NCT03286907

An RCT Promoting HPV Vaccination Among Chinese MSM

Completed NA Last updated 18 June 2020

What this trial tests

NA trial testing Online videos in Health Behavior in 624 participants. Completed in 31 December 2019.

Timeline

1 August 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	624
Start date	1 August 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Hong Kong

Drugs / interventions tested

• Online videos
• Online videos and MI
• Control group — full drug profile →

Conditions studied

• Health Behavior — all drugs for Health Behavior →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, male only, with Health Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Wang Z, Lau JTF, Ip TKM, Yu Y, et al · · 2021 · cited 20× · PMID 33528372 · DOI 10.2196/21465
2. Behavioral intention to perform risk compensation behaviors after receiving HPV vaccination among men who have sex with men in China.
   Wu T, Qu S, Fang Y, Ip M, et al · · 2019 · cited 6× · PMID 31157598 · DOI 10.1080/21645515.2019.1622975