Trial Outcomes & Findings for Community Pharmacists Vaccinate Against Cancer (NCT NCT04072159)
NCT ID: NCT04072159
Last Updated: 2024-02-28
Results Overview
Whether child completed HPV vaccine series with pharmacist (self-report on post-test and patient medical record)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
6 months post baseline
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
Pharmacist-Administered Human Papillomavirus (HPV) Vaccine Series Completion Group
For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
|
Primary Care Provider HPV Vaccine Series Completion
Primary Care Provider HPV Vaccine Series Completion Group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Pharmacist-Administered Human Papillomavirus (HPV) Vaccine Series Completion Group
For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
|
Primary Care Provider HPV Vaccine Series Completion
Primary Care Provider HPV Vaccine Series Completion Group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Community Pharmacists Vaccinate Against Cancer
Baseline characteristics by cohort
| Measure |
Pharmacist-Administered HPV Vaccine Series Completion Group
n=16 Participants
For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
|
Primary Care Provider HPV Vaccine Series Completion
n=17 Participants
Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.8 years
n=5 Participants
|
37.1 years
n=7 Participants
|
37.4 years
n=5 Participants
|
|
Sex: Female, Male
Sex: Female, Male · Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Sex: Female, Male · Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post baselineWhether child completed HPV vaccine series with pharmacist (self-report on post-test and patient medical record)
Outcome measures
| Measure |
Pharmacist-Administered HPV Vaccine Series Completion Group
n=8 Participants
For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
|
Primary Care Provider HPV Vaccine Series Completion
n=11 Participants
Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
|
|---|---|---|
|
Number of Participants Who Completed HPV Vaccine Series(Preliminary Efficacy)
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 year after intervention baseline (March 2020)Ability to enroll 90 participants into study and retain study participants, ability to retain 90 participants post-intervention (as evidenced by collecting intervention and control group post-tests) - Compare recruitment/enrollment and intervention completion
Outcome measures
| Measure |
Pharmacist-Administered HPV Vaccine Series Completion Group
n=14 Participants
For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant.
|
Primary Care Provider HPV Vaccine Series Completion
Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
|
|---|---|---|
|
Intervention Feasibility in Participant Enrollment/Study Completion
|
8 Participants
|
—
|
Adverse Events
Pharmacist-Administered HPV Vaccine Series Completion Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Care Provider HPV Vaccine Series Completion
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. Alexis Koskan (Assistant Professor)
Arizona State University, College of Health Solutions
Phone: 602-827-2792
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place