Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

NCT ID: NCT02046265

Last Updated: 2017-08-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-04-30

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.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Step Up to Prevention: knowledge

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Step Up to Prevention:belief

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Step Up to Prevention

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Offered HPV vaccine only

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Offered HPV vaccine only

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne M Teitelman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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StepUpToPrevention

Identifier Type: -

Identifier Source: org_study_id

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