Marketability of a Technology-based Intervention to Increase HPV Vaccination

The overall goal of this SBIR Phase II project is to reduce cancer rates by marketing a brief, easily implemented technology-based intervention that increases human papillomavirus (HPV) vaccination among Planned Parenthood and other clients. The intervention's innovative technology allows for the investigators' narrative videos to be presented along will reminder texts. It will be evaluated for use in waiting rooms and promises to overcome vaccination barriers among high risk but underserved low SES and minority populations.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus
• Intervention / Treatment: Behavioral: Women's Stories

Detailed Description

The purpose of this Phase II research project is to evaluate and market an innovative health message intervention to increase uptake of the human papillomavirus (HPV) vaccine and reduce women's cervical cancer risk through partnership with Planned Parenthood. The overall aim is to reach a broad population through Planned Parenthood, the nation's leading sexual and reproductive health care center, especially among low socioeconomic status (SES) and historically underserved populations. Despite an overall increase in vaccination and reduction in HPV-related infections in younger populations targeted by previous health promotion efforts, young adult women who are recommended for vaccination demonstrate much lower vaccination rates and higher rates of infection. In a recent Phase I grant, the investigators developed and demonstrated the usability and feasibility of an innovative, culturally-grounded, technology-based narrative intervention that delivers decision narratives in the form of videos via a health kiosk, an underutilized communication strategy for reaching less involved audiences. This brief, low-cost, easily implementable intervention doubled the uptake of the vaccine in a separate pilot study. The proposed Phase II project will: (1) Complete development of the intervention, (2) Evaluate its effectiveness through a randomized clinical trial, and (3) Prepare the product for the market. To accomplish these aims, the investigators will develop the intervention for implementation in waiting rooms as part of check-in procedures. Development includes programming and installing tablets to accomplish these tasks (Aim 1). The investigators will then conduct the evaluation study in four Planned Parenthood clinics in southeastern Pennsylvania (Aim 2). Eligible women will be consented, complete a pretest, and then randomized to view the brief intervention or attention control messages via the tablet. After viewing the messages, the participants will complete a short posttest. Treatment participants will receive follow up texts/emails as reminders to vaccinate, and all participants will receive texts/emails with links that allow completion of posttest surveys at 3- and 9 months. Finally, the investigators will prepare the intervention for the market that includes not only Planned Parenthood but other clinics that are currently served by the project partners as well as the broader market for HPV vaccination (Aim 3). In summary, the proposed communication strategy has wide reaching implications not only for reducing cancer risk, but more broadly for designing brief and easily implemented prevention messages across many domains of public health. The research will also close the health disparities gap in minority, under-served young adult women's access to preventive health care.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697-7700
      • University of California, Irvine
  • Illinois
    • Chicago, Illinois, United States, 60603
      • Planned Parenthood of Illinois
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Planned Parenthood of the St. Louis Region and Southwest Missouri
  • New Jersey
    • Clifton, New Jersey, United States, 07013
      • REAL Prevention LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Public Health Management Corporation
    • Philadelphia, Pennsylvania, United States, 19107-6734
      • Planned Parenthood of Southeastern Pennsylvania
    • York, Pennsylvania, United States, 17401-3333
      • St. Andrew Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All English-speaking women clients of 4 Planned Parenthood clinics who are between 18 and 26 and have not been vaccinated.

Exclusion Criteria:

• Men, women who do not speak English or are not between 18 and 26 years old, anyone not a client of the 4 Planned Parenthood clinics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Women's Stories; Participants in this group will be randomly assigned to use the Women's Stories intervention.	Behavioral: Women's Stories; Women's Stories is a brief, HPV vaccination promotion intervention. It presents vaccine information and videos of HPV vaccine decision making. It also includes follow up vaccine reminder text messages.
NO_INTERVENTION: Programming as usual; Participants in this group will be randomly assigned participate in their usual programming.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Vaccination	Uptake of HPV Vaccine as measured by medical records review and self report	9 months

Collaborators and Investigators

• Sponsor: Real Prevention, LLC
• Collaborators: University of California, Irvine

Publications and helpful links

General Publications

• Hopfer S, Ray AE, Hecht ML, Miller-Day M, Belue R, Zimet G, Evans WD, McKee FX. Taking an HPV vaccine research-tested intervention to scale in a clinical setting. Transl Behav Med. 2018 Sep 8;8(5):745-752. doi: 10.1093/tbm/ibx066.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): March 29, 2021
• Study Completion (ACTUAL): March 29, 2021

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (ACTUAL): April 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: vaccine narratives; HPV prevention; vaccine promotion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: R44DP006291 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidential data cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No