HPV InfectionNCT04438291
HPV Vaccination Health-promotion Programme on Vaccine Acceptance and Uptake Among Female Adolescents
A study testing MDL-SHPVP and 30-minute educational video in people with HPV Infection and Health Behavior, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Health Behavior, Health Attitude
- What is being tested?
- MDL-SHPVP and 30-minute educational video
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,340 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2020to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female;
- Age 14-17 years;
Who cannot join
- Have received the HPV vaccination before
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- HPV Infection, Health Behavior, Health Attitude
- Being tested
- MDL-SHPVP, 30-minute educational video
- Medical subject headings
- Papillomavirus Infections, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MDL-SHPVP |
| Control schools | Other | Control and usual care Receives: Other: 30-minute educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female adolescents' uptake of the HPV vaccine
Self report uptake of the HPV vaccine by the female adolescents in the past 12 months.
Measured: 1 year post-intervention
Secondary outcomes (5)
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.
Measured: baseline, 1 month post-intervention
Change of vaccine acceptance among parents/guardians
Precaution Adoption Process Model will be used to measure the vaccine acceptance.
Measured: baseline, 1 month post-intervention
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.
Measured: baseline, 1 month post-intervention
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.
Measured: baseline, 1 month post-intervention
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.
Measured: baseline, 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Dec 2020
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chau Pak Chun Janita, Chinese University of Hong Kong
- Investigators
- Pak Chun Janita Chau, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438291
- Sponsor's protocol ID
- 14606919
- Status last verified
- Sep 2024
- First submitted
- 12 Jun 2020
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41068722Chau 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.
PubMed 32925744
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04438291
- Acronym / sponsor ID
- 14606919
- Conditions
- HPV Infection, Health Behavior, Health Attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention schools | Experimental | Other: MDL-SHPVPA 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 schools | Other | Other: 30-minute educational videoControl and usual care |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Female;
- Age 14-17 years;
Key exclusion criteria (1 listed)
- Have received the HPV vaccination before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDL-SHPVPA 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 | Intervention schools |
| 30-minute educational videoA 30-minute education video (DVD) on HPV, cervical cancer and the HPV vaccine that is designed to enhance HPV vaccine acceptance | Other | Control schools |
Primary outcome
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.
5 secondary outcomes
Change of female adolescents' intention to receive HPV vaccination
Time frame: baseline, 1 month post-intervention
Change of vaccine acceptance among parents/guardians
Time frame: baseline, 1 month post-intervention
Change of female adolescents' and parents'/ guardians' HPV knowledge
Time frame: baseline, 1 month post-intervention
Change of female adolescents' HPV attitudes and beliefs
Time frame: baseline, 1 month post-intervention
Change of parents'/ guardians' HPV attitudes and beliefs
Time frame: baseline, 1 month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Derived from this study: PubMed 41068722Lo 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.
- Derived from this study: PubMed 32925744Chau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pak Chun Janita Chau, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDL-SHPVP and 30-minute educational video in people with HPV Infection and Health Behavior, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female adolescents' uptake of the HPV vaccine (time frame: 1 year post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.