Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03497936 |
| Other study ID # |
R44DP006291 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2018 |
| Est. completion date |
March 29, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
Real Prevention, LLC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
