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临床试验/NCT07068802
NCT07068802已完成不适用

Message Framing in HPV Vaccination Decision: A Survey Experimental Study Among Chinese Male College Students

Zhejiang University1 个研究点 分布在 1 个国家目标入组 612 人开始时间: 2024年12月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
612
试验地点
1
主要终点
HPV vaccination intention

研究概览

简要总结

The goal of this clinical trial is to determine if different risk communication strategies can increase the intention to receive the HPV vaccine among male college students in China. The study focuses on male college students aged 18-25 years, who are healthy volunteers and have not previously received the HPV vaccine. The main question it aims to answer is:

Can specific risk communication interventions increase the willingness to receive the HPV vaccine among male college students?

Researchers will compare four different interventions to see if they have a significant effect on vaccination intention:

Control group: Receiving a standard statement about HPV risks. Personal risks group: Receiving information on male-specific health risks. Partner risks group: Receiving information on risks to female partners. Combined risks group: Receiving information on both personal risks and risks to female partners.

Participants will:

Provide electronic informed consent. Complete pre-exposure questionnaires. Be exposed to a 120-second message based on their assigned group. Complete an immediate post-exposure assessment. This study aims to identify effective communication strategies to promote HPV vaccination among male college students, especially in light of the upcoming approval of the first male HPV vaccine in China.

详细描述

Study design We conducted a randomized survey experiment with pre-post design between December 2024 to January 6th 2025, right before the approval of the first HPV vaccine for male in the country in January 8th across three geographically dispersed Chinese universities (eastern, western, and northern regions). This study was conducted from The Institutional Review Board of Hangzhou Normal University, School of Public Health approved this study (approval no. 20240010).

Participants The proportion of male college students intending to receive the HPV vaccine was assumed to be 45% in the calculation of sample size, based on a previous report in China [28]. We assumed an increase in vaccination willingness to 55% for the personal risks group and partner risks group and 65% for the both risks group. To detect a significant intervention effect with a 2-sided α = .05, a power of 0.80, and an 80% valid response rate, we calculated that 169 participants were required (676 participants total).

From 720 initially involved in baseline evaluation, we excluded 82 due to incompleteness (>10% missing data) or invalidity (i.e., inconsistent responses to attention-check items), and 35 additional participants reporting prior HPV vaccination or definite baseline vaccination intention, yielding a final analytical sample of 612 male college students.

Randomization and interventions Participants provided electronic informed consent with voluntary withdraw options. Randomization was implemented through a 1:1:1:1 allocation ratio to four conditions: Control group (Group 1, n=154) receiving a standard statement of HPV risks (In mainland China, HPV vaccines are currently approved only for female use. However, in other countries, they are also available for males. HPV can cause cancers throughout the body, from the head to the reproductive system. Thus, HPV vaccination can protect against many cancer types. Annually, over 120,000 Chinese are diagnosed with HPV-related cancers, with about 50,000 dying from them.); Intervention 1 (Group 2, n=152) adding male-specific health risks; Intervention 2 (Group 3, n=153) adding risk to female partners; Intervention 3 (Group 4, n=153) adding both personal risk and risk to female partners. The protocol involved sequential completion of pre-exposure questionnaires, timed 120-second message exposure, and immediate post-exposure assessment.

Measures We evaluated three primary outcomes. The first outcome is vaccination intention ("If HPV vaccine were available for males in China, would you get vaccinate?"). The answer was measured using a 5-point Likert scale (1= "not at all willing" to 5= "highly willing") and then dichotomized into "willing (4-5)" vs. "unwilling (1-3)". The second outcome is Precaution Adoption Process Model (PAPM) adapted decisional readiness. A single question was asked "Before today, what do your stance on HPV vaccination?" the answer was categories as "pre-decisional (never heard/knew but no consideration) vs. "decisional (active refusal/acceptance). The third outcome aims to test the respondents' perceived responsibility toward HPV infection prevention with a single question "HPV infection is a shared responsibility of both genders." The answer was measured using a 5-point Likert scale on agreement (1= "strongly disagree" to 5= "strongly agree"). The final answer was dichotomized into "agree (4-5)" and "disagree (1-3)".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

The study is double-blinded, meaning that both the subjects and the researchers are unaware of the group assignments. The randomization of groups is conducted using Wenjuanxing (a survey tool). However, blinding is not implemented during data analysis.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • aged above 18, male,college student, willing to participate

排除标准

  • vaccinated with one dose or more HPV vaccine or decided to get vaccinated with HPV vaccine.

结局指标

主要结局

HPV vaccination intention

时间窗: Immediately after the 120-second message exposure.

The primary outcome measure is the intention to receive the HPV vaccine among male college students, assessed through a question: "If HPV vaccine were available for males in China, would you get vaccinate?". The answer was measured using a 5-point Likert scale (1= "not at all willing" to 5= "highly willing")

Precaution Adoption Process Model (PAPM) adapted decisional readiness

时间窗: Immediately after the 120-second message exposure.

A single question was asked "Before today, what do your stance on HPV vaccination?" the answer was categories as "pre-decisional (never heard/knew but no consideration) vs. "decisional (active refusal/acceptance).

respondents' perceived responsibility toward HPV infection prevention

时间窗: Immediately after the 120-second message exposure.

The third outcome aims to test the respondents' perceived responsibility toward HPV infection prevention with a single question "HPV infection is a shared responsibility of both genders." The answer was measured using a 5-point Likert scale on agreement (1= "strongly disagree" to 5= "strongly agree").

次要结局

未报告次要终点

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Yan

professor

Zhejiang University

研究点 (1)

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