Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors (StepUp)

June 28, 2017 updated by: University of Pennsylvania

Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention

The project is a clinical behavioral research project based at University of Pennsylvania. The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and theory-based health promotion intervention to enhance cervical cancer prevention among young women ages 18-26 living in economically disadvantaged urban communities. The investigators will evaluate the intervention for feasibility, acceptability and preliminary efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18-26 years
  • Not yet received the HPV vaccine
  • Speak, read, and understand 5th grade level of English;
  • Had vaginal sex with a male partner in the past 2 months.

Exclusion Criteria:

• Currently pregnant and/or plan to be pregnant in next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Step Up to Prevention: knowledge
Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Behavioral: Step Up to Prevention: knowledge
Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Experimental: Step Up to Prevention:belief
Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Behavioral: Step Up to Prevention:belief
Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Experimental: Step up to Prevention
Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.
Behavioral: Step Up to Prevention
Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Active Comparator: Offered HPV vaccine only
Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Behavioral: Offered HPV vaccine only
Participant is offered the HPV vaccine only by their nurse practitioner in clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Human Papilloma Virus (HPV) Vaccine #1 Acceptance
Time Frame: For each participant, at end of first study visit. Will assess until all subjects enrolled in study.
For each participant, at end of first study visit. Will assess until all subjects enrolled in study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Anne M Teitelman, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StepUpToPrevention

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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