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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Step Up to Prevention
Step Up to Prevention: knowledge
Step Up to Prevention:belief
Offered HPV vaccine only
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Cervical cancer prevention

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Step Up to Prevention: knowledge

Step Up to Prevention:belief

Step up to Prevention

Offered HPV vaccine only

Arm Description

Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.

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.

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.

Participant is offered the HPV vaccine only by their nurse practitioner in clinic.

Outcomes

Primary Outcome Measures

Human Papilloma Virus (HPV) Vaccine #1 Acceptance

Secondary Outcome Measures

Full Information

First Posted
January 14, 2014
Last Updated
June 28, 2017
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02046265
Brief Title
Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors
Acronym
StepUp
Official Title
Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Step Up to Prevention: knowledge
Arm Type
Experimental
Arm Description
Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Arm Title
Step Up to Prevention:belief
Arm Type
Experimental
Arm Description
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.
Arm Title
Step up to Prevention
Arm Type
Experimental
Arm Description
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.
Arm Title
Offered HPV vaccine only
Arm Type
Active Comparator
Arm Description
Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Intervention Type
Behavioral
Intervention Name(s)
Step Up to Prevention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Step Up to Prevention: knowledge
Intervention Description
Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Intervention Type
Behavioral
Intervention Name(s)
Step Up to Prevention:belief
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Offered HPV vaccine only
Intervention Description
Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne M Teitelman, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

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