NCT02046265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 28, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 3, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

January 14, 2014

Results QC Date

February 7, 2017

Last Update Submit

June 28, 2017

Conditions

Cervical Cancer

Keywords

Cervical cancer prevention

Outcome Measures

Primary Outcomes (1)

  • Human Papilloma Virus (HPV) Vaccine #1 Acceptance

    For each participant, at end of first study visit. Will assess until all subjects enrolled in study.

Study Arms (4)

Step Up to Prevention: knowledge

EXPERIMENTAL

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

Step Up to Prevention:belief

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.

Behavioral: Step Up to Prevention:belief

Step up to Prevention

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.

Behavioral: Step Up to Prevention

Offered HPV vaccine only

ACTIVE COMPARATOR

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

Behavioral: Offered HPV vaccine only

Interventions

Step Up to PreventionBEHAVIORAL

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: knowledgeBEHAVIORAL

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
Step Up to Prevention:beliefBEHAVIORAL

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
Offered HPV vaccine onlyBEHAVIORAL

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

Offered HPV vaccine only

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Dr. Anne Teitelman
Organization
University of Pennsylvania School of Nursing
teitelm@nursing.upenn.edu
215-898-1910

Study Officials

  • Anne M Teitelman, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 27, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2016

Study Completion

April 1, 2017

Last Updated

August 3, 2017

Results First Posted

March 28, 2017

Record last verified: 2017-06

Locations

US(1)