Condition category
Cancer
Date applied
08/06/2020
Date assigned
27/07/2020
Last edited
09/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Accounting for 569,847 new cases and 311,000 deaths in 2018, cervical cancer is classified as the fourth most frequent female cancer worldwide. Human papillomavirus, a sexually transmitted disease, is identified as the source of 99.7% of cervical cancers. Being the cause of essentially all cervical cancer, HPV is also related to vulva, vaginal, oropharyngeal, penis and anal cancers as well as genital warts. Available for more than a decade, HPV immunization is a very safe and effective primary prevention measure. The third and last available HPV vaccine launched in 2014 has been approved for females aged 9 to 45 and males aged 9 to 26. Unfortunately, despite being a largely preventable disease, wild variation in HPV coverage is observed among women depending on their race, incomes, geography and education level. To date, there is no research evaluating the use of educational phone calls to increase the HPV vaccination rate, particularly in a high-risk population. The aim of this study is to measure the effect of educative reminder telephone calls on HPV immunization rate.

Who can participate?
Women who agree to get a prescription of HPV vaccination and understand French

What does the study involve?
Participants will be randomly allocated to receive one (control group) or three (intervention group) phone calls to inform them about the HPV vaccination and also to answer their questions. The rate of HPV vaccination is measured after 6 months.

What are the possible benefits and risks of participating?
The only drawbacks for patients are having one (control group) or a few (intervention group) phone follow-ups. No visit is planned. Participants will receive $15 in compensation at the end of the study.

Where is the study run from?
Sherbrooke University Hospital Center (Canada)

Where is the study starting and how long is it expected to run for?
July 2019 to June 2020

Who is funding the study?
1. Sherbrooke University (Canada)
2. Merck Company Foundation (USA)

Who is the main contact?
Dr Jessica Ruel-Laliberté
jessica.ruel-laliberte@usherbrooke.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Korine Lapointe-Milot

ORCID ID

Contact details

3001 12e Avenue N
Sherbrooke
J1H 5N4
Canada
+1 (0)819 346 1110
korine.lapointe-milot@usherbrooke.ca

Type

Public

Additional contact

Dr Jessica Ruel-Laliberte

ORCID ID

https://orcid.org/0000-0002-6108-838X

Contact details

3001 12e Avenue N
Sherbrooke
J1H 5N4
Canada
+1 (0)819 346 1110
jessica.ruel-laliberte@usherbrooke.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2020-3319

Study information

Scientific title

Effect of educative reminder telephone calls on human papillomavirus immunization rate: a randomised controlled trial

Acronym

Study hypothesis

Reminder educative phone calls increase the human papillomavirus (HPV) vaccination rate in adult women age 18 to 45 with risk factors of cervical cancer.

Ethics approval

Approved 25/09/2019, Sherbrooke Research Ethics Committee (3001, 12e avenue Nord, Sherbrooke, Canada; +1 (0)819 346-1110 #12856; ethique.recherche.ciussse-chus@ssss.gouv.qc.ca), ref: 2020-3319

Study design

Interventional single-blnid randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet (available in French)

Condition

Prevention of cervical cancer

Intervention

The randomization schedule will be done in blocks of 6 in a 50:50 ratio. Allocation will only occur once the consent will be obtained. A secured order list made by a computer generator will determine the group allocation of each patient. Only the two principal authors will have access to the secured computer list for the reminder educative telephone calls. Given the nature of the intervention, study investigators and research coordinators will not be blinded to treatment allocation.

All eligible participants will be given an initial recruitment questionnaire where risk factors of cervical cancer and immunization status are assessed. The risk factors identified are based upon a clinical gynecology oncology reference book (L. Stewart Massad, 2018). They will receive a file containing a three-dose HVP vaccine prescription, vaccination clinic contact list and an HPV virus information brochure from the Canadian Obstetric Gynaecology Society.

If a participant is assigned to the intervention group, she will receive a total of three standardised phone calls made by either the same author or one of the two research medical student involved at 1, 3 and 6 months after randomisation. During the first two interventions, callers will need to follow the instruction of an educative script and at each intervention call, participants will verbally inform research team if they got vaccinated and if not, investigators will ask what barriers they faced. If barriers identified concern lack of patient knowledge, the research team will provide a specific answer to any questions and calm any doubts or fear. If it concerns a logistical issue such as a loss of a prescription or not knowing where to get vaccinated, a new prescription will directly be made at the pharmacy and the vaccination clinic contact list will be provided by email or discussed by phone.

The control group will receive a phone call at 6 months to assess HPV immunization status and barriers to vaccination.

When patients do not answer phone calls, a total of two callbacks will be made and an email will be sent with the script and the two questions. Patients who will complete the study will receive a check by mail of 15 Canadian dollars each as a reward for their participation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Rate of HPV vaccination at 6 months after randomisation

Secondary outcome measures

1. Rates of vaccination measured using phone call at 6 months for high-risk patients in intervention and control groups. High-risk patients are categorized as presenting one or more of these risk factors: smoker or past smoker, more than two sexual partners in the past 12 months, low education status (high school or college), history of abnormal pap smear or had their last pap smear more than 3 years ago
2. Type and frequency of barriers to vaccination in intervention and control groups mentioned by non-vaccinated patients in a phone call at 6 months
3. Type and frequency of barriers to vaccination in intervention group mentioned in phone calls at 1 and 3 months which were overcome by recall calls

Overall trial start date

01/07/2019

Overall trial end date

01/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women are eligible for study enrollment if:
1. They agree to get a prescription of HPV vaccination
2. Understand French

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

142

Total final enrolment

130

Participant exclusion criteria

Women who:
1. Do not know their HPV immunization status
2. Refuse vaccination

Recruitment start date

01/10/2019

Recruitment end date

10/10/2019

Locations

Countries of recruitment

Canada

Trial participating centre

Centre Hospitalier Universitaire de Sherbrooke
3001, 12e Avenue Nord
Sherbrooke
J1H 5H3
Canada

Sponsor information

Organisation

Centre Hospitalier Universitaire de Sherbrooke

Sponsor details

3001
12e avenue Nord
Sherbrooke
J1H 5N3
Canada
+1 (0)819 346 1110
ethique.recherche.ciussse-chus@ssss.gouv.qc.ca

Sponsor type

Hospital/treatment centre

Website

http://www.chus.qc.ca/en/

Funders

Funder type

Industry

Funder name

Merck Company Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United States of America

Funder name

Université de Sherbrooke

Alternative name(s)

University of Sherbrooke, UdeS

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Canada

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jessica Ruel-Laliberté (jessica.ruel-laliberte@usherbrooke.ca).

Intention to publish date

01/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/06/2020: Trial's existence confirmed by Centre Hospitalier Universitaire de Sherbrooke.