Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Behavioral: Step Up to Prevention; Behavioral: Offered HPV vaccine only

• Registration Number: NCT02046265
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Study Start: 2014-06
• Primary Completion: 2016-03
• Results First Submitted: 2017-02-07
• Results First Submitted QC: 2017-02-07
• Results First Posted: 2017-03-28
• Study Completion: 2017-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Step Up to Prevention:belief	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.
Step up to Prevention	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.
Offered HPV vaccine only	Offered HPV vaccine only	Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention: knowledge	Step Up to Prevention	Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic; 🇺🇸 Philadelphia, Pennsylvania, United States