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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Eligible for HPV Vaccine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Educational Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Day 0/Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 and 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention's delivery and patient-level & system-level impact. | Interventions that can be delivered to impact patients & clinics are easier to implement. As determined by rates of HPV vaccine dose completion reported by clinics | 3, 6, 9 and 12 months post intervention |
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sindy Gonzalez | Contact | 303-724-5445 | Sindy.Gonzalez@CUAnschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Evelinn Borrayo | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Recruiting | Denver | Colorado | 80237 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2024 | Nov 19, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2025 | Nov 19, 2025 | ICF_001.pdf |
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