HPVNCT04505930
Pilot HPV Vaccination in Chinese American Community
A study testing Interventional HPV vaccination video modules and General Vaccination Education in people with HPV, run by Temple University at 1 site in United States.
Trial summary
This study provides a pioneer model in increasing knowledge of HPV vaccination among Chinese American families through culturally tailored interventions, and eventually increase the HPV vaccine uptake among Chinese American adolescents. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- HPV
- What is being tested?
- Interventional HPV vaccination video modules and General Vaccination Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2015to 31 Aug 2017
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified Chinese Parents or legal guardian with children aged 11-18 years old;
- The children have not received any does of HPV vaccination
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Asian Health, Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: Developing and Pilot Testing a Multilevel HPV Vaccination Intervention in Chinese American Community
This study provides a pioneer model in increasing knowledge of HPV vaccination among Chinese American families through culturally tailored interventions, and eventually increase the HPV vaccine uptake among Chinese American adolescents.
- Conditions
- HPV
- Being tested
- Interventional HPV vaccination video modules, General Vaccination Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional HPV vaccination video modulesBehavioural
The study team provide participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. The educational videos were aiming to reinforcement and improvement the awareness, knowledge, attitude, intention and actual uptake of HPV vaccination shots among Chinese parents.
General Vaccination EducationBehavioural
Education session conducted using only handouts of vaccinations including HPV
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group with active education | Experimental | The study team provides participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. Receives: Behavioral: Interventional HPV vaccination video modules |
| Control Group with handouts | Active comparator | The study team provides the participants in the control group with education, using only handouts of vaccinations including HPV, but not using interactive video watch and dynamic discussion Receives: Behavioral: General Vaccination Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline HPV vaccine uptake rate at 6-month follow up
the rate of getting HPV vaccination uptake 6 months post intervention
Measured: baseline, and 6-month follow up
Secondary outcomes (2)
change of HPV knowledge from baseline to 6-month follow up
Knowledge scores ranged from 0 to 7, computed by taking the total number of correct answers to the questions with a higher numeric value indicating better knowledge
Measured: baseline, and 6-month
change in adolescents engagement percentage
change in the percents of engaging adolescents in decision-making at post intervention
Measured: baseline, and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start27 Apr 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Grace X Ma, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505930
- Sponsor's protocol ID
- Pilot HPV Vaccination
- Other IDs
- U54CA153513
- Status last verified
- Apr 2023
- First submitted
- 23 Jul 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot Testing a Multilevel HPV Vaccination Intervention in Chinese American Community
- ClinicalTrials.gov ID
- NCT04505930
- Acronym / sponsor ID
- Pilot HPV Vaccination
- Conditions
- HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 10 Aug 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.
This study provides a pioneer model in increasing knowledge of HPV vaccination among Chinese American families through culturally tailored interventions, and eventually increase the HPV vaccine uptake among Chinese American adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group with active education | Experimental | Behavioral: Interventional HPV vaccination video modulesThe study team provides participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. |
| Control Group with handouts | Active comparator | Behavioral: General Vaccination EducationThe study team provides the participants in the control group with education, using only handouts of vaccinations including HPV, but not using interactive video watch and dynamic discussion |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-identified Chinese Parents or legal guardian with children aged 11-18 years old;
- The children have not received any does of HPV vaccination
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Interventional HPV vaccination video modulesThe study team provide participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. The educational videos were aiming to reinforcement and improvement the awareness, knowledge, attitude, intention and actual uptake of HPV vaccination shots among Chinese parents. | Behavioural | Intervention Group with active education |
| General Vaccination EducationEducation session conducted using only handouts of vaccinations including HPV | Behavioural | Control Group with handouts |
Primary outcome
changes from baseline HPV vaccine uptake rate at 6-month follow up
Time frame: baseline, and 6-month follow up
the rate of getting HPV vaccination uptake 6 months post intervention
2 secondary outcomes
change of HPV knowledge from baseline to 6-month follow up
Time frame: baseline, and 6-month
change in adolescents engagement percentage
Time frame: baseline, and 6-month
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 13 Apr 2023.
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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.
Grace X Ma, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional HPV vaccination video modules and General Vaccination Education in people with HPV, run by Temple University at 1 site in United States.
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 13 Apr 2023. 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 United States. 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?
changes from baseline HPV vaccine uptake rate at 6-month follow up (time frame: baseline, and 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2023.