MATRIX-002

Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films.

Rationale

Topical microbicides play a crucial role in mitigating the risk of HIV transmission through sexual contact by applying them to the genital or rectal mucosa. Among various delivery options, vaginal films stand out as a compelling choice for administering anti-HIV drugs. These films offer several advantages, including cost-effectiveness, scalability, stability, and compatibility with diverse active ingredients and excipient combinations. They are discreet, portable, and easy to store, delivering fixed doses of drugs without the need for an applicator and with minimal mess or leakage.

Moreover, vaginal films have been shown to have minimal impact on the innate microbiome and cause less dilution of antiviral or antibacterial properties in vaginal fluids compared to gels. Positive feedback from women in clinical and focus-group studies supports the acceptability and advancement of vaginal films for discreet HIV prevention.

The VALUE (Vaginal film as A Low-cost, User-administered, and Extended-release product) project’s overarching objective is to develop and evaluate an extended-release vaginal film containing dapivirine, a potent NNRTI, offering at least one month of HIV protection per application. Previous work by the Pitt/MWRIF team has demonstrated the feasibility of quick dissolve films and monthly film platforms, with successful retention during menses and sexual activity in nonhuman primates.

The MATRIX-002 trial is designed to assess the acceptability and safety of two placebo vaginal film products differing in shape. This study will provide critical insights into product acceptability, usability, and self-insertion success during sexual activity across multiple clinical sites in the United States and several African countries. By leveraging existing evidence and incorporating diverse perspectives, this study aims to enhance understanding of vaginal film acceptability and usage patterns, informing future strategies for HIV prevention education and product promotion.

Investigators

• Wits RHI
• Prof Thesla Palanee-Phillips (Site Investigator)
• Dr Nkosiphile Ndlovu (Site Investigator of Record)

Latest Update

April 2024

For more details about MATRIX-002 please email rhicomms@wrhi.ac.za

Click here for further details regarding the MATRIX-002 study.