Clinical trial NCT04438291: 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
Overall status: COMPLETED
Phase: NA
Conditions: HPV Infection
Health Behavior
Health Attitude
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 1340
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Female;
* Age 14-17 years;

Exclusion Criteria:

* Have received the HPV vaccination before

Primary outcomes:
measure: Female adolescents' uptake of the HPV vaccine
timeFrame: 1 year post-intervention
Secondary outcomes:
measure: Change of female adolescents' intention to receive HPV vaccination
timeFrame: baseline, 1 month post-intervention
measure: Change of vaccine acceptance among parents/guardians
timeFrame: baseline, 1 month post-intervention
measure: Change of female adolescents' and parents'/ guardians' HPV knowledge
timeFrame: baseline, 1 month post-intervention
measure: Change of female adolescents' HPV attitudes and beliefs
timeFrame: baseline, 1 month post-intervention
measure: Change of parents'/ guardians' HPV attitudes and beliefs
timeFrame: baseline, 1 month post-intervention
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Pak Chun Janita Chau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.