NCT05756192

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

January 30, 2023

Last Update Submit

July 10, 2023

Conditions

Human Papilloma VirusCervical Dysplasia

Keywords

cervical cancer screeningpap smearHPV vaccination

Outcome Measures

Primary Outcomes (2)

  • Pre Knowledge score

    Knowledge scores regarding cervical cancer screening and prevention. This will be scored as percentage correct out of 13 questions.

    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.

    Will be measured immediately after the appointment.

Secondary Outcomes (1)

  • Post Satisfaction scores

    Will be measured immediatley after the provider visit and/or administration or video based educational tool (if randomized to the intervention line).

Study Arms (2)

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.

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.

Interventions

Educational videoOTHER

Intervention is a 10-minute animated video that explains cervical cancer screening and prevention.

Video and physician counseling arm

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patient
  • Hispanic patients
  • Between age 21-65 y/o
  • Receiving pap smear during clinic appointment

You may not qualify if:

  • Non-female patients
  • Non-Hispanic patients
  • Age less than 21
  • Age greater than 65
  • not receiving pap smear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephanie Wang

Washington D.C., District of Columbia, 20052, United States

Location

Related Publications (9)

  • 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.

    PMID: 31234354BACKGROUND

  • Gibb 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.

    PMID: 21617785BACKGROUND

  • Joura 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.

    PMID: 25693011BACKGROUND

  • Henk 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.

    PMID: 20040833BACKGROUND

  • Lichter 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.

    PMID: 32282601BACKGROUND

  • Akinlotan 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.

    PMID: 28155005BACKGROUND

  • Rahman 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.

    PMID: 34571210BACKGROUND

  • Pallett 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.

    PMID: 29959929BACKGROUND

  • Wang 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.

    PMID: 40483901DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Care providers will be masked as we do not want bias to impact provider counseling at time of visit.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 6, 2023

Study Start

November 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)