The Effect of Interventions on Human Papillomavirus Vaccination Rate Based on Information-Motivation-Behavioral Skills Model for 11-13-Year- Old Girls in Central and Western China: a Study Protocol for a Randomized Controlled Trial

Abstract

Background Persistent infection of high-risk human papillomavirus (HPV) can lead to cervical intraepithelial neoplasia (CIN), cervical cancer, and even death. HPV vaccination for girls ages 9 to 14 years can effectively prevent the occurrence of cervical cancer. Free HPV vaccination pilot projects will be carried out among this population by our research team in central and western China. However, some parents might refuse to vaccinate their daughters. This protocol reports the design of a randomized controlled trial aiming to explore the efficacy of a mobile-based education intervention based on the Information-Motivation-Behavioral skills (IMB) model, in improving the HPV vaccination rate of 11-13-year-old girls in central and western China. Methods A multicenter intervention study based on an online applet will be conducted in March 2024, and at least 750 eligible parents of 11-13-year-old girls will be assigned 1:1 to an intervention group receiving a 7-day mobile-based education on HPV vaccines based on the IMB model or control group using non-HPV publicity materials. All participants will be asked to complete online questionnaires at baseline, post-intervention, and 1, 2, and 3 months after the intervention. The primary outcome of this study will be receipt of the first HPV vaccination or appointments for HPV vaccination within 3 months. Data will be analyzed based on an intention-to-treat approach, and SAS 9.4 will be used for statistical analysis. Discussion This study aims to improve the HPV vaccination rate of 11-13-year-old girls and will examine the impact of a mobile-based education on HPV vaccines, based on IMB model. The findings of this study may offer promising intervention measures on HPV vaccine hesitancy in low health resource areas in the future. Trial registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2300067402; Registered on 6 January 2023.