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NCT Number: NCT04611022

Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Denver, Colorado, 80237, United States

Location status: Recruiting

Location contact

Evelinn Borrayo

PRINCIPAL_INVESTIGATOR

Sindy Gonzalez

CONTACT

[email protected]

303-724-5445

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

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).

    Time frame: 3 and 6 months post intervention

    As determined by follow up phone calls. Number of vaccine doses are used to assess full protection (3 doses) or partial (<3 doses)

Other outcomes

  1. Intervention's delivery and patient-level & system-level impact.

    Time frame: 3, 6, 9 and 12 months post intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sindy Gonzalez

CONTACT

[email protected]

303-724-5445

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Nov 2, 2020
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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