About this HPV Clinical Trial
What You Need to Know
Leading-edge medical treatments and medicines are discovered because people participate in research studies to test their safety and effectiveness. The process involves a partnership that brings together medical researchers with people willing to participate in clinical trials.
This trial is to evaluate the usefulness of carrageenans in preventing human papillomavirus (HPV) infection. Carrageenans are naturally derived compounds that come from red seaweed. They are found in various common products (like makeup), food and are as food emulsifiers.
The study will also allow researchers to see if regular use at the time of sex will alter the effectiveness of a carrageenan-containing lubricant. All participants will get regular testing for other diseases transmitted by sex.
What Women Who Take Part in This Study Can Expect
Women will be given free single-use applicators containing a lubricant. Some will get lubricant that contains carrageenans, and others will receive a lubricant that will not contain carrageenans.
This is a randomized controlled trial; participants are randomly assigned to receive either the carrageenan lubricant or a placebo lubricant. You will not be told which type of lubricant you have received. Participants will not be allowed to choose which group they are in or be allowed to switch groups. The investigators will also not be aware of which group participants are in to minimize bias. This randomness will be maintained throughout the study.
Study participants are being asked to use each single-use applicator before and after they have sex. Routine screening for HPV and sexually transmitted diseases will be conducted during the course of the study. At these visits, additional swabs and noninvasive sample collection will also be performed to further assess the vaginal environment.
Interested in more information or interested in participating? Call 1-646-574-2369 or email StopHPV@montefiore.org.