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Randomized Controlled Trial
. 2024 May 1;7(5):e2411938.
doi: 10.1001/jamanetworkopen.2024.11938.

Effectiveness of a School- and Primary Care-Based HPV Vaccination Intervention: The PrevHPV Cluster Randomized Trial

Nathalie Thilly  1   2 , Morgane Michel  3   4 , Maïa Simon  1   2 , Aurélie Bocquier  1 , Amandine Gagneux-Brunon  5   6   7 , Aurélie Gauchet  8 , Serge Gilberg  9 , Anne-Sophie Le Duc-Banaszuk  10 , Sébastien Bruel  11   12 , Judith E Mueller  13   14 , Bruno Giraudeau  15   16 , Karine Chevreul  3   4 ; PrevHPV Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Effectiveness of a School- and Primary Care-Based HPV Vaccination Intervention: The PrevHPV Cluster Randomized Trial

Nathalie Thilly et al. JAMA Netw Open. .

Abstract

Importance: The human papillomavirus (HPV) vaccine is safe and effective, yet vaccination coverage remains below public health objectives in many countries.

Objective: To examine the effectiveness of a 3-component intervention on HPV vaccination coverage among adolescents aged 11 to 14 years 2 months after the intervention ended, each component being applied alone or in combination.

Design, setting, and participants: A cluster randomized trial with incomplete factorial design (PrevHPV) was conducted between July 1, 2021, and April 30, 2022, in French municipalities receiving 0, 1, 2, or 3 components of the intervention. Randomization was stratified by school district and municipalities' socioeconomic level. Analyses were carried out on 11- to 14-year-old adolescents living in all participating municipalities, regardless of what had been implemented.

Intervention: The PrevHPV intervention had 3 components: (1) educating and motivating 11- to 14-year-old adolescents in middle schools, along with their parents; (2) training general practitioners (GPs) on up-to-date HPV information and motivational interviewing techniques; and (3) free HPV vaccination at school.

Main outcomes and measures: The primary outcome was HPV vaccination coverage (≥1 dose) 2 months after the intervention ended among 11- to 14-year-old adolescents living in participating municipalities, based on the French national reimbursement database and data collected during the trial in groups randomized to implement at-school vaccination.

Results: A total of 91 municipalities comprising 30 739 adolescents aged 11 to 14 years (15 876 boys and 14 863 girls) were included and analyzed. Half the municipalities were in the 2 lowest socioeconomic quintiles and access to GPs was poor in more than two-thirds of the municipalities. Thirty-eight of 61 schools (62.3%) implemented actions and 26 of 45 municipalities (57.8%) had at least 1 trained GP. The median vaccination coverage increased by 4.0 percentage points (IQR, 2.0-7.3 percentage points) to 14.2 percentage points (IQR, 9.1-17.3 percentage points) at 2 months. At-school vaccination significantly increased vaccination coverage (5.50 percentage points [95% CI, 3.13-7.88 percentage points]) while no effect was observed for adolescents' education and motivation (-0.08 percentage points [95% CI, -2.54 to 2.39 percentage points]) and GPs' training (-1.46 percentage points [95% CI, -3.44 to 0.53 percentage points]). Subgroup analyses found a significant interaction between at-school vaccination and access to GPs, with a higher effect when access was poor (8.62 percentage points [95% CI, 5.37-11.86 percentage points] vs 2.13 percentage points [95% CI, -1.25 to 5.50 percentage points]; P = .007 for interaction).

Conclusions and relevance: In this cluster randomized trial, within the context of the late COVID-19 pandemic period and limited school and GP participation, at-school HPV vaccination significantly increased vaccination coverage. The trial did not show a significant effect for training GPs and education and motivation, although it may be observed after more time has elapsed after the intervention.

Trial registration: ClinicalTrials.gov Identifier: NCT04945655.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gagneux-Brunon reported receiving honoraria from MSD, Moderna, and Pfizer paid to her institution and financial support for attending meetings and/or travel from MSD and Moderna, all outside the submitted work. Dr Gauchet reported receiving honoraria from MSD paid to her institution and finanical support for attending meetings and/or travel from MSD, all outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Flowchart of the Municipalities’ Selection and Group Allocation
GP indicates general practitioner; NA, not applicable.
See this image and copyright information in PMC

References

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