Consensus for integrating the point-of-care Genital Inflammation Test (GIFT) into sexually transmitted infection management guidelines: results from a two-round modified Delphi survey

BACKGROUND: Sexually transmitted infections (STIs) and bacterial vaginosis (BV) are frequently asymptomatic in women, causing genital inflammation and increasing transmission and acquisition of HIV. The Genital Inflammation Test (GIFT) is a novel, point-of-care (POC) device under development for detecting genital inflammation in women. We aimed to obtain consensus to inform the integration of GIFT into STI 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 strategies from round one. Survey sections included participant demographics and test implementation, integration into current guidelines and purpose. The round two survey employed a five-point Likert scale from strongly agree to strongly disagree. Consensus was reached if ≥70% of participants selected strongly agreed or agreed. RESULTS: We received 28 responses in the first round and 68 in the second. In 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 that would benefit most from GIFT would be young asymptomatic women (16-24 years) in high HIV prevalence settings and high-risk women of any age, such as female sex workers and those with multiple partners. Attributes of GIFT ranked as most important included ease-of-use, stability at room temperature and high diagnostic accuracy. Barriers were test stock-outs, complexity of use and high cost. CONCLUSION: While Delphi consensus was for GIFT as a POC screening tool, factors such as supply chain, storage and stakeholder engagement are crucial for its integration into STI management guidelines.