Trial Outcomes & Findings for Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination (NCT NCT03501992)
NCT ID: NCT03501992
Last Updated: 2024-10-24
Results Overview
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females in the study step who received the dose of HPV vaccine dose due by the end of the study step.
COMPLETED
NA
9242 participants
The dose had to have been received during the 12-month-long study step.
2024-10-24
Participant Flow
During each trial month for each practice, we identified patients both age- and dose-eligible. To become age eligible for a particular trial month and for the rest of the step, the patient must turn 11 or 12 years of age during the calendar month that preceded the calendar month before the given trial month. To be dose eligible for the same period, the patient must be due for an HPV vaccine dose in the month following their 11th or 12th birthday (ie, the month prior to the relevant trial month).
A patient empaneled to a practice who was both age and dose eligible for one 12-month step may become age and dose eligible in the following 12-month step. We included patients in a step who were age and dose eligible for a preceding step who remained empaneled to a practice and became age and dose eligible in the next step. The dose eligibility may result from either still being due for the first, initial HPV vaccine dose or now being due for the second, final HPV vaccine dose. Others aged out.
Participant milestones
| Measure |
Practice A
24 months usual care, followed by 12 months reminder recall, followed by 12 months combination
|
Practice B
12 months usual care, followed by 12 months reminder recall, followed by 24 months combination
|
Practice C
12 months usual care, followed by 24 months feedback, followed by 12 months combination
|
Practice D
24 months usual care, followed by 12 months feedback, followed by 12 months combination
|
Practice E
12 months usual care, followed by 24 months reminder recall, followed by 12 months combination
|
Practice F
12 months usual care, followed by 12 months feedback, followed by 24 months combination
|
|---|---|---|---|---|---|---|
|
Step 1 - Months 1-12
STARTED
|
848
|
228
|
479
|
320
|
414
|
265
|
|
Step 1 - Months 1-12
COMPLETED
|
848
|
228
|
479
|
320
|
414
|
265
|
|
Step 1 - Months 1-12
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 2 - Months 13-24
STARTED
|
726
|
218
|
434
|
292
|
386
|
264
|
|
Step 2 - Months 13-24
COMPLETED
|
726
|
218
|
434
|
292
|
386
|
264
|
|
Step 2 - Months 13-24
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 3 - Months 25-36
STARTED
|
702
|
188
|
401
|
241
|
364
|
309
|
|
Step 3 - Months 25-36
COMPLETED
|
702
|
188
|
401
|
241
|
364
|
309
|
|
Step 3 - Months 25-36
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 4 - Months 37-48
STARTED
|
682
|
161
|
421
|
254
|
342
|
303
|
|
Step 4 - Months 37-48
COMPLETED
|
682
|
161
|
421
|
254
|
342
|
303
|
|
Step 4 - Months 37-48
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination
Baseline characteristics by cohort
| Measure |
Usual Care
n=3572 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care.
|
Parent Reminder-Recall Letter
n=1670 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention.
|
Provider Audit-Feedback Intervention.
n=1340 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention.
|
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions
n=2660 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions.
|
Total
n=9242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
11 years old
|
1984 Participants
n=5 Participants
|
943 Participants
n=7 Participants
|
741 Participants
n=5 Participants
|
1497 Participants
n=4 Participants
|
5165 Participants
n=21 Participants
|
|
Age, Customized
12 years old
|
1588 Participants
n=5 Participants
|
727 Participants
n=7 Participants
|
599 Participants
n=5 Participants
|
1163 Participants
n=4 Participants
|
4077 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1667 Participants
n=5 Participants
|
799 Participants
n=7 Participants
|
648 Participants
n=5 Participants
|
1280 Participants
n=4 Participants
|
4394 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1905 Participants
n=5 Participants
|
871 Participants
n=7 Participants
|
692 Participants
n=5 Participants
|
1380 Participants
n=4 Participants
|
4848 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
2517 Participants
n=5 Participants
|
1161 Participants
n=7 Participants
|
1036 Participants
n=5 Participants
|
1984 Participants
n=4 Participants
|
6698 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
329 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
832 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
197 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
430 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
71 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
458 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
1067 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3572 participants
n=5 Participants
|
1670 participants
n=7 Participants
|
1340 participants
n=5 Participants
|
2660 participants
n=4 Participants
|
9242 participants
n=21 Participants
|
|
Human Papillomavirus (HPV) Vaccine Status
Initiating the HPV vaccine series
|
2738 Participants
n=5 Participants
|
1167 Participants
n=7 Participants
|
946 Participants
n=5 Participants
|
1705 Participants
n=4 Participants
|
6556 Participants
n=21 Participants
|
|
Human Papillomavirus (HPV) Vaccine Status
Completing the HPV vaccine series
|
834 Participants
n=5 Participants
|
503 Participants
n=7 Participants
|
394 Participants
n=5 Participants
|
955 Participants
n=4 Participants
|
2686 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The dose had to have been received during the 12-month-long study step.Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males and females in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of participants analyzed for the Usual Care Arm/Group, which is 3572.
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females in the study step who received the dose of HPV vaccine dose due by the end of the study step.
Outcome measures
| Measure |
Usual Care
n=3572 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care.
|
Parent Reminder-Recall Letter
n=1670 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention.
|
Provider Audit-Feedback Intervention.
n=1340 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention.
|
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions
n=2660 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions.
|
|---|---|---|---|---|
|
Human Papillomavirus or HPV-vaccine-dose Receipt
|
782 Participants
|
578 Participants
|
408 Participants
|
1056 Participants
|
SECONDARY outcome
Timeframe: The initiating dose had to have been received during the 12-month-long study step.Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males and females due for their first doses in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of participants analyzed for the Usual Care Arm/Group, which is 2738.
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their first doses of the HPV vaccine series in the study step who received the first dose of HPV vaccine dose due by the end of the study step, thus initiating the HPV vaccine series.
Outcome measures
| Measure |
Usual Care
n=2738 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care.
|
Parent Reminder-Recall Letter
n=1167 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention.
|
Provider Audit-Feedback Intervention.
n=946 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention.
|
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions
n=1705 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions.
|
|---|---|---|---|---|
|
Initiation
|
482 Participants
|
329 Participants
|
251 Participants
|
490 Participants
|
SECONDARY outcome
Timeframe: The final dose had to have been received during the 12-month-long study step.Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males and females due for their final doses in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of participants analyzed for the Usual Care Arm/Group, which is 834.
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their final doses of the HPV vaccine series in the study step who received the final dose of HPV vaccine dose due by the end of the study step, thus completing the HPV vaccine series.
Outcome measures
| Measure |
Usual Care
n=834 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care.
|
Parent Reminder-Recall Letter
n=503 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention.
|
Provider Audit-Feedback Intervention.
n=394 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention.
|
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions
n=955 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions.
|
|---|---|---|---|---|
|
Completion
|
300 Participants
|
249 Participants
|
157 Participants
|
566 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The dose had to have been received during the 12-month-long study step.Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible females in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of female participants analyzed for the Usual Care Arm/Group, which is 1667.
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible females in the study step who received the dose of HPV vaccine dose due by the end of the study step.
Outcome measures
| Measure |
Usual Care
n=1667 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care.
|
Parent Reminder-Recall Letter
n=799 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention.
|
Provider Audit-Feedback Intervention.
n=648 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention.
|
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions
n=1280 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions.
|
|---|---|---|---|---|
|
HPV-vaccine-dose Receipt in Females
|
385 Participants
|
296 Participants
|
188 Participants
|
517 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The dose had to have been received during the 12-month-long study step.Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of male participants analyzed for the Usual Care Arm/Group, which is 1905.
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males in the study step who received the dose of HPV vaccine dose due by the end of the study step.
Outcome measures
| Measure |
Usual Care
n=1905 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care.
|
Parent Reminder-Recall Letter
n=871 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention.
|
Provider Audit-Feedback Intervention.
n=692 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention.
|
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions
n=1380 Participants
Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions.
|
|---|---|---|---|---|
|
HPV-vaccine-dose Receipt in Males
|
397 Participants
|
282 Participants
|
220 Participants
|
539 Participants
|
Adverse Events
Usual Care
Provider Audit-Feedback Intervention.
Parent Reminder-Recall Letter
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place