Vaccine AcceptanceNCT02196454
Video to Promote HPV Vaccination
A study testing Educational Video with Male or Female Narrator in people with Vaccine Acceptance and Social Acceptance, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
The purpose of this research study is to determine if video-based education will increase HPV vaccination rates among 11 - 17 year olds. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Acceptance, Social Acceptance, Acceptance Processes
- What is being tested?
- Educational Video with Male or Female Narrator
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to 31 May 2018
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent-child dyads in which the child is a male or female age 11 to 17 years who has not received the HPV vaccine
Who cannot join
- Parent-child dyads in which the child has received the HPV vaccine
- Parent-child dyads in which the child is older than 18 at the time of enrollment
- Non-English speakers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Primary Care, Flourtown, Children's Hospital of Philadelphia
Flourtown, Pennsylvania, 19031
Nicholas and Athena Karabots Pediatric Care Center
Philadelphia, Pennsylvania, 19139
About this study
Official title: Educating Pre/Teens and Their Parents on the Importance of HPV Vaccination
The purpose of this research study is to determine if video-based education will increase HPV vaccination rates among 11 - 17 year olds.
Read the detailed description
Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential to cause cancer. The vaccine is recommended because it prevents the HPV infections that most commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive the complete, three-vaccine series and have time to develop an immune response before being exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.
Results from this study will help us learn why participants do or do not get the HPV vaccination and whether video-based education can help improve vaccination rates
- Conditions
- Vaccine Acceptance, Social Acceptance, Acceptance Processes, Health Behavior, Human Papillomavirus
- Being tested
- Educational Video with Male or Female Narrator
- Keywords
- HPV vaccine, vaccination, immunization, video, health education, communication
- Medical subject headings
- Behavior, Health Behavior, Health Education, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video with Male or Female NarratorOther
Participants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Information Statement | No intervention | Study participants will receive the HPV Vaccine Information Statement (VIS) which is part of routine care. |
| Video & Vaccine Information Statement | Experimental | Participants will view an educational video about the HPV vaccine with a male or female narrator. Participants will also receive the HPV Vaccine Information Statement (VIS) which is part of routine care. Receives: Other: Educational Video with Male or Female Narrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccination Series Initiation
Number of HPV vaccine doses received among study participants
Measured: 90 days
HPV Vaccine Series Initiation
HPV Vaccine Receipt among study participants
Measured: 0 days
Secondary outcomes (2)
HPV Vaccine Series Initiation (depending on male versus female narrator)
Difference in rate of HPV vaccine receipt between study participants who viewed a video narrated by a male versus a female
Measured: 0 days
HPV Vaccine Series Initiation (depending on male versus female narrator)
Difference in number of HPV vaccine doses between study participants who viewed a video narrated by a male versus a female
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine AcceptanceStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Noble Medical, LLC
- Responsible party
- Sponsor
- Investigators
- Kristen A. Feemster, MD MPH MSHP, Principal investigator, Children's Hospital of Philadephia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196454
- Sponsor's protocol ID
- IRB 14-011091
- Status last verified
- May 2018
- First submitted
- 16 Jul 2014
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Pre/Teens and Their Parents on the Importance of HPV Vaccination
- ClinicalTrials.gov ID
- NCT02196454
- Acronym / sponsor ID
- IRB 14-011091
- Conditions
- Vaccine Acceptance, Social Acceptance, Acceptance Processes, Health Behavior, Human Papillomavirus
- Keywords
- HPV vaccine, vaccination, immunization, video, health education, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Noble Medical, LLC
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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 purpose of this research study is to determine if video-based education will increase HPV vaccination rates among 11 - 17 year olds.
Detailed description
Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential to cause cancer. The vaccine is recommended because it prevents the HPV infections that most commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive the complete, three-vaccine series and have time to develop an immune response before being exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.
Results from this study will help us learn why participants do or do not get the HPV vaccination and whether video-based education can help improve vaccination rates
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Information Statement | No intervention | –Study participants will receive the HPV Vaccine Information Statement (VIS) which is part of routine care. |
| Video & Vaccine Information Statement | Experimental | Other: Educational Video with Male or Female NarratorParticipants will view an educational video about the HPV vaccine with a male or female narrator. Participants will also receive the HPV Vaccine Information Statement (VIS) which is part of routine care. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parent-child dyads in which the child is a male or female age 11 to 17 years who has not received the HPV vaccine
Key exclusion criteria (3 listed)
- Parent-child dyads in which the child has received the HPV vaccine
- Parent-child dyads in which the child is older than 18 at the time of enrollment
- Non-English speakers
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 |
|---|---|---|
| Educational Video with Male or Female NarratorParticipants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female. | Other | Video & Vaccine Information Statement |
Primary outcome
HPV Vaccination Series Initiation
Time frame: 90 days
Number of HPV vaccine doses received among study participants
HPV Vaccine Series Initiation
Time frame: 0 days
HPV Vaccine Receipt among study participants
2 secondary outcomes
HPV Vaccine Series Initiation (depending on male versus female narrator)
Time frame: 0 days
HPV Vaccine Series Initiation (depending on male versus female narrator)
Time frame: 90 days
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 1 Jun 2018.
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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.
Kristen A. Feemster, MD MPH MSHP principal investigator
Children's Hospital of Philadephia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video with Male or Female Narrator in people with Vaccine Acceptance and Social Acceptance, run by Children's Hospital of Philadelphia at 2 sites 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 1 inclusion and 3 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
HPV Vaccination Series Initiation (time frame: 90 days). The study lists 2 primary outcomes in all. 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 1 Jun 2018.