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

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ClinicalTrials.gov Identifier: NCT02046265
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : March 28, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Step Up to Prevention Behavioral: Step Up to Prevention: knowledge Behavioral: Step Up to Prevention:belief Behavioral: Offered HPV vaccine only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention
Study Start Date : June 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.




Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046265


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Anne M Teitelman, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02046265     History of Changes
Other Study ID Numbers: StepUpToPrevention
First Posted: January 27, 2014    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: August 3, 2017
Last Verified: June 2017
Keywords provided by University of Pennsylvania:
Cervical cancer prevention
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Vaccines
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs