Trial Outcomes & Findings for Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors (NCT NCT04469569)

NCT ID: NCT04469569

Last Updated: 2026-08-03

Results Overview

The primary outcome was the percentage of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the study year, and who had initiated the HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8120 participants

Primary outcome timeframe

The survivor must have initiated the HPV vaccine as of the final day of the study year

Results posted on

2026-08-03

Participant Flow

Patients included all cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit at one of the sites during at least one study year, resided in the state where the clinic is located, and had a record in the state vaccine registry were included. Providers included all healthcare providers licensed to order vaccines who were caring for cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy at one of the sites during at least one study year

Patients who continued to meet inclusion criteria were included in each study year during which they completed at least one clinic visit at a participating site. Healthcare providers who continued to meet inclusion criteria were invited to participate in each study year during which they continued to care for cancer survivors at a participating site

Participant milestones

Participant milestones
Measure
Early Intervention - Site D
Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4
Early Intervention - Site E
Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4
Early Intervention - Site F
Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4
Delayed Intervention - Site A
Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4
Delayed Intervention - Site B
Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4
Delayed Intervention - Site C
Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned 24 months pre-intervention, followed by 12 months intervention, followed by 12 months sustainability.
Year 1
STARTED
358
221
88
575
478
104
Year 1
Patients
337
211
73
560
471
99
Year 1
Providers
21
10
15
15
7
5
Year 1
COMPLETED
358
221
88
575
478
104
Year 1
NOT COMPLETED
0
0
0
0
0
0
Year 2
STARTED
363
229
76
606
614
151
Year 2
Patients
343
219
66
587
606
146
Year 2
Providers
20
10
10
19
8
5
Year 2
COMPLETED
363
229
76
606
614
151
Year 2
NOT COMPLETED
0
0
0
0
0
0
Year 3
STARTED
380
249
89
620
634
177
Year 3
Patients
361
243
76
606
625
170
Year 3
Providers
19
6
13
14
9
7
Year 3
COMPLETED
380
249
89
620
634
177
Year 3
NOT COMPLETED
0
0
0
0
0
0
Year 4
STARTED
368
278
97
585
620
160
Year 4
Patients
355
273
81
571
612
154
Year 4
Providers
13
5
16
14
8
6
Year 4
COMPLETED
368
278
97
585
620
160
Year 4
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This baseline measure represents the mean (standard deviation) age of survivors only at study entry.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pre-Intervention
n=3195 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed at least one clinic visit at one of the six participating sites during Study Year 1, and those at three sites randomized to Group 2 who completed at least one clinic visit during Study Year 2, resided in the state where the clinic is located, and had a record in the state vaccine registry were included. All healthcare providers licensed to order vaccines and who were caring for cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy at one of the participating sites during Study Year 1, and those at sites randomized to Group 2 during Study Year 2, who had agreed to participate in the study, were included in the Pre-intervention portion of the analysis.
Intervention
n=2099 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 2, and at sites randomized to Group 2 who completed at least one clinic visit during Study Year 3, resided in the state where the clinic is located, and had a record in the state vaccine registry were included. All healthcare providers licensed to order vaccines and who were caring for cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 during Study Year 2, and at sites randomized to Group 2 during Study Year 3, who had agreed to participate in the study, were included in the Intervention portion of the analysis.
Sustainability
n=2826 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 3, and at sites randomized to Group 1 or 2 who completed at least one clinic visit during Study Year 4, resided in the state where the clinic is located, and had a record in the state vaccine registry were included. All healthcare providers licensed to order vaccines and who were caring for cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 during Study Year 3, and at sites randomized to Group 1 or 2 during Study Year 4, who had agreed to participate in the study, were included in the Sustainability portion of the analysis.
Total
n=8120 Participants
Total of all reporting groups
Age, Continuous
13.29 years
STANDARD_DEVIATION 2.54 • n=3090 Participants • This baseline measure represents the mean (standard deviation) age of survivors only at study entry.
12.7 years
STANDARD_DEVIATION 2.48 • n=2029 Participants • This baseline measure represents the mean (standard deviation) age of survivors only at study entry.
12.21 years
STANDARD_DEVIATION 2.43 • n=2726 Participants • This baseline measure represents the mean (standard deviation) age of survivors only at study entry.
12.76 years
STANDARD_DEVIATION 2.53 • n=7845 Participants • This baseline measure represents the mean (standard deviation) age of survivors only at study entry.
Age, Customized
Less than 30 years
7 Participants
n=105 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
2 Participants
n=70 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
3 Participants
n=100 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
12 Participants
n=275 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
Age, Customized
30-39 years
39 Participants
n=105 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
30 Participants
n=70 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
41 Participants
n=100 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
110 Participants
n=275 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
Age, Customized
40-49 years
36 Participants
n=105 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
23 Participants
n=70 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
27 Participants
n=100 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
86 Participants
n=275 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
Age, Customized
50-59 years
10 Participants
n=105 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
8 Participants
n=70 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
16 Participants
n=100 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
34 Participants
n=275 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
Age, Customized
60 years and older
13 Participants
n=105 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
7 Participants
n=70 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
13 Participants
n=100 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
33 Participants
n=275 Participants • This baseline measure represents the number providers only by categorical age (\<30 years, 30-39 years, 40-49 years, 50-59 years, 60 years and older) at study entry.
Sex: Female, Male
Female
1370 Participants
n=3090 Participants • This baseline measure represents the count of survivors only by sex at study entry.
895 Participants
n=2029 Participants • This baseline measure represents the count of survivors only by sex at study entry.
1227 Participants
n=2726 Participants • This baseline measure represents the count of survivors only by sex at study entry.
3492 Participants
n=7845 Participants • This baseline measure represents the count of survivors only by sex at study entry.
Sex: Female, Male
Male
1720 Participants
n=3090 Participants • This baseline measure represents the count of survivors only by sex at study entry.
1134 Participants
n=2029 Participants • This baseline measure represents the count of survivors only by sex at study entry.
1499 Participants
n=2726 Participants • This baseline measure represents the count of survivors only by sex at study entry.
4353 Participants
n=7845 Participants • This baseline measure represents the count of survivors only by sex at study entry.
Sex/Gender, Customized
Sex/Gender, Customized · Female
75 Participants
n=105 Participants • This baseline measure represents the count of providers only by sex at study entry.
48 Participants
n=70 Participants • This baseline measure represents the count of providers only by sex at study entry.
69 Participants
n=100 Participants • This baseline measure represents the count of providers only by sex at study entry.
192 Participants
n=275 Participants • This baseline measure represents the count of providers only by sex at study entry.
Sex/Gender, Customized
Sex/Gender, Customized · Male
30 Participants
n=105 Participants • This baseline measure represents the count of providers only by sex at study entry.
22 Participants
n=70 Participants • This baseline measure represents the count of providers only by sex at study entry.
30 Participants
n=100 Participants • This baseline measure represents the count of providers only by sex at study entry.
82 Participants
n=275 Participants • This baseline measure represents the count of providers only by sex at study entry.
Sex/Gender, Customized
Sex/Gender, Customized · Missing
0 Participants
n=105 Participants • This baseline measure represents the count of providers only by sex at study entry.
0 Participants
n=70 Participants • This baseline measure represents the count of providers only by sex at study entry.
1 Participants
n=100 Participants • This baseline measure represents the count of providers only by sex at study entry.
1 Participants
n=275 Participants • This baseline measure represents the count of providers only by sex at study entry.
Race/Ethnicity, Customized
Hispanic
6 Participants
n=105 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
3 Participants
n=70 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
5 Participants
n=100 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
14 Participants
n=275 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
Race/Ethnicity, Customized
Non-Hispanic White
86 Participants
n=105 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
59 Participants
n=70 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
79 Participants
n=100 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
224 Participants
n=275 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
Race/Ethnicity, Customized
Non-Hispanic Black
1 Participants
n=105 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
0 Participants
n=70 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
1 Participants
n=100 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
2 Participants
n=275 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
Race/Ethnicity, Customized
Non-Hispanic Other
11 Participants
n=105 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
6 Participants
n=70 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
13 Participants
n=100 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
30 Participants
n=275 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
Race/Ethnicity, Customized
Missing
1 Participants
n=105 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
2 Participants
n=70 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
2 Participants
n=100 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry
5 Participants
n=275 Participants • This baseline measure represents the number of providers only by race/ethnicity (Hispanic, non-Hispanic White, non-Hispanic Black, Non-Hispanic Other, Missing) at study entry

PRIMARY outcome

Timeframe: The survivor must have initiated the HPV vaccine as of the final day of the study year

The primary outcome was the percentage of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the study year, and who had initiated the HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records.

Outcome measures

Outcome measures
Measure
Pre-Intervention
n=3090 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed at least one clinic visit at one of the six participating sites during Study Year 1, and those at three sites randomized to Group 2 who completed at least one clinic visit during Study Year 2, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Intervention
n=2029 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 2, and at sites randomized to Group 2 who completed at least one clinic visit during Study Year 3, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Sustainability
n=2726 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 3, and at sites randomized to Group 1 or 2 who completed at least one clinic visit during Study Year 4, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
HPV Vaccine Initiation Rates
52.2 Percentage
61.8 Percentage
62.2 Percentage

SECONDARY outcome

Timeframe: Qualitative interviews: Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F, and Year 3 for sites A, B, C); Quantitative survey: Administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.

Descriptive statistics summarizing provider survey data and qualititatively coded provider interview data were integrated to evaluate the feasability, acceptability, and appropriateness of the HPV-PROTECT intervention to the pediatric oncology setting, and provider adherence (fidelity) to intervention components. Quantitative item: Change in healthcare provider practice of recommending HPV vaccine to their patients (item 13c): Percentage of participants reporting "often/always"

Outcome measures

Outcome measures
Measure
Pre-Intervention
n=105 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed at least one clinic visit at one of the six participating sites during Study Year 1, and those at three sites randomized to Group 2 who completed at least one clinic visit during Study Year 2, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Intervention
n=70 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 2, and at sites randomized to Group 2 who completed at least one clinic visit during Study Year 3, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Sustainability
n=100 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 3, and at sites randomized to Group 1 or 2 who completed at least one clinic visit during Study Year 4, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Provider Perspectives Regarding Intervention Feasibility, Acceptability, Appropriateness, Fidelity
42.16 Percentage reporting "often/always"
1.4
75.38 Percentage reporting "often/always"
.91
72.63 Percentage reporting "often/always"
.88

SECONDARY outcome

Timeframe: Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.

Change in healthcare provider HPV and HPV vaccine-related knowledge, as measured quantitatively via 16 survey items, and reported as a combined mean score of proportion of items answered correctly (lowest possible mean score: 0; highest possible mean score: 1.0). A higher score indicates more HPV vaccine-related knowledge.

Outcome measures

Outcome measures
Measure
Pre-Intervention
n=105 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed at least one clinic visit at one of the six participating sites during Study Year 1, and those at three sites randomized to Group 2 who completed at least one clinic visit during Study Year 2, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Intervention
n=70 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 2, and at sites randomized to Group 2 who completed at least one clinic visit during Study Year 3, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Sustainability
n=100 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 3, and at sites randomized to Group 1 or 2 who completed at least one clinic visit during Study Year 4, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Change in Provider HPV Vaccine-related Knowledge
.72 Score on a scale
Standard Deviation .15
.80 Score on a scale
Standard Deviation .10
.79 Score on a scale
Standard Deviation .11

SECONDARY outcome

Timeframe: Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.

Change in HPV vaccine-related practices, as measured by the mean score +/- standard deviation of the healthcare provider survey responses to the following items: (a) "I order the HPV vaccine to be given to my patients in the pediatric oncology clinic" and (b) "I check to make sure that my patients complete the HPV vaccine series." Each of these two items were rated by the providers using a Likert scale with the lowest possible score of 1 ("Never") and the highest possible score of 5 ("Always"). Outcomes are reported as the Mean and Standard Deviation of the Likert scale score for each of these two survey items.

Outcome measures

Outcome measures
Measure
Pre-Intervention
n=105 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed at least one clinic visit at one of the six participating sites during Study Year 1, and those at three sites randomized to Group 2 who completed at least one clinic visit during Study Year 2, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Intervention
n=70 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 2, and at sites randomized to Group 2 who completed at least one clinic visit during Study Year 3, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Sustainability
n=100 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 3, and at sites randomized to Group 1 or 2 who completed at least one clinic visit during Study Year 4, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Change in Provider HPV Vaccine-related Practices
Mean/SD score: I order the HPV vaccine to be given to my patients in the peds oncology clinic
1.66 Score on a scale
Standard Deviation 1.11
2.55 Score on a scale
Standard Deviation 1.46
2.58 Score on a scale
Standard Deviation 1.31
Change in Provider HPV Vaccine-related Practices
Mean/SD score: I check to make sure that my patients complete the HPV vaccine series
2.31 Score on a scale
Standard Deviation 1.30
3.42 Score on a scale
Standard Deviation 1.04
3.28 Score on a scale
Standard Deviation 0.98

OTHER_PRE_SPECIFIED outcome

Timeframe: The survivor must have completed the 3-dose HPV vaccine series as of the final day of the study year

The percentage of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the study year, and who had completed the 3-dose HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records.

Outcome measures

Outcome measures
Measure
Pre-Intervention
n=3090 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed at least one clinic visit at one of the six participating sites during Study Year 1, and those at three sites randomized to Group 2 who completed at least one clinic visit during Study Year 2, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Intervention
n=2029 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 2, and at sites randomized to Group 2 who completed at least one clinic visit during Study Year 3, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Sustainability
n=2726 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 3, and at sites randomized to Group 1 or 2 who completed at least one clinic visit during Study Year 4, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
HPV Vaccine Series Completion Rates
6.6 Percentage
15.4 Percentage
21.2 Percentage

OTHER_PRE_SPECIFIED outcome

Timeframe: The survivor must have initiated the HPV vaccine as of the final day of the study year

Population: This outcome only applies to the Sustainability condition.

The percentage of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the study year, and who had initiated the HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records. Applies only to the Sustainability condition.

Outcome measures

Outcome measures
Measure
Pre-Intervention
n=2726 Participants
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed at least one clinic visit at one of the six participating sites during Study Year 1, and those at three sites randomized to Group 2 who completed at least one clinic visit during Study Year 2, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Intervention
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 2, and at sites randomized to Group 2 who completed at least one clinic visit during Study Year 3, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Sustainability
All cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, at sites randomized to Group 1 who completed at least one clinic visit during Study Year 3, and at sites randomized to Group 1 or 2 who completed at least one clinic visit during Study Year 4, resided in the state where the clinic is located, and had a record in the state vaccine registry were included.
Sustainability of HPV Vaccine Initiation Rates
62.2 Percentage

Adverse Events

Pre-Intervention (Healthcare Providers)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention (Healthcare Providers)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sustainability (Healthcare Providers)

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

Wendy Landier, PhD, CRNP

University of Alabama at Birmingham

Phone: (205) 638-2120

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place