HPV Vaccination Health-promotion Programme on Vaccine Acceptance and Uptake Among Female Adolescents

Not Applicable

• Conditions: Health Behavior; HPV Infection; Health Attitude
• Interventions: Other: 30-minute educational video; Other: MDL-SHPVP

• Registration Number: NCT04438291
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The MDL-SHPVP will be developed and a clustered randomised controlled trial will be conducted to evaluate the effects of the MDL-SHPVP and to examine whether the effect of the MDL-SHPVP on the rate of HPV vaccine uptake 1 year after intervention is mediated by parents'/guardians' and female adolescents' HPV knowledge, attitudes and beliefs, adolescents' intention to receive HPV vaccination and vaccine acceptance among their parents/guardians.

Detailed Description

2520 adolescents and their parents or guardians from 18 local secondary day schools will be recruited. Multicomponent interventions will be offered to the intervention schools. To build and strengthen the community capacity in health promotion, a team of volunteers will be established to raise awareness of HPV, cervical cancer and HPV vaccine.

Data will be collected at baseline, 1 month and 1 year after intervention. The mixed-effects model will be used to compare the differential changes for each of the primary and secondary outcomes across time between the two groups.

The project is expected to instil a more accurate understanding of HPV and HPV vaccination and support the decision to undergo vaccination.

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Study Start: 2020-12-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-07-30
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2520

Inclusion Criteria

• Female;
• Age 14-17 years;

Exclusion Criteria

• Have received the HPV vaccination before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control schools	30-minute educational video	Control and usual care
Intervention schools	MDL-SHPVP	A 2-hour education session with multicomponent interventions including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers and educational computer games

Primary Outcome Measures

Name	Time	Method
Female adolescents' uptake of the HPV vaccine	1 year post-intervention	Self report uptake of the HPV vaccine by the female adolescents in the past 12 months.

Secondary Outcome Measures

Name	Time	Method
Change of female adolescents' and parents'/ guardians' HPV knowledge	baseline, 1 month post-intervention	HPV General and HPV Vaccine Knowledge Scale will be used to measure the knowledge.1 point will be given to each correct answer and 0 points will be given to each incorrect or "Don't know" answer. Higher scores mean more HPV knowledge.
Change of vaccine acceptance among parents/guardians	baseline, 1 month post-intervention	Precaution Adoption Process Model will be used to measure the vaccine acceptance.
Change of female adolescents' HPV attitudes and beliefs	baseline, 1 month post-intervention	Carolina HPV Immunisation Attitudes and Beliefs Scale will be used to measure the attitudes and belief.; An 11-point Likert scale will be used, with 0, 5, 7 and 10 indicate "strongly disagree," "somewhat disagree," "somewhat agree" and "strongly agree" respectively, or indicate "extremely ineffective, "somewhat ineffective," "somewhat effective" and "extremely effective" respectively. Higher values mean stronger agreement with the statement and less agreement with or endorsement of HPV vaccination. Five items will be reverse-coded.
Change of female adolescents' intention to receive HPV vaccination	baseline, 1 month post-intervention	A 10-point Likert scale will be used to measure the intention indicates "Definitely". 1 indicates "Definitely not" and 10 indicates "Definitely". Higher value means higher intention.
Change of parents'/ guardians' HPV attitudes and beliefs	baseline, 1 month post-intervention	Carolina HPV Immunisation Attitudes and Beliefs Scale will be used to measure the attitudes and belief.; A 4-point Likert scale will be used. 1,2,3 and 4 indicate "strongly disagree," "somewhat disagree," somewhat agree," and "strongly agree" respectively. Higher values indicate stronger agreement with the statement.

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong