Electronic Messaging to Increase Human Papillomavirus Vaccine Utilization and Adherence Among College Students

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by East Carolina University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Alice Richman, East Carolina University
ClinicalTrials.gov Identifier:
NCT01568515
First received: March 22, 2012
Last updated: March 29, 2012
Last verified: March 2012
  Purpose
  1. 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.
  2. 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.
  3. 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.

Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568515

Contacts
Contact: Christina T Tyler, BA 252-328-4817 tylerc10@students.ecu.edu
Contact: Alice R Richman, PhD 252-328-6431 Richmana@ecu.edu

Locations
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         
Sponsors and Collaborators
East Carolina University
Merck Sharp & Dohme Corp.
Investigators
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 October 22, 2014