Cervical CancerStepUpNCT02046265
Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors
A study testing Step Up to Prevention, Step Up to Prevention: knowledge and Step Up to Prevention:belief in people with Cervical Cancer, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Step Up to Prevention, Step Up to Prevention: knowledge and Step Up to Prevention:belief
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Currently pregnant and/or plan to be pregnant in next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic
Philadelphia, Pennsylvania, 19104
About this study
Official title: Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention
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.
- Conditions
- Cervical Cancer
- Being tested
- Step Up to Prevention, Step Up to Prevention: knowledge, Step Up to Prevention:belief, Offered HPV vaccine only
- Keywords
- Cervical cancer prevention
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Up to PreventionBehavioural
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: knowledgeBehavioural
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:beliefBehavioural
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 onlyBehavioural
Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Step Up to Prevention |
| Offered HPV vaccine only | Active comparator | Participant is offered the HPV vaccine only by their nurse practitioner in clinic. Receives: Behavioral: Offered HPV vaccine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papilloma Virus (HPV) Vaccine #1 Acceptance
Measured: For each participant, at end of first study visit. Will assess until all subjects enrolled in study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne M Teitelman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046265
- Sponsor's protocol ID
- StepUpToPrevention
- Acronym
- StepUp
- Status last verified
- Jun 2017
- First submitted
- 14 Jan 2014
- Last updated
- 3 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention
- ClinicalTrials.gov ID
- NCT02046265
- Acronym / sponsor ID
- StepUp / StepUpToPrevention
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Step Up to Prevention: knowledge | Experimental | Behavioral: Step Up to Prevention: knowledgeParticipant 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 | Experimental | Behavioral: Step Up to Prevention:beliefParticipant 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 | Experimental | Behavioral: Step Up to PreventionParticipant 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. |
| Offered HPV vaccine only | Active comparator | Behavioral: Offered HPV vaccine onlyParticipant is offered the HPV vaccine only by their nurse practitioner in clinic. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Currently pregnant and/or plan to be pregnant in next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step Up to PreventionParticipant 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. | Behavioural | Step up to Prevention |
| Step Up to Prevention: knowledgeParticipant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic. | Behavioural | Step Up to Prevention: knowledge |
| Step Up to Prevention:beliefParticipant 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. | Behavioural | Step Up to Prevention:belief |
| Offered HPV vaccine onlyParticipant is offered the HPV vaccine only by their nurse practitioner in clinic. | Behavioural | Offered HPV vaccine only |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne M Teitelman, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step Up to Prevention, Step Up to Prevention: knowledge and Step Up to Prevention:belief in people with Cervical Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.