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Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors (StepUp)

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ClinicalTrials.gov Identifier: NCT02046265
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : March 28, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Cervical Cancer
Interventions Behavioral: Step Up to Prevention
Behavioral: Step Up to Prevention: knowledge
Behavioral: Step Up to Prevention:belief
Behavioral: Offered HPV vaccine only
Enrollment 60
Recruitment Details Participants were recruited from 2 sites, both with federally-supported family planning programs.
Pre-assignment Details All participants completed a baseline survey prior to randomization.
Arm/Group Title Step Up to Prevention: Knowledge Step Up to Prevention:Belief Step up to Prevention Offered HPV Vaccine Only
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 17 17 12 14
Completed 16 15 10 12
Not Completed 1 2 2 2
Arm/Group Title Step Up to Prevention: Knowledge Step Up to Prevention:Belief Step up to Prevention Offered HPV Vaccine Only Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 17 17 12 14 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 12 participants 14 participants 60 participants
22.06  (2.14) 21.56  (2.00) 21.75  (2.59) 20.77  (1.80) 21.54  (2.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 12 participants 14 participants 60 participants
Female
17
 100.0%
17
 100.0%
12
 100.0%
14
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 12 participants 14 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.9%
0
   0.0%
2
  16.7%
2
  14.3%
5
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  64.7%
10
  58.8%
7
  58.3%
6
  42.9%
34
  56.7%
White
5
  29.4%
5
  29.4%
2
  16.7%
5
  35.7%
17
  28.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
  11.8%
1
   8.3%
1
   7.1%
4
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 12 participants 14 participants 60 participants
17 17 12 14 60
1.Primary Outcome
Title Human Papilloma Virus (HPV) Vaccine #1 Acceptance
Hide Description [Not Specified]
Time Frame For each participant, at end of first study visit. Will assess until all subjects enrolled in study.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the analysis were eligible to recieve the HPV vaccine.
Arm/Group Title Step Up to Prevention: Knowledge Step Up to Prevention:Belief Step up to Prevention Offered HPV Vaccine Only
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 16 15 10 12
Measure Type: Count of Participants
Unit of Measure: Participants
13
  81.3%
12
  80.0%
7
  70.0%
3
  25.0%
Time Frame 21 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Step Up to Prevention: Knowledge Step Up to Prevention:Belief Step up to Prevention Offered HPV Vaccine Only
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Step Up to Prevention: Knowledge Step Up to Prevention:Belief Step up to Prevention Offered HPV Vaccine Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/12 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Step Up to Prevention: Knowledge Step Up to Prevention:Belief Step up to Prevention Offered HPV Vaccine Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/12 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Step Up to Prevention: Knowledge Step Up to Prevention:Belief Step up to Prevention Offered HPV Vaccine Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/12 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anne Teitelman
Organization: University of Pennsylvania School of Nursing
Phone: 215-898-1910
EMail: teitelm@nursing.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02046265     History of Changes
Other Study ID Numbers: StepUpToPrevention
First Submitted: January 14, 2014
First Posted: January 27, 2014
Results First Submitted: February 7, 2017
Results First Posted: March 28, 2017
Last Update Posted: August 3, 2017