Women with STIs and BV are at increased risk for HIV infection and pregnancy complications, with the genital inflammation associated with these conditions being an important contributor to this increased risk. In resource-limited settings, these conditions are only treated if women present with clinical signs or symptoms of an STI or BV (according to WHO syndromic management guidelines). Syndromic management of STIs/BV is easily implemented, inexpensive and patients can be treated immediately. However, clinical signs and symptoms in women with discharge-causing STIs or BV are relatively poor predictors of active infections, and the majority of women who have a laboratory-confirmed discharge causing STI or BV are asymptomatic. Women with asymptomatic STIs/BV have the same level of genital inflammation as women with symptomatic infections, which is elevated compared to women who do not have an infection.

We have developed a first-generation lateral flow device that can be used at the point-of-care – GIFT (https://gift.org.za/) – which detects biomarkers of genital inflammation that is caused by STIs and BV in asymptomatic women.

This study aims to optimize the GIFT device and evaluate the performance across three countries in Africa (South Africa, Madagascar and Zimbabwe). The study will also develop strategies to integrate GIFT into current STI/BV management guidelines in resource limited settings. GIFT-Africa is a truly international consortium with experts in manufacture, laboratory testing, public health, epidemiology and statistics, qualitative research methodology, health economics, and commercialisation of medical devices, funded by the EDCTP (RIA2020I-3297; 3 years). The GIFT-Africa team will evaluate the specificity, sensitivity, positive predictive value and negative predictive value of the next generation GIFT lateral flow device to detect asymptomatic STIs and BV in young sexually-active, non-pregnant women in regions in Africa where syndromic management is the standard of care (including South Africa, Madagascar and Zimbabwe), in a regulatory body-approved clinical trial in preparation for subsequent licensure and CE-mark applications for this device in the EU and Africa.

The goal of GIFT-Africa is to develop clear guidelines for implementation of the GIFT device in Africa, in broad consultation with national and international stakeholders. Averting even a small proportion of HIV infections and adverse birth outcomes linked to undetected STIs/BV would have a massive economic and social impact. GIFT could improve the health of women in Africa and other regions where syndromic management is implemented.