Human Papillomavirus-Related CarcinomaNCT04880837
Human Papillomavirus Education Programs
A study testing Educational Intervention, Informational Intervention and Survey Administration in people with Human Papillomavirus-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial aims to implement a culturally-tailored educational outreach actives with the goal of increasing knowledge of human papillomavirus (HPV) types that can lead to cancer and uptake of the available vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus-Related Carcinoma
- What is being tested?
- Educational Intervention, Informational Intervention and Survey Administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 31 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- From Ohio
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
This clinical trial aims to implement a culturally-tailored educational outreach actives with the goal of increasing knowledge of human papillomavirus (HPV) types that can lead to cancer and uptake of the available vaccine. The initiative also addresses barriers to vaccination and refer people to sites where they can get the HPV vaccine (e.g., private doctor offices, community health clinics, school-based health centers, and health departments). The HPV education program may help increase HPV vaccination rates and ultimately prevent HPV-related cancers.
Read the detailed description
PRIMARY OBJECTIVE:
- To implement culturally tailored educational outreach activities with the goal of increasing knowledge of HPV types that can lead to cancer and uptake of the available vaccine.
OUTLINE:
Participants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. Participants participate in surveys over telephone or face-to-face at 3 and 6 months.
- Conditions
- Human Papillomavirus-Related Carcinoma
- Being tested
- Educational Intervention, Informational Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend educational session
Informational InterventionOther
Receive handouts
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Prevention (educational session, handout, survey) | Experimental | Participants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. In addition, participants complete surveys over telephone or face-to-face at 3 and 6 months. Receives: Other: Educational Intervention; Other: Informational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in human papillomavirus (HPV) knowledge
Change in knowledge and strength of intention to be vaccinated will be correlated with key outcomes, specifically actual vaccination and actions promoting vaccination (e.g., encouraging HPV vaccination with family/friends, talking to their doctor/provider about the HPV vaccine). Multivariable logistic regression analyses will be conducted to examine the impact of knowledge change and strength of intentions on these binary outcomes (vaccinated/not vaccinated and encouraged/did not encourage HPV vaccination) controlling for important covariates such as age, sex, race/ethnicity, education, primary language, and health insurance/health care coverage.
Measured: Baseline 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 posted11 May 2021
- Study start27 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra D Paskett, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880837
- Sponsor's protocol ID
- OSU-20370
- Other IDs
- NCI-2021-00730
- Status last verified
- Oct 2023
- First submitted
- 6 May 2021
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus Education Programs
- ClinicalTrials.gov ID
- NCT04880837
- Acronym / sponsor ID
- OSU-20370
- Conditions
- Human Papillomavirus-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 May 2021 (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 clinical trial aims to implement a culturally-tailored educational outreach actives with the goal of increasing knowledge of human papillomavirus (HPV) types that can lead to cancer and uptake of the available vaccine. The initiative also addresses barriers to vaccination and refer people to sites where they can get the HPV vaccine (e.g., private doctor offices, community health clinics, school-based health centers, and health departments). The HPV education program may help increase HPV vaccination rates and ultimately prevent HPV-related cancers.
Detailed description
PRIMARY OBJECTIVE:
- To implement culturally tailored educational outreach activities with the goal of increasing knowledge of HPV types that can lead to cancer and uptake of the available vaccine.
OUTLINE:
Participants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. Participants participate in surveys over telephone or face-to-face at 3 and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (educational session, handout, survey) | Experimental | Other: Educational Intervention, Other: Informational Intervention, Other: Survey AdministrationParticipants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. In addition, participants complete surveys over telephone or face-to-face at 3 and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and older
- From Ohio
Key exclusion criteria (0 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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend educational session | Other | Prevention (educational session, handout, survey) |
| Informational InterventionReceive handouts | Other | Prevention (educational session, handout, survey) |
| Survey AdministrationComplete surveys | Other | Prevention (educational session, handout, survey) |
Primary outcome
Change in human papillomavirus (HPV) knowledge
Time frame: Baseline up to 6 months
Change in knowledge and strength of intention to be vaccinated will be correlated with key outcomes, specifically actual vaccination and actions promoting vaccination (e.g., encouraging HPV vaccination with family/friends, talking to their doctor/provider about the HPV vaccine). Multivariable logistic regression analyses will be conducted to examine the impact of knowledge change and strength of intentions on these binary outcomes (vaccinated/not vaccinated and encouraged/did not encourage HPV vaccination) controlling for important covariates such as age, sex, race/ethnicity, education, primary language, and health insurance/health care coverage.
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 2 Nov 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Human Papillomavirus-Related Carcinoma
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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.
Electra D Paskett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
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 Intervention, Informational Intervention and Survey Administration in people with Human Papillomavirus-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 0 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 2 Nov 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?
Change in human papillomavirus (HPV) knowledge (time frame: Baseline up to 6 months). 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 2 Nov 2023.