<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02984007</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1578</org_study_id>
    <nct_id>NCT02984007</nct_id>
  </id_info>
  <brief_title>PROMOtion of VAccination in Canada (PromovaC Study)</brief_title>
  <acronym>PromovaC</acronym>
  <official_title>Addressing Vaccine Hesitancy: Pan-Canadian Validation of an Effective Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Sherbrooke</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Synopsis: In most countries, there is an increase in the number of parents who refuse some,&#xD;
      most or all vaccines or who adopt delayed vaccination schedule. Vaccine hesitancy (VH) is a&#xD;
      global phenomenon that needs to be measured and addressed. However, to this date, no&#xD;
      effective strategy has been identified. Dr Gagneur have developed and validated a new&#xD;
      approach to educate parents of newborns about vaccination, based on motivational interviewing&#xD;
      (MI) techniques. MI is a method to elicit and strengthen motivation for change based on the&#xD;
      person's own arguments for change that has been shown effective for the adoption of many&#xD;
      preventive health behaviors. This approach has been validated for vaccination during a pilot&#xD;
      study as well as in a provincial RCT in Quebec. Now that a proof of concept has been made in&#xD;
      Quebec, the investigators will validate the approach in other contexts (e.g. English-speaking&#xD;
      provinces and settings with different ways to deliver maternity care and childhood vaccines).&#xD;
&#xD;
      Hypothesis: An educational strategy, based on MI techniques, delivered in the maternity ward&#xD;
      increases parents' intention to vaccinate their infant, reduces VH scores and increases&#xD;
      infants' vaccine uptake in Quebec. This approach may be applicable across the country in&#xD;
      order to tackle VH and thus improve infants' vaccine coverage (VC).&#xD;
&#xD;
      Objective: To evaluate the impact of the MI intervention on parents' intention to vaccinate&#xD;
      their child and their VH score and on infants' VC at 3 months of age, in a pan-Canadian&#xD;
      context.&#xD;
&#xD;
      Methods: Multicentre RCT in maternity wards of 5 provinces (QC, BC, ON, NS/PE). Parents will&#xD;
      be randomized to receive the MI intervention (intervention group) or to receive an&#xD;
      information flyer on vaccines (control group). MI intervention will be delivered by research&#xD;
      assistant that will have first received a standardized training session on the content and&#xD;
      techniques of MI. Parents will complete a self-administered questionnaire to measure&#xD;
      knowledge and vaccination intention as well as VH before and after the intervention.&#xD;
      Immunization data will be collected through an online questionnaire sent when the child will&#xD;
      reach 3 months of age.&#xD;
&#xD;
      Expected benefits: The strategy will be validated across different immunization programs from&#xD;
      5 Canadian provinces to take account of the differences in logistics and cultural contexts.&#xD;
      Results from this study will provide to the provincial and national public health authorities&#xD;
      an effective strategy to tackle VH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES&#xD;
&#xD;
      Main objective: To evaluate the impact of the motivational interviewing (MI) intervention on&#xD;
      parents' intention to vaccinate their infant and their vaccine hesitancy (VH) score in a&#xD;
      Pan-Canadian context. In order to explore differences in the intervention's impact according&#xD;
      to cultural and organizational factors, all analysis will also be conducted at the level of&#xD;
      each center.&#xD;
&#xD;
      Specific objectives:&#xD;
&#xD;
        1. To assess parents' intention to vaccinate their infant before the intervention and&#xD;
           immediately after the intervention, globally and at each center level.&#xD;
&#xD;
        2. To assess parents' VH scores before the intervention, immediately after the intervention&#xD;
           and when their infant is 3 months of age, globally and at each center level.&#xD;
&#xD;
        3. To assess parents' knowledge, attitudes and beliefs (KAB) about vaccination before the&#xD;
           intervention, immediately after the intervention and when their infant is 3 months of&#xD;
           age:&#xD;
&#xD;
             -  Descriptive analysis according to a composite model inspired from the Health Belief&#xD;
                Model (HBM), the Theory of Planned Behavior, and the VH measures (based on a&#xD;
                validated questionnaire);&#xD;
&#xD;
             -  Research of the determinants of vaccination intention.&#xD;
&#xD;
        4. To compare vaccine coverage (VC) at 3 months of age of infants whose parents has&#xD;
           received (intervention group) or not (control group) the intervention in the maternity&#xD;
           ward during the recruitment period.&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
      This study is a multicentre randomized controlled trial (RCT) with single unit of&#xD;
      randomization that will be conducted in maternity wards of 5 provinces: Quebec (QC), British&#xD;
      Columbia (BC), Ontario (ON), and Nova Scotia (NS)/ Prince Edward Island (PEI). In each&#xD;
      center, parents will be randomized to receive the MI intervention (intervention group) or to&#xD;
      receive an information flyer on childhood vaccines (control group). The flyer that will be&#xD;
      given to mothers of the control group will be the one that is usually given to parents at the&#xD;
      maternity ward or at the first home visit after birth during the first week. Thus, flyers&#xD;
      will be different according to the participating regions in this study. Randomization will be&#xD;
      stratified by center and will be made in blocks of 4, 6 and 8 participants.&#xD;
&#xD;
      STUDY POPULATION&#xD;
&#xD;
      Study participants&#xD;
&#xD;
      The study population will include 1,600 mothers of infants born in the participating&#xD;
      maternity wards during the recruitment period.&#xD;
&#xD;
      Study centers&#xD;
&#xD;
      The study will be conducted in 6 maternity wards located in 4 different centers:&#xD;
&#xD;
        1. Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, QC;&#xD;
&#xD;
        2. B.C. Women's Hospital &amp; Health Centre, Vancouver, BC and Surrey Memorial Hospital,&#xD;
           Surrey, BC;&#xD;
&#xD;
        3. North York General Hospital, Toronto, ON;&#xD;
&#xD;
        4. IWK Health Centre, Halifax, NS and Queen Elizabeth Hospital, Charlottetown, PE.&#xD;
&#xD;
      The choice of these 6 maternity wards is the best compromise between the study feasibility&#xD;
      and the diversity of the Canadian population. More than 2,500 deliveries per year occur in&#xD;
      each maternity ward (except for Queen Elizabeth Hospital with approximately 1200 annual&#xD;
      births), which ensures the feasibility of the study.&#xD;
&#xD;
      CONDUCT OF STUDY&#xD;
&#xD;
      Enrollment&#xD;
&#xD;
      Each subject must participate in the informed consent process and sign and date the informed&#xD;
      consent form before any procedures specified in this protocol are performed. Mothers&#xD;
      attending the participant maternity wards will be entirely free to participate in the study.&#xD;
      Benefits of the study will be the chance for the parents to discuss childhood immunizations&#xD;
      in a non-confronting and non-judgemental climate and the improvement of their knowledge.&#xD;
      Participation in the study will not involve risk, besides the risk of breach of&#xD;
      confidentiality for which precautions will be taken.&#xD;
&#xD;
      Regulatory considerations&#xD;
&#xD;
      The study will be registered with ClinicalTrials.gov.&#xD;
&#xD;
      Recruitment&#xD;
&#xD;
      Mothers will be approached to participate during the postpartum stay at the maternity ward.&#xD;
      The MI intervention will be delivered by a research assistant (RA) (or a research nurse) that&#xD;
      will have first received a standardized training session on the content and techniques of MI.&#xD;
      Since the postpartum stay may last less than 24 hours in some provinces, RAs will recruit&#xD;
      mothers in a chronological way according to the birth time of the mother to ensure to meet&#xD;
      the highest number of mothers as possible.&#xD;
&#xD;
      The recruitment will be conducted during 4 to 6 months. In the Quebec RCT, 25 participants&#xD;
      were recruited in average each week, so it is feasible to recruit 400 participants within 4&#xD;
      to 6 months.&#xD;
&#xD;
      Study plan&#xD;
&#xD;
      After the mothers agree to participate, they will have to complete an initial questionnaire&#xD;
      (Q1) to assess their intention to vaccinate, their VH scores and their KAB about vaccination,&#xD;
      as well as their socio-demographics characteristics. RAs will collect this questionnaire and&#xD;
      proceed to the randomization of the participating mother to receive the MI intervention or to&#xD;
      receive a flyer on childhood immunizations. Depending on the randomization result, RAs will&#xD;
      perform the MI intervention with the parents or only give the information flyer. RAs will&#xD;
      then distribute a similar questionnaire (Q2) to parents of both groups to assess their&#xD;
      intention to vaccinate, their VH scores and their KAB about vaccination, as well as their&#xD;
      satisfaction of the intervention received (MI or flyer). Before leaving the maternity ward,&#xD;
      parents will have to return their completed questionnaire to the RA or in a designated place.&#xD;
      When the child is 3 months of age, an online survey (Q3) will be sent to participants by&#xD;
      email to assess their VH score and their KAB as well as the child's vaccine status.&#xD;
&#xD;
      Standardization of the intervention&#xD;
&#xD;
      To ensure that the content of the information sessions will be standardized and similar for&#xD;
      each center or RA, a reference document on the primary vaccination (vaccines administered&#xD;
      before the age of 1 year) will be made according to the provincial recommendations for each&#xD;
      center and will be used for the training of RAs. This training will be conducted over 3 days&#xD;
      including supervision via audio recordings (2 days + 1 day). First, RAs will participate in a&#xD;
      2-day centralized training seminar in Montreal on the MI techniques given by a certified&#xD;
      trainer before the beginning of the study. Subsequently, RAs will practice their MI skills&#xD;
      during a 4 to 6-week trial period in their respective maternity ward. During this time, RAs&#xD;
      will send an online audio recording of their MI intervention with a mother in the maternity&#xD;
      ward (a separate informed consent form will be signed by these mothers to authorize the&#xD;
      record and the sending of the MI intervention). The audio recordings will be securely&#xD;
      transferred to the certified MI trainer through a web-based application named REDCap&#xD;
      (Research Electronic Data Capture). Based on this recording, the certified MI trainer will&#xD;
      assess their MI skills and offer them support and feedback to improve their practice. After 6&#xD;
      weeks of trial, the study coordinator and the certified MI trainer will visit each center to&#xD;
      give individual feedback and coaching to each RA. They will observe and validate the MI&#xD;
      intervention performed by the RAs and identify possible barriers to the implementation of the&#xD;
      study according to each maternity ward. This training framework is consistent with the&#xD;
      literature since MI training indeed requires training in 2 steps with feedback training and&#xD;
      coaching in real situations after the initial training. Data collected during the 6-week&#xD;
      trial period will be discarded since the RAs will be practising conducting the study. Data&#xD;
      will only be used to monitor good clinical practices (GCPs) in each center during the audit&#xD;
      by the study coordinator. After this training, RAs will officially start the recruitment in&#xD;
      the maternity wards. The MI trainer will be available to answer questions and offer support&#xD;
      to the RAs regarding their MI techniques throughout the study.&#xD;
&#xD;
      Confidentiality protection&#xD;
&#xD;
      Source documents containing names, addresses and other contact information of participants&#xD;
      will be stored at each local site in individual folders, identified by the assigned&#xD;
      participant identification number (PID) number. These documents are stored in locked filing&#xD;
      cabinets in a secure research facility, with controlled access, limited to authorized staff&#xD;
      and investigators. No personal identifiers will appear in any summary or report of the study&#xD;
      data and will not be sent to the coordinating center.&#xD;
&#xD;
      STATISTICAL CONSIDERATIONS&#xD;
&#xD;
      Sample size&#xD;
&#xD;
      In order to identify a statistically significant amelioration of 8% in parents' intention to&#xD;
      vaccinate, and taking account of a basic intention to vaccinate of 78%, a risk of alpha error&#xD;
      of 0.05 and a power of 80%, a total of 400 parents by center will be included. This sample&#xD;
      size will also allow detect a minimum of 5% reduction in VH scores in each center. The total&#xD;
      sample of 1,600 families will allow detecting a significant amelioration of 6% in infants'&#xD;
      VC.&#xD;
&#xD;
      Data analysis&#xD;
&#xD;
      A descriptive analysis of responses from Q1, Q2 and Q3 will be conducted. Q1 and Q2 responses&#xD;
      as well as Q1 and Q3 responses (KAB, vaccination intention and VH scores) will be compared&#xD;
      for mothers belonging to the intervention group in order to assess intervention's&#xD;
      effectiveness, globally and for each participating center. Q1, Q2 and Q3 responses (KAB,&#xD;
      vaccination intention and VH scores) will be also compared between intervention and control&#xD;
      groups in order to demonstrate the MI intervention's effectiveness compared to the&#xD;
      information flyer. Parents' intention to vaccinate their infant measured before the&#xD;
      intervention will be dichotomized as &quot;certainly&quot; vs. &quot;probably&quot;; &quot;probably not&quot; and&#xD;
      &quot;certainly not&quot; and compared to all covariates measured before the intervention. Multivariate&#xD;
      logistic regression analysis will be conducted to identify independent determinants&#xD;
      influencing vaccination intention. Regarding VC, it will be defined as the proportion of&#xD;
      children having a complete vaccine status on the total of participating children. A child is&#xD;
      considered having a complete vaccine status if he has received all vaccines and antigens&#xD;
      recommended by his respective provincial immunization schedule at 3 months of age.&#xD;
&#xD;
      Q1 and Q2 responses (KAB, vaccination intention and VH scores) will be first compared using&#xD;
      McNemar's test and Wilcoxon's signed rank test for paired data for mothers belonging to the&#xD;
      intervention group. Thereafter, Q1, Q2 and Q3 responses (KAB, vaccination intention and VH&#xD;
      scores) will be compared between intervention and control groups using the Chi-square test or&#xD;
      the Fisher's exact test as appropriate while continuous variables will be compared using the&#xD;
      Student's t-test or the Mann-Whitney U test as appropriate. Moreover, covariates will be&#xD;
      compared with vaccination intention using the appropriate tests mentioned. In multivariate&#xD;
      analysis, collinearity of the variables included in the model will be checked and the model&#xD;
      adequacy will be assessed by the Hosmer-Lemeshow test and the deviance test. Finally, VC will&#xD;
      be analyzed globally, comparing proportion of properly vaccinated children between&#xD;
      intervention and control groups using the Chi-square test. The SAS software (version 9.4, SAS&#xD;
      Institute, Inc., Cary, NC) will be used for all statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2017</start_date>
  <completion_date type="Actual">April 6, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaccination status of the child at 3 months of age</measure>
    <time_frame>3 months after the intervention at the maternity ward</time_frame>
    <description>Information on the first vaccines that the child might have received assessed at 3 months of age by an online questionnaire sent to parents by email.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intention to vaccinate</measure>
    <time_frame>During the 24-hour postpartum stay at the maternity ward</time_frame>
    <description>Parents' intention to vaccinate their child at 2 months of age assessed by a questionnaire based on the Health Belief Model (HBM) before and after the intervention at the maternity ward.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine hesitancy</measure>
    <time_frame>During the 24-hour postpartum stay at the maternity ward and 3 months later at home</time_frame>
    <description>Parents' vaccine hesitancy score assessed by a questionnaire based on the Parent Attitudes about Childhood Vaccines (PACV) before and after the intervention at the maternity ward and 3 months later at home.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">667</enrollment>
  <condition>Vaccination Promotion</condition>
  <arm_group>
    <arm_group_label>Motivational Interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational session based on the motivational interviewing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information flyer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Information flyer on childhood vaccines</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <description>Mothers randomized in the intervention group will receive an educational session based on the motivational interviewing (MI) approach with a research assistant (RA). The RA will have first received a standardized training session on the content and techniques of MI.&#xD;
The MI intervention will be carried out in simple and understandable language in order to allow discussion and questions from parents rather than provide prescriptive and direct information. The intervention will last approximatively 15 to 20 minutes.</description>
    <arm_group_label>Motivational Interviewing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information flyer</intervention_name>
    <description>Mothers randomized in the control group will receive a locally information flyer on childhood vaccines without any oral explanation by the research assistant.</description>
    <arm_group_label>Information flyer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All mothers of infants born in 1 of the 6 participating maternity wards.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers aged &lt;18 years;&#xD;
&#xD;
          -  Mothers who do not speak English or French;&#xD;
&#xD;
          -  Any health situation of the newborn or the mother requiring acute care (i.e. if the&#xD;
             newborn needs to be hospitalized in the neonatology unit or if the mother has an&#xD;
             incompatible condition for an interview);&#xD;
&#xD;
          -  Mothers who have participated in one of the two studies evaluating the impact of the&#xD;
             MI intervention in the Eastern Townships in 2009-2010 and in the province of Quebec in&#xD;
             2014-2015.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnaud Gagneur, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Sherbrooke</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Surrey Memorial Hospital</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>B.C. Women's Hospital &amp; Health Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North York General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M2K 1E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Charlottetown</city>
        <state>Prince Edward Island</state>
        <zip>C1A 8T5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier universitaire de Sherbrooke (CHUS)</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
    <investigator_full_name>Arnaud Gagneur</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984007
org study id: 2017-1578
nct id: NCT02984007
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Synopsis: In most countries, there is an increase in the number of parents who refuse some,
      most or all vaccines or who adopt delayed vaccination schedule. Vaccine hesitancy (VH) is a
      global phenomenon that needs to be measured and addressed. However, to this date, no
      effective strategy has been identified. Dr Gagneur have developed and validated a new
      approach to educate parents of newborns about vaccination, based on motivational interviewing
      (MI) techniques. MI is a method to elicit and strengthen motivation for change based on the
      person's own arguments for change that has been shown effective for the adoption of many
      preventive health behaviors. This approach has been validated for vaccination during a pilot
      study as well as in a provincial RCT in Quebec. Now that a proof of concept has been made in
      Quebec, the investigators will validate the approach in other contexts (e.g. English-speaking
      provinces and settings with different ways to deliver maternity care and childhood vaccines).

      Hypothesis: An educational strategy, based on MI techniques, delivered in the maternity ward
      increases parents' intention to vaccinate their infant, reduces VH scores and increases
      infants' vaccine uptake in Quebec. This approach may be applicable across the country in
      order to tackle VH and thus improve infants' vaccine coverage (VC).

      Objective: To evaluate the impact of the MI intervention on parents' intention to vaccinate
      their child and their VH score and on infants' VC at 3 months of age, in a pan-Canadian
      context.

      Methods: Multicentre RCT in maternity wards of 5 provinces (QC, BC, ON, NS/PE). Parents will
      be randomized to receive the MI intervention (intervention group) or to receive an
      information flyer on vaccines (control group). MI intervention will be delivered by research
      assistant that will have first received a standardized training session on the content and
      techniques of MI. Parents will complete a self-administered questionnaire to measure
      knowledge and vaccination intention as well as VH before and after the intervention.
      Immunization data will be collected through an online questionnaire sent when the child will
      reach 3 months of age.

      Expected benefits: The strategy will be validated across different immunization programs from
      5 Canadian provinces to take account of the differences in logistics and cultural contexts.
      Results from this study will provide to the provincial and national public health authorities
      an effective strategy to tackle VH.
OBJECTIVES

      Main objective: To evaluate the impact of the motivational interviewing (MI) intervention on
      parents' intention to vaccinate their infant and their vaccine hesitancy (VH) score in a
      Pan-Canadian context. In order to explore differences in the intervention's impact according
      to cultural and organizational factors, all analysis will also be conducted at the level of
      each center.

      Specific objectives:

        1. To assess parents' intention to vaccinate their infant before the intervention and
           immediately after the intervention, globally and at each center level.

        2. To assess parents' VH scores before the intervention, immediately after the intervention
           and when their infant is 3 months of age, globally and at each center level.

        3. To assess parents' knowledge, attitudes and beliefs (KAB) about vaccination before the
           intervention, immediately after the intervention and when their infant is 3 months of
           age:

             -  Descriptive analysis according to a composite model inspired from the Health Belief
                Model (HBM), the Theory of Planned Behavior, and the VH measures (based on a
                validated questionnaire);

             -  Research of the determinants of vaccination intention.

        4. To compare vaccine coverage (VC) at 3 months of age of infants whose parents has
           received (intervention group) or not (control group) the intervention in the maternity
           ward during the recruitment period.

      STUDY DESIGN

      This study is a multicentre randomized controlled trial (RCT) with single unit of
      randomization that will be conducted in maternity wards of 5 provinces: Quebec (QC), British
      Columbia (BC), Ontario (ON), and Nova Scotia (NS)/ Prince Edward Island (PEI). In each
      center, parents will be randomized to receive the MI intervention (intervention group) or to
      receive an information flyer on childhood vaccines (control group). The flyer that will be
      given to mothers of the control group will be the one that is usually given to parents at the
      maternity ward or at the first home visit after birth during the first week. Thus, flyers
      will be different according to the participating regions in this study. Randomization will be
      stratified by center and will be made in blocks of 4, 6 and 8 participants.

      STUDY POPULATION

      Study participants

      The study population will include 1,600 mothers of infants born in the participating
      maternity wards during the recruitment period.

      Study centers

      The study will be conducted in 6 maternity wards located in 4 different centers:

        1. Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, QC;

        2. B.C. Women's Hospital & Health Centre, Vancouver, BC and Surrey Memorial Hospital,
           Surrey, BC;

        3. North York General Hospital, Toronto, ON;

        4. IWK Health Centre, Halifax, NS and Queen Elizabeth Hospital, Charlottetown, PE.

      The choice of these 6 maternity wards is the best compromise between the study feasibility
      and the diversity of the Canadian population. More than 2,500 deliveries per year occur in
      each maternity ward (except for Queen Elizabeth Hospital with approximately 1200 annual
      births), which ensures the feasibility of the study.

      CONDUCT OF STUDY

      Enrollment

      Each subject must participate in the informed consent process and sign and date the informed
      consent form before any procedures specified in this protocol are performed. Mothers
      attending the participant maternity wards will be entirely free to participate in the study.
      Benefits of the study will be the chance for the parents to discuss childhood immunizations
      in a non-confronting and non-judgemental climate and the improvement of their knowledge.
      Participation in the study will not involve risk, besides the risk of breach of
      confidentiality for which precautions will be taken.

      Regulatory considerations

      The study will be registered with ClinicalTrials.gov.

      Recruitment

      Mothers will be approached to participate during the postpartum stay at the maternity ward.
      The MI intervention will be delivered by a research assistant (RA) (or a research nurse) that
      will have first received a standardized training session on the content and techniques of MI.
      Since the postpartum stay may last less than 24 hours in some provinces, RAs will recruit
      mothers in a chronological way according to the birth time of the mother to ensure to meet
      the highest number of mothers as possible.

      The recruitment will be conducted during 4 to 6 months. In the Quebec RCT, 25 participants
      were recruited in average each week, so it is feasible to recruit 400 participants within 4
      to 6 months.

      Study plan

      After the mothers agree to participate, they will have to complete an initial questionnaire
      (Q1) to assess their intention to vaccinate, their VH scores and their KAB about vaccination,
      as well as their socio-demographics characteristics. RAs will collect this questionnaire and
      proceed to the randomization of the participating mother to receive the MI intervention or to
      receive a flyer on childhood immunizations. Depending on the randomization result, RAs will
      perform the MI intervention with the parents or only give the information flyer. RAs will
      then distribute a similar questionnaire (Q2) to parents of both groups to assess their
      intention to vaccinate, their VH scores and their KAB about vaccination, as well as their
      satisfaction of the intervention received (MI or flyer). Before leaving the maternity ward,
      parents will have to return their completed questionnaire to the RA or in a designated place.
      When the child is 3 months of age, an online survey (Q3) will be sent to participants by
      email to assess their VH score and their KAB as well as the child's vaccine status.

      Standardization of the intervention

      To ensure that the content of the information sessions will be standardized and similar for
      each center or RA, a reference document on the primary vaccination (vaccines administered
      before the age of 1 year) will be made according to the provincial recommendations for each
      center and will be used for the training of RAs. This training will be conducted over 3 days
      including supervision via audio recordings (2 days + 1 day). First, RAs will participate in a
      2-day centralized training seminar in Montreal on the MI techniques given by a certified
      trainer before the beginning of the study. Subsequently, RAs will practice their MI skills
      during a 4 to 6-week trial period in their respective maternity ward. During this time, RAs
      will send an online audio recording of their MI intervention with a mother in the maternity
      ward (a separate informed consent form will be signed by these mothers to authorize the
      record and the sending of the MI intervention). The audio recordings will be securely
      transferred to the certified MI trainer through a web-based application named REDCap
      (Research Electronic Data Capture). Based on this recording, the certified MI trainer will
      assess their MI skills and offer them support and feedback to improve their practice. After 6
      weeks of trial, the study coordinator and the certified MI trainer will visit each center to
      give individual feedback and coaching to each RA. They will observe and validate the MI
      intervention performed by the RAs and identify possible barriers to the implementation of the
      study according to each maternity ward. This training framework is consistent with the
      literature since MI training indeed requires training in 2 steps with feedback training and
      coaching in real situations after the initial training. Data collected during the 6-week
      trial period will be discarded since the RAs will be practising conducting the study. Data
      will only be used to monitor good clinical practices (GCPs) in each center during the audit
      by the study coordinator. After this training, RAs will officially start the recruitment in
      the maternity wards. The MI trainer will be available to answer questions and offer support
      to the RAs regarding their MI techniques throughout the study.

      Confidentiality protection

      Source documents containing names, addresses and other contact information of participants
      will be stored at each local site in individual folders, identified by the assigned
      participant identification number (PID) number. These documents are stored in locked filing
      cabinets in a secure research facility, with controlled access, limited to authorized staff
      and investigators. No personal identifiers will appear in any summary or report of the study
      data and will not be sent to the coordinating center.

      STATISTICAL CONSIDERATIONS

      Sample size

      In order to identify a statistically significant amelioration of 8% in parents' intention to
      vaccinate, and taking account of a basic intention to vaccinate of 78%, a risk of alpha error
      of 0.05 and a power of 80%, a total of 400 parents by center will be included. This sample
      size will also allow detect a minimum of 5% reduction in VH scores in each center. The total
      sample of 1,600 families will allow detecting a significant amelioration of 6% in infants'
      VC.

      Data analysis

      A descriptive analysis of responses from Q1, Q2 and Q3 will be conducted. Q1 and Q2 responses
      as well as Q1 and Q3 responses (KAB, vaccination intention and VH scores) will be compared
      for mothers belonging to the intervention group in order to assess intervention's
      effectiveness, globally and for each participating center. Q1, Q2 and Q3 responses (KAB,
      vaccination intention and VH scores) will be also compared between intervention and control
      groups in order to demonstrate the MI intervention's effectiveness compared to the
      information flyer. Parents' intention to vaccinate their infant measured before the
      intervention will be dichotomized as "certainly" vs. "probably"; "probably not" and
      "certainly not" and compared to all covariates measured before the intervention. Multivariate
      logistic regression analysis will be conducted to identify independent determinants
      influencing vaccination intention. Regarding VC, it will be defined as the proportion of
      children having a complete vaccine status on the total of participating children. A child is
      considered having a complete vaccine status if he has received all vaccines and antigens
      recommended by his respective provincial immunization schedule at 3 months of age.

      Q1 and Q2 responses (KAB, vaccination intention and VH scores) will be first compared using
      McNemar's test and Wilcoxon's signed rank test for paired data for mothers belonging to the
      intervention group. Thereafter, Q1, Q2 and Q3 responses (KAB, vaccination intention and VH
      scores) will be compared between intervention and control groups using the Chi-square test or
      the Fisher's exact test as appropriate while continuous variables will be compared using the
      Student's t-test or the Mann-Whitney U test as appropriate. Moreover, covariates will be
      compared with vaccination intention using the appropriate tests mentioned. In multivariate
      analysis, collinearity of the variables included in the model will be checked and the model
      adequacy will be assessed by the Hosmer-Lemeshow test and the deviance test. Finally, VC will
      be analyzed globally, comparing proportion of properly vaccinated children between
      intervention and control groups using the Chi-square test. The SAS software (version 9.4, SAS
      Institute, Inc., Cary, NC) will be used for all statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Vaccination status of the child at 3 months of age
time frame: 3 months after the intervention at the maternity ward
description: Information on the first vaccines that the child might have received assessed at 3 months of age by an online questionnaire sent to parents by email.
measure: Intention to vaccinate
time frame: During the 24-hour postpartum stay at the maternity ward
description: Parents' intention to vaccinate their child at 2 months of age assessed by a questionnaire based on the Health Belief Model (HBM) before and after the intervention at the maternity ward.
measure: Vaccine hesitancy
time frame: During the 24-hour postpartum stay at the maternity ward and 3 months later at home
description: Parents' vaccine hesitancy score assessed by a questionnaire based on the Parent Attitudes about Childhood Vaccines (PACV) before and after the intervention at the maternity ward and 3 months later at home.
arm group label: Motivational Interviewing
arm group type: Experimental
description: Educational session based on the motivational interviewing
arm group label: Information flyer
arm group type: Other
description: Information flyer on childhood vaccines
intervention type: Behavioral
intervention name: Motivational Interviewing
description: Mothers randomized in the intervention group will receive an educational session based on the motivational interviewing (MI) approach with a research assistant (RA). The RA will have first received a standardized training session on the content and techniques of MI.
The MI intervention will be carried out in simple and understandable language in order to allow discussion and questions from parents rather than provide prescriptive and direct information. The intervention will last approximatively 15 to 20 minutes.
arm group label: Motivational Interviewing
intervention type: Other
intervention name: Information flyer
description: Mothers randomized in the control group will receive a locally information flyer on childhood vaccines without any oral explanation by the research assistant.
arm group label: Information flyer
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Arnaud Gagneur, MD, PhD
role: Principal Investigator
affiliation: Université de Sherbrooke
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Sherbrooke
investigator full name: Arnaud Gagneur
investigator title: Principal Investigator
sharing ipd: No