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临床试验/NCT03286907
NCT03286907已完成不适用

A Randomized Controlled Trial Evaluating Efficacy of Promoting Human Papillomavirus (HPV) Vaccination Among Chinese Men Who Have Sex With Men

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 624 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
624
试验地点
2
主要终点
Uptake of three required doses of HPV vaccination

研究概览

简要总结

Objectives:

To evaluate efficacies of two online and theory-based interventions [HC: health communication only and HC-MI health communication plus motivational interviewing (MI)] in increasing uptake of three doses of HPV vaccines within the 9-month follow-up period among Hong Kong Chinese men who have sex with men (MSM).

Hypothesis:

The HPV vaccination rate of the three groups would be in the order HC-MI group > HC group > Control group.

Design and subjects:

A three-arm randomized controlled trial (RCT) will be conducted (n= 624). With informed consent, anonymous surveys will be conducted at baseline, Months 3, 6, and 9. Inclusion criteria: 1) HK Chinese men aged >18, 2) oral or anal intercourse with men in the last six months; 3) no intention to leave HK for one month consecutively within the next 12 months, 4) regular internet access, and 5) willing to be followed up by phone.

Study instruments:

Structured questionnaires

Interventions:

  1. Group HC: exposure to web-based, interactive and theory-based health communication promoting HPV vaccination uptake; 2) Group HC-MI: same exposure as Group HC plus MI; and 3) Group C: exposure to online materials about mental health (control group).

Main outcome measures:

Uptake of three doses of HPV vaccination within the follow-up period.

Data analysis and expected results:

Intention-to-treat analysis, General Estimation Equation (GEE) and Cox regression methods will be used. Significance differences in HPV vaccination uptake rates will be found among the three groups.

详细描述

Aims and objectives

  1. The primary objective of the RCT study is to evaluate the relative efficacies of two online, theory-based and interactive interventions [health communication (HC) and health communication plus MI (HC-MI)] in increasing uptake of three required doses of HPV vaccination within a 9-month follow-up period among Hong Kong Chinese MSM who had not previously taken up any dose of HPV vaccination, as compared to the control group (Group C)
  2. Secondary objectives are to evaluate the relative efficacies of the interventions in increasing the following responses at the end of the 9-month follow up period:

i) Intention to take up all doses of HPV vaccination in the next 12 months. ii) Theory-based cognitions supportive of HPV vaccination [e.g. those of the Health Belief Model (HBM)].

Study design A three-arm parallel RCT will be conducted. Background information and potential confounder(s) are recorded at baseline. Three post-intervention evaluations will be performed through short telephone surveys 3, 6 and 9 months after exposure to the intervention. Participants who have already taken up all three doses of HPV vaccination at Month 3 or 6 will be asked the termination questionnaire (same as that for Month 9). Interviewers and data analysts are blinded from participants' randomization status.

Subject Inclusion criteria: 1) Hong Kong Chinese speaking men of aged ≥18, 2) self-reported oral or anal intercourse with ≥1 man (last six months); 3) no intention to leave Hong Kong for >1 month consecutively within the next nine months, 4) regular internet access and 5) willing to be followed up by phone. Those who have ever received HPV vaccination will be excluded.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • HK Chinese speaking men of aged ≥18
  • Self-reported oral or anal intercourse with ≥1 man (last six months)
  • No intention to leave HK for >1 month consecutively within the next nine months
  • Regular internet access
  • Willing to be followed up by phone.

排除标准

  • Had ever received HPV vaccination

结局指标

主要结局

Uptake of three required doses of HPV vaccination

时间窗: 24 months

Uptake of three required doses of HPV vaccination within a 24-month follow-up period

次要结局

  • Behavioral intention to take up all doses of HPV vaccination(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zixin Wang

Research Assistant Professor

Chinese University of Hong Kong

研究点 (2)

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