Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01568515
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2012-03-22
Brief Title:
Electronic Messaging to Increase Human Papillomavirus Vaccine Utilization and Adherence Among College Students
Sponsor:
East Carolina University
Organization:
East Carolina University
Study Overview
Official Title:
A Randomized Longitudinal Intervention Study to Assess Whether Electronic Messaging Can Increase HPV Vaccine Utilization and Adherence Among College Students in Eastern North Carolina
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Although vaccination against HPV and subsequent HPV-related cancers is a significant breakthrough uptake is low We sought to understand whether a low-cost intervention of electronic text andor email appointment reminders coupled with electronic health educational messaging about HPV and the HPV vaccine could increase HPV vaccine uptake and knowledge among college students
Methods Study participants included both female and male English speaking students between the ages of 18-26 who attended a large university in North Carolina Students were randomized to the intervention or control group Intervention group participants received the electronic messaging while the control group received standard of care at the student health center across a 7-month study period Baseline and follow-up survey data was collected Main outcome measures were completion of HPV-2 and HPV-3 and HPV and HPV vaccine knowledge Study recruitment ran from August 2011 to December 2013
Results Completion rates for the intervention and control group were similar for HPV-2 53 vs 52 and HPV-3 34 vs 32 respectively The mean knowledge score at follow-up for intervention group participants n44 mean knowledge score 93 SD 008 was significantly higher p001 than the mean knowledge score at baseline n44 mean knowledge score 87 SD 011 No significant changes in knowledge from baseline to follow-up were found for control group participants The single most important predictor of HPV vaccine uptake overall was female gender where female participants were 235 times confidence interval CI 117-469 as likely to complete the series as compared to male participants
Conclusion In this sample of college students the electronic messaging intervention increased knowledge but not uptake More randomized controlled trials on the efficacy of HPV vaccine electronic reminder interventions for catch-up age populations for both females and males are needed
Methods Study participants included both female and male English speaking students between the ages of 18-26 who attended a large university in North Carolina Students were randomized to the intervention or control group Intervention group participants received the electronic messaging while the control group received standard of care at the student health center across a 7-month study period Baseline and follow-up survey data was collected Main outcome measures were completion of HPV-2 and HPV-3 and HPV and HPV vaccine knowledge Study recruitment ran from August 2011 to December 2013
Results Completion rates for the intervention and control group were similar for HPV-2 53 vs 52 and HPV-3 34 vs 32 respectively The mean knowledge score at follow-up for intervention group participants n44 mean knowledge score 93 SD 008 was significantly higher p001 than the mean knowledge score at baseline n44 mean knowledge score 87 SD 011 No significant changes in knowledge from baseline to follow-up were found for control group participants The single most important predictor of HPV vaccine uptake overall was female gender where female participants were 235 times confidence interval CI 117-469 as likely to complete the series as compared to male participants
Conclusion In this sample of college students the electronic messaging intervention increased knowledge but not uptake More randomized controlled trials on the efficacy of HPV vaccine electronic reminder interventions for catch-up age populations for both females and males are needed
Detailed Description:
Oncogenic types of human papillomavirus HPV infection can cause cervical cancer with HPV types 16 and 18 causing roughly 70 of cervical cancers worldwide1 Persistent HPV infection has also been linked to vaginal and vulvar cancer in women penile cancer in men as well as oral pharyngeal cancer anal cancer and genital warts in both sexes2-4 There are two safe and effective vaccines which protect against HPV types 16 and 18 and one of the two vaccines HPV4 also protects against two additional HPV types that account for 90 of the cases of genital warts5 Because HPV vaccination provides maximum protection if administered prior to sexual debut HPV4 guidelines recommend administration to males and females ages 11 and 12 with catch-up vaccination up to age 26 for the prevention of cervical and anal cancers as well as for the prevention of genital warts15-8 Although vaccination against HPV-related cancers is a significant breakthrough uptake is low The National Immunization Survey-Teen NIS-teen estimated that in 2013 HPV vaccination coverage for 13-17 year-old females was 376 while for males in the same age group coverage was 139 Additionally coverage for 13-17 year-old females dropped slightly between 2011 and 20129 Although vaccination coverage for teens has been increasing over time overall these rates are far from meeting the Healthy People 2020 goal of 80 of 13-15 year old females being fully vaccinated against HPV by 2020 In addition to teens it has been shown that there is a benefit to providing HPV vaccines to young adults even those who have already been sexually active However an NIS-adult study showed that only 10-12 of 18-26 year-old women are completing the HPV vaccine series10 Additionally studies have found significantly lower completion rates among African Americans911-12 This is problematic given that African American women demonstrate a mortality rate from cervical cancer that is twice that of Caucasian women13 It has also been suggested that lack of knowledge may be a barrier to vaccine adherence14 and that educational interventions may increase adherence among 18-26 year-old women12 Given the importance of immunizing young adults for the prevention of cancer and given the low uptake of HPV vaccines in this group it is important to develop and evaluate strategies to increase use and adherence among this population We sought to understand whether a low-cost intervention of electronic text andor email appointment reminders coupled with electronic health educational messaging about HPV and the HPV vaccine could increase HPV vaccine utilization adherence and knowledge among college students both female and male attending a large university in eastern North Carolina Although we only found one peer-reviewed study that assessed text and email electronic HPV reminders primarily among adolescents we found a few other studies that assessed mail and telephone HPV vaccination reminders among adolescents All of these studies found vaccination reminders to be effective in increasing adherence among adolescents andor young adults15-17 Hard copy and electronic messaging reminders have also proven to be effective when coupled with other prevention strategies such as immunizations for influenza and pneumococcal pneumonia as well as screening for colon breast and cervical cancer in adults18 We found no literature that tested electronic HPV vaccine interventions among a college population
Our primary hypothesis was that students who receive the intervention would be more compliant in their uptake of the second HPV-2 and third HPV-3 doses of the vaccine as compared to the control group Secondarily we further hypothesized that students that receive the intervention will demonstrate higher knowledge about HPV and the HPV vaccine as compared to the control group and that African American students and younger students defined as 18-19 years of age would be less compliant as compared to Caucasian and older students defined as students 20 and older as demonstrated in the literature Lastly we sought to describe satisfaction of health messages and reminders among those that received it
Our primary hypothesis was that students who receive the intervention would be more compliant in their uptake of the second HPV-2 and third HPV-3 doses of the vaccine as compared to the control group Secondarily we further hypothesized that students that receive the intervention will demonstrate higher knowledge about HPV and the HPV vaccine as compared to the control group and that African American students and younger students defined as 18-19 years of age would be less compliant as compared to Caucasian and older students defined as students 20 and older as demonstrated in the literature Lastly we sought to describe satisfaction of health messages and reminders among those that received it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None