Trial Outcomes & Findings for Text and Talk: A Multi-level Intervention to Increase Provider HPV Vaccine Recommendation Effectiveness (NCT NCT05006833)
NCT ID: NCT05006833
Last Updated: 2026-08-04
Results Overview
Binary measure at the participant level of receipt of one or more does of the HPV vaccine. The percentage of participants is estimated with predicted probabilities to adjust for clustering at the clinic-level.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8043 participants
Primary outcome timeframe
24 months
Results posted on
2026-08-04
Participant Flow
Community outreach methods were used to recruit 30 Florida pediatric primary care clinics (December 2020 to March 2021). Clinicians, stratified by clinic, were randomized to 3 arms for trainings (labeled CL). Patients were randomized into 3 arms for text messages (labeled P). The double randomization for adolescents equals 3x3=9 treatment arms. Clinicians and adolescents were followed for 2 years. Parents, completed a one-time survey, and were assigned to arms corresponding to their adolescent.
30 clinics (and clinicians within clinics) were randomized equally to 3 clinician training arms: 10 clinics in clinician bundled training, 10 clinics in clinician benefits training, and 10 clinics to no training.
Participant milestones
| Measure |
Parent Arm 8: CL= No Training and P=Benefits Text
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were sent text messages following the benefits strategy.
|
Parent Arm 9: CL= No Training and P=No Text (Control Arm)
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were NOT sent text messages.
|
Adolescent Arm 1: CL=Bundled Training and P=Bundled Text
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 2: CL= Bundled Training and P=Benefits Text
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the benefit strategy.
|
Adolescent Arm 3: CL= Bundled Training and P=No Text
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were NOT sent text messages.
|
Adolescent Arm 4: CL= Benefits Training and P=Bundled Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 5: CL= Benefits Training and P=Benefits Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 6: CL= Benefits Training and P=No Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were NOT sent text messages
|
Adolescent Arm 7: CL= No Training and P=Bundled Text
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 8: CL= No Training and P=Benefits Text
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 9: CL= No Training and P=No Text (Control Arm)
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were NOT sent text messages.
|
Clinician Arm 1 - Bundled
The clinicians within the 10 randomized clinics were assigned to a training focused on a bundled strategy to recommending vaccines. These clinicians are associated with adolescent arms 1-3.
|
Clinician Arm 2- Benefits
The clinicians within the 10 randomized clinics were assigned to a training focused on a benefits strategy to recommending vaccines. These clinicians are associated with adolescent arms 4-6.
|
Clinician Arm 3 - Deferred Training
The clinicians within the 10 randomized clinics were assigned to a receive training after the study was concluded and thus serve as a control group. These clinicians are associated with adolescent arms 7-9.
|
Parent Arm 1: CL=Bundled Training and P=Bundled Text
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were sent text messages following the bundled strategy
|
Parent Arm 2: CL=Bundled Training and P=Benefits Text
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were sent text messages following the benefit strategy
|
Parent Arm 3: CL= Bundled Training and P=No Text
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were NOT sent text messages.
|
Parent Arm 4: CL= Benefits Training and P=Bundled Text
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were sent text messages following the bundled strategy.
|
Parent Arm 5: CL= Benefits Training and P=Benefits Text
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were sent text messages following the benefits strategy.
|
Parent Arm 6: CL= Benefits Training and P=No Text
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were NOT sent text messages
|
Parent Arm 7: CL= No Training and P=Bundled Text
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were sent text messages following the bundled strategy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
169
|
1
|
808
|
824
|
807
|
600
|
595
|
632
|
960
|
989
|
1019
|
21
|
17
|
21
|
136
|
129
|
4
|
61
|
64
|
6
|
180
|
|
Overall Study
COMPLETED
|
169
|
1
|
769
|
785
|
770
|
600
|
595
|
630
|
752
|
785
|
812
|
16
|
16
|
18
|
136
|
129
|
4
|
61
|
64
|
6
|
180
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
39
|
39
|
37
|
0
|
0
|
2
|
208
|
204
|
207
|
5
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Parent Arm 8: CL= No Training and P=Benefits Text
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were sent text messages following the benefits strategy.
|
Parent Arm 9: CL= No Training and P=No Text (Control Arm)
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were NOT sent text messages.
|
Adolescent Arm 1: CL=Bundled Training and P=Bundled Text
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 2: CL= Bundled Training and P=Benefits Text
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the benefit strategy.
|
Adolescent Arm 3: CL= Bundled Training and P=No Text
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were NOT sent text messages.
|
Adolescent Arm 4: CL= Benefits Training and P=Bundled Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 5: CL= Benefits Training and P=Benefits Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 6: CL= Benefits Training and P=No Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were NOT sent text messages
|
Adolescent Arm 7: CL= No Training and P=Bundled Text
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 8: CL= No Training and P=Benefits Text
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 9: CL= No Training and P=No Text (Control Arm)
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were NOT sent text messages.
|
Clinician Arm 1 - Bundled
The clinicians within the 10 randomized clinics were assigned to a training focused on a bundled strategy to recommending vaccines. These clinicians are associated with adolescent arms 1-3.
|
Clinician Arm 2- Benefits
The clinicians within the 10 randomized clinics were assigned to a training focused on a benefits strategy to recommending vaccines. These clinicians are associated with adolescent arms 4-6.
|
Clinician Arm 3 - Deferred Training
The clinicians within the 10 randomized clinics were assigned to a receive training after the study was concluded and thus serve as a control group. These clinicians are associated with adolescent arms 7-9.
|
Parent Arm 1: CL=Bundled Training and P=Bundled Text
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were sent text messages following the bundled strategy
|
Parent Arm 2: CL=Bundled Training and P=Benefits Text
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were sent text messages following the benefit strategy
|
Parent Arm 3: CL= Bundled Training and P=No Text
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were NOT sent text messages.
|
Parent Arm 4: CL= Benefits Training and P=Bundled Text
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were sent text messages following the bundled strategy.
|
Parent Arm 5: CL= Benefits Training and P=Benefits Text
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were sent text messages following the benefits strategy.
|
Parent Arm 6: CL= Benefits Training and P=No Text
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were NOT sent text messages
|
Parent Arm 7: CL= No Training and P=Bundled Text
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were sent text messages following the bundled strategy.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
39
|
39
|
37
|
0
|
0
|
0
|
208
|
204
|
207
|
3
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant changed clinics and arm assignment during the study
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Did not attend the training
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Age data were not collected for clinician participants.
Baseline characteristics by cohort
| Measure |
Parent Arm 4: CL= Benefits Training and P=Bundled Text
n=61 Participants
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were sent text messages following the bundled strategy.
|
Parent Arm 5: CL= Benefits Training and P=Benefits Text
n=64 Participants
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were sent text messages following the benefits strategy.
|
Parent Arm 6: CL= Benefits Training and P=No Text
n=6 Participants
For parents in this arm, their child's clinicians were trained in the benefits approach to vaccine recommendation and they were NOT sent text message
|
Parent Arm 7: CL= No Training and P=Bundled Text
n=180 Participants
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were sent text messages following the bundled strategy.
|
Parent Arm 8: CL= No Training and P=Benefits Text
n=169 Participants
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were sent text messages following the benefits strategy.
|
Parent Arm 9: CL= No Training and P=No Text (Control Arm)
n=1 Participants
For parents in this arm, their child's clinicians were NOT trained until the study was over and they were NOT sent text messages.
|
Total
n=8043 Participants
Total of all reporting groups
|
Adolescent Arm 1: CL= Bundled Training and P=Bundled Text
n=808 Participants
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the bundled strategy
|
Adolescent Arm 2: CL= Bundled Training and P=Benefits Text
n=824 Participants
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the benefit strategy.
|
Adolescent Arm 3: CL= Bundled Training and P=No Text
n=807 Participants
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were NOT sent text messages.
|
Adolescent Arm 4: CL= Benefits Training and P=Bundled Text
n=600 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 5: CL= Benefits Training and P=Benefits Text
n=595 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 6: CL= Benefits Training and P=No Text
n=632 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were NOT sent text messages
|
Adolescent Arm 7: CL= No Training and P=Bundled Text
n=960 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 8: CL= No Training and P=Benefits Text
n=989 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 9: CL= No Training and P=No Text (Control Arm)
n=1019 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were NOT sent text messages.
|
Clinician Arm 1 - Bundled
n=21 Participants
The clinicians within the 10 randomized clinics were assigned to a training focused on a bundled strategy to recommending vaccines. These clinicians are associated with adolescent arms 1-3.
|
Clinician Arm 2- Benefits
n=17 Participants
The clinicians within the 10 randomized clinics were assigned to a training focused on a benefits strategy to recommending vaccines. These clinicians are associated with adolescent arms 4-6.
|
Clinician Arm 3 - Deferred Training
n=21 Participants
The clinicians within the 10 randomized clinics were assigned to a receive training after the study was concluded and thus serve as a control group. These clinicians are associated with adolescent arms 7-9.
|
Parent Arm 1: CL= Bundled Training and P=Bundled Text
n=136 Participants
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were sent text messages following the bundled strategy
|
Parent Arm 2: CL=Bundled Training and P=Benefits Text
n=129 Participants
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were sent text messages following the benefit strategy
|
Parent Arm 3: CL= Bundled Training and P=No Text
n=4 Participants
For parents in this arm, their child's clinicians were training in the bundled approach to vaccine recommendation and they were NOT sent text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.7 Years
STANDARD_DEVIATION 6.4 • n=61 Participants • Age data were not collected for clinician participants.
|
40.2 Years
STANDARD_DEVIATION 6.9 • n=64 Participants • Age data were not collected for clinician participants.
|
44.7 Years
STANDARD_DEVIATION 8.9 • n=6 Participants • Age data were not collected for clinician participants.
|
39.8 Years
STANDARD_DEVIATION 8.4 • n=180 Participants • Age data were not collected for clinician participants.
|
39.3 Years
STANDARD_DEVIATION 7.6 • n=169 Participants • Age data were not collected for clinician participants.
|
36.0 Years
STANDARD_DEVIATION 0 • n=1 Participants • Age data were not collected for clinician participants.
|
10.6 Years
STANDARD_DEVIATION 0.7 • n=7984 Participants • Age data were not collected for clinician participants.
|
10.6 Years
STANDARD_DEVIATION 0.7 • n=808 Participants • Age data were not collected for clinician participants.
|
10.6 Years
STANDARD_DEVIATION 0.7 • n=824 Participants • Age data were not collected for clinician participants.
|
10.6 Years
STANDARD_DEVIATION 0.7 • n=807 Participants • Age data were not collected for clinician participants.
|
10.7 Years
STANDARD_DEVIATION 0.7 • n=600 Participants • Age data were not collected for clinician participants.
|
10.7 Years
STANDARD_DEVIATION 0.7 • n=595 Participants • Age data were not collected for clinician participants.
|
10.7 Years
STANDARD_DEVIATION 0.7 • n=632 Participants • Age data were not collected for clinician participants.
|
10.7 Years
STANDARD_DEVIATION 0.7 • n=960 Participants • Age data were not collected for clinician participants.
|
10.6 Years
STANDARD_DEVIATION 0.7 • n=989 Participants • Age data were not collected for clinician participants.
|
10.7 Years
STANDARD_DEVIATION 0.7 • n=1019 Participants • Age data were not collected for clinician participants.
|
—
|
—
|
—
|
39.6 Years
STANDARD_DEVIATION 7.1 • n=136 Participants • Age data were not collected for clinician participants.
|
40.4 Years
STANDARD_DEVIATION 8.0 • n=129 Participants • Age data were not collected for clinician participants.
|
43.0 Years
STANDARD_DEVIATION 1.4 • n=4 Participants • Age data were not collected for clinician participants.
|
|
Sex/Gender, Customized
Female
|
55 Participants
n=61 Participants
|
56 Participants
n=64 Participants
|
6 Participants
n=6 Participants
|
169 Participants
n=180 Participants
|
149 Participants
n=169 Participants
|
1 Participants
n=1 Participants
|
4207 Participants
n=8043 Participants
|
385 Participants
n=808 Participants
|
391 Participants
n=824 Participants
|
407 Participants
n=807 Participants
|
283 Participants
n=600 Participants
|
285 Participants
n=595 Participants
|
303 Participants
n=632 Participants
|
466 Participants
n=960 Participants
|
471 Participants
n=989 Participants
|
488 Participants
n=1019 Participants
|
16 Participants
n=21 Participants
|
12 Participants
n=17 Participants
|
16 Participants
n=21 Participants
|
127 Participants
n=136 Participants
|
117 Participants
n=129 Participants
|
4 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=61 Participants
|
7 Participants
n=64 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=180 Participants
|
18 Participants
n=169 Participants
|
0 Participants
n=1 Participants
|
3830 Participants
n=8043 Participants
|
423 Participants
n=808 Participants
|
433 Participants
n=824 Participants
|
400 Participants
n=807 Participants
|
317 Participants
n=600 Participants
|
310 Participants
n=595 Participants
|
329 Participants
n=632 Participants
|
494 Participants
n=960 Participants
|
518 Participants
n=989 Participants
|
531 Participants
n=1019 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=136 Participants
|
12 Participants
n=129 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=61 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=180 Participants
|
0 Participants
n=169 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8043 Participants
|
0 Participants
n=808 Participants
|
0 Participants
n=824 Participants
|
0 Participants
n=807 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=595 Participants
|
0 Participants
n=632 Participants
|
0 Participants
n=960 Participants
|
0 Participants
n=989 Participants
|
0 Participants
n=1019 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Did not answer
|
0 Participants
n=61 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=180 Participants
|
2 Participants
n=169 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=8043 Participants
|
0 Participants
n=808 Participants
|
0 Participants
n=824 Participants
|
0 Participants
n=807 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=595 Participants
|
0 Participants
n=632 Participants
|
0 Participants
n=960 Participants
|
0 Participants
n=989 Participants
|
0 Participants
n=1019 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic White
|
17 Participants
n=61 Participants
|
25 Participants
n=64 Participants
|
0 Participants
n=6 Participants
|
63 Participants
n=180 Participants
|
62 Participants
n=169 Participants
|
0 Participants
n=1 Participants
|
1534 Participants
n=8043 Participants
|
103 Participants
n=808 Participants
|
106 Participants
n=824 Participants
|
99 Participants
n=807 Participants
|
71 Participants
n=600 Participants
|
73 Participants
n=595 Participants
|
89 Participants
n=632 Participants
|
224 Participants
n=960 Participants
|
228 Participants
n=989 Participants
|
217 Participants
n=1019 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
70 Participants
n=136 Participants
|
64 Participants
n=129 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic Black
|
20 Participants
n=61 Participants
|
16 Participants
n=64 Participants
|
1 Participants
n=6 Participants
|
40 Participants
n=180 Participants
|
31 Participants
n=169 Participants
|
1 Participants
n=1 Participants
|
1166 Participants
n=8043 Participants
|
125 Participants
n=808 Participants
|
135 Participants
n=824 Participants
|
139 Participants
n=807 Participants
|
73 Participants
n=600 Participants
|
76 Participants
n=595 Participants
|
71 Participants
n=632 Participants
|
123 Participants
n=960 Participants
|
125 Participants
n=989 Participants
|
134 Participants
n=1019 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
22 Participants
n=136 Participants
|
29 Participants
n=129 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 Participants
n=61 Participants
|
17 Participants
n=64 Participants
|
4 Participants
n=6 Participants
|
66 Participants
n=180 Participants
|
60 Participants
n=169 Participants
|
0 Participants
n=1 Participants
|
1920 Participants
n=8043 Participants
|
151 Participants
n=808 Participants
|
160 Participants
n=824 Participants
|
159 Participants
n=807 Participants
|
120 Participants
n=600 Participants
|
104 Participants
n=595 Participants
|
117 Participants
n=632 Participants
|
278 Participants
n=960 Participants
|
297 Participants
n=989 Participants
|
287 Participants
n=1019 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=17 Participants
|
8 Participants
n=21 Participants
|
34 Participants
n=136 Participants
|
22 Participants
n=129 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=61 Participants
|
3 Participants
n=64 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=180 Participants
|
10 Participants
n=169 Participants
|
0 Participants
n=1 Participants
|
387 Participants
n=8043 Participants
|
32 Participants
n=808 Participants
|
34 Participants
n=824 Participants
|
27 Participants
n=807 Participants
|
31 Participants
n=600 Participants
|
37 Participants
n=595 Participants
|
38 Participants
n=632 Participants
|
41 Participants
n=960 Participants
|
45 Participants
n=989 Participants
|
49 Participants
n=1019 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=136 Participants
|
11 Participants
n=129 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=61 Participants
|
3 Participants
n=64 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=180 Participants
|
6 Participants
n=169 Participants
|
0 Participants
n=1 Participants
|
3036 Participants
n=8043 Participants
|
397 Participants
n=808 Participants
|
389 Participants
n=824 Participants
|
383 Participants
n=807 Participants
|
305 Participants
n=600 Participants
|
305 Participants
n=595 Participants
|
317 Participants
n=632 Participants
|
294 Participants
n=960 Participants
|
294 Participants
n=989 Participants
|
332 Participants
n=1019 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=136 Participants
|
3 Participants
n=129 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsBinary measure at the participant level of receipt of one or more does of the HPV vaccine. The percentage of participants is estimated with predicted probabilities to adjust for clustering at the clinic-level.
Outcome measures
| Measure |
Clinician Arm 2- Benefits
n=785 Participants
The clinicians within the 10 randomized clinics were assigned to a training focused on a benefits strategy to recommending vaccines. These clinicians are associated with adolescent arms 4-6.
|
Clinician Arm 3 - Deferred Training
n=770 Participants
The clinicians within the 10 randomized clinics were assigned to a receive training after the study was concluded and thus serve as a control group. These clinicians are associated with adolescent arms 7-9
|
Adolescent Arm 1: CL= Bundled Training and P=Bundled Text
n=769 Participants
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the bundled strategy
|
Adolescent Arm 4: CL= Benefits Training and P=Bundled Text
n=600 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 5: CL= Benefits Training and P=Benefits Text
n=595 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 6: CL= Benefits Training and P=No Text
n=630 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were NOT sent text messages.
|
Adolescent Arm 7: CL= No Training and P=Bundled Text
n=752 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 8: CL= No Training and P=Benefits Text
n=785 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 9: CL= No Training and P=No Text (Control Arm)
n=812 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were NOT sent text messages.
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|---|---|---|---|---|---|---|---|---|---|
|
Initiation of the HPV Vaccine
|
48.1 Percent of participants
Interval 40.8 to 56.8
|
44.4 Percent of participants
Interval 37.8 to 52.2
|
44.3 Percent of participants
Interval 37.3 to 52.6
|
44.8 Percent of participants
Interval 40.5 to 49.6
|
43.1 Percent of participants
Interval 35.7 to 52.1
|
44.8 Percent of participants
Interval 39.0 to 51.4
|
48.6 Percent of participants
Interval 39.8 to 59.5
|
48.5 Percent of participants
Interval 40.7 to 57.8
|
49.2 Percent of participants
Interval 40.0 to 60.4
|
PRIMARY outcome
Timeframe: 24 monthsBinary measure at the participant level of receipt of two or more doses of the HPV vaccine
Outcome measures
| Measure |
Clinician Arm 2- Benefits
n=785 Participants
The clinicians within the 10 randomized clinics were assigned to a training focused on a benefits strategy to recommending vaccines. These clinicians are associated with adolescent arms 4-6.
|
Clinician Arm 3 - Deferred Training
n=770 Participants
The clinicians within the 10 randomized clinics were assigned to a receive training after the study was concluded and thus serve as a control group. These clinicians are associated with adolescent arms 7-9
|
Adolescent Arm 1: CL= Bundled Training and P=Bundled Text
n=769 Participants
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the bundled strategy
|
Adolescent Arm 4: CL= Benefits Training and P=Bundled Text
n=600 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 5: CL= Benefits Training and P=Benefits Text
n=595 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 6: CL= Benefits Training and P=No Text
n=630 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were NOT sent text messages.
|
Adolescent Arm 7: CL= No Training and P=Bundled Text
n=752 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 8: CL= No Training and P=Benefits Text
n=785 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 9: CL= No Training and P=No Text (Control Arm)
n=812 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were NOT sent text messages.
|
|---|---|---|---|---|---|---|---|---|---|
|
Up to Date for the HPV Vaccine
|
9.9 Percent of participants
Interval 6.5 to 14.9
|
8.4 Percent of participants
Interval 5.3 to 13.4
|
7.8 Percent of participants
Interval 4.3 to 13.9
|
9.4 Percent of participants
Interval 6.4 to 13.9
|
6.4 Percent of participants
Interval 4.2 to 9.8
|
7.5 Percent of participants
Interval 4.4 to 12.9
|
13.2 Percent of participants
Interval 7.2 to 24.3
|
14.2 Percent of participants
Interval 8.8 to 23.1
|
11.6 Percent of participants
Interval 5.8 to 23.3
|
SECONDARY outcome
Timeframe: 12 monthsPercentage of visits for 11- to 12-year-old patient visits for which the provider reports recommending the HPV vaccine among completed surveys
Outcome measures
| Measure |
Clinician Arm 2- Benefits
n=16 Participants
The clinicians within the 10 randomized clinics were assigned to a training focused on a benefits strategy to recommending vaccines. These clinicians are associated with adolescent arms 4-6.
|
Clinician Arm 3 - Deferred Training
n=18 Participants
The clinicians within the 10 randomized clinics were assigned to a receive training after the study was concluded and thus serve as a control group. These clinicians are associated with adolescent arms 7-9
|
Adolescent Arm 1: CL= Bundled Training and P=Bundled Text
n=16 Participants
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the bundled strategy
|
Adolescent Arm 4: CL= Benefits Training and P=Bundled Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 5: CL= Benefits Training and P=Benefits Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 6: CL= Benefits Training and P=No Text
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were NOT sent text messages.
|
Adolescent Arm 7: CL= No Training and P=Bundled Text
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 8: CL= No Training and P=Benefits Text
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 9: CL= No Training and P=No Text (Control Arm)
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were NOT sent text messages.
|
|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Clinician Recommendation
|
89.8 % of time clinicians recommend HPV vac
Standard Deviation 16.5
|
90.6 % of time clinicians recommend HPV vac
Standard Deviation 15.5
|
94.7 % of time clinicians recommend HPV vac
Standard Deviation 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Upon receipt of text messagePopulation: The analysis population is limited to parents who reported that they remembered receiving a text message.
Among parents who remembered receiving the text message, the number who recommend all parents receive a similar text message.
Outcome measures
| Measure |
Clinician Arm 2- Benefits
n=106 Participants
The clinicians within the 10 randomized clinics were assigned to a training focused on a benefits strategy to recommending vaccines. These clinicians are associated with adolescent arms 4-6.
|
Clinician Arm 3 - Deferred Training
n=3 Participants
The clinicians within the 10 randomized clinics were assigned to a receive training after the study was concluded and thus serve as a control group. These clinicians are associated with adolescent arms 7-9
|
Adolescent Arm 1: CL= Bundled Training and P=Bundled Text
n=90 Participants
For adolescents in this arm, their clinicians were trained in the bundled approach to vaccine recommendation and parents were sent text messages following the bundled strategy
|
Adolescent Arm 4: CL= Benefits Training and P=Bundled Text
n=50 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 5: CL= Benefits Training and P=Benefits Text
n=51 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 6: CL= Benefits Training and P=No Text
n=2 Participants
For adolescents in this arm, their clinicians were trained in the benefits approach to vaccine recommendation and parents were NOT sent text messages.
|
Adolescent Arm 7: CL= No Training and P=Bundled Text
n=126 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the bundled strategy.
|
Adolescent Arm 8: CL= No Training and P=Benefits Text
n=131 Participants
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were sent text messages following the benefits strategy.
|
Adolescent Arm 9: CL= No Training and P=No Text (Control Arm)
For adolescents in this arm, their clinicians were NOT trained until the study was over and parents were NOT sent text messages.
|
|---|---|---|---|---|---|---|---|---|---|
|
Parent Text Message Acceptability
|
73 Number of parents
|
0 Number of parents
|
62 Number of parents
|
38 Number of parents
|
38 Number of parents
|
2 Number of parents
|
82 Number of parents
|
103 Number of parents
|
—
|
Adverse Events
Bundled Clinician Training and no Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Benefits Clinician Training and Bundled Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Benefits Clinician Training and Benefits Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Benefits Clinician Training and no Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deferred-clinician Training and Bundled Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deferred-clinician Training and Benefits Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deferred-clinician Training and no Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bundled Clinician Training and Bundled Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bundled Clinician Training and Benefits Text Messages
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place