Condition category
Infections and Infestations
Date applied
10/02/2012
Date assigned
07/03/2012
Last edited
12/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 to 29 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.
Our base for recruitment will be the McGill and Concordia University Health Services Clinics. 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 Student Health Services of McGill and Concordia Universities in Montreal 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 July 2016 (one year after the last participant has been enrolled).

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

Trial website

http://www.mcgill.ca/catch

Contact information

Type

Scientific

Primary contact

Dr Eduardo Franco

ORCID ID

Contact details

McGill University
Division of Cancer Epidemiology
546
Pine Avenue West
Montreal
H2W 1S6
Canada
+1 514 398 8014
eduardo.franco@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized controlled trial evaluating the efficacy of carrageenan as a topical microbicide against HPV Infection

Acronym

CATCH

Study hypothesis

1. To evaluate the efficacy of carrageenan in reducing genital HPV incidence, i.e., in preventing new HPV infection, in young sexually active women.
2. To evaluate the efficacy of carrageenan in reducing genital HPV prevalence, i.e., in accelerating clearance of existing infections, in young sexually active women.

Ethics approval

1. The Institutional Review Board, McGill University, Canada, 13/12/2011, ref: A12-M93-09B
2. Health Canada - Natural Health Products Directorate, 18/07/2011, ref: 169160

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human papillomavirus infection

Intervention

Intervention: Treatment with carrageenan-containing vaginal gel, self-applied every other day (whether or not participants have intercourse) for the first month and prior to each act of vaginal or anal intercourse during the entire follow up period (1 year).

Control: Treatment with placebo vaginal gel, self-applied every other day (whether or not participants have intercourse) for the first month and prior to each act of vaginal or anal intercourse during the entire follow up period (1 year).

Prior to vaginal intercourse, participants will be asked to apply the study gel either directly inside their vagina and externally on the genitals. During intercourse, additional lubricant can be applied as desired. During the first month, participants will be asked to apply the gel both inside their vagina, as well as on to their genitals every other regardless of whether or not they have intercourse. Study participants will be asked to continue using the assigned intervention for the complete follow up period (1 year) along with any other methods of contraception and/or sexually transmitted infection (STI) prevention (e.g., condoms).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Reduction in HPV incidence
2. Presence of:
2.1. A newly detected vaginal infection in someone who was HPV negative at enrolment or
2.2. HPV types other than those observed at enrolment
3. Clearance of infections with HPV types observed at baseline.

HPV DNA detection and genotyping of vaginal samples will be done by the PGMY polymerase chain reaction protocol. HPV infection status will be measured at baseline (enrolment/ time 0), 14 days and 1, 3, 6, 9 and 12 months after enrolment.

Secondary outcome measures

Reduction in HPV prevalence (i.e., clearance of infections with HPV types observed at baseline).

HPV DNA detection and genotyping of vaginal samples will be done by the PGMY polymerase chain reaction protocol. HPV infection status will be measured at baseline (enrolment/time 0), 14 days and 1, 3, 6, 9 and 12 months after enrolment.

Overall trial start date

15/04/2012

Overall trial end date

15/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 12/09/2013:
1. Female 18-29 living in Montreal
2. Plan to remain in Montreal for at least the next year
3. 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, regardless of whether or not the male partner(s) will change
4. Not currently in a relationship that has lasted longer than 6 months
5. Be willing to follow study instructions
6. Understand French or English
7. Be willing to comply with follow-up for at least 12 months
8. Have an intact uterus
9. Have no history of cervical lesions/cancer or genital warts
10. Not be pregnant or planning to immediately become pregnant and not currently breast-feeding
11. Not had a recent (within the last 6 weeks) pregnancy, abortion, or genital surgery
12. Be using a medically acceptable method of contraception and intend to use it for the duration of the trial
13. Have no HIV infection
14. Have no known allergy or hypersensitivity to vaginal lubricants
15. Have no allergy to all of the ingredients of the study product or placebo

Previous inclusion criteria:
1. Female 18-24 living in Montreal
2. Plan to remain in Montreal for at least the next year
3. Have had vaginal sex with a male partner during the last 30 days and expect that they will do so again in the next month, regardless of whether or not the male partner(s) will change
4. Not currently in a relationship that has lasted longer than 3 months
5. Be willing to follow study instructions
6. Understand French or English
7. Be willing to comply with follow-up for at least 12 months
8. Have an intact uterus
9. Have no history of cervical lesions/cancer or genital warts
10. Not previously vaccinated against HPV
11. Not be pregnant or planning to immediately become pregnant and not currently breast-feeding
12. Not had a recent (within the last 6 weeks) pregnancy, abortion, or genital surgery
13. Be using a medically acceptable method of contraception and intend to use it for the duration of the trial
14. Have no HIV infection
15. Have no known allergy or hypersensitivity to vaginal lubricants
16. Have no allergy to all of the ingredients of the study product or placebo

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

465

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/04/2012

Recruitment end date

15/04/2016

Locations

Countries of recruitment

Canada

Trial participating centre

McGill University
Montreal
H2W 1S6
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

160 Elgin Street
Ottawa
K1A 0W9
Canada
+1 613 941 2672
info@cihr-irsc.gc.ca

Sponsor type

Government

Website

http://www.cihr-irsc.gc.ca/e/193.html

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research (CIHR) (Canada)

Alternative name(s)

Instituts de recherche en santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes