Marketability of a Technology-based Intervention to Increase HPV Vaccination

NCT ID: NCT03497936

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-03-29

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.

Conditions

Human Papilloma Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Women's Stories

Participants in this group will be randomly assigned to use the Women's Stories intervention.

Group Type: EXPERIMENTAL

Women's Stories

Intervention Type: BEHAVIORAL

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.

Programming as usual

Participants in this group will be randomly assigned participate in their usual programming.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: collaborator

Real Prevention, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hecht, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Real Prevention, LLC

Locations

University of California, Irvine

Irvine, California, United States

Planned Parenthood of Illinois

Chicago, Illinois, United States

Planned Parenthood of the St. Louis Region and Southwest Missouri

St Louis, Missouri, United States

REAL Prevention LLC

Clifton, New Jersey, United States

Public Health Management Corporation

Philadelphia, Pennsylvania, United States

Planned Parenthood of Southeastern Pennsylvania

Philadelphia, Pennsylvania, United States

St. Andrew Development

York, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29425333 (View on PubMed)

Other Identifiers

R44DP006291

Identifier Type: NIH

Identifier Source: org_study_id

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