Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Step Up to Prevention
* Behavioral: Step Up to Prevention: knowledge
* Behavioral: Step Up to Prevention:belief
* Behavioral: Offered HPV vaccine only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step Up to Prevention: knowledge<br>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<br>* Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.<br>|
| Experimental: Step Up to Prevention:belief<br>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<br>* 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.<br>|
| Experimental: Step up to Prevention<br>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<br>* 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.<br>|
| Active Comparator: Offered HPV vaccine only<br>Participant is offered the HPV vaccine only by their nurse practitioner in clinic. | Behavioral: Offered HPV vaccine only<br>* Participant is offered the HPV vaccine only by their nurse practitioner in clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Papilloma Virus (HPV) Vaccine #1 Acceptance |  | For each participant, at end of first study visit. Will assess until all subjects enrolled in study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer prevention