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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Offered HPV vaccine only | Active Comparator | Participant is offered the HPV vaccine only by their nurse practitioner in clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step Up to Prevention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Human Papilloma Virus (HPV) Vaccine #1 Acceptance | For each participant, at end of first study visit. Will assess until all subjects enrolled in study. |
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Inclusion Criteria:
Exclusion Criteria:
• Currently pregnant and/or plan to be pregnant in next 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Anne M Teitelman, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic | Philadelphia | Pennsylvania | 19104 | United States |
All participants completed a baseline survey prior to randomization.
Participants were recruited from 2 sites, both with federally-supported family planning programs.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| FG003 | Offered HPV Vaccine Only | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Human Papilloma Virus (HPV) Vaccine #1 Acceptance | All participants in the analysis were eligible to recieve the HPV vaccine. | Posted | Count of Participants | Participants | For each participant, at end of first study visit. Will assess until all subjects enrolled in study. |
|
21 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Teitelman | University of Pennsylvania School of Nursing | 215-898-1910 | teitelm@nursing.upenn.edu |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Step Up to Prevention: knowledge | 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 | 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 | Behavioral | Participant is offered the HPV vaccine only by their nurse practitioner in clinic. |
|
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | Offered HPV Vaccine Only | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
| OG002 | 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. 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. |
| OG003 | Offered HPV Vaccine Only | 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. |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | 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. 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Offered HPV Vaccine Only | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |