基于 "信息-动机-行为技能模型 "的干预措施对中国中西部地区 11-13 岁女孩人乳头瘤病毒疫苗接种率的影响:随机对照试验方案》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-11-19 DOI:10.2196/58873
Shu Jing, Yijin Wu, Zhenwei Dai, Shenglan Tang, Xiaoyou Su, Youlin Qiao
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引用次数: 0

摘要

背景:高危人乳头瘤病毒(HPV)的持续感染可导致宫颈上皮内瘤变、宫颈癌,甚至死亡。为 9-14 岁女童接种 HPV 疫苗可有效预防宫颈癌的发生。中国部分省市已开展了针对适龄女童的免费 HPV 疫苗接种项目,但由于政府缺乏扶持政策、HPV 疫苗价格昂贵且供应短缺、疫苗接种犹豫不决等原因,部分家长拒绝为女儿接种疫苗:本方案报告了一项随机对照试验(RCT)的设计,旨在探讨基于信息-动机-行为技能(IMB)模型的数字化HPV疫苗接种教育干预对提高中国中西部地区11-13岁女孩HPV疫苗接种率的效果:将于2024年12月开展一项基于在线小程序的多中心干预研究,将约750名符合条件的11-13岁女孩家长按1:1的比例分配到干预组,接受为期7天的基于IMB模式的数字化HPV疫苗接种教育,或分配到使用非HPV宣传材料的对照组。我们的研究团队将在中国中部和西部地区的这一人群中开展免费 HPV 疫苗接种试点项目(部分家长可能会拒绝为女儿接种疫苗)。所有参与者将被要求在基线、干预后、干预后 1 周、1 个月和 3 个月完成在线问卷调查:本研究的主要结果是在 3 个月内接受第一次 HPV 疫苗接种。数据将根据意向治疗方法进行分析,统计分析将使用 Stata 16.0:本研究旨在提高 11-13 岁女孩的 HPV 疫苗接种率,并将研究基于 IMB 模型的数字化 HPV 疫苗接种教育干预措施的影响。本研究的结果可能会为未来低卫生资源地区的HPV疫苗接种犹豫提供有前景的干预措施:中国临床试验注册中心,ChiCTR2300067402;https://tinyurl.com/v5zt4hc9.International 注册报告标识符(irrid):PRR1-10.2196/58873。
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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.

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.

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