A new lubricant may be the key to preventing HPV transmission during sex.
A year-old study done by McGill University’s Division of Cancer Epidemiology that tested a way of preventing the transmission of human papillomavirus (HPV) during sex has paved the way for a new McGill study on preventing the transmission of HPV among men who have sex with men.
The first study — called CATCH, an acronym for Carrageenan-Gel Against Transmission of Cervical HPV — is a double-blind, randomized, controlled trial involving more than 450 women. Each woman receives either an active gel, containing a sea algae extract called carrageenan, or a placebo gel. Dr Eduardo Franco, director of the Division of Cancer Epidemiology, leads the research team.
While the HPV vaccine Gardasil protects against only four strains of the virus, Franco says the carrageenan-based lubricant can provide total protection from HPV.
“We began the [initial] catch study in January 2013, but it took a long time to get it going because we needed approval from Health Canada,” Franco says. “I decided to do this study after casually reading an article from 2006 by a group in the National Institutes of Health [NIH] in the United States, screening different compounds to fight HPV. One of them was carrageenan, a large molecule, this jelly that’s been known to the food industry for quite some time. So we called the investigators at the NIH and said we needed to bring this to a clinical testing to see if it will [also] prevent the transmission of HPV. We tried several times to get a grant application from Health Canada because no one believed this was doable. Eventually, we were vindicated.”
The multiyear CATCH study is expected to release preliminary results in 2015 and has also laid the groundwork for the launch of Franco’s second multiyear study, the MSM study called LIMIT-HPV.
The carrageenan gel used in both studies is called Divine 9, a water-based moisturizer gel manufactured by the American company CarraShield Labs, Inc. However, both studies are independent of CarraShield Labs, which believes carrageenan gel lubricants are the future of the condom business. For now, the lubricant must be reapplied each time there is sexual contact. While researchers believe Divine 9 protects against the transmission of HPV, it does not act as a contraceptive or prevent other sexually transmitted infections or diseases.
“HPV is difficult to detect and spreads easily, in no small part due to a condom’s inability to prevent transmission,” says Dylan Mckay, Divine 9’s spokesperson. “In addition to cervical cancer, certain types of HPV cause anal, penis and throat cancers and genital warts. Eighty percent of women will be infected by HPV sometime in their lifetime, and 50 percent of all sexually active gay men are infected with HPV right now.”
According to a CDC report, HPV “is most commonly spread during vaginal or anal sex. HPV can be passed even when an infected person has no signs or symptoms. Anyone who is sexually active can get HPV, even if you have had sex with only one person. You also can develop symptoms years after you have sex with someone who is infected, making it hard to know when you first became infected. There is no test to find out a person’s HPV status. Also, there is no approved HPV test to find HPV in the mouth or throat.”
Franco hopes to begin the MSM study in early 2015. “Many participants are being solicited at Montreal’s four major universities: McGill, Concordia, UQAM and the Université de Montréal. We will be splitting the men into two groups, about 200 at HIV clinics who are already HIV-positive and 300 men [who are not], to be able to identify the reasonable protective effect,” he says. “Health Canada has already approved this study. Most of the complicated steps were completed with the first study — the female study — and now we’re [nailing down] funding from Canadian Institutes of Health Research and the Canadian Cancer Society. As soon as we get the approval, we will receive in-kind product from Divine 9, who are providing the carrageenan and the placebo in unmarked packaging so that no one knows which is which.”
McKay says another study is being conducted by the Albert Einstein College of Medicine in the United States. He adds that Divine 9 is already available as a personal lubricant in pharmacies and drugstores in Canada and the United States. “It is [currently] sold as a cosmetic application,” he says.
Franco has high hopes for his MSM study because, he says, gay and bisexual men are less resistant to applying lubricant each time they have sex. He hopes preliminary results of the MSM study will be available in 2016.