Human Papilloma VirusNCT04611022
Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine
A study testing HPV Educational Intervention in people with Human Papilloma Virus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The educational intervention to be delivered by the PN(Patient Navigator) consists of "toolkit education materials" developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that our research team has developed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- HPV Educational Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Be a Denver Health patient* 18-26 years old, who has not started or completed the HPV vaccine series (Vaccine completion for this age group is 3 doses).
- Be a parent of a Denver Health adolescent patient* aged 9-17 years old, who has not started or completed the HPV vaccine series. (Vaccine completion is 2 doses for 9-14-year-old, and 3 doses for 14-17-year old)
- English and/or Spanish Speaking
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Denver Health patients will be identified from one of the following clinics; Denver Health Clinics Eastside Adult Clinic, Eastside Women's Care Clinic, Westside Adult Clinic, Westside Women's Care Clinic, Pavilion C: Women's Care Clinic, La Casa-Quigg Newton Family Health Center, Lowry Family Health Center, Montbello Family Health Center, Westwood Family Health Center, Parkhill Family Health Center, Webb Center For Primary Care, Pena Southwest Clinic
Who cannot join
- Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish [at the discretion of the CHE or PN upon recruitment]
- Decisionally-challenged adults with cognitive or personality impairment or due to intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study [at the discretion of the CHE or PN upon recruitment]
- Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment [at the discretion of the CHE or PN upon recruitment]
- Individuals under the age of 18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Denver, Colorado, 80237
Sindy Gonzalez, 303-724-5445, Sindy.Gonzalez@CUAnschutz.edu
Evelinn Borrayo
About this study
Official title: Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series
The educational intervention to be delivered by the PN(Patient Navigator) consists of "toolkit education materials" developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that our research team has developed. The NCI-produced toolkit education materials consist of Power Point presentations, flyers, and posters that contain information about HPV(Human Papilloma Virus), HPV-related cancers, and the importance of the HPV vaccine series for adolescents (9-17 years old) and young adults (18-26 year old) who are eligible for the vaccine.
Read the detailed description
The investigator will use a one-group post-test design to assess the effects of the intervention on the primary outcomes. The educational intervention will be delivered to 400 participants by a trained CHE who will deliver the educational materials to eligible DHHA patients. The CHE will administer the post-education survey at baseline to participants. Additionally, we will use a one-group post-test design to assess the impact of the intervention on the secondary outcomes. At the patient-level, we will track participants that receive (a) 1st dose, 2nd dose, or 3rd dose of the HPV vaccine; and the number of referrals to care by recording the number of patients received (b) referrals to health insurance, discount, or no-cost HPV vaccine programs; or (c) to other services to facilitate HPV vaccine dose completion. To assess clinic-level impact, we will track each clinic's HPV vaccine rates for adolescents (9-17 years old) and young adults (18-26) and compare rates from before we start the intervention and then quarterly there after we have introduced the intervention to each respective Denver Health clinic.
- Conditions
- Human Papilloma Virus
- Being tested
- HPV Educational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Educational InterventionBehavioural
The videos are 8-minute narrative films created using an entertainment-education (E-E) approach that embeds an educational narrative message into an entertainment format such as media. E-E narratives have demonstrated a significant effect (r = .12, p < .001) on health behavior change. Evidence-based small media interventions that Dr. Borrayo has produced include videos that are highly verbal, visual, and entertaining (e.g., acted fictional stories). The aims of the video will be to model uptake of the HPV vaccine, but also to reinforce self-efficacy, subjective norms, and behavioral intentions, all significant precursors to behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Patients Eligible for HPV Vaccine | Experimental | Not described Receives: Behavioral: HPV Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine
Behavioral factors precede uptake of preventive vaccines. Measured by survey post watching HPV video.
Measured: Day 0/Baseline
Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake
Collected by the study team. Variables known as associated with vaccine uptake
Measured: Day 0/Baseline
Secondary outcomes (1)
Uptake of one, two, or three HPV vaccine doses among adolescents (9 to 17 years old) and young adults (18-26 years old).
As determined by follow up phone calls. Number of vaccine doses are used to assess full protection (3 doses) or partial (<3 doses)
Measured: 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start28 Aug 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Evelinn Borrayo, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611022
- Sponsor's protocol ID
- 19-2236.cc
- Other IDs
- P30CA046934
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2020
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series
- ClinicalTrials.gov ID
- NCT04611022
- Acronym / sponsor ID
- 19-2236.cc
- Conditions
- Human Papilloma Virus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 2 Nov 2020 (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 educational intervention to be delivered by the PN(Patient Navigator) consists of "toolkit education materials" developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that our research team has developed. The NCI-produced toolkit education materials consist of Power Point presentations, flyers, and posters that contain information about HPV(Human Papilloma Virus), HPV-related cancers, and the importance of the HPV vaccine series for adolescents (9-17 years old) and young adults (18-26 year old) who are eligible for the vaccine.
Detailed description
The investigator will use a one-group post-test design to assess the effects of the intervention on the primary outcomes. The educational intervention will be delivered to 400 participants by a trained CHE who will deliver the educational materials to eligible DHHA patients. The CHE will administer the post-education survey at baseline to participants. Additionally, we will use a one-group post-test design to assess the impact of the intervention on the secondary outcomes. At the patient-level, we will track participants that receive (a) 1st dose, 2nd dose, or 3rd dose of the HPV vaccine; and the number of referrals to care by recording the number of patients received (b) referrals to health insurance, discount, or no-cost HPV vaccine programs; or (c) to other services to facilitate HPV vaccine dose completion. To assess clinic-level impact, we will track each clinic's HPV vaccine rates for adolescents (9-17 years old) and young adults (18-26) and compare rates from before we start the intervention and then quarterly there after we have introduced the intervention to each respective Denver Health clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Eligible for HPV Vaccine | Experimental | Behavioral: HPV Educational Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be a Denver Health patient* 18-26 years old, who has not started or completed the HPV vaccine series (Vaccine completion for this age group is 3 doses).
- Be a parent of a Denver Health adolescent patient* aged 9-17 years old, who has not started or completed the HPV vaccine series. (Vaccine completion is 2 doses for 9-14-year-old, and 3 doses for 14-17-year old)
- English and/or Spanish Speaking
- Stated willingness to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (4 listed)
- Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish [at the discretion of the CHE or PN upon recruitment]
- Decisionally-challenged adults with cognitive or personality impairment or due to intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study [at the discretion of the CHE or PN upon recruitment]
- Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment [at the discretion of the CHE or PN upon recruitment]
- Individuals under the age of 18 years.
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 |
|---|---|---|
| HPV Educational InterventionThe videos are 8-minute narrative films created using an entertainment-education (E-E) approach that embeds an educational narrative message into an entertainment format such as media. E-E narratives have demonstrated a significant effect (r = .12, p < .001) on health behavior change. Evidence-based small media interventions that Dr. Borrayo has produced include videos that are highly verbal, visual, and entertaining (e.g., acted fictional stories). The aims of the video will be to model uptake of the HPV vaccine, but also to reinforce self-efficacy, subjective norms, and behavioral intentions, all significant precursors to behavior change. | Behavioural | Patients Eligible for HPV Vaccine |
Primary outcome
The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine
Time frame: Day 0/Baseline
Behavioral factors precede uptake of preventive vaccines. Measured by survey post watching HPV video.
Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake
Time frame: Day 0/Baseline
Collected by the study team. Variables known as associated with vaccine uptake
1 secondary outcome
Uptake of one, two, or three HPV vaccine doses among adolescents (9 to 17 years old) and young adults (18-26 years old).
Time frame: 3 and 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Evelinn Borrayo principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Educational Intervention in people with Human Papilloma Virus, run by University of Colorado, Denver 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 5 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sindy Gonzalez (303-724-5445, Sindy.Gonzalez@CUAnschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine (time frame: Day 0/Baseline). 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 25 Nov 2025.