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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HPV Infection, Health Behavior, Health Attitude

Intervention / Treatment
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* Other: MDL-SHPVP
* Other: 30-minute educational video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female; Age 14-17 years; Exclusion Criteria: Have received the HPV vaccination before

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention schools<br>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 | Other: MDL-SHPVP<br>* 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<br>|
| Other: Control schools<br>Control and usual care | Other: 30-minute educational video<br>* A 30-minute education video (DVD) on HPV, cervical cancer and the HPV vaccine that is designed to enhance HPV vaccine acceptance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change of vaccine acceptance among parents/guardians | Precaution Adoption Process Model will be used to measure the vaccine acceptance. | baseline, 1 month post-intervention | 
| 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 | 
| 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 | 
| 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 |