CClinicalTrials.gg
RecruitingNCT05565755MOTI-VAC_IMGUpdated Aug 9, 2023

Impact on Patients' Vaccine Hesitancy of a Motivational Interviewing Training in Initial Medical Training Course

An interventional study of Motivational interview in Vaccination Hesitancy, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2023-08-09.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jul 2020, registered Sep 2022).
  • Started Jul 2020; still recruiting 6 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Sex
All
01

Study summary

In France, vaccination coverage of adolescents remains suboptimal, partly because of a loss of confidence, favoring the re-emergence of epidemics. Despite the extension of mandatory vaccination, some vaccines are still recommended.

Motivational Interviewing (MI), which reinforces a person's own motivation and commitment to change, has been shown to be effective in addiction, nutrition, physical activity and vaccination (Promovac study in Quebec). However, it has not been evaluated in the French cultural context (with mandatory vaccination).

The main objective will be to measure the effect of training in MI for general medical interns at the end of their studies on the vaccine hesitancy (VH) of parents of adolescents consulting in primary care, using a validated scale: VCS.

A multicenter study will be conducted in two university departments of general medicine (Marseille and Nice), comparative, clustered exposure/non-exposure type. It will compare the HV of parents of adolescents during consultations by 2 different groups of interns:

  • a group of interns trained in MI,
  • a group of interns not trained in MI. The randomization will be done by random draw from the 3rd year list of GP interns not in SASPAS training.

After the MI training, each intern in the "exposed" and "unexposed" groups will have 4 months to include at least 3 parents of adolescents seen in consultation.

Descriptive analyses will be performed followed by statistical analysis by modeling the standardized HV score using hierarchical linear regression.

Training of interns in MI applied to vaccination will increase their knowledge, skills and confidence in using this technique.

We can expect a decrease in VH among parents in primary care who consulted a physician trained in MI.

02

Conditions studied

  • Vaccination Hesitancy
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Interns who are not in SASPAS for the semester from early November 2020 to the end of April 2021 and who will complete the SASPAS internship in the following semester (May 2021 to October 2021).

Exclusion criteria

Exclusion Criteria:

  • Intern on availability or inter-CHU internship for the semester November 2020 to end of April 2021
  • Interns who have already received training at the MI
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Parents of adolescents who had a consultation with a group of IM-trained interns.

    Other: Motivational interview

  • No intervention
    Parents of adolescents who have not had a consultation with a group of IM trained interns.

Interventions

  • OtherMotivational interview

    Motivational interview Training

06

What researchers measure

Primary outcomes

  1. Vaccine hesitancy score of parents of adolescents

    Score measured using the validated VCS: Vaccination Confidence Scale. This scale is composed of 8 items, each receiving a score ranging from 0 (strongly disagree) to 10 (strongly agree), with the highest score expressing the highest degree of confidence in vaccines and the lowest expressing the highest degree of VH.

    Time frame: through study completion, an average of 2 years

Secondary outcomes

  1. Behaviour, beliefs and knowledge about vaccines

    Reponses to Questions about Behaviour, beliefs and knowledge about vaccine

    Time frame: through study completion, an average of 2 years

  2. Parent and medical intern satisfaction with the consultation

    Level of parent satisfaction on a scale (not very satisfied to very satisfied)

    Time frame: through study completion, an average of 2 years

  3. MI learning, knowledge and skills for vaccination promotion in interns

    Score to the motivational interviewing skills in immunization Questionnaire (MISI)

    Time frame: year 2

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05565755
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Jul 15, 2020
Primary completion
Dec 31, 2022
Completion
Aug 8, 2023 (estimated)
Last update
Aug 9, 2023

Study contacts

Eva MITILIAN
Contact
eva.MITILIAN@univ-amu.fr
0491000000
François CREMIEUX
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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