Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatments step up to prevention, step up to prevention: knowledge, step up to prevention:belief, offered hpv vaccine only
Sponsor University of Pennsylvania
Start date June 2014
End date March 2016
Trial size 60 participants
Trial identifier NCT02046265, StepUpToPrevention

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
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: knowledge
Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
(Experimental)
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: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)
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.
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)
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.

Primary Outcomes

Measure
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.
Change from Baseline in Consistent Condom Use at 3 months
time frame: 3 months

Secondary Outcomes

Measure
Change from Baseline in Consistent Condom Use at 6 months
time frame: 6 months

Eligibility Criteria

Female participants from 18 years up to 26 years old.

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

Additional Information

Official title Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention
Principal investigator Anne M Teitelman, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.