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

Health Behavior Clinical Trial

Official title:

Effects of a Multidisciplinary Team-led School-based Human Papillomavirus Vaccination Health-promotion Programme (MDL-SHPVP) on Improving Vaccine Acceptance and Uptake Among Female Adolescents: A Cluster Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438291
• Other study ID #: 14606919
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2021
• Source: Chinese University of Hong Kong
• Contact: Pak Chun Janita Chau, PhD
• Phone: +852 3949 6226
• Email: janitachau[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2520
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 17 Years

Eligibility

Inclusion Criteria:

• Female;

• Age 14-17 years;

Exclusion Criteria:

• Have received the HPV vaccination before

Related Conditions & MeSH terms

• Health Attitude
• Health Behavior
• HPV Infection
• Papillomavirus Infections

Intervention

Other:
• 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
• 30-minute educational video
A 30-minute education video (DVD) on HPV, cervical cancer and the HPV vaccine that is designed to enhance HPV vaccine acceptance

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female adolescents' uptake of the HPV vaccine	Self report uptake of the HPV vaccine by the female adolescents in the past 12 months.	1 year post-intervention
Secondary	Change of female adolescents' intention to receive HPV vaccination	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.	baseline, 1 month post-intervention
Secondary	Change of vaccine acceptance among parents/guardians	Precaution Adoption Process Model will be used to measure the vaccine acceptance.	baseline, 1 month post-intervention
Secondary	Change of female adolescents' and parents'/ guardians' HPV knowledge	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.	baseline, 1 month post-intervention
Secondary	Change of female adolescents' HPV attitudes and beliefs	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.	baseline, 1 month post-intervention
Secondary	Change of parents'/ guardians' HPV attitudes and beliefs	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.	baseline, 1 month post-intervention