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An RCT Promoting HPV Vaccination Among Chinese MSM

NCT03286907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2020-06-18

No results posted yet for this study

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.

Conditions

  • Health Behavior

Interventions

BEHAVIORAL

Online videos

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.

BEHAVIORAL

Online videos and MI

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.

BEHAVIORAL

Control group

Receive online health communication messages about prevalence of some common mental health problems among MSM and introduction of stress reduction exercises

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Zixin Wang, PhD · Centre for Health Behaviours Research, JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03286907 on ClinicalTrials.gov