Cervical Cancer
Conditions
Keywords
Cervical cancer prevention
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.
Interventions
BEHAVIORALStep 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.
BEHAVIORALStep 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.
BEHAVIORALStep 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.
BEHAVIORALOffered HPV vaccine only
Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 26 Years
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
Design outcomes
Primary
| Measure | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 17 |
| 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. | 12 |
| 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. | 14 |
| Total | 60 |
Baseline characteristics
| Characteristic | Step Up to Prevention: Knowledge | Total | Offered HPV Vaccine Only | Step up to Prevention | Step Up to Prevention:Belief |
|---|---|---|---|---|---|
| Age, Continuous | 22.06 years STANDARD_DEVIATION 2.14 | 21.54 years STANDARD_DEVIATION 2.13 | 20.77 years STANDARD_DEVIATION 1.8 | 21.75 years STANDARD_DEVIATION 2.59 | 21.56 years STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 34 Participants | 6 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 17 Participants | 5 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 17 participants | 60 participants | 14 participants | 12 participants | 17 participants |
| Sex: Female, Male Female | 17 Participants | 60 Participants | 14 Participants | 12 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 12 | 0 / 14 |
Outcome results
Primary
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.
Population: All participants in the analysis were eligible to recieve the HPV vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Step Up to Prevention: Knowledge | Human Papilloma Virus (HPV) Vaccine #1 Acceptance | 13 Participants |
| Step Up to Prevention:Belief | Human Papilloma Virus (HPV) Vaccine #1 Acceptance | 12 Participants |
| Step up to Prevention | Human Papilloma Virus (HPV) Vaccine #1 Acceptance | 7 Participants |
| Offered HPV Vaccine Only | Human Papilloma Virus (HPV) Vaccine #1 Acceptance | 3 Participants |