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.

BACKGROUND: Human papillomavirus (HPV) vaccination is effective in the prevention of vaccine-type genital warts and cancers among men who have sex with men (MSM).
OBJECTIVE: The primary objective of this randomized controlled trial (RCT) is to evaluate the efficacies of 2 web- and theory-based interventions with and without brief motivational interviewing (MI) over the phone to increase the completion of HPV vaccination among unvaccinated participants within a 24-month follow-up period compared with the control group.
METHODS: A 3-arm parallel-group RCT was conducted between July 2017 and December 2019. Five telephone surveys were conducted at baseline and at 3, 6, 9, and 24 months by blinded interviewers. Participants were Hong Kong Chinese-speaking MSM aged between 18 and 45 years with regular internet access who were recruited from outreaching at venues, web-based recruitment, and peer referral. Those who had ever received HPV vaccination were excluded. A total of 624 participants were randomized into either the online tutorial (OT) only group (n=208), the OT plus MI group (OT-MI; n=208), or the control group (n=208). In total, 459 (459/624, 73.6%) completed the follow-up evaluation at 24 months. Participants in the OT group received a fully automated OT developed based on the health belief model. On top of the same OT, the OT-MI group received brief MI over the phone. Reminders were sent to the participants of the OT and OT-MI groups after 1, 2, 4, 6, and 8 months. Participants in the control group received web-based health communication messages unrelated to HPV or HPV vaccination. The research team validated the self-reported HPV vaccination uptake. Intention-to-treat analysis was used for outcome analyses. Logistic regression models and multivariable linear regression models were used to test the between-group differences in primary and secondary outcomes. Baron and Kenny's methods were used to test the mediation hypothesis.
RESULTS: The participants in the OT-MI group reported a significantly higher validated completion of HPV vaccination at 24 months than the control group (36/208, 17.3% vs 15/208, 7.2%; P=.006). However, the difference in HPV vaccination completion between the OT and the control groups (24/208, 11.5% vs 15/208, 7.2%; P=.17), or between OT-MI and OT groups (P=.13), was not statistically significant. The association between randomization status (OT-MI group vs control group) and HPV vaccination completion became statistically nonsignificant after controlling for changes in the perceived susceptibility to HPV (24 months vs baseline), whereas perceived susceptibility remained strongly associated with HPV vaccination uptake in the model (P<.001). Changes in perceived susceptibility fully mediated the intervention effect.
CONCLUSIONS: Theory-based OT with brief MI over the phone was effective in increasing HPV vaccination completion among Chinese MSM. Perceived susceptibility is an active theoretical component that causes behavioral changes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03286907; https://clinicaltrials.gov/ct2/show/NCT03286907. ©Zixin Wang, Joseph T F Lau, Tsun Kwan Mary Ip, Yebo Yu, Francois Fong, Yuan Fang, Phoenix K H Mo. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.02.2021.

RCT Entities:   Population Interventions Outcomes