Trial Outcomes & Findings for Increasing Optimal Use of HPV Vaccination in Primary Care (NCT NCT04180462)
NCT ID: NCT04180462
Last Updated: 2025-03-25
Results Overview
The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
24 months
Results posted on
2025-03-25
Participant Flow
Unit of analysis: practices
Participant milestones
| Measure |
Intervention Group
Practices randomly assigned to this arm will receive the multi-component intervention.
|
Wait List Control Group
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
4362 10
|
3025 10
|
|
Overall Study
24 Months Post-randomization
|
2151 10
|
1615 10
|
|
Overall Study
36 Months Post-randomization
|
2211 10
|
1410 9
|
|
Overall Study
COMPLETED
|
4362 10
|
3025 9
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Optimal Use of HPV Vaccination in Primary Care
Baseline characteristics by cohort
| Measure |
Intervention Group (24 Months Post-randomization)
n=2151 Participants
Practices randomly assigned to this arm will receive the multi-component intervention.
|
Wait List Control Group (24 Months Post-randomization)
n=1615 Participants
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
|
Intervention Group (36 Months Post-randomization)
n=2211 Participants
Practices randomly assigned to this arm will receive the multi-component intervention.
|
Wait List Control Group (36 Months Post-randomization)
n=1410 Participants
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
|
Total
n=7387 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2151 Participants
n=5 Participants
|
1615 Participants
n=7 Participants
|
2211 Participants
n=5 Participants
|
1410 Participants
n=4 Participants
|
7387 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
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
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex/Gender, Customized
Female
|
1037 Participants
n=5 Participants
|
818 Participants
n=7 Participants
|
1108 Participants
n=5 Participants
|
701 Participants
n=4 Participants
|
3664 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
1113 Participants
n=5 Participants
|
797 Participants
n=7 Participants
|
1103 Participants
n=5 Participants
|
704 Participants
n=4 Participants
|
3717 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1634 Participants
n=5 Participants
|
1226 Participants
n=7 Participants
|
1692 Participants
n=5 Participants
|
1128 Participants
n=4 Participants
|
5680 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
485 Participants
n=5 Participants
|
326 Participants
n=7 Participants
|
487 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
1557 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
60 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
92 Participants
n=5 Participants
|
446 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
384 Participants
n=4 Participants
|
1042 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1514 Participants
n=5 Participants
|
890 Participants
n=7 Participants
|
1560 Participants
n=5 Participants
|
819 Participants
n=4 Participants
|
4783 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
454 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
1282 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2151 participants
n=5 Participants
|
1615 participants
n=7 Participants
|
2211 participants
n=5 Participants
|
1410 participants
n=4 Participants
|
7387 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Outcome measures
| Measure |
Intervention Group
n=2151 Participants
Practices randomly assigned to this arm will receive the multi-component intervention.
|
Wait List Control Group
n=1615 Participants
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
|
|---|---|---|
|
Initiation of the HPV Vaccine 2-dose Series.
|
1723 Participants
|
1219 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.
Outcome measures
| Measure |
Intervention Group
n=2151 Participants
Practices randomly assigned to this arm will receive the multi-component intervention.
|
Wait List Control Group
n=1615 Participants
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
|
|---|---|---|
|
Completion of the HPV Vaccine 2-dose Series.
|
1135 Participants
|
809 Participants
|
SECONDARY outcome
Timeframe: 36 monthsThe proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization
Outcome measures
| Measure |
Intervention Group
n=2211 Participants
Practices randomly assigned to this arm will receive the multi-component intervention.
|
Wait List Control Group
n=1410 Participants
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
|
|---|---|---|
|
Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.
|
1812 Participants
|
1052 Participants
|
SECONDARY outcome
Timeframe: 36 monthsThe proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization
Outcome measures
| Measure |
Intervention Group
n=2211 Participants
Practices randomly assigned to this arm will receive the multi-component intervention.
|
Wait List Control Group
n=1410 Participants
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
|
|---|---|---|
|
Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.
|
1279 Participants
|
703 Participants
|
Adverse Events
Intervention Group (24 Months Post-randomization)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control Group (24 Months Post-randomization)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group (36 Month Post-randomization)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control Group (36 Months Post-randomization)
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
Allison King, M.D., Ph.D., MPH
Washington University School of Medicine
Phone: 314-454-4291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place