An RCT Promoting HPV Vaccination Among Chinese MSM
A Randomized Controlled Trial Evaluating Efficacy of Promoting Human Papillomavirus (HPV) Vaccination Among Chinese Men Who Have Sex With Men
1 other identifier
interventional
624
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJune 18, 2020
June 1, 2020
2.4 years
August 28, 2017
June 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uptake of three required doses of HPV vaccination
Uptake of three required doses of HPV vaccination within a 24-month follow-up period
24 months
Secondary Outcomes (1)
Behavioral intention to take up all doses of HPV vaccination
12 months
Study Arms (3)
Online videos
EXPERIMENTALParticipants will watch two online videos, complete a self-administered online tutorial, and receive reminders at Month 1, 2, 4, 6 \& 8
Online videos and MI
EXPERIMENTALParticipants will watch two online videos, complete a self-administered online tutorial, received motivational interviewing (MI), and receive reminders at Month 1, 2, 4, 6 \& 8
Control group
ACTIVE COMPARATORParticipants will receive online messages about mental health problems and stress reduction exercises
Interventions
Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise and receive reminders at month 1, 2, 4, 6 \& 8.
Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise, receive 15 minutes motivational interviewing through telephone and reminders at month 1, 2, 4, 6, \& 8.
Receive online health communication messages about prevalence of some common mental health problems among MSM and introduction of stress reduction exercises
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Had ever received HPV vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Health Behaviours Research, the Chinese University of Hong Kong
Hong Kong, 666888, Hong Kong
Related Publications (1)
Wang Z, Lau JTF, Ip TKM, Yu Y, Fong F, Fang Y, Mo PKH. Two Web-Based and Theory-Based Interventions With and Without Brief Motivational Interviewing in the Promotion of Human Papillomavirus Vaccination Among Chinese Men Who Have Sex With Men: Randomized Controlled Trial. J Med Internet Res. 2021 Feb 2;23(2):e21465. doi: 10.2196/21465.
PMID: 33528372DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zixin Wang, PhD
Centre for Health Behaviours Research, JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
August 28, 2017
First Posted
September 19, 2017
Study Start
August 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
June 18, 2020
Record last verified: 2020-06