Trial Outcomes & Findings for Healthy, Immunized Communities Study (NCT NCT03854734)
NCT ID: NCT03854734
Last Updated: 2024-07-12
Results Overview
Parental intent to vaccinate their adolescent child with Tdap, MCV, and HPV vaccines, was dichotomized for each vaccine in the survey. Tdap and MCV included the options 1) intention to vaccinate/vaccinated ("plan to get this shot before the first day of 7th grade" or "up-to-date with this shot") or 2) no intention to vaccinate ("no plans to get this shot" or "have or plan to submit an exemption for this shot"). The HPV variable excluded the option "have or plan to submit an exemption for this shot" as vaccine is not required for school entry. Variables (Tdap, MCV, HPV) were compared within and between treatment groups from baseline to 6 mo. follow up with a generalized estimating equations model using the framework of a log-binomial logistic regression model. Risk ratios resulting from these models were used to quantify the magnitude and direction of any significant differences.
COMPLETED
NA
148 participants
Participants were assessed at baseline and follow-up at 6 months.
2024-07-12
Participant Flow
Recruitment occurred between February and September 2019. Participants were recruited through the participating school partner, who distributed a recruitment flyer via email and through social media channels. Participants were also recruited through in-person events at the participating schools, such as chorus concerts and parent-teacher conferences.
Four schools were randomized to two arms (intervention vs. control). 502 individuals were assessed for eligibility and 354 were excluded for not meeting inclusion criteria (n=265) or declining to participate (n=89).
Unit of analysis: Schools
Participant milestones
| Measure |
Usual Care
Educational emails about broad health topics to keep control group engaged
|
Multi-Component Intervention
(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material
Community Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
Educational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants
|
|---|---|---|
|
Overall Study
STARTED
|
70 2
|
78 2
|
|
Overall Study
COMPLETED
|
70 2
|
78 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy, Immunized Communities Study
Baseline characteristics by cohort
| Measure |
Usual Care
n=70 Participants
Educational emails about broad health topics to keep control group engaged
|
Multi-Component Intervention
n=78 Participants
(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material
Community Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
Educational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.00 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
40.46 years
STANDARD_DEVIATION 8.59 • n=7 Participants
|
39.32 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
57 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · No response
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
32 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · No response
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Relationship Status
Single OR separated OR divorced OR widowed
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Relationship Status
Married OR living with partner
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Relationship Status
No response
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Annual household income
≤$40,000
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Annual household income
$40,001 - $80,000
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Annual household income
>$80,000
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Annual household income
No Response
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
High School or Less
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Education
Some College
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Education
College Graduate
|
20 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Education
No response
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Relationship to child
Mother
|
56 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Relationship to child
Father
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Relationship to child
Guardian/Grandparent
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Grade of child
6th
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Grade of child
7th
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Grade of child
8th
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Gender of child
Male
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Gender of child
Female
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Parent participation in school events per year
≤1
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Parent participation in school events per year
2-5
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Parent participation in school events per year
≥6
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Parent participation in school events per year
No response
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were assessed at baseline and follow-up at 6 months.Population: 4 middle schools were randomized to either a usual care or multi-component intervention arm. Participants (parents) were assigned to a study arm based on their associated middle school. 30 participants either did not complete the follow up survey (n=27) or did not answer all questions (n=3), as questions were not required. Discrepancies in percentage reporting in the outcomes table below results from inconsistent rates of missingess (range 0-4) across variables (Tdap, MCV, HPV).
Parental intent to vaccinate their adolescent child with Tdap, MCV, and HPV vaccines, was dichotomized for each vaccine in the survey. Tdap and MCV included the options 1) intention to vaccinate/vaccinated ("plan to get this shot before the first day of 7th grade" or "up-to-date with this shot") or 2) no intention to vaccinate ("no plans to get this shot" or "have or plan to submit an exemption for this shot"). The HPV variable excluded the option "have or plan to submit an exemption for this shot" as vaccine is not required for school entry. Variables (Tdap, MCV, HPV) were compared within and between treatment groups from baseline to 6 mo. follow up with a generalized estimating equations model using the framework of a log-binomial logistic regression model. Risk ratios resulting from these models were used to quantify the magnitude and direction of any significant differences.
Outcome measures
| Measure |
Usual Care
n=2 Middle Schools
Educational emails about broad health topics to keep control group engaged
|
Multi-Component Intervention
n=2 Middle Schools
(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material
Community Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
Educational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants
|
|---|---|---|
|
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at baseline
|
74.3 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at follow-up
|
97.9 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Meningococcal conjugate vaccine (MCV) : Vaccine intention at baseline
|
72.9 percentage of participants
|
80.5 percentage of participants
|
|
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Meningococcal conjugate vaccine (MCV) : Vaccine intention at follow-up
|
91.5 percentage of participants
|
91.6 percentage of participants
|
|
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Human papillomavirus (HPV) : Vaccine intention at baseline
|
84.1 percentage of participants
|
84.4 percentage of participants
|
|
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Human papillomavirus (HPV) : Vaccine intention at follow-up
|
85.7 percentage of participants
|
87.3 percentage of participants
|
Adverse Events
Usual Care
Multi-Component Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Kraschnewski, Professor of Medicine and Public Health Sciences
Penn State College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place