eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care



Status:Recruiting
Healthy:No
Age Range:12 - 16
Updated:12/7/2018
Start Date:April 26, 2017
End Date:March 2020
Contact:Guillermo Prado, Ph.D.
Email:gprado@miami.edu
Phone:305-243-2748

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Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care

The purpose of this study is to test the relative effectiveness of a Hispanic-specific
eHealth intervention, "e-Health Familias Unidas," in preventing and reducing drug use, sexual
risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited
through four pediatric primary care settings. Pediatric staff and research team members,
including nurse assistants and mental health professionals, will implement eHealth Familias
Unidas.

To test the effectiveness of eHealth Familias Unidas Primary Care in preventing drug use,
unprotected sexual behavior, and STIs in a universal sample of Hispanic youth, a randomized
trial design will be used with two levels of intervention (eHealth Familias Unidas Primary
Care and Treatment as Usual) as the between subjects factor with five repeated measures
assessments at baseline, 6, 12, 24, and 36 months post baseline as the within subject factor.

Participants will be recruited from four primary care clinics: two located within the
University of Miami Health System, Jackson Memorial Medical Center (South Florida's only
county health hospital), and a general community clinic in Miami (not affiliated with either
the University of Miami Health System or Jackson Memorial Medical Center). The first site is
an academic pediatric clinic within the University of Miami's Health District. This practice
serves mostly insured individuals. The second pediatric site is a University of Miami mobile
clinic that provides medical care at no charge to uninsured youth. The third pediatric clinic
is a public health clinic located within Jackson Memorial Hospital, South Florida's only
public health hospital. This clinic serves mostly underinsured or uninsured youth. The fourth
site is a private pediatric care clinic. In total, these pediatric clinics jointly serve over
3,400 Hispanic between the ages of 12 -16 per year.

A total of 456 Hispanic adolescents (between 12 to 16 years old) and their primary caregivers
(expected age range 35-55) will be recruited. All adolescent participants will be of Hispanic
ancestry, with both males and females represented. Women are likely to be over-represented
among primary caregivers.

AIM 1: Evaluate the effectiveness of eHealth Familias Unidas delivered in a primary care
setting (referred hereafter as eHealth Familias Unidas Primary Care) in preventing/reducing
drug use, unprotected sexual behavior, and sexually transmitted infections (STIs;
specifically gonorrhea and chlamydia).

H1a: eHealth Familias Unidas Primary Care will be effective, relative to Treatment as Usual,
in reducing the frequency of (past 90-day) drug use in Hispanic adolescents over time H1b:
eHealth Familias Unidas Primary Care will be effective, relative to Treatment as Usual, in
reducing the frequency of (past 90-day) unprotected sex in Hispanic adolescents over time
H1c: eHealth Familias Unidas Primary Care will be effective, relative to Treatment as Usual,
in reducing STI incidence (specifically, the incidence of gonorrhea and chlamydia).

AIM 2: Determine whether intervention effects are mediated by: 1) family functioning for drug
use and unprotected sexual behavior and 2) family functioning and unprotected sexual behavior
for STI incidence.

H2a: Intervention effects on frequency of drug use will be partially mediated by improvements
in family functioning over time H2b: Intervention effects on unprotected sex will be
partially mediated by improvements in family functioning over time H2c: Intervention effects
on STI incidence will be partially mediated by improvements in family functioning and
decreases in unprotected sexual behavior over time.

AIM 3: Estimate the cost effectiveness of eHealth Familias Unidas Primary Care over a three
year follow up.

H3: eHealth Familias Unidas Primary Care will be more cost effective than Treatment as Usual
in reducing drug use, unprotected sexual behavior, and STI incidence.

As an exploratory aim, investigators will collect data on clinic level leadership and climate
from the primary care clinic physicians and staff attitudes towards eHealth Familias Unidas
from Primary Care facilitators. Specifically, investigators will explore whether clinic level
leadership and climate will predict staff attitudes towards eHealth Familias Unidas Primary
Care which will predict changes in the proposed outcomes.

Inclusion Criteria:

- Female and male adolescents of Hispanic immigrant origin, defined by at least one
parent born in a Spanish speaking country of the Americas. Parent must understand
Spanish given that parent sessions are delivered in Spanish.

- Adolescent between the ages of 12 - 16 years

- Adolescent living with an adult primary caregiver who is willing to participate

- Families must have broadband internet access on a device, including (but not limited
to) a smart phone, iPad, tablet, a home computer or a computer at another location
(e.g., school, library, etc.)

Exclusion Criteria:

- Families reporting plans to move out of the South Florida area during the study period

- Families reporting that adolescent has been diagnosed with a developmental delay
We found this trial at
12
sites
211 Northeast 89th Street
Miami, Florida 33137
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5590 West 20th Avenue
Hialeah, Florida 33016
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1611 Northwest 12th Avenue
Miami, Florida 33136
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1601 Northwest 12th Avenue
Miami, Florida 33136
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1150 Northwest 14th Street
Miami, Florida 33136
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3601 Northeast 4th Court
Miami, Florida 33137
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8932 Southwest 97th Avenue
Miami, Florida 33176
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Miami, Florida 33196
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Miami, Florida 33134
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Miami, Florida 33137
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Miami, Florida 33145
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Miami, Florida 33173
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