Study assesses vaginal film for HIV prevention 

A vaginal film designed to slowly dissolve over the course of 30 days is being trialled to determine its feasibility and acceptability as a potential HIV prevention method for women.

The trial is being conducted in the US and Africa by MATRIX, a United States Agency for International Development (USAID)-funded project focused on R&D of innovative HIV prevention products for women. 

According to UNAIDS, women and girls accounted for 63 percent of all new HIV infections in sub-Saharan Africa in 2022, versus 46 percent globally. In much of Africa, daily oral pre-exposure prophylaxis (PrEP), which requires taking an antiretroviral tablet every day, is the only biomedical prevention method available. 

Dapivirine is already known to be safe and effective for preventing HIV when formulated as a monthly vaginal ring, and is recommended by the World Health Organization (WHO) and approved in several African countries, however neither method is yet widely available.

The monthly dapivirine film is one of nine products being developed as part of the MATRIX initiative. It also includes a dual-purpose monthly film containing both dapivirine and a hormonal contraceptive to prevent pregnancy. 

The new study, known as MATRIX-002, researchers are assessing the acceptability, usability and safety of two prototype monthly vaginal films that contain no active drug. In this way, they will be able to learn what refinements may be needed in the film’s design, before conducting a first-in-human study of the monthly dapivirine film.

MATRIX-002 will enrol 100 women, as well as 30 sexual partners, at five sites in Kenya, South Africa, Zimbabwe and the US. Enrollment of the first participants took place at the University of Pittsburgh and Magee-Women’s Research Institute in the US, which is also where the monthly dapivirine vaginal film products are being developed.

Women who participate  in the study will be randomly assigned to use one of the two 2” x 2” placebo films – either a film with straight corners or one with rounded corners – which they will test over a two-month period. During the first month of film use, women are to refrain from vaginal sex and vaginal product use. During the second month, when a new film will be used, there will be no restrictions.

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As part of the study, participants will be asked questions about their experiences, including likes and dislikes. Up to 35 participants will also be asked to take part in an in-depth interview so that the study can gain deeper insight. In-depth interviews will also be conducted with around 30 sexual partners.

“By conducting a study of placebo films with no active drug, we will be able to answer fundamentally important questions,” explained Nyaradzo Mgodi, MATRIX-002 protocol co-chair and investigator of record at the Harare Health and Research Consortium (HHRC) Zengeza clinical research site (CRS) in Zimbabwe, one of the five sites conducting the study.

“For instance, are women, especially African women, comfortable with the idea of using a vaginal film that takes 30 days to dissolve? What kind of support and counselling will they need to use it properly?,” he asked. 

Follow-up is expected to be completed in July or August 2024, with study results anticipated by the end of next year. MATRIX would then expect to begin the first-in-human study of the monthly dapivirine film in 2025.