Sexual and Reproductive Health

In some settings, sexually transmitted infections and bacterial vaginosis go untreated in asymptomatic women because accurate diagnostic tests are too expensive to use widely. Inflammation in the genital tracts of these women is associated with an increased risk of HIV and reproductive complications. We are developing a point-of-care diagnostic test for genital inflammation to be used as a screening tool to identify women with asymptomatic sexually transmitted infections and bacterial vaginosis.

We aim to implement our test as a triage tool to identify women with genital inflammation. These women can then be referred for etiological testing and treatment for sexually transmitted diseases and bacterial vaginosis, pre-exposure HIV prophylaxis (if they are considered high risk), and/or close monitoring during pregnancy.

2013-ongoing

Our team at the University of Cape Town has identified and validated three biomarkers of genital inflammation. In partnership with a South African biotechnology company, Medical Diagnostech, we have developed two prototype devices to measure these biomarkers. Through partnerships with the Institut Pasteur de Madagascar, Desmond Tutu Health Foundation and Organization for Public Health Interventions and Development, we have evaluated these devices in Madagascar, South Africa and Zimbabwe, respectively.

Towards the development of appropriate implementation strategies for this test, together with our collaborators at the University of Cape Town and London School of Hygiene and Tropical Medicine, we have administered a Delphi survey to evaluate stakeholder recommendations and have conducted cost effectiveness and user experience studies. Discrete choice experiments and modelling analyses are ongoing. These data will be used to develop the final optimized device that will be evaluated in a clinical trial in South Africa in 2024/2025. Our aim is to extend this research to evaluate GIFT in the Asia-Pacific region in the future.

This work may lead to the development of an accessible, low-cost point-of-care diagnostic test for inflammation caused by sexually transmitted infections and bacterial vaginosis. We envisage that this test would be offered to sexually active women attending family planning clinics, community health centres, hospitals and mobile clinics, particularly in populations at high risk of HIV and adverse birth outcomes. By using this screening strategy to improve the management of sexually transmitted infections and bacterial vaginosis, our aim is to reduce the incidence of HIV acquisition and adverse reproductive outcomes. 

Doctor Lindi Masson

Contact Doctor Lindi Masson for more information about this project.

EMAIL

Funding
Partners

  • EDCTP
  • South African Medical Research Council
  • South African Technology Innovation Agency

Partners +
Collaborators

  • University of Cape Town, South Africa
  • Desmond Tutu Health Foundation, South Africa
  • Institut Pasteur de Madagascar, Madagascar
  • Organization for Public Health Interventions and Development, Zimbabwe
  • London School of Hygiene and Tropical Medicine
  • Institut Pasteur, France
  • Hitotsubashi University, Japan
  • Utrecht University, Netherlands
  • Medical Diagnostech, South Africa