Vusumuzi Dube
Robin Muchetu, Senior Reporter
COWDRAY Park Clinic in Bulawayo has been identified as a site for the CATALYST Study, where the feasibility and acceptability of new HIV prevention products to stop the spread of infection in women are being done. According to the Zimbabwe Public Health Impact Assessment (ZIMPHIA) conducted in 2020, women aged 15 are three times more likely to be infected by HIV than men.
Catalysing Access to New Prevention Products to Stop HIV (CATALYST) is the flagship HIV prevention product introduction study of the Maximising Options to Advance Informed Choice for HIV Prevention (MOSAIC) project.
Cowdray Park Clinic has already been providing the HIV prevention product, daily oral Pre-exposure Prophylaxis (PrEP). In July, the clinic introduced the Dapivirine vaginal ring (PrEP ring) in a bid to provide greater choice in PrEP products for women seeking to protect themselves from contracting HIV.
Injectable cabotegravir (CAB PrEP) which will be available later during the study will also be offered to the participants.
Dr Emily Gwavava the MOSAIC Project Lead and Co-Principal Investigator of the CATALYST Study which is introducing new prevention products for women shed light on the new products.
“The Ring is a flexible silicone ring inserted into the female reproductive organ that continually releases the antiretroviral drug dapivirine over one month. We are hoping to introduce stage two of the study around September/October this year depending on the availability of the long-acting injectable cabotegravir that will be given every two months after two monthly loading doses. At this stage, you inject the drug and you are protected for two months. In the trials, they found out that the injectable was superior to oral PrEP, there are fewer issues of adherence versus an oral drug that is taken daily,” added Dr Gwavava.
Over the next three years, the CATALYST study will produce critical evidence to help transform the HIV prevention landscape in Zimbabwe and inform future scale-up and sustainability of the HIV prevention options.
“What we are testing is the feasibility of offering PrEP choice in Zimbabwe. Informed PrEP choice means individuals have the autonomy, knowledge, and freedom from coercion at any given time to select the best HIV prevention method for them among those available to them,” said Dr Gwavava.
She said the newer forms of PrEP with more discreet and less frequent delivery methods, have recently been proven safe and effective at preventing HIV in clinical trials and have been approved for use in Zimbabwe. The CATALYST study is also being carried out in Lesotho, Uganda, Kenya and South Africa.
In Zimbabwe, it is being conducted by Pangaea Zimbabwe AIDS Trust (PZAT) in collaboration with Organisation for Public Health Interventions & Development (OPHID) and in partnership with the Ministry of Health and Child Care.
The sites for the study are Plumtree District Hospital, Beitbridge Wellness Center, Ngundu Rural Health Center, Runyararo Clinic in Masvingo, Cowdray Park Clinic as well as CitiMed Hospital in Chitungwiza.
Implementing an informed PrEP choice approach will allow participating women, with support from their providers, to choose the PrEP products that are most effective for them based on their unique needs and preferences.
However, for women who will be interested in the long-acting injectable, there is a ceiling in the numbers that can access it for now.
“This injectable drug is coming as a donation from the product developer (Viiv Healthcare), and it is not yet widely available outside of the study, so we are getting enough supply to provide this injectable to a limited number of women in Zimbabwe to be covered for the duration of the study,” she added.
The Rings, which are manufactured by the Population Council, are being provided by USAID. The response to the new prevention products in Cowdray Park has been good as the co-principal investigator noted that the site is very busy.
“It’s a busy site, and by the end of July we had enrolled a number of women into the study, some opted for oral PrEP, others, the ring and some are still undecided on which method to use although they are interested in the study. We however, discovered that some women that are not taking up any other methods are interested in the injectable which will be rolled out soon. They prefer this as they say it is highly discreet,” she added.
Participants leave the site of the facility with their choice of product and there they are followed up at week one to check if they are using their preferred PrEP method and if there are any challenges. They are monitored throughout the study.
Dr Gwavava said affordability and access to the use of the new HIV prevention products when they are eventually rolled out, will ensure that women are protected from HIV infection owing to the data provided by the ZIMPHIA in 2020 which stated that women 15 years and above are three times more likely to be infected with HIV than men.
Despite the expansion of HIV care and treatment, HIV remains a pressing health challenge in Zimbabwe, particularly for specific groups such as adolescent girls and young women, female sex workers, pregnant and breastfeeding women, and other key populations.
“We want to close that tap of new infections in Zimbabwe so we are hoping that these products will be provided and accessible and affordable to women anywhere in the country in the long run,” said Dr Gwavava.
MOSAIC is a five-year (2021-2026) global project led by FHI 360 and funded by the U.S President’s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID) to help women prevent HIV by accelerating the introduction and scale-up of new and emerging biomedical prevention products.
PEPFAR is offering only one type of PrEP in the form of a daily oral pill but for the CATALYST study in the five African countries, they have included the additional two methods of the long-acting injectable and the Dapivirine ring. Over the next three years, the study is expected to produce critical evidence to help transform the HIV prevention landscape and inform future scale-up and sustainability of HIV prevention options.
Researchers note that oral Prep Products present a powerful tool for HIV prevention, however, barriers to the daily adherence required for the oral pill’s efficacy diminish the product’s potential for HIV prevention for individual clients and the overall HIV epidemic impact.
All women, including those in Zimbabwe who will take part in the study, will be counseled on ways to prevent HIV infection including condom use, and offered a choice of PrEP products after being fully informed of the benefits and potential drawbacks of each method.
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