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Marketability of a Technology-based Intervention to Increase HPV Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497936
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
University of California, Irvine
Information provided by (Responsible Party):
Real Prevention, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Behavioral: Women's Stories Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomly assigned to one of two arms (intervention, no intervention). Intervention participants receive Women's Stories. No intervention participants receive treatment as usual. All participants are administered a pretest and two post tests, and clinical records are examined for vaccination outcomes.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Marketability of a Technology-based Intervention to Increase HPV Vaccination
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 30, 2020

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.



Primary Outcome Measures :
  1. HPV Vaccination [ Time Frame: 9 months ]
    Uptake of HPV Vaccine as measured by medical records review and self report



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women are the targets for this intervention.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497936


Contacts
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Contact: Michael L Hecht, Ph.D. 8143601893 hechtpsu@gmail.com
Contact: Ann Bolser, AA 814-360-0203 ann@real-prevention.com

Locations
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United States, California
University of California, Irvine Active, not recruiting
Irvine, California, United States, 92697-7700
United States, Illinois
Planned Parenthood of Illinois Recruiting
Chicago, Illinois, United States, 60603
Contact: Sara Newton    312-592-6800    saran@ppil.org   
United States, Missouri
Planned Parenthood of the St. Louis Region and Southwest Missouri Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Shreya Nagendra    314-531-7526 ext 338    Shreya.Nagendra@ppslr.org   
United States, New Jersey
REAL Prevention LLC Active, not recruiting
Clifton, New Jersey, United States, 07013
United States, Pennsylvania
Public Health Management Corporation Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Dinetta Armstrong, MBA    215-731-2406    diarmstrong@phmc.org   
Planned Parenthood of Southeastern Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107-6734
Contact: Jane Napoli, SPHR    215-351-5500    ppso@ppso.0rg   
St. Andrew Development Active, not recruiting
York, Pennsylvania, United States, 17401-3333
Sponsors and Collaborators
Real Prevention, LLC
University of California, Irvine
Investigators
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Principal Investigator: Michael Hecht, Ph.D. Real Prevention, LLC
Publications:
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Responsible Party: Real Prevention, LLC
ClinicalTrials.gov Identifier: NCT03497936    
Other Study ID Numbers: R44DP006291 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Confidential data cannot be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Real Prevention, LLC:
vaccine narratives
HPV prevention
vaccine promotion
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms