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. 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.

Key messages

• There is a need to identify BV and STIs in asymptomatic women, however, laboratory diagnostics services are severely limited in most low- and middle-income countries

• If the GIFT test has high diagnostic accuracy, it promises to be a valuable point-of-care screening tool for detecting genital inflammation in asymptomatic women and may be useful to inform the management of women with symptoms.

• It is important to obtain feedback from a variety of stakeholders when considering test design and implementation to increase the test’s utility and likely adoption in policy and routine care.