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

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

MDL-SHPVP

30-minute educational video

About this trial

This is an interventional other trial for HPV Infection

Eligibility Criteria

14 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Female;
Age 14-17 years;

Exclusion Criteria:

Have received the HPV vaccination before

Sites / Locations

The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention schools

Control schools

Arm Description

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

Control and usual care

Outcomes

Primary Outcome Measures

Female adolescents' uptake of the HPV vaccine

Self report uptake of the HPV vaccine by the female adolescents in the past 12 months.

Secondary Outcome Measures

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.

Change of vaccine acceptance among parents/guardians

Precaution Adoption Process Model will be used to measure the vaccine acceptance.

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.

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.

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.

Full Information

NCT ID

NCT04438291

First Posted

June 12, 2020

Last Updated

July 29, 2021

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT04438291

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV Infection, Health Behavior, Health Attitude

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

2520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention schools

Arm Type

Experimental

Arm Description

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

Arm Title

Control schools

Arm Type

Other

Arm Description

Control and usual care

Intervention Type

Other

Intervention Name(s)

MDL-SHPVP

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

30-minute educational video

Intervention Description

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

Primary Outcome Measure Information:

Title

Female adolescents' uptake of the HPV vaccine

Description

Self report uptake of the HPV vaccine by the female adolescents in the past 12 months.

Time Frame

1 year post-intervention

Secondary Outcome Measure Information:

Title

Change of female adolescents' intention to receive HPV vaccination

Description

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.

Time Frame