Carrageenan Against Transmission of Cervical Human papillomavirus (HPV)

Phase 2

Completed

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

• Registration Number: ISRCTN96104919
• Lead Sponsor: Canadian Institutes of Health Research (CIHR) (Canada)

Brief Summary

2019 Interim results article in https://pubmed.ncbi.nlm.nih.gov/29684633/ interim results (added 23/10/2020) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34487919/ (added 07/09/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37396806/ (added 04/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-07
• Study Completion: 2021-10-20
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 461

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

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> Current secondary outcome measures as of 14/10/2022:<br><br> Patient adherence to the intervention as measured by behavioural characteristics assessed by questionnaires.<br><br> _____<br><br> Previous secondary outcome measures:<br><br> Reduction in HPV prevalence (i.e., clearance of infections with HPV types observed at baseline).<br><br> 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.<br>