Clinical studies bring GIFT of sexual health closer for women

Written by Dave Chambers for Jive Media Africa, research communications partner to GIFT

A South African innovation designed to screen for inflammation associated with HIV infections and improve women’s sexual and reproductive health has been manufactured and has entered its first in-field clinical studies.

Almost 700 women will be involved in the validation of the Genital Inflammation Test (GIFT) developed at the University of Cape Town (UCT). GIFT is the focus of an international collaboration of almost exclusively female scientists led by Professor Jo-Ann Passmore of UCT and Dr Lindi Masson, originally of UCT, but now of the Burnet Institute in Australia.

The trial development includes a partnership with Cape Town biotechnology company Medical Diagnostech under the leadership of Ashley Uys and Lyndon Mungar.

GIFT intends to be a low-cost rapid test to detect vaginal inflammation, one of the biggest drivers of HIV risk in young women. It is often caused by sexually transmitted infections (STIs) and bacterial vaginosis.

These conditions are typically treatable with antibiotics, but because most women don’t have symptoms, they are often undiagnosed and untreated. And that’s where GIFT’s developers believe the test could fundamentally transform the landscape.

The clinical studies in South Africa, Zimbabwe and Madagascar are a key step in confirming the performance of the lateral flow test, which uses very sensitive antibodies to identify inflammation biomarkers, even when they are present in amounts weighing a few trillionths of a gram (picograms).

“Developing effective ways to reduce HIV risk in women in South Africa is critical. Since a significant proportion of [HIV] risk comes from undiagnosed but treatable STIs, improved STI management using innovations like GIFT is something that is urgently needed,” says Passmore,

Inflammatory enemy

GIFT’s roots lie in the discovery that South African women with asymptomatic STIs and bacterial vaginosis ‒ a disturbance of healthy bacterial communities ‒ had levels of vaginal inflammation similar to women with symptoms.

This is worrying, because inflammation makes it easier for HIV infection to occur. If left untreated, it can also lead to pelvic inflammatory disease, pre-term labour, fallopian tube injury, scarring of the upper reproductive tract and infertility.

“Treatable STIs and bacterial vaginosis are highly prevalent in South Africa and other resource-limited settings, and we found that even though most women don’t have symptoms, only women with symptoms are treated,” says Masson. “This is because etiological testing is too costly for implementation in these settings.”

Aiming to develop a low-cost diagnostic, the GIFT team began by identifying and evaluating biomarkers of inflammation. Then it turned its attention to the development of a device ‒ similar to a pregnancy test ‒ to measure the biomarkers.

Dr Monalisa Manhanzva (who is project managing GIFT) and Dr Fezile Khumalo (who heads the Translational Research Hub at UCT) worked on the development of the device with Medical Diagnostech.

“Development of the GIFT device has been quite challenging because the inflammation biomarkers are present in the vagina in very low (picogram) concentrations,” says Manhanzva. “We were tasked with identifying antibodies capable of detecting these extremely low concentrations and yielding a visible result to the naked eye. This led us to meticulously screen thousands of different antibody combinations”

Khumalo adds: “The beauty of the innovation lies in its simplicity to both run/test (detect inflammation) and interpret the results. We used a simple method with standard components to keep costs low and ensure user-friendliness. This formed our product profile, which made it easier to develop and eventually manufacture GIFT devices for clinical study.

“The device itself is very simple, as it needs to be to keep costs low. It’s really just a standard lateral flow test made of standard components but able to detect very low amounts of inflammation. Once we found the right antibodies that were sensitive enough, getting the rest right and manufacturing was relatively straightforward.”

Passmore says: “Measuring these biomarkers in vaginal samples was another challenge altogether. Vaginal samples are messy – mucous is not our friend. We had to find innovative ways to make sure that we reliably detected the biomarkers, irrespective of the sample matrix.”

Covid to the rescue

The team’s next challenge in developing a test suitable for low-resource settings was to find a way to process vaginal swab samples in the simplest way possible.

“Usually, we use a vortex to mix up the sample and get all of the sample out of the swab,” says Masson. “For this, we learnt from the Covid pandemic that used some great approaches for processing nasal swabs by hand.

“Micaela Lurie, whose PhD I am co-supervising with Jo-Ann, showed that if we used soft tubes, we could squeeze the swab between our fingers and effectively wring out the swab, and this actually worked even better than our standard lab processing methods.”

When it came to manufacturing the test, the GIFT team forged what Masson calls a “unique partnership” with Medical Diagnostech, a developer and manufacturer of lateral flow test kits.

“The work done at UCT to identify the biomarkers for the GIFT project enabled us to optimally develop a product for clinical trials within a short period of time. These collaborations are critical to maximise commercialisation of quality first-to-world products” says Uys.

This private-public partnership is unusual due to intellectual property and confidentiality issues, says Masson. “But Medical Diagnostech very generously allowed our UCT students and post-docs to work in their labs, side by side with their staff, during the device development process.”

Khumalo adds: “This joining of teams and minds [UCT and Medical Diagnostech] meant we were able to expedite the development process and share experience. The academic and industry perspectives were invaluable to our ability to progress to this stage.”

Written by Dave Chambers for Jive Media Africa, research communications partner to GIFT


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