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Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03497936
Study type Interventional
Source Real Prevention, LLC
Contact Michael L Hecht, Ph.D.
Phone 8143601893
Status Not yet recruiting
Phase N/A
Start date May 1, 2018
Completion date September 30, 2018

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