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The Quatro Study

Status
Completed
Phase
Open Label
Principal Investigator(s)
Jill Schwartz, MD, MPH
Objective

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.    

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
Mode of Delivery
Film
Ring
Tablet
ARMs
Experimental
Description
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
Mode of Delivery
Gel
ARMs
Placebo Comparator
Trial Sponsors
CONRAD
November 2015
May 2018
Enrollment
400
18
Years
30
Years
Population
Women
Sites

MatCH Research Site

Durban
South Africa

UZ-UCSF Collaborative Research Program

Harare
Zimbabwe