By Sharon Atieno

With women accounting for six out of ten of new HIV infections in sub-Saharan Africa, Kenya joins Lesotho, South Africa, Zimbabwe and Uganda in implementing a study that will pave the way for women to access new HIV prevention products in the country.

The Catalyzing Access to New Prevention Products to Stop HIV (CATALYST) study seeks to introduce a service delivery package that provides informed choice of Pre-Exposure Prophylaxis (PrEP) products among women, Millicent Kiruki, Study Coordinator CATALYST, LVCT Health Kenya said during a Media for Environment, Science, Health and Agriculture (MESHA) café in Nairobi, Kenya.

These products include oral PrEP, PrEP ring (dapivirine vaginal ring), and injectable cabotegravir.

She said the study also aims to inform the scale-up of already approved products, that is, oral PrEP and the PrEP ring. The injectable cabotegravir is still pending approval.

Running until 2026, the study will be carried out in six United States Agency for International Development (USAID) supported sites across Kisumu, Nairobi and Mombasa. Recruitment of participants has started in Kisumu.

It focuses on HIV-negative women interested in HIV prevention, implementers and other stakeholders, PrEP influencers (parents, caregivers, and partners) as well as public health delivery sites.

The CATALYST study, Kiruki said, is based on three broad objectives which includes learning about this service delivery package that offers choice from women, health service providers and the health systems. It also entails looking at barriers at the individual, provider and facility levels.

The second objective focuses on the uptake, finding out which women are interested in different products. It will describe patterns of PrEP use and find out what informs the decision to move from one method to another or discontinue use. It will also look at product acceptability among women.

Additionally, she noted that the study will also track important indicators such as seroconversions (moving from negative to positive) and drug resistance when using PrEP.

The study will be carried out in two phases with stage one focusing on the two approved products while stage two focuses on the three products together.

Justifying the study, Kiruki observed that despite progress made by Kenya in controlling HIV, there is still some unmet need for prevention especially among adolescent girls and young women, who are registering high new infections.

Between 2021 and 2022, the rate of HIV infections increased from 32,000 to 34,000 with youths (15 to 24 years) accounting for 41% of adult infections.

She said by having new HIV prevention methods and introducing choice, women might find new methods that will work for them.

“Whatever is available at the moment have not slowed down new infections, especially among women. A lot of the products we have in the market have been male-controlled,” Patricia Jeckonia, Snr. Technical Advisor Policy and Partnership and Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC) Lead, said. “The ring is the only female-controlled product, there is need for more discreet options.”

She observed that many women who are on oral PrEP are reporting a lot of gender-based violence in their relationships, adding that women need multiple prevention options.

Oral PrEP, a daily pill, which was approved by the Kenyan government for use in 2017 has been found to be highly effective, affordable (given out for free at various health facilities), readily available and safe to use during pregnancy.

Despite this, challenges still remain in uptake including adherence where users find it difficult to take pills daily, some forget. The side effects associated with the method are also a barrier to uptake including nausea, diarrhea, fatigue and headache among others.

The users also face stigma as oral PrEP is offered under HIV care and treatment programme. Those taking the pills are also perceived to be promiscuous.

The dapivirine vaginal ring is a long-acting method approved for use in Kenya in 2021, however, it is still not widely available in the country. Some of its advantages include being safe during pregnancy, discreet, and non-systemic with minimal side effects.

Challenges associated with the PrEP ring include the unfamiliar formulation whereby women are not comfortable with inserting things in their vagina and concerns about the product affecting their fertility. Compared to the other two methods, the PrEP ring has been found to be moderately effective. It is also still very expensive compared to oral PrEP.

Cabotegravir PrEP, a bi-monthly injectable drug, is pending approval in the country, however, it has been found to be highly effective, discreet and the formulation is familiar (people are used to having injections as a method of medication).

The challenges associated with this method include a long drug tail whereby the drug stays in the body 12 months after discontinuing, hence in case of HIV infection, the person risks drug resistance.

There is also a need for effective HIV testing approaches before administering the cabotegravir injection because if the person is injected when they are HIV positive, they risk developing drug resistance.

Studies are still ongoing about the safety of this method during pregnancy. Besides, the injection is very expensive.

The CATALYST study is part of MOSAIC, a five-year (2021-2026) global project funded by USAID to help women including adolescent girls and young women prevent HIV by
accelerating the introduction and scale-up of new and emerging biomedical prevention

The MOSAIC consortium is led by FHI 360 along with core partners Wits Reproductive Health and HIV Institute (Wits RHI), Pangaea Zimbabwe AIDS Trust (PZAT), LVCT Health, Jhpiego, and AVAC.

Priority countries for the consortium’s work are Eswatini, Kenya, Lesotho, Namibia, Nigeria, South Africa, Uganda, Zambia, and Zimbabwe.