Marketability of a Technology-based Intervention to Increase HPV Vaccination
Primary Purpose
Human Papilloma Virus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Women's Stories
Sponsored by
About this trial
This is an interventional prevention trial for Human Papilloma Virus focused on measuring vaccine narratives, HPV prevention, vaccine promotion
Eligibility 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.
Sites / Locations
- University of California, Irvine
- Planned Parenthood of Illinois
- Planned Parenthood of the St. Louis Region and Southwest Missouri
- REAL Prevention LLC
- Public Health Management Corporation
- Planned Parenthood of Southeastern Pennsylvania
- St. Andrew Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Women's Stories
Programming as usual
Arm Description
Participants in this group will be randomly assigned to use the Women's Stories intervention.
Participants in this group will be randomly assigned participate in their usual programming.
Outcomes
Primary Outcome Measures
HPV Vaccination
Uptake of HPV Vaccine as measured by medical records review and self report
Secondary Outcome Measures
Full Information
NCT ID
NCT03497936
First Posted
April 10, 2018
Last Updated
September 16, 2022
Sponsor
Real Prevention, LLC
Collaborators
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT03497936
Brief Title
Marketability of a Technology-based Intervention to Increase HPV Vaccination
Official Title
Marketability of a Technology-based Intervention to Increase HPV Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 29, 2021 (Actual)
Study Completion Date
March 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Prevention, LLC
Collaborators
University of California, Irvine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
vaccine narratives, HPV prevention, vaccine promotion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Women's Stories
Arm Type
Experimental
Arm Description
Participants in this group will be randomly assigned to use the Women's Stories intervention.
Arm Title
Programming as usual
Arm Type
No Intervention
Arm Description
Participants in this group will be randomly assigned participate in their usual programming.
Intervention Type
Behavioral
Intervention Name(s)
Women's Stories
Intervention Description
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.
Primary Outcome Measure Information:
Title
HPV Vaccination
Description
Uptake of HPV Vaccine as measured by medical records review and self report
Time Frame
9 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women are the targets for this intervention.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hecht, Ph.D.
Organizational Affiliation
Real Prevention, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697-7700
Country
United States
Facility Name
Planned Parenthood of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60603
Country
United States
Facility Name
Planned Parenthood of the St. Louis Region and Southwest Missouri
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
REAL Prevention LLC
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
Public Health Management Corporation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Planned Parenthood of Southeastern Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-6734
Country
United States
Facility Name
St. Andrew Development
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17401-3333
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Confidential data cannot be shared.
Citations:
PubMed Identifier
29425333
Citation
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.
Results Reference
background
Learn more about this trial
Marketability of a Technology-based Intervention to Increase HPV Vaccination
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