Pharmacy and Poisons Board
Protocol No: ECCT/23/10/08 Date of Protocol: 24-05-2023
Study Title:
Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films (MATRIX-002)

N/A

Study Objectives:

Primary Objective

Acceptability

  • To assess the acceptability of two placebo film types (A and B) when administered vaginally once monthly for two months.

Secondary Objectives

Safety

  • To assess the safety of two placebo film types (A and B) when administered vaginally once monthly for two months.

Usability

  • To assess participants’ ability to properly insert the placebo vaginal film.

Exploratory Objectives

Participant acceptability, attitudes and experiences

  • To explore multiple dimensions of acceptability of two placebo film types (A and B) and participants’ attitudes towards and experiences with the vaginal film.

Sexual partner attitudes and experiences

  • To explore sexual partners’ attitudes towards and experiences with the vaginal film.

Vaginal microenvironment

  • To assess the impact of placebo film use on participants’ vaginal microenvironment when administered vaginally once monthly for two months.

Social harms and social benefits

  • To describe the reported experiences of social harms and social benefits over the course of vaginal film use.
1 N/A
Laymans Summary:

Topical microbicides are agents designed to prevent or at least substantially reduce the risk of sexual acquisition and transmission of HIV when applied to the genital or rectal mucosa. Vaginal films are an attractive dosing option for topical (vaginal) delivery of anti-HIV drugs.

The long-term goal of the VALUE (Vaginal film as A Low-cost, User-administered, and Extended-release product) project is to develop and evaluate an extended-release vaginal film containing dapivirine, which could provide protection from HIV for at least one month following a single application.

The main aim of this clinical trial is to assess the acceptability and safety of two vaginal placebo films that differ in shape. The proposed study will evaluate the acceptability, safety, and self-insertion success as well as topics relevant to adherence and preference of these 1-month placebo film products when applied vaginally with and without sex. The study will also explore the attitudes and experiences of sexual partners with the vaginal film.
1 N/A
Abstract of Study:

Topical microbicides are agents designed to prevent or at least substantially reduce the risk of sexual acquisition and transmission of HIV when applied to the genital or rectal mucosa. Vaginal films are an attractive dosing option for topical (vaginal) delivery of anti-HIV drugs. In terms of costs of production and manufacturing, films are relatively inexpensive, scalable, physically, and chemically stable, and amenable to a range of active ingredients including combinations of excipients. In terms of use, films are discreet, portable, and easy to store. Vaginal films can deliver fixed doses of pharmacologically active agents with minimal mess or leakage and without an applicator. Due to their small volume, films also generate no significant alterations in innate microbiome and incur less dilution of endogenous antiviral or antibacterial properties in vaginal fluids as compared to vaginal gels.

The long-term goal of the VALUE (Vaginal film as A Low-cost, User-administered, and Extended-release product) project is to develop and evaluate an extended-release vaginal film containing dapivirine, a potent NNRTI, which could provide protection from HIV for at least one month following a single application.
1

N/A