Trial Outcomes & Findings for Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors (NCT NCT02046265)
NCT ID: NCT02046265
Last Updated: 2017-08-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
For each participant, at end of first study visit. Will assess until all subjects enrolled in study.
Results posted on
2017-08-03
Participant Flow
Participants were recruited from 2 sites, both with federally-supported family planning programs.
All participants completed a baseline survey prior to randomization.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
12
|
14
|
|
Overall Study
COMPLETED
|
16
|
15
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors
Baseline characteristics by cohort
| Measure |
Step Up to Prevention: Knowledge
n=17 Participants
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.
|
Step Up to Prevention:Belief
n=17 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.
|
Step up to Prevention
n=12 Participants
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.
|
Offered HPV Vaccine Only
n=14 Participants
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
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
22.06 years
STANDARD_DEVIATION 2.14 • n=5 Participants
|
21.56 years
STANDARD_DEVIATION 2.00 • n=7 Participants
|
21.75 years
STANDARD_DEVIATION 2.59 • n=5 Participants
|
20.77 years
STANDARD_DEVIATION 1.80 • n=4 Participants
|
21.54 years
STANDARD_DEVIATION 2.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
12 participants
n=5 Participants
|
14 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Step Up to Prevention: Knowledge
n=16 Participants
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.
|
Step Up to Prevention:Belief
n=15 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.
|
Step up to Prevention
n=10 Participants
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.
|
Offered HPV Vaccine Only
n=12 Participants
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.
|
|---|---|---|---|---|
|
Human Papilloma Virus (HPV) Vaccine #1 Acceptance
|
13 Participants
|
12 Participants
|
7 Participants
|
3 Participants
|
Adverse Events
Step Up to Prevention: Knowledge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Step Up to Prevention:Belief
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Step up to Prevention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Offered HPV Vaccine Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Anne Teitelman
University of Pennsylvania School of Nursing
Phone: 215-898-1910
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place