- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759236
Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging
Background: Prevention of cervical cancer and genital warts could be achieved by immunization with the prophylactic human papillomavirus (HPV) vaccines commercially available. However, in the U.S. only 38% of females and 14% of males in the recommended age group (9-26 years) receive the complete, three-dose HPV vaccine. Because the HPV vaccine is covered under the Vaccine for Children Program, the underinsured and uninsured have no-cost access. Nonetheless, data from Los Angeles county suggest that HPV vaccination rates among the uninsured and underinsured groups are significantly lower than the national average, likely related to knowledge of the vaccine, transportation, number of doses and concern of side effects.
Aim: To evaluate the efficacy of health oriented text messaging to increase HPV vaccine uptake versus standard health messaging (Center for Disease Control and Prevention (CDC) HPV vaccine information flyers).
Hypothesis: The investigators hypothesize that receiving general health messaging, including messages regarding the benefits of the HPV vaccine, will increase HPV vaccine uptake. Text messaging will also be more successful in reaching the uninsured and underinsured populations than will traditional flyers/information pamphlets used in clinics.
Methods: A cluster randomized trial design will be used to recruit participants from four clinics in Los Angeles County which offer pediatric vaccination to uninsured and underinsured children. The sample will include women aged 18-45 years of age. Two of the sites will be randomized to the text messaging arm and the other clinic will be randomized to the control arm (standard messaging: CDC flyers and pamphlets available for patients at the clinic). Outcome measures will be HPV vaccinations rates at those clinics. Rates will be defined into groups who received 1 dose, 2 doses and 3 doses.
Anticipated Results: The investigators expect to find statistically significant higher HPV vaccination rates among children and women in the text messaging study arm compared to the control arm.
Implications and Future Studies: This pilot study will give us preliminary data to submit a larger randomized controlled trial to examine the efficacy of text messaging.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prevention of cervical cancer and genital warts could be achieved by immunization with the prophylactic human papillomavirus (HPV) vaccines commercially available. However, in the U.S. only 38% of females and 14% of males in the recommended age group (9-26 years) receive the complete, three-dose HPV vaccine. Because the HPV vaccine is covered under the Vaccine for Children Program, the underinsured and uninsured have no-cost access. Nonetheless, data from Los Angeles county suggest that HPV vaccination rates among the uninsured and underinsured groups are significantly lower than the national average, likely related to knowledge of the vaccine, transportation, number of doses and concern of side effects. The primary objective of this pilot study is to evaluate the efficacy of health oriented text messaging to increase HPV vaccine uptake versus standard health messaging (Center for Disease Control and Prevention (CDC) HPV vaccine information flyers).
The investigators hypothesize HPV vaccine uptake will be improved through the receipt of general health messaging that includes HPV vaccine messages. Such messaging will increase knowledge about HPV vaccine availability, as well as improve the perceptions around HPV vaccination. Text messaging will also be more successful in reaching large population groups than traditional flyers/information pamphlets used in clinics.
First, among our three participating clinics, the investigators convened community advisory boards (CABs) of individuals who are English and Spanish speaking to identify appropriate text messages including content, length of message and frequency of messaging (once a week, every other week). Topics included HPV vaccine messages, contraceptive information on hormonal contraception, long-acting reversible contraceptive (LARC) methods, dysmenorrhea, frequent menses, and vaginal discharge. The investigators focused on all topics and specifically messaging of HPV vaccine that are considered neutral and yet compelling. The investigators built upon the feedback obtained from the CAB. Each clinic serves at least 500 uninsured and underinsured children that offer regular HPV vaccination to these children. Of these three clinics, two of the sites will be randomized to the intervention arm (text messaging) and 1 site to have CDC flyers only. The sites currently collect information on all immunization given at their site. The sites will de-identify their vaccine rates for HPV at the end of the study and send us the de-identified data sets for vaccine rates, age (not birth date) and number of nursing/doctor visits made by age group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California Los Angeles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women who are patients at the clinic
- Age 18+
- Have a working mobile phone with SMS capability
Exclusion Criteria:
- Male
- <18 years of age
- Do not have a working mobile phone with SMS capability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Health Messaging via SMS
Clinics randomized to this arm will receive the health messaging via SMS intervention.
Flyers and information cards will be made available in all exam rooms and the waiting room, which contain information about the health messaging program.
Patients must voluntarily elect to enroll in the program using their mobile device.
Patients who enroll will receive a variety of health messages on topics including HPV Vaccine, Cervical Cancer screening, Birth Control options, Menstrual Problems, diet and exercise.
Text messages are sent out using a third party interface, Twilio, at a frequency of 2 times each week for a duration of 1 year.
These are one-way messages which only allow for texts to be sent to the participant.
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This intervention aims to provide health education on topics including HPV Vaccination, Cervical Cancer screening, contraceptive methods, menstrual problems, diet and exercise geared towards women with children of vaccination age.
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ACTIVE_COMPARATOR: CDC Pamphlets
The clinic randomized to this control arm will receive standard Center for Disease Control health pamphlets about the HPV Vaccine.
Flyers are posted in the clinic waiting room and exam room.
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This intervention aims to provide health education on the HPV Vaccination to women with children of vaccination age.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HPV Vaccination Rate
Time Frame: 1 year
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In both arms of the study, we will collect data on the number of females aged 9- 26 years who made any visit to the clinic (denominator) and the number of females aged 9-26 vaccinated (numerator).
Vaccination rates will be defined into groups who received at least 1 dose, compared to receiving none.
We will also examine those receiving at least 2 doses vs 1 vs none.
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1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anna-Barbara Moscicki, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 48789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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