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

NCT03759236 | Completed

• 1 other identifier: 48789
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papilloma Virus

Keywords

Health Messaging; Health Education; Human Papilloma Virus; HPV Vaccination

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Health Messaging via SMS

EXPERIMENTAL

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.

Behavioral: Health Messaging via SMS

CDC Pamphlets

ACTIVE COMPARATOR

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.

Behavioral: CDC Health Pamphlets

Interventions

Health Messaging via SMS BEHAVIORAL

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.

Health Messaging via SMS

CDC Health Pamphlets BEHAVIORAL

This intervention aims to provide health education on the HPV Vaccination to women with children of vaccination age.

CDC Pamphlets

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are patients at the clinic
• Age 21+
• Have a working mobile phone with SMS capability

You may not qualify if:

• Male
• \<21 years of age
• Do not have a working mobile phone with SMS capability

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anna-Barbara Moscicki, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two clinics are randomized to receive the health messaging via SMS and the third clinic is randomized to receive standard CDC health education materials.

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 29, 2018
• Study Start: April 25, 2018
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: April 1, 2025

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)