A Randomized Controlled Trial Evaluating Efficacy of Promoting Human Papillomavirus (HPV) Vaccination Among Chinese Men Who Have Sex With Men
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:
- 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
- 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)
- 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
- 是
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
Zixin Wang
Research Assistant Professor
Chinese University of Hong Kong
