HPV-Related Cervical CarcinomaNCT03337269
Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake
A study testing Educational video and Educational handout in people with HPV-Related Cervical Carcinoma, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Read more about this study
- Who is it for?
- Ages 12 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV-Related Cervical Carcinoma
- What is being tested?
- Educational video and Educational handout
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 15 Feb 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 12 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females ages greater than or equal to 12 years and less than or equal to 26 years
- Presenting to a gynecology clinic for a routine or problem visit
- Ability to read and write
Who cannot join
- Women ages less than or greater than 12 years or greater than 26 years
- Women with known cervical cancer
- Known pregnancy
- Prior initiation or completion of the HPV vaccine series
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be reviewed to assess for initiation of the HPV vaccine.
- Conditions
- HPV-Related Cervical Carcinoma
- Being tested
- Educational video, Educational handout, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Approximately 7 minute video on the HPV vaccine
Educational handoutOther
One page handout on the HPV vaccine
ControlOther
Control
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Subject does not receive an educational intervention Receives: Other: Control |
| Educational video | Other | Subject watches an educational video Receives: Other: Educational video |
| Educational handout | Other | Subject reads an educational handout Receives: Other: Educational handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccine acceptability
Subject reported willingness to accept the HPV vaccination, as assessed through agreement or disagreement to the statement "I would be willing to accept the HPV vaccine today."
Measured: Up to 6 months
Secondary outcomes (1)
HPV vaccine knowledge
Subject knowledge of the HPV vaccine and its associated risks and benefits, as assessed through a survey. Subjects are asked to answer 7 questions and total knowledge score is calculated by an unweighted sum of correct answers.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Mar 2017
- Primary completion15 Aug 2017
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV-Related Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337269
- Sponsor's protocol ID
- 826486
- Status last verified
- Apr 2018
- First submitted
- 13 Sep 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cory L, Cha B, Ellenberg S, Bogner HR, Hwang WT, Smith JS, Haggerty A, Morgan M, Burger R, Chu C, Ko EM. Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):376-384. doi: 10.1097/AOG.0000000000003379.
PubMed 31306313
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake
- ClinicalTrials.gov ID
- NCT03337269
- Acronym / sponsor ID
- 826486
- Conditions
- HPV-Related Cervical Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 8 Nov 2017 (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 aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be reviewed to assess for initiation of the HPV vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlSubject does not receive an educational intervention |
| Educational video | Other | Other: Educational videoSubject watches an educational video |
| Educational handout | Other | Other: Educational handoutSubject reads an educational handout |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Females ages greater than or equal to 12 years and less than or equal to 26 years
- Presenting to a gynecology clinic for a routine or problem visit
- Ability to read and write
Key exclusion criteria (4 listed)
- Women ages less than or greater than 12 years or greater than 26 years
- Women with known cervical cancer
- Known pregnancy
- Prior initiation or completion of the HPV vaccine series
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 videoApproximately 7 minute video on the HPV vaccine | Other | Educational video |
| Educational handoutOne page handout on the HPV vaccine | Other | Educational handout |
| ControlControl | Other | Control |
Primary outcome
HPV vaccine acceptability
Time frame: Up to 6 months
Subject reported willingness to accept the HPV vaccination, as assessed through agreement or disagreement to the statement "I would be willing to accept the HPV vaccine today."
1 secondary outcome
HPV vaccine knowledge
Time frame: Up to 6 months
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 11 Apr 2018.
- Derived from this study: PubMed 31306313Cory L, Cha B, Ellenberg S, Bogner HR, Hwang WT, Smith JS, Haggerty A, Morgan M, Burger R, Chu C, Ko EM. Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):376-384. doi: 10.1097/AOG.0000000000003379.
- Individual participant dataSharing planned: No
Related trials for HPV-Related Cervical Carcinoma
Active, not recruitingPhase 2
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
Oropharyngeal Cancer
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
Active, not recruitingPhase 4
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
Human Papillomavirus-Related Cervical Carcinoma
Active, not recruitingPhase 1/2
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video and Educational handout in people with HPV-Related Cervical Carcinoma, run by University of Pennsylvania 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 3 inclusion and 4 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 11 Apr 2018. 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?
HPV vaccine acceptability (time frame: Up to 6 months). 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 NCT03337269, which also lists 1 linked publication.
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 11 Apr 2018.