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

September 2, 2024 updated by: Chau Pak Chun Janita, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female;
  • Age 14-17 years;

Exclusion Criteria:

  • Have received the HPV vaccination before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention schools
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
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: Control schools
Control and usual care
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female adolescents' uptake of the HPV vaccine
Time Frame: 1 year post-intervention
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
Time Frame: 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.
baseline, 1 month post-intervention
Change of vaccine acceptance among parents/guardians
Time Frame: baseline, 1 month post-intervention
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
Time Frame: 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.
baseline, 1 month post-intervention
Change of female adolescents' HPV attitudes and beliefs
Time Frame: 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.
baseline, 1 month post-intervention
Change of parents'/ guardians' HPV attitudes and beliefs
Time Frame: 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.
baseline, 1 month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Pak Chun Janita Chau, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

May 28, 2024

Study Completion (Actual)

May 28, 2024

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14606919

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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