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Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging

Primary Purpose

Human Papilloma Virus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Messaging via SMS
CDC Health Pamphlets
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus focused on measuring Health Messaging, Health Education, Human Papilloma Virus, HPV Vaccination

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Health Messaging via SMS

CDC Pamphlets

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HPV Vaccination Rate
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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2018
Last Updated
February 19, 2020
Sponsor
University of California, Los Angeles
Collaborators
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03759236
Brief Title
Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging
Official Title
Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
February 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
Health Messaging, Health Education, Human Papilloma Virus, HPV Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two clinics are randomized to receive the health messaging via SMS and the third clinic is randomized to receive standard CDC health education materials.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Messaging via SMS
Arm Type
Experimental
Arm Description
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.
Arm Title
CDC Pamphlets
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Messaging via SMS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CDC Health Pamphlets
Intervention Description
This intervention aims to provide health education on the HPV Vaccination to women with children of vaccination age.
Primary Outcome Measure Information:
Title
HPV Vaccination Rate
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Barbara Moscicki, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging

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