NCT04438291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

3.5 years

First QC Date

June 12, 2020

Last Update Submit

September 2, 2024

Conditions

HPV InfectionHealth BehaviorHealth Attitude

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change of female adolescents' intention to receive HPV vaccination

    baseline, 1 month post-intervention

  • Change of vaccine acceptance among parents/guardians

    baseline, 1 month post-intervention

  • Change of female adolescents' and parents'/ guardians' HPV knowledge

    baseline, 1 month post-intervention

  • Change of female adolescents' HPV attitudes and beliefs

    baseline, 1 month post-intervention

  • Change of parents'/ guardians' HPV attitudes and beliefs

    baseline, 1 month post-intervention

Study Arms (2)

Intervention schools

EXPERIMENTAL

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

Control schools

OTHER

Control and usual care

Other: 30-minute educational video

Interventions

MDL-SHPVPOTHER

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 schools
30-minute educational videoOTHER

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

Control schools

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe HPV vaccination mainly targets at female in Hong Kong, with the inclusion in Hong Kong Child Immunisation Programme to eligible female students at Primary 5 and 6 from 2019/2020 school year.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Female;
  • Age 14-17 years;

You may not qualify if:

  • Have received the HPV vaccination before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

Related Publications (2)

  • Lo SHS, Chau JPC, Choi KC, Butt L, Lui GCY, Lee VWY, Lau AYL. Effects of an educational health promotion intervention to improve human papillomavirus vaccination acceptance and uptake among adolescent girls: a cluster randomized controlled trial. BMC Public Health. 2025 Oct 9;25(1):3419. doi: 10.1186/s12889-025-24511-4.

    PMID: 41068722DERIVED

  • Chau JPC, Lo SHS, Choi KC, Lee VWY, Lui GCY, Chan KM, Lau AYL. Effects of a multidisciplinary team-led school-based human papillomavirus vaccination health-promotion programme on improving vaccine acceptance and uptake among female adolescents: A cluster randomized controlled trial. Medicine (Baltimore). 2020 Sep 11;99(37):e22072. doi: 10.1097/MD.0000000000022072.

    PMID: 32925744DERIVED

MeSH Terms

Conditions

Papillomavirus InfectionsHealth Behavior

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Pak Chun Janita Chau, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 18, 2020

Study Start

December 1, 2020

Primary Completion

May 28, 2024

Study Completion

May 28, 2024

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)