Clinical trial NCT03209713: Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination
Official title: Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parents
Keywords: Mexican
Mexican-American
17-336
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Hackensack Meridian Health
First posted: 2017-07-06
Enrollment: 672
Sex: ALL
Minimum age (years): 21
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Vaccination completion assessment rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Alivio Medical Center
state: Illinois
city: Las Vegas
country: United States
facility: Research, Education and Access to Community Health (REACH)
state: Nevada
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: El Paso
country: United States
facility: The University of Texas at El Paso
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Francesca Gany, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aragones A, Zamore C, Moya EM, Cordero JI, Gany F, Bruno DM. The Impact of Restrictive Policies on Mexican Immigrant Parents and Their Children's Access to Health Care. Health Equity. 2021 Sep 14;5(1):612-618. doi: 10.1089/heq.2020.0111. eCollection 2021.