StepUp: Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02046265
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4
• Duration (Months): 34
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Behavioral: Step Up to Prevention; Behavioral: Step Up to Prevention: knowledge; Behavioral: Step Up to Prevention:belief; Behavioral: Offered HPV vaccine only	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	Behavioral: 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: Offered HPV vaccine only Participant is offered the HPV vaccine only by their nurse practitioner in clinic.	Behavioral: Offered HPV vaccine only; Participant is offered the HPV vaccine only by their nurse practitioner in clinic.

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 26 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Anne M Teitelman, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02046265
• Other Study ID Numbers: StepUpToPrevention
• First Posted: Jan 27, 2014
• Last Update Posted: Aug 3, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by University of Pennsylvania: Cervical cancer prevention
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 2 sites, both with federally-supported family planning programs.
Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Step Up to Prevention: Knowledge	Step Up to Prevention:Belief	Step up to Prevention	Offered HPV Vaccine Only	Total
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 Participants	17	17	12	14	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.06 (2.14)	21.56 (2.00)	21.75 (2.59)	20.77 (1.80)	21.54 (2.13)
Sex: Female, Male (Count of Participants)
Female	17 100%	17 100%	12 100%	14 100%	60 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 5.9%	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%
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%
Unknown or Not Reported	0 0%	2 11.8%	1 8.3%	1 7.1%	4 6.7%
Region of Enrollment (participants) [Number]
United States	17 100%	17 100%	12 100%	14 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	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.

Outcome Measure Data

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
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.
Measure Participants	16	15	10	12
Count of Participants [Participants]	13 76.5%	12 70.6%	7 58.3%	3 21.4%

Adverse Events

Time Frame	21 months
Arm/Group Title	Step Up to Prevention: Knowledge		Step Up to Prevention:Belief		Step up to Prevention		Offered HPV Vaccine Only
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/12 (0%)		0/14 (0%)
Serious Adverse Events
	Step Up to Prevention: Knowledge		Step Up to Prevention:Belief		Step up to Prevention		Offered HPV Vaccine Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/12 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Step Up to Prevention: Knowledge		Step Up to Prevention:Belief		Step up to Prevention		Offered HPV Vaccine Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/12 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.