Human Papilloma VirusNCT05756192
Educational Video's Impact on Knowledge Regarding Cervical Cancer Screening
A study testing Educational video in people with Human Papilloma Virus and Cervical Dysplasia, run by George Washington University at 1 site in United States.
Trial summary
The researchers will be conducting a prospective randomized trial where the researchers will be introducing an educational video to see whether there is an increase in knowledge scores surrounding cervical cancer, cervical cancer screening, and prevention with HPV vaccinations. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Cervical Dysplasia
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Feb 2023
- 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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patient
- Hispanic patients
- Between age 21-65 y/o
- Receiving pap smear during clinic appointment
Who cannot join
- Non-female patients
- Non-Hispanic patients
- Age less than 21
- Age greater than 65
- not receiving pap smear
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephanie Wang
Washington D.C., District of Columbia, 20052
About this study
Official title: An Educational Video's Impact on Knowledge About HPV Vaccination and Cervical Cancer Screening Among Hispanic Patients: a Randomized Control Trial
The researchers will be conducting a prospective randomized trial where the researchers will be introducing an educational video to see whether there is an increase in knowledge scores surrounding cervical cancer, cervical cancer screening, and prevention with HPV vaccinations.
Read the detailed description
The researchers are conducting a single-blinded randomized controlled trial. All patients who meet exclusion criteria will be recruited at the time of their visit where a Pap smear will be collected at an ob/gyn clinic. If patients agree to participate in the study, they will be randomized into one of two arms. A control arm or an interventional arm. The control arm just includes physician counseling regarding cervical cancer screening/prevention, while the interventional arm includes patient's watching a video on cervical cancer screening/prevention as well as physician counseling. Patient will be administered a survey before and after to assess knowledge and satisfaction scores.
- Conditions
- Human Papilloma Virus, Cervical Dysplasia
- Being tested
- Educational video
- Keywords
- cervical cancer screening, pap smear, HPV vaccination
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Intervention is a 10-minute animated video that explains cervical cancer screening and prevention.
| Study group | Role | What they receive |
|---|---|---|
| Video and physician counseling arm | Experimental | This groups will complete a pre survey and will then watch the 10-minute educational video on cervical cancer screening and prevention prior to seeing their provider. Patients will then see the provider and will complete a post survey following appointment. Receives: Other: Educational video |
| Physician counseling arm | No intervention | This group will complete a pre survey and will then see their provider. Following provider visit patients will complete a post survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre Knowledge score
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.
Measured: Will be measured immediately before the appointment.
Post knowledge score
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.
Measured: Will be measured immediately after the appointment.
Secondary outcomes (1)
Post Satisfaction scores
Satisfaction scores regarding intervention and appointment. Satisfaction questions will be scored on Likert scale from 1-5 with 5 being most satisfied and 1being the least sat
Measured: Will be measured immediatley after the provider visit and/or administration or video based educational tool (if randomized to the intervention line).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Nov 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma VirusStudies 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
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Wang, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756192
- Sponsor's protocol ID
- NCR224166
- Status last verified
- Jul 2023
- First submitted
- 30 Jan 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olusola P, Banerjee HN, Philley JV, Dasgupta S. Human Papilloma Virus-Associated Cervical Cancer and Health Disparities. Cells. 2019 Jun 21;8(6):622. doi: 10.3390/cells8060622.
PubMed 31234354Gibb RK, Martens MG. The impact of liquid-based cytology in decreasing the incidence of cervical cancer. Rev Obstet Gynecol. 2011;4(Suppl 1):S2-S11.
PubMed 21617785Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.
PubMed 25693011Henk HJ, Insinga RP, Singhal PK, Darkow T. Incidence and costs of cervical intraepithelial neoplasia in a US commercially insured population. J Low Genit Tract Dis. 2010 Jan;14(1):29-36. doi: 10.1097/LGT.0b013e3181ac05e9.
PubMed 20040833Lichter K, Krause D, Xu J, Tsai SHL, Hage C, Weston E, Eke A, Levinson K. Adjuvant Human Papillomavirus Vaccine to Reduce Recurrent Cervical Dysplasia in Unvaccinated Women: A Systematic Review and Meta-analysis. Obstet Gynecol. 2020 May;135(5):1070-1083. doi: 10.1097/AOG.0000000000003833.
PubMed 32282601Akinlotan M, Bolin JN, Helduser J, Ojinnaka C, Lichorad A, McClellan D. Cervical Cancer Screening Barriers and Risk Factor Knowledge Among Uninsured Women. J Community Health. 2017 Aug;42(4):770-778. doi: 10.1007/s10900-017-0316-9.
PubMed 28155005Rahman S, Kripalani S, Keegan E, Sparks A, Amdur R, Moawad G, Sheth S, Klebanoff J. An educational video's impact on the induction of labor experience: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100495. doi: 10.1016/j.ajogmf.2021.100495. Epub 2021 Sep 24.
PubMed 34571210Pallett AC, Nguyen BT, Klein NM, Phippen N, Miller CR, Barnett JC. A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy. Am J Obstet Gynecol. 2018 Sep;219(3):277.e1-277.e7. doi: 10.1016/j.ajog.2018.06.016. Epub 2018 Jun 28.
PubMed 29959929Wang SM, Rahman S, Salinas M, Castro J, Aldous A, Huerta E, Chappell NP. Impact of educational video on cervical cancer knowledge in hispanic patients: A randomized trial. Patient Educ Couns. 2025 Sep;138:109202. doi: 10.1016/j.pec.2025.109202. Epub 2025 Jun 6.
PubMed 40483901
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Video's Impact on Knowledge About HPV Vaccination and Cervical Cancer Screening Among Hispanic Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05756192
- Acronym / sponsor ID
- NCR224166
- Conditions
- Human Papilloma Virus, Cervical Dysplasia
- Keywords
- cervical cancer screening, pap smear, HPV vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 6 Mar 2023 (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 researchers will be conducting a prospective randomized trial where the researchers will be introducing an educational video to see whether there is an increase in knowledge scores surrounding cervical cancer, cervical cancer screening, and prevention with HPV vaccinations.
Detailed description
The researchers are conducting a single-blinded randomized controlled trial. All patients who meet exclusion criteria will be recruited at the time of their visit where a Pap smear will be collected at an ob/gyn clinic. If patients agree to participate in the study, they will be randomized into one of two arms. A control arm or an interventional arm. The control arm just includes physician counseling regarding cervical cancer screening/prevention, while the interventional arm includes patient's watching a video on cervical cancer screening/prevention as well as physician counseling. Patient will be administered a survey before and after to assess knowledge and satisfaction scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video and physician counseling arm | Experimental | Other: Educational videoThis groups will complete a pre survey and will then watch the 10-minute educational video on cervical cancer screening and prevention prior to seeing their provider. Patients will then see the provider and will complete a post survey following appointment. |
| Physician counseling arm | No intervention | –This group will complete a pre survey and will then see their provider. Following provider visit patients will complete a post survey. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patient
- Hispanic patients
- Between age 21-65 y/o
- Receiving pap smear during clinic appointment
Key exclusion criteria (5 listed)
- Non-female patients
- Non-Hispanic patients
- Age less than 21
- Age greater than 65
- not receiving pap smear
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 videoIntervention is a 10-minute animated video that explains cervical cancer screening and prevention. | Other | Video and physician counseling arm |
Primary outcome
Pre Knowledge score
Time frame: Will be measured immediately before the appointment.
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.
Post knowledge score
Time frame: Will be measured immediately after the appointment.
Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.
1 secondary outcome
Post Satisfaction scores
Time frame: Will be measured immediatley after the provider visit and/or administration or video based educational tool (if randomized to the intervention line).
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 Jul 2023.
- Background: PubMed 31234354Olusola P, Banerjee HN, Philley JV, Dasgupta S. Human Papilloma Virus-Associated Cervical Cancer and Health Disparities. Cells. 2019 Jun 21;8(6):622. doi: 10.3390/cells8060622.
- Background: PubMed 21617785Gibb RK, Martens MG. The impact of liquid-based cytology in decreasing the incidence of cervical cancer. Rev Obstet Gynecol. 2011;4(Suppl 1):S2-S11.
- Background: PubMed 25693011Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.
- Background: PubMed 20040833Henk HJ, Insinga RP, Singhal PK, Darkow T. Incidence and costs of cervical intraepithelial neoplasia in a US commercially insured population. J Low Genit Tract Dis. 2010 Jan;14(1):29-36. doi: 10.1097/LGT.0b013e3181ac05e9.
- Background: PubMed 32282601Lichter K, Krause D, Xu J, Tsai SHL, Hage C, Weston E, Eke A, Levinson K. Adjuvant Human Papillomavirus Vaccine to Reduce Recurrent Cervical Dysplasia in Unvaccinated Women: A Systematic Review and Meta-analysis. Obstet Gynecol. 2020 May;135(5):1070-1083. doi: 10.1097/AOG.0000000000003833.
- Background: PubMed 28155005Akinlotan M, Bolin JN, Helduser J, Ojinnaka C, Lichorad A, McClellan D. Cervical Cancer Screening Barriers and Risk Factor Knowledge Among Uninsured Women. J Community Health. 2017 Aug;42(4):770-778. doi: 10.1007/s10900-017-0316-9.
- Background: PubMed 34571210Rahman S, Kripalani S, Keegan E, Sparks A, Amdur R, Moawad G, Sheth S, Klebanoff J. An educational video's impact on the induction of labor experience: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100495. doi: 10.1016/j.ajogmf.2021.100495. Epub 2021 Sep 24.
- Background: PubMed 29959929Pallett AC, Nguyen BT, Klein NM, Phippen N, Miller CR, Barnett JC. A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy. Am J Obstet Gynecol. 2018 Sep;219(3):277.e1-277.e7. doi: 10.1016/j.ajog.2018.06.016. Epub 2018 Jun 28.
- Derived from this study: PubMed 40483901Wang SM, Rahman S, Salinas M, Castro J, Aldous A, Huerta E, Chappell NP. Impact of educational video on cervical cancer knowledge in hispanic patients: A randomized trial. Patient Educ Couns. 2025 Sep;138:109202. doi: 10.1016/j.pec.2025.109202. Epub 2025 Jun 6.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
Recruiting
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
HPV Vaccination
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia
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 in people with Human Papilloma Virus and Cervical Dysplasia, run by George Washington 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 4 inclusion and 5 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 Jul 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?
Pre Knowledge score (time frame: Will be measured immediately before the appointment.). 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?
On the ClinicalTrials.gov record for NCT05756192, which also lists 9 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 11 Jul 2023.