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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Patients Eligible for HPV VaccineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 0/Baseline
2

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

Time frame
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)

Time frame
3 and 6 months post intervention

Other outcomes

1

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator