Asymptomatic STIs pose a formidable challenge to women’s sexual and reproductive health, particularly in low and middle-income settings. A newly developed, low-cost screening device – the Genital Inflammation Test (GIFT) – could enable healthcare workers to detect many STI cases that would otherwise have been missed. Timeous treatment of asymptomatic STIs can prevent greater risk for HIV acquisition, pregnancy complications and other health complications. But what would it take to roll out GIFT in low- and middle-income countries? The GIFT team conducted a survey study to gather insights from healthcare workers, clinicians, and policymakers on the potential integration of GIFT into current STI management practices.
A point-of-care test is optimally suited for screening asymptomatic cases of bacterial vaginosis (BV) and sexually transmitted infections (STIs) in low and middle-resource settings. This was the consensus from a survey that sought the opinions of expert healthcare workers, researchetrs, and policymakers on how to roll out the novel Genital Inflammation Test (GIFT) device in real-world settings.
While existing molecular-based tests can accurately diagnose BV and STIs, such tests are costly and resource-intensive. As a result, healthcare providers in low- and middle-income countries (LMICs) frequently rely on syndromic management to treat BV and STIs, leaving many asymptomatic infections untreated. A 2024 meta-analysis of STIs among women in LMICS found that, between 2020 and 2022, asymptomatic infections accounted for 60.7% of Chlamydia trachomatis cases, 53.3% of Neisseria gonorrhoeae cases, and 56.9% of Trichomonas vaginalis cases.
GIFT may be a game-changer for screening asymptomatic women in these settings. A lateral flow device that tests for the tell-tale biomarkers of vaginal inflammation associated with BV and STIs, GIFT produces results in just 15 minutes. Upscaling asymptomatic screening is essential for reducing STI transmission at a community level.
“We’re envisioning a situation where women can run the test on themselves and self-report within clinics and primary healthcare systems,” said Eneyi Kpokiri, part of the GIFT research team.
To make this a reality, the team sought insights from experts in the field on how to integrate the device into existing STI treatment guidelines and which attributes to prioritise. They used a modified Delphi method – a communication technique that builds consensus on a topic through iterative survey rounds.
Gathering expert insights
In the first round of the survey, the team aimed to gather diverse ideas on the device’s purpose, implementation, and integration into healthcare. “We got good diversity in terms of geographic spread and expertise,” Kpokiri said. Among the 28 respondents were contributors to STI management guidelines for LMICs, clinicians who implement and use the guidelines, and experts in STI management programs and policy. Most were women and from African countries. Their detailed responses to open-ended questions informed the questions of the second round.
To maximise participation, the researchers translated the questions into other languages, leveraged expert networks, and provided hard copy options for those with limited data or connectivity. They received 68 responses (a 75% response rate) and reached a consensus on how GIFT could best be implemented.
Three-quarters (76%) of the participants agreed that GIFT should be used as a screening tool. Almost all the participants (89%) agreed that the Gift device should be prioritised for women facing the highest HIV risk (transactional sex or commercial sex workers). A consensus also emerged on integrating the GIFT device into current symptomatic STI/BV management guidelines.
The Delphi expert panel agreed that the most important factors for a successful roll-out were ease of use, rapid turnaround time, stability when stored at room temperature, affordability (no more than $4), and high accuracy as a screening device for vaginal inflammation.
In a separate study, the GIFT team will investigate which test attributes are most important to women. Additionally, a cost-effectiveness study will estimate the cost and health outcomes associated with different integration strategies. Based on the feedback and findings from these studies, the team will finalise the attributes of the GIFT device, prioritising those considered most important to rollout and uptake.
Keeping it simple
The Delphi study experts emphasised the importance of integrating GIFT into healthcare routines without requiring significant extra time and resources.
How could GIFT be integrated into the syndromic treatment protocols in low and middle-income settings? Around half (51%) of the respondents suggested that GIFT could fit into the third and fourth World Health Organisation (WHO) pathways for vaginal discharge management.
In the WHO guidelines, Pathway 3 is used when doctors can perform a speculum exam (a standard procedure to look inside the vagina) but don’t have access to more advanced tests. Pathway 4 is for situations where neither a speculum exam nor advanced tests are possible. In these settings, using GIFT during the exam could confirm the presence of vaginal inflammation associated with STIs or BV. Where women are at high risk for STIs/BV, healthcare workers could follow the GIFT-enhanced fourth pathway regardless of vaginal discharge presence.
The survey indicated that stock shortages, insufficient provider knowledge, and the need for more private areas within healthcare facilities could hinder the tests’ integration. Kpokiri noted that conducting awareness campaigns and promoting the GIFT device test prior to rollout would be beneficial. The team also plans to tap into existing distribution networks to ensure consistent availability.
Alternative uses
The Delphi experts offered some ideas on alternative uses for the GIFT device, including sexual health self-care, HIV risk assessments, and helping people stay on their pre-exposure prophylaxis regimes (HIV prevention medication). The GIFT team would need to research the feasibility and acceptability of these additional use cases and how they would affect the device’s most important features.
During the developmental stages, combining insights from the Delphi survey and other arms of GIFT research will be critical to actualising the device’s potential. Once rolled out, “the GIFT device itself would be really valuable and impactful in diagnosis, treatment and managing STIs in low-income settings, particularly for asymptomatic women,” said Kpokiri.