Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination

Study Overview
=================
Brief Summary
-----------------
This study is a two-arm randomized controlled trial, implemented to assess the effectiveness of a community-based educational program with and without a text messaging reminder system, in increasing the rate of HPV vaccination completion among children of Mexican Americans. The investigator's have extended the duration that participants are followed in assessing their child's uptake of the HPV vaccine to coincide with the COVID-19 related clinic closures and/or allow flexibility for participants who decide to delay their child's vaccination for fear of exposure to the COVID-19 infection. A survey will also assess the participants concerns regarding the impact COVID-19 has had in their daily life, such as financial insecurity, food access, housing insecurity and among other most common concerns during this unprecedented time. Additional navigation, referrals and interviewer notes will also be captured. Participants may be called by site or MSK staff to complete study surveys and will be informed verbally or by a mailed letter.

Official Title
-----------------
Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination

Conditions
-----------------
Parents

Intervention / Treatment
-----------------
* Behavioral: HPV Vaccine Education
* Behavioral: Text Messaging Reminder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born in Mexico or born in U.S. but self-describes as Mexican-American Spanish is his or her primary language Has a minimum of one child between the ages of 11 and 17 who has not initiated or completed the HPV vaccine seriest (as per the age-recommended timeframe) Self-identifies as the child's main caregiver Currently owns a cell phone and uses text messaging services and is willing to accept text messages for this study 21 to 84 years old Exclusion Criteria: Presence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional's judgment.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parental Education<br>Participants will receive parental education on HPV vaccine and the vaccine's benefits. | Behavioral: HPV Vaccine Education<br>* A one on one twenty-minute parental educational program (in-person or over the phone) providing facts about HPV, HPV-related cancers, and the HPV vaccine.<br>|
| Experimental: Parental Education + Text Messaging<br>Participants will receive parental education on HPV vaccine and the vaccine's benefits plus text messaging reminder. | Behavioral: HPV Vaccine Education<br>* A one on one twenty-minute parental educational program (in-person or over the phone) providing facts about HPV, HPV-related cancers, and the HPV vaccine.<br>Behavioral: Text Messaging Reminder<br>* Participants will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after participating in the education session (in-person or over the phone). All participants randomized to the text message reminder arm will receive a welcome text message from the automated web-based text messaging service, Mosio, within 72 hours from registration. One week after receiving the welcome text message, they will receive the first weekly text messages reminding them of their child's eligibility for the first dose HPV vaccine. These weekly reminders will occur until uptake of the first dose of the vaccine is reported (through self-report outcome survey completion or submission of the HPV vaccination card/child's official immunization card) or for up to 12 weeks<br>* Other names: EdTech-HPV;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination completion assessment rate | Comparison rates of vaccination completion will be assessed by Fisher's exact test. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mexican, Mexican-American, 17-336