Background: Sexually transmitted infections (STIs) and bacterial vaginosis (BV) are frequently asymptomatic in women. They cause genital inflammation and can increase transmission and acquisition of HIV. GIFT (Genital InFlammation Test) is a novel, point-of-care (POC) device under development for detecting genital inflammation in women. We aimed to obtain consensus to inform the development of GIFT and its integration into management guidelines. Methods: We employed a Delphi technique through two rounds of online surveys. Respondents included service providers, health programmers, researchers, and policy makers. Round one questions generated ideas, and round two built consensus on the strategies from round one. Survey sections included demographics, implementation of the test, integration into current guidelines and purpose. Round two survey employed a five-point Likert scale from strongly agree to strongly disagree. Consensus was reached if ≥70% of participants selected strongly agree or agree. Results: We received 28 to the first and 68 to the second round. From both rounds, participants were healthcare providers (41%) or researchers (26%), residing in Africa (57%), Europe (21%) and America (10%). Most participants agreed that GIFT should be used as a screening tool to be followed by confirmatory STI testing before treatment: 75% (round 1), 69% ( round 2). There was consensus that populations to benefit most from GIFT were young asymptomatic women (16-24 years) in high HIV prevalence settings, and high-risk women like female sex workers and those with multiple partners of any age. Attributes of GIFT ranked as most important included ease-of-use, stability at room temperature, high diagnostic accuracy and barriers were test stock-outs, complexity of use and high cost, Conclusion: While the Delphi process suggests the purpose of GIFT is as a POC screening tool, factors like supply chain, storage and stakeholder engagement are crucial for its integration into management guidelines.

LM and JAP are co-inventors on South African (Patent No. 2016/03606) and European (Patent No. 14809984.9) patents for a method for diagnosing an inflammatory condition in the female genital tract.

Funding for this study was received through an unrestricted grant by the European and Developing Countries Clinical Trials Partnership (EDCTP), Grant Number RIA2020I-3297.

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