Electronic Messaging to Increase Human Papillomavirus Vaccine Utilization and Adherence Among College Students
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Purpose
- The investigators hypothesize that students who receive the intervention will be more compliant at 3 months and at 7 months as compared to the control group.
- The investigators hypothesize that students that receive the intervention will demonstrate higher (20%) knowledge about human papillomavirus (HPV) and HPV vaccine as compared to the control group.
- The investigators hypothesize that African American students and younger students (defined as 18-19 years of age) will be less compliant as compared to Caucasian and older students (defined as students 20 and older) as demonstrated in the literature.
| Condition | Intervention | Phase |
|---|---|---|
|
Patient Compliance Health Knowledge, Attitudes, Practice |
Procedure: Electronic Message |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| 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. |
- Increase in HPV vaccine uptake among intervention group participants. [ Time Frame: One year ] [ Designated as safety issue: No ]To determine if electronic reminders coupled with electronic educational messaging can increase HPV vaccine use and adherence among college students in eastern North Carolina.
- Increase in HPV knowledge among intervention group participants [ Time Frame: One year ] [ Designated as safety issue: No ]To measure whether electronic health educational messaging increases HPV knowledge among college students in eastern North Carolina.
- Compliance rates among Race/ethnicity and other socio-demographic characteristics. [ Time Frame: One year ] [ Designated as safety issue: No ]We hypothesize that African American students and younger students (defined as 18-19 years of age) will be less compliant as compared to Caucasian and older students (defined as students 20 and older) as demonstrated in the literature. Items measuring race/ethnicity and socio-demographic variables will be included on baseline and follow-up surveys. We will assess whether these variables predict vaccine adherence among study participants.
| Estimated Enrollment: | 270 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Electronic Messages |
Procedure: Electronic Message
Students enrolled in the intervention group will receive 8 electronic contacts over a 7 month period. Specifically participants will receive 4 electronic education messages, 2 electronic reminder/education messages as well as 1 baseline & 1 final assessment contacts. Up to 2 reminder contacts will be used if surveys are not completed for both intervention and control group participants. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment. Up to 2 reminder contacts will be used if surveys are not completed. Intervention & control groups will be compared longitudinally for 7 months on the differences in HPV vaccine utilization and adherence, knowledge and attitudes about HPV, and the HPV vaccine (parallel design).
|
| Active Comparator: Gardasil |
Procedure: Electronic Message
Students enrolled in the intervention group will receive 8 electronic contacts over a 7 month period. Specifically participants will receive 4 electronic education messages, 2 electronic reminder/education messages as well as 1 baseline & 1 final assessment contacts. Up to 2 reminder contacts will be used if surveys are not completed for both intervention and control group participants. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment. Up to 2 reminder contacts will be used if surveys are not completed. Intervention & control groups will be compared longitudinally for 7 months on the differences in HPV vaccine utilization and adherence, knowledge and attitudes about HPV, and the HPV vaccine (parallel design).
|
Detailed Description:
Oncogenic types of human papillomavirus (HPV) infection cause cervical cancer, with HPV types 16 and 18 causing about 70% of cervical cancers worldwide. 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 sexes. HPV vaccines prevent infection with types 16 and 18 and one of the vaccines (HPV4) prevents infection with two additional types that account for 90% of cases of genital warts. Although vaccination against cancer is a significant breakthrough, uptake is low. The National Immunization Survey—Teen (NIS-teen) estimated that in 2009, HPV vaccination coverage for 13-17 year-olds was 26.7%. Although vaccination coverage for teens is increasing over time, only a little over a quarter of teens are completing required doses. However, the NIS-adult study showed that only 10-12% of 18-26 year-old women are completing the HPV vaccine series. Additionally, studies have found significantly lower completion rates among African Americans. This is problematic given the racial disparity in cervical cancer where African American women have higher rates of cervical cancer mortality as compared to Caucasian women. Given the importance of immunizing young adults for the prevention of cancer and given the low uptake of the HPV vaccine in this group, it is important to develop and evaluate strategies to increase use and adherence among this population. The investigators propose to conduct an experiment to understand whether electronic (text and/or email) reminders of scheduled appointment times coupled with electronic health educational messaging about HPV and the HPV vaccine can increase HPV vaccine utilization, adherence, and knowledge among college students (both female and male) attending a large college in eastern North Carolina.
Eligibility| Ages Eligible for Study: | 18 Years to 26 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male & Female Students enrolled at East Carolina University (ECU)
Exclusion Criteria:
- Non-English speaking students
- Students under the age of 18 or over 26
- Individuals not enrolled at ECU
Contacts and Locations| Contact: Christina T Tyler, BA | 252-328-4817 | tylerc10@students.ecu.edu |
| Contact: Alice R Richman, PhD | 252-328-6431 | Richmana@ecu.edu |
| United States, North Carolina | |
| East Carolina University Student Health Services | Recruiting |
| Greenville, North Carolina, United States, 27858 | |
| Contact: Alice R Richman, PhD 252-328-6431 Richmana@ecu.edu | |
| Contact: Christina T Tyler, BA 252-328-4817 tylerc10@students.ecu.edu | |
| Principal Investigator: Alice R Richman, PhD, MPH | |
| Sub-Investigator: Sloane Burke, PhD, MS | |
| Principal Investigator: | Alice R Richman, PhD | East Carolina University |
More Information
No publications provided
| Responsible Party: | Dr. Alice Richman, Assistant Professor, East Carolina University |
| ClinicalTrials.gov Identifier: | NCT01568515 History of Changes |
| Other Study ID Numbers: | MISP-39631 |
| Study First Received: | March 22, 2012 |
| Last Updated: | March 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by East Carolina University:
|
HPV vaccine Vaccine adherence Vaccine utilization Electronic Messaging |
ClinicalTrials.gov processed this record on May 16, 2013