PA-456 Field testing of a novel point-of-care Genital InFlammation Test (GIFT) in low- middle-income countries in Africa: aiming to prevent HIV infection and improve reproductive health

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Background Sexually transmitted infections (STIs) and bacterial vaginosis (BV) are major risk factors for HIV infection and reproductive complications in women living in sub-Saharan Africa, in part because of inflammation associated with these conditions. In women, most STIs and BV are asymptomatic, and therefore not diagnosed in low and middle income countries (LMICs), where etiologic testing is not common and infections are treated based on presence of signs or symptoms (syndromic management). To improve STI/BV case finding in LMICs, we have been developing a true point-of-care low cost lateral flow test based on inflammation biomarkers – called the Genital Inflammation Test (GIFT) – to screen women who would benefit from further etiologic testing. Methods Through an EDCTP2 RIA2020I funding mechanism, the first version of the GIFT device has been developed in South Africa and is currently being evaluated in three parallel clinical studies in South Africa, Zimbabwe and Madagascar. Field testing is intended to inform optimisation of the final prototype device. Results The GIFT-Africa consortium (www.GIFT-Africa.org.za) includes a cross-disciplinary team of experts, including those working on design, optimisation, manufacture and laboratory validation of the first in field GIFT device, clinical performance in each region compared to inflammation biomarkers measured by ELISA, STIs measured using NAATs, and BV measured by Nugent. In addition to assessing sensitivity/specificity in different LMIC settings, implementation of the GIFT device into reproductive health services will be evaluated using: in-depth interviews with patients and healthcare professionals (user experience); discrete choice experiments with end-users; cost, budget impact and cost-effectiveness analyses, and; a DELPHI survey to evaluate key stakeholder recommendations for implementation. Conclusion The GIFT device is positioned to cost-effectively increase STI/BV case-finding, but also to improve STI/BV management for women in LMICs, who are at high risk of HIV infection and reproductive complications.

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