Carrageenan Against Transmission of Cervical Human papillomavirus (HPV)

Plain English summary of protocol

Background and study aims
Worldwide, cervical cancer is the second leading cause of cancer in women. Cervical cancer is most common in Latin America, eastern and southern Africa, and the Caribbean. Because it is much more common in developing countries, it has been described as a disease of poorer nations. We now know that human papillomavirus (HPV) is the central cause of cervical cancer. HPV is the most common sexually transmitted infection, and most sexually active women acquire HPV infection over their lifetime. Usually these infections are not noticed or only cause external warts, which although benign, are difficult to treat and often lead to social stigmatization. Most HPV infections will not lead to cervical cancer, only those that involve certain types of this virus and that persist for a long time. There is currently a vaccine available that prevents the types of HPV infection that cause most cases of cervical cancer, but unfortunately it is effective only before and not after the infection is established. Furthermore, HPV vaccination is too expensive for use in developing countries. An HPV inhibitory compound in the form of a topical microbicide that kills viruses might be useful for blocking the spread of HPV. Researchers have identified carrageenan (an inexpensive gelling agent) as a potent HPV infection inhibitor. There has been interest in carrageenan as a topical microbicide targeting HIV and herpes viruses, but laboratory tests have found that it is a thousand times more effective against HPV. If an inexpensive topical microbicide is identified that prevents HPV, this would serve as a very useful method to help reduce the burden of HPV infection and cervical cancer in developing and developed countries, in a cost-effective way. The main aims of this study are to find out whether a topical microbicide that contains carrageenan is effective in preventing new HPV infections and clearing existing HPV infections.

Who can participate?
We will recruit female students aged 18 or older and living in Montreal. Eligible subjects must: plan to remain in Montreal for at least the next year; have had vaginal sex with a male partner during the last 3 months and expect that they will do so again in the next 3 months; understand French or English; be willing to comply with follow-up for at least 12 months; have an intact uterus; have no history of cervical lesions/cancer or genital warts; not be pregnant or planning to immediately become pregnant and not currently breast-feeding; not had a recent (within the last 6 weeks) pregnancy, abortion, or genital surgery; be using a medically acceptable method of contraception and intend to use it for the duration of the trial; have no HIV infection; have no known allergy or hypersensitivity to vaginal lubricants; and have no known allergy to all of the ingredients of the study product or placebo. Since there are many HPV types, this trial will not exclude women who have a detectable HPV type upon enrolment as these women could still become infected with another HPV type. The McGill and Concordia University Health Services Clinics and the CISSS (Centre intégré de santé et de services sociaux) de la Montérégie-Centre will serve as recruitment centers. The clinics provide medical care year-round to full-time students. Recruitment will be bolstered through campus-wide appeals (e.g. posted notices, e-mails to student lists). Additional efforts will include mail-outs to students living in residence, presentations to students in professional schools (e.g. medical school), and information booths at student activities. To enrol, participants will have to give their informed consent.

What does the study involve?
Two different lubricant gels are being compared in this trial, i.e., one that contains carrageenan (treatment) and one that does not (placebo/dummy). Participants will be asked to apply the gel that they receive to their genital area and inside their vagina prior to vaginal sex. They will also be asked to use the gel every other day during the first month, regardless of whether or not they have sex. Over the course of the study, participants will be asked to complete questionnaires and to provide cervical samples for HPV testing. While one group will receive the lubricant that contains carrageenan, the other group will receive a lubricant that is similar but that does not contain carrageenan. Both groups will receive the exact same care throughout their involvement in the study.

What are the possible benefits and risks of participating?
The risks in this study are minimal as the collection of a vaginal specimen for HPV testing is a safe procedure. There is the possibility that slight discomfort might be felt during the insertion of the sampler to collect the specimen. Also, using either carrageenan or the comparison gel may cause itching, burning or pain but these symptoms are unlikely (<5% chance). These gels are readily available in drug stores and cosmetic shops as sexual lubricants. Taking part in this study may or may not make participants health better. While we hope that the intervention under study will be useful in protecting against infection with HPV, there is no proof of this yet.

Where is the study run from?
The McGill and Concordia University Health Services Clinics and the CISSS (Centre intégré de santé et de services sociaux) de la Montérégie-Centre will serve as recruitment centers. Study oversight and data management will be carried out at McGill University’s Division of Cancer Epidemiology.

When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between April 2012 and July 2015, or until the required sample size has been reached. Follow-up examinations will continue until October 2021.

Who is funding the study?
Canadian Institutes of Health Research (CIHR) (Canada).

Who is the main contact?
Dr Eduardo Franco (Principal Investigator)
eduardo.franco@mcgill.ca

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Canada

Study participating centres

Sponsor information

Canadian Institutes of Health Research (CIHR) (Canada)
Government

160 Elgin Street
Ottawa
K1A 0W9
Canada

Phone	+1 (0)613 941 2672
Email	info@cihr-irsc.gc.ca
Website	http://www.cihr-irsc.gc.ca/e/193.html
"ROR"	https://ror.org/01gavpb45

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN96104919_BasicResults_02Mar23.pdf

Editorial Notes

04/07/2023: Publication reference added.
27/03/2023: The IPD sharing statement was updated and the dataset was added.
02/03/2023: The basic results have been uploaded to the trial outputs table.
14/10/2022: The following changes were made to the trial record:
1. The contact was updated.
2. The study hypothesis was updated.
3. The secondary outcome measures were changed.
4. The target number of participants was changed from 462 to 461.
5. The intention to publish date was changed from 20/10/2022 to 01/01/2023.
17/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/10/2020 to 30/09/2020.
2. The overall end date was changed from 31/12/2021 to 20/10/2021.
3. The intention to publish date was changed from 01/03/2022 to 20/10/2022.
4. The plain English summary was updated to reflect these changes.
07/09/2021: Publication reference added.
02/11/2020: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 31/12/2020 to 28/10/2020.
23/10/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/04/2018 to 31/12/2020.
2. The overall end date was changed from 15/04/2019 to 31/12/2021.
3. The intention to publish date was changed from 15/12/2017 to 01/03/2022.
4. The plain English summary was updated to reflect these changes.
5. Publication reference added.
14/03/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/04/2016 to 15/04/2018.
2. The overall trial end date was changed from 15/04/2016 to 15/04/2019.