The Effect of Interventions Based on the Information-Motivation-Behavioral Skills Model on the Human Papillomavirus Vaccination Rate Among 11-13-Year-Old Girls in Central and Western China: Protocol for a Randomized Controlled Trial.
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BACKGROUND: Persistent infection of high-risk human papillomavirus (HPV) can lead to cervical intraepithelial neoplasia, cervical cancer, and even death. HPV vaccination for girls aged 9-14 years can effectively prevent the occurrence of cervical cancer. Some Chinese provinces and cities have launched free HPV vaccination programs for school-age girls; however, due to the lack of supportive government policies, the high price and supply shortage of HPV vaccines, and vaccine hesitancy, some parents refuse to vaccinate their daughters. OBJECTIVE: This protocol reports the design of a randomized controlled trial (RCT) aiming to explore the efficacy of a digital HPV vaccination education intervention based on the information-motivation-behavioral skills (IMB) model in improving the HPV vaccination rate among 11-13-year-old girls in central and western China. METHODS: A multicenter intervention study based on an online applet will be conducted in December 2024, and about 750 eligible parents of 11-13-year-old girls will be assigned in a 1:1 ratio to an intervention group receiving 7-day digital HPV vaccination education based on the IMB model or a control group using non-HPV publicity materials. Free HPV vaccination pilot projects will be carried out among this population by our research team in central and western China (some parents might refuse to vaccinate their daughters). All participants will be asked to complete online questionnaires at baseline; postintervention; and 1 week, 1 month, and 3 months after the intervention. RESULTS: The primary outcome of this study will be receipt of the first HPV vaccination within 3 months. Data will be analyzed based on an intention-to-treat approach, and Stata 16.0 will be used for statistical analysis. CONCLUSIONS: This study aims to improve the HPV vaccination rate among 11-13-year-old girls and will examine the impact of a digital HPV vaccination education intervention based on the IMB model. The findings of this study may offer promising intervention measures for HPV vaccine hesitancy in low-health-resource areas in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2300067402; https://tinyurl.com/v5zt4hc9. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/58873.