Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

Cervical Cancer Clinical Trial

— StepUp  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02046265
• Other study ID #: StepUpToPrevention
• Status: Active, not recruiting
• Phase: N/A
• First received: January 14, 2014
• Last updated: August 30, 2016
• Start date: June 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic	Philadelpahia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Papilloma virus (HPV) vaccine #1 acceptance		For each participant, at end of first study visit. Will assess until all subjects enrolled in study.	No
Primary	Change from Baseline in Consistent Condom Use at 3 months		3 months	No
Secondary	Change from Baseline in Consistent Condom Use at 6 months		6 months	No