Carrageenan Against Transmission of Cervical Human papillomavirus (HPV)

Conditions

Human papillomavirus infection Infections and Infestations Papillomavirus as the cause of diseases classified to other chapters

Laurie C, El-Zein M, Botting-Provost S, Tota JE, Tellier PP, Coutlée F, Burchell AN, Franco EL.

2023-06-0812 citations

10.1016/j.eclinm.2023.102038

Design and methods for the Carrageenan-gel Against Transmission of Cervical Human papillomavirus (CATCH) study: A randomized controlled trial.

Laurie C, Tota JE, El-Zein M, Tellier PP, Coutlée F, Burchell AN, Franco EL.

2021-09-047 citations

10.1016/j.cct.2021.106560

Interventions

Current interventions as of 01/03/2017: Intervention: Treatment with carrageenan-containing vaginal gel, self-applied every other day (whether or not participants have intercourse) for

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Added 01/03/2017: Current inclusion criteria as of 17/11/2014: 1. Female aged 18 or older 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 breastfeeding 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 from 12/09/2013: 1. Female aged 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 Original inclusion criteria: 1. Female aged 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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 14/10/2022: Patient adherence to the intervention as measured by behavioural characteristics assessed by questionnaires. _____ Previous 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.	—

Measure

Time frame

Current secondary outcome measures as of 14/10/2022: Patient adherence to the intervention as measured by behavioural characteristics assessed by questionnaires. _____ Previous 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.

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Countries

Canada

Outcome results

None listed