Transforming women’s health: GIFT device offers early detection of STIs in women

A large clinical study involving three countries is underway to assess the effectiveness of a user-friendly device in detecting sexually transmitted infections (STIs) and bacterial vaginosis (BV) in women who show no symptoms. This will make routine screening for asymptomatic STIs and BV one step closer to becoming a reality for women in low- and middle-income countries (LMICs). The Genital Inflammation Test (GIFT), was developed by a team of female scientists at the University of Cape Town (UCT), in partnership with Medical Diagnostech, a South African biotech company, and the Burnet Institute in Australia. Together with 19 investigators from partnering institutions in Zimbabwe, Madagascar, United Kingdom, Netherlands, France, Japan, and Australia, the team has begun to evaluate the first in-field performance of the GIFT device, and how to integrate it into routine healthcare.

Tania Crucitti and her colleagues at the Institut Pasteur de Madagascar are leading the clinical testing of the GIFT device. The study protocol was published in BMJ Open  on May 1, 2024.

GIFT has the potential to empower women in low and middle-resource settings to test for inflammation caused by STIs and BV during healthcare visits. Such screening would aid in early detection and treatment, facilitating better health outcomes. 

“Most women with an STI or BV don’t have symptoms, so they don’t seek healthcare. Although highly accurate diagnostic tests have been developed, they're currently too expensive for widespread use in resource-limited settings," says co-author Lindi Masson of Burnet Institute and UCT’s Institute of Infectious Diseases and Molecular Medicine.Even in cases where women are able to access laboratory tests, long wait times for results can delay or hinder treatment.

 

Silent infections

STIs and BV remain significant health concerns for women, putting them at greater risk for HIV acquisition, pelvic inflammatory disease and pregnancy complications. In 2016, over 70% of the 377 million new cases of common curable STIs (including Chlamydia trachomatis and Neisseria gonorrhoeae) were recorded in LMICs, notably in Sub-Saharan Africa and Latin America. BV, while not an STI, is an imbalance of the naturally occurring bacteria that keep the vagina healthy. This imbalance causes genital inflammation similar to that caused by STIs, predisposing women to HIV infection and other health complications.

Despite the availability of treatment for bacterial STIs, these infections remain widespread. This is partly because women often do not experience symptoms that cause them concern and are thus unaware that they require treatment.

A lateral flow device that looks similar to an over-the-counter pregnancy test, GIFT aims to overcome significant resource barriers to STI and BV screening in asymptomatic women in low and middle-resource settings. Screening for genital inflammation markers – present in STI and BV cases – is a completely new way to ascertain whether a woman is likely to have an STI or BV that requires treatment. Because GIFT produces results in minutes, a woman can be screened and receive her results during the same clinic visit. 

Integrating GIFT into care

To assess the first in-field GIFT device’s performance, the team recruited nearly 700 women attending family planning clinics in South Africa, Zimbabwe, and Madagascar. In the diagnostic component of the study, the researchers will compare the GIFT results from participants across the three sites, which have varying prevalences of STIs, BV and HIV, to results from standard laboratory tests for STIs, BV and inflammation. They will analyse two key metrics for the GIFT device: sensitivity, the percentage of correctly identified positive cases of STIs or BV, and specificity, the percentage of correctly identified negative cases.

The second part of this major clinical study, the GIFT device integration component, will explore the feasibility, acceptability and cost-effectiveness of integrating GIFT into routine care in LMICs. The goal is to develop a GIFT-based STI/BV screening and treatment process that is feasible, acceptable, and economically viable.    

 In order to accomplish this, the team will begin by collecting feedback from women in each country regarding their experiences using the device and their preferences for different aspects of the screening and treatment process. Another study will be conducted to gather perspectives from experts in STI management, including healthcare professionals, programmers, and policymakers, to identify optimal methods for incorporating GIFT into low-resource environments. Agreement on key factors essential for a successful implementation, such as cost and accessibility, will assist the researchers in refining the device's features and deployment strategies.

The team will then design and test a decision-making algorithm that integrates GIFT into routine care. This clinical tool will aid healthcare workers in deciding on the next steps after a woman has been screened, considering factors such as symptoms, sexual behaviour, and medical history, and GIFT results. The intention is to design this tool to be as simple as possible and usable in routine practice.

Empowering women

Finally, the team will determine the cost implications of the proposed management tool. By calculating the costs per person tested and treated, they will analyse the budget impact of scaling up the service in different scenarios (e.g. family planning clinics, primary care, etc.). They will develop a model to estimate the cost and health outcomes associated with different integration strategies, developed either via the decision-making tool or through consultations with national stakeholders. This model will measure the cost-effectiveness of each approach for correctly diagnosing STIs and BV in women. 

The first in-field clinical study results for GIFT are expected in December 2024. After this, the team will finalise the homegrown medical device and prioritise its registration with the South African Health Professions Council (SAHPRA), with funding from the Technology Innovation Agency (TIA) and the South African Medical Research Council (SAMRC).

“Knowledge about their vaginal health will empower young women and contribute to a healthier society,” says Crucitti.

Media enquiries: tanya.pidwell@uct.ac.za