Marketability of a Technology-based Intervention to Increase HPV Vaccination

NCT03497936 | Completed DMC

• 1 other identifier: R44DP006291
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 7

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.

Conditions

Human Papilloma Virus

Keywords

vaccine narratives; HPV prevention; vaccine promotion

Outcome Measures

Primary Outcomes (1)

• HPV Vaccination

  Uptake of HPV Vaccine as measured by medical records review and self report

  9 months

Study Arms (2)

Women's Stories

EXPERIMENTAL

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

Behavioral: Women's Stories

Programming as usual

NO INTERVENTION

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

Interventions

Women's Stories 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.

Women's Stories

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: Women are the targets for this intervention.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All English-speaking women clients of 4 Planned Parenthood clinics who are between 18 and 26 and have not been vaccinated.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Real Prevention, LLC: lead
• University of California, Irvine: collaborator

Study Sites (7)

University of California, Irvine

Irvine, California, 92697-7700, United States

Location

Planned Parenthood of Illinois

Chicago, Illinois, 60603, United States

Location

Planned Parenthood of the St. Louis Region and Southwest Missouri

St Louis, Missouri, 63108, United States

Location

REAL Prevention LLC

Clifton, New Jersey, 07013, United States

Location

Public Health Management Corporation

Philadelphia, Pennsylvania, 19102, United States

Location

Planned Parenthood of Southeastern Pennsylvania

Philadelphia, Pennsylvania, 19107-6734, United States

Location

St. Andrew Development

York, Pennsylvania, 17401-3333, United States

Location

Related Publications (1)

• 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.

  PMID: 29425333 BACKGROUND

Study Officials

• Michael Hecht, Ph.D.

  Real Prevention, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 13, 2018
• Study Start: May 1, 2018
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)