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NCT Number: NCT04438291

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

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.

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Key information

Conditions

HPV Infection Behavior Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Health Attitude Health Behavior Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

14 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female;
  • Age 14-17 years;

Exclusion criteria

  • Have received the HPV vaccination before

Treatment and study plan

MDL-SHPVP

Other

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2020
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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