As the HIV infection rate in young African women continues to rise despite ongoing educational efforts, the prevention field is working to better understand the lifestyles and user preferences of this high risk group. Following on the launch of a human centered design study in South Africa called Project EMOTION, CONRAD today announced enrollment of the first participant in The Quatro Study.
The Quatro Study will inform ongoing product development efforts, as well as expand upon the findings of the ASPIRE and Ring study results, by gathering end-user input that is both qualitative and quantitative. Quatro is the first acceptability study that will assess preferences and user experiences of four vaginal delivery systems developed for HIV and multipurpose prevention in the population most at risk for HIV, young women.
So named for the four products that will be evaluated during the course of the study, Quatro will have women assess a rapidly disintegrating vaginal insert, an intravaginal ring (IVR), a vaginally inserted film and a vaginal gel. All are placebos and contain no active ingredients.
The study is recruiting 200 healthy, sexually active women ages 18-30 years old at MatCH Research in Durban, South Africa, and University of Zimbabwe-University of California San Francisco Collaborative Research Program in Harare, Zimbabwe. Every volunteer will be shown the products and asked for their preference before use. They will then be randomized and assigned to use each of the four delivery systems for one month. After this four month period, they will choose a preferred delivery system to use for an additional month. Adherence to each product will be monitored by objective biomarkers of adherence, recently developed by CONRAD.
Focus group discussions with a subset of volunteers will delve into preferences related to each vaginal delivery system. Key informant interviews will also be conducted to explore health care provider and other stakeholders' attitudes toward the different products, and to explore perceptions of appropriate educational and marketing messages for each delivery form. The product experienced participants will be joined by an additional 200 product naïve volunteers to be part of a discrete choice experiment at the end of the study.
Quatro Co-Investigator and CONRAD Medical Director Jill Schwartz, MD said, "We're very excited about the end-user and human centered design studies we've launched over the past year, which include Project Karoo, Project EMOTION, and now Quatro. The end-user insights provide crucial data that informs the entire spectrum of development, through to future implementation."
CONRAD serves as lead sponsor for Quatro with collaboration from RTI International, UZ-UCSF Collaborative Research Programme and MatCH Research. Funding is provided by the President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID) and the Bill & Melinda Gates Foundation.