Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care
Phase: NA
Conditions: Sexual Risk Behavior, Drug Use, Family Functioning
Sponsor: University of Miami

 
 
 
 
 
Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care 
 
NCT03009539 
 
November 28, 2017 

 
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1) Protocol Title 
Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care 
 
2) IRB Review History 
A prior protocol was approved. The approved protocol was recently modified to 
incorporate a pilot study. The current amendment is to incorporate the changes that 
were made in the pilot to the main study.   
 
3) Objectives 
Hispanic adolescents in the U.S. experience significant health disparities, particularly 
as it relates to drug use and STIs, including HIV/AIDS. Familias Unidas, the proposed 
prevention intervention for this study, is a Hispanic-specific, parent-centered 
intervention found to be efficacious in preventing and reducing drug use and HIV 
sexual risk behaviors (Prado et al., 2007; 2011; Pantin et al., 2009). To date, it has 
been exclusively delivered face-to-face in school settings. The proposed study is an 
Internet adaptation of Familias Unidas, “eHealth Familias Unidas”, in which the 
intervention is delivered via a website and Internet communication technology and 
the families are recruited in the pediatric primary care setting. Pediatric staff and 
research team members, including nurse assistants and mental health professionals, 
will implement eHealth Familias Unidas in pediatric primary care clinics. The purpose 
of the study is to test the relative effectiveness of a Hispanic-specific eHealth 
intervention in preventing and reducing drug use, sexual risk behaviors, and STIs 
among Hispanic youth in primary care.  
 
The hypotheses of the proposed study are:  
 
H1a: eHealth Familias Unidas Primary Care will be effective, relative to prevention 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 prevention 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 prevention as 
usual, in reducing STI incidence (specifically, the incidence of gonorrhea and 
chlamydia). 
H2a: Intervention effects on frequency of drug use will be partially mediated by 
improvements in family functioning over time. 
H2b: Intervention effects on frequency of 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 sex over time. 
 

 
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4) Background 
(a) Significance and Gaps in Current Knowledge  
 
Hispanic youth are disproportionately affected by certain health behaviors and 
conditions, such as drug use, sexual risk behaviors, and STIs, compared to their 
African American and non-Hispanic White counter parts. Fortunately, in multiple 
reviews of the literature specifically examining efficacious preventive interventions 
for Hispanic youth, family-based interventions have been found among the most 
efficacious. In fact, approximately three quarters of evidence-based preventive 
interventions for Hispanic youth are family-based interventions, highlighting the 
importance of targeting the family as the change agent. Familias Unidas is an 
example of an evidence-based family-based preventive intervention found to be 
efficacious in preventing/reducing drug use, unprotected sexual behavior, and self-
reported STIs. An Internet adaptation of Familias Unidas, “eHealth Familias Unidas”, 
was recently developed and tested for use in the school setting, but also for use in 
pediatric primary care settings. Identifying novel contexts, such as primary care 
settings, to implement cost effective evidence-based drug use and sexual risk 
behavior preventive interventions, such as eHealth interventions, for Hispanic 
adolescents is an urgent public health issue (Bustamante et al., 2010). 
 
Currently there are no efficacious or effective, Hispanic-specific, Internet-based drug 
use and sexual risk behavior preventive interventions in primary or pediatric settings 
despite the fact that: (1) EHealth interventions have been found to impact a number 
of outcomes, including family functioning, drug use, and unsafe sexual behavior; (2) 
more than three in four Hispanics report using the Internet (Lopez, Gonzalez-Barrera 
& Patten, 2013); (3) preventive interventions in primary care settings have shown 
promising results for alcohol, smoking cessation, and drug use among youth and 
adults; and, (4) The Patient Protection and Affordable Care Act contains several 
strategic initiatives aimed at increasing Hispanics’ use of primary care services, 
including pediatric services, and has expanded access to health insurance for 4.2 
million uninsured children (10-19 years old), 35% of whom were Hispanic (Pilkey et 
al., 2013; Russell & Davenport, 2010). 
 
Thus, the proposed research is significant in that the study has the potential to 
capitalize on Hispanics’ projected increased use of pediatric care, an under used 
context and novel approach to drug use and sexual risk behavior preventive 
interventions. We have chosen diverse primary care pediatric settings (academic 
practice, public health clinic, mobile clinic, private practice) likely to see expanded 
services for Hispanics, so that our findings can be immediately disseminated to a 
broader range of settings. Notably, the 2009 IOM report on Preventing Mental, 
Emotional, and Behavioral Disorders among Young People, stated that although 
there are a wide range of preventive intervention programs with evidence of 
efficacy, there is a need to disseminate these programs more widely in innovative 

 
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settings and to increase the understanding of the effective dissemination of these 
prevention programs. 
 
(b) Relevant Prior Experience and Preliminary Results 
 
Below we describe the main findings of three published face-to-face Familias Unidas 
efficacy trials in school settings, a completed face-to-face Familias Unidas 
effectiveness trial in a school setting, an efficacy eHealth Familias Unidas trial in a 
school setting, and a feasibility/acceptability study of eHealth Familias Unidas in a 
primary care setting. Because the completed efficacy trials have been published, the 
description of these studies is brief. 
 
First Efficacy Study of Familias Unidas in a School Setting. Prado and colleagues 
evaluated the efficacy of Familias Unidas in preventing adolescent drug use, 
cigarette use, alcohol use, and unprotected sexual behavior, relative to (1) an HIV 
preventive intervention and (2) a cardiovascular preventive intervention. 
Participants (n = 266, mean age = 13.4, SD = .68) were assessed at baseline, 
randomized, and reassessed at 6, 12, 24, and 36 months post baseline. Familias 
Unidas was efficacious, relative to the cardiovascular intervention in reducing past 
90-day illicit drug use (z = 2.02, p < .05), efficacious relative to both the HIV 
intervention (z = 3.25, p < .002) and the cardiovascular intervention (z = 2.66, p < 
.008) in reducing past 90-day cigarette use, and in reducing unprotected sexual 
behavior at last sexual intercourse (X2(1) = 3.87, p < .05). The effects of Familias 
Unidas were partially mediated by improvements in family functioning. Finally, post-
hoc analyses also showed that the incidence of (self-reported) STIs in Familias 
Unidas was significantly lower than for adolescents in either of the two control 
conditions (Fisher’s Exact p-value = .05). 
 
Second efficacy study of Familias Unidas in a School Setting. Pantin and colleagues 
evaluated the efficacy of Familias Unidas in preventing adolescent substance use as 
well as unprotected sexual behavior, relative to prevention as usual in a sample of 
behavior problem youth. 213 participants (mean age =14.3, SD =0.7) and their 
primary caregivers were enrolled. Participants were assessed at baseline, 
randomized, and reassessed at 6, 18, and 30 months post baseline. Analyses showed 
a significant difference in past 30-day substance use (b=0.53, z =2.42, p < .02; d 
=0.25) and in the frequency of condom use (b= -0.306, z = -2.214, p<.03; d =0.30) 
between Familias Unidas and prevention as usual.  
 
Third efficacy study of Face-to-Face Familias Unidas in a School Setting. Prado and 
colleagues evaluated the efficacy of Familias Unidas in reducing past-90 day illicit 
drug use and unprotected sexual behavior, relative to prevention as usual, among 
adjudicated Hispanic youth. 212 (mean age = 14.6, SD = 1.36) juveniles and their 
primary caregivers were assessed at baseline and reassessed at 6 and 12 months 
post baseline. The results showed that Familias Unidas was efficacious, relative to 

 
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prevention as usual, in improving family functioning (b=.28, p=0.02), increasing past 
90-day condom use (b=0.68, OR = 1.97, p=0.015), and in reducing past 90-day illicit 
drug use (b=-0.72, p=0.04).  
 
Face-to-Face Effectiveness Study of Familias Unidas in a School Setting. Prado and 
colleagues (under review) evaluated the effectiveness of face-to-face Familias 
Unidas in reducing the frequency of drug use, alcohol use, and unprotected sexual 
behavior, relative to prevention as usual, among 746 Hispanic youth (mean age = 
13.9, SD = 0.67) recruited from 18 middle schools. School counselors were trained to 
deliver Familias Unidas. Participants were assessed at baseline and reassessed at 6, 
18 and 30 months post baseline. The results showed that there was, a significant 
intervention effect on drug use frequency (b = -0.201, p < 0.001, d = 0.265). Among 
participants who reported being sexually active (n = 130) in the 90 days prior to any 
of the assessments, the analyses showed significant differences between Familias 
Unidas and Prevention as Usual in past 90 day condom use frequency (b = 0.093, p 
=.008, d = 0.98). At 6 months post-baseline, parents of youth randomized to Familias 
Unidas reported significantly higher levels of family functioning relative to parents of 
youth randomized to Prevention as Usual (b = 0.148, p = 0.014, d = 0.47) 
 
Efficacy Study of eHealth Familias Unidas in School Settings. In an ongoing 
randomized trial, Estrada, Prado and colleagues are investigating the efficacy of an 
eHealth adaptation of Familias Unidas in reducing drug use and unprotected sex 
relative to prevention as usual among 256 Hispanic youth (CDC Grant # 
U01PS003316; Estrada, PI; Prado, Mentor). eHealth Familias Unidas was developed 
utilizing the intervention manual from the face-to-face Familias Unidas intervention, 
and an independent rater determined that 91% of the components of face-to-face 
Familias Unidas were present in the eHealth adaptation. Details on eHealth Familias 
Unidas and its components are described under “eHealth Familias Unidas Primary 
Care.”  
 
The 6 month follow up has been completed for this study and preliminary results 
indicate that eHealth Familias Unidas in schools has high family engagement (mean 
number of sessions = 8.4 out of 12; SD = 4.6) and is having a significant effect on 
parent-adolescent communication (b = -5.11; p = .05; see Figure below), the 
intervention’s mediator. Results on drug use and unsafe sexual behavior are in the 
expected direction and of similar effect size as in previous Familias Unidas trials 
(effect sizes = 0.79 and 0.40 for drug use and unsafe sex, respectively) at 6 month 
follow up. It is worth noting that in all of our intervention trials, changes in parent-
adolescent communication were observed between the baseline and 6-month 
follow up assessment, and those changes in turn significantly impacted the distal 
outcomes, drug use and unsafe sex, at subsequent time points.  
 
Pilot Study of eHealth Familias Unidas in Primary Care. Prado and colleagues 
evaluated the feasibility and acceptability of delivering eHealth Familias Unidas 

 
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Primary Care in a universal sample of Hispanic youth. Study staff recruited 48 
Hispanic youth and their primary caregivers from four sites: a mobile clinic, an 
academic pediatric clinic, a public health clinic (Jackson Memorial Hospital), and a 
private practice clinic (Kidstown Pediatrics, LLC). The pilot study’s aim was not to 
assess efficacy or effectiveness but rather to assess the: 1) feasibility of recruiting 
families from pediatric care clinics, 2) feasibility of having pediatric clinic personnel 
deliver eHealth Familias Unidas, and 3) acceptability of the intervention from both 
the participants’ and clinic staff’s perspective.    
 
To recruit study participants, our study team interfaced with pediatric care staff. 
Clinic staff let the study team know when (date and time) Hispanic youth between 
the ages of 12 - 16 (the target age range for the proposed study) and their caregivers 
were scheduled. During those times, a recruiter/assessor was present to recruit, 
consent and screen the family. Parent-child dyads were eligible to participate if they 
self-identified as Hispanic, the youth was between the ages of 12 - 16, both youth 
and parent were willing to participate, the parent had Internet access, and the 
family did not have plans of moving from South Florida within the next year.  
 
Individual in-depth qualitative interviews with clinic personnel and intervention 
facilitators. In-depth qualitative interviews with pediatric clinic personnel and e-
Health Familias Unidas Primary Care facilitators were conducted. These interviews 
had two aims: 1) Receive feedback with regard to clinic personnel and facilitator 
experience in delivering eHealth Familias Unidas Primary Care and 2) to explore 
possible implementation and dissemination barriers. Clinic personnel (i.e., clinic 
managers, physicians) and facilitators were invited to participate in one-on-one 
interviews. Participants were recruited via email and interviewed for 30-60 minutes.  
 
5) Inclusion and Exclusion Criteria 
(a) Participants 
 
The baseline sample will consist of 456 Hispanic female and male adolescents and 
their primary caregivers recruited from one of the pediatric care clinics. 
  
(b) Inclusion criteria 
 
i) 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 this language. 
In past studies, over 99% of all Hispanic parents understood Spanish. 
ii) Adolescent between the ages of 12 – 16 years 
iii) Adolescent living with an adult primary caregiver who is willing to participate  
iv) Families must have broadband Internet access on a device, including (but not 
limited to) a smartphone, iPad, tablet, computer at their home or other 
location (e.g., school, library, etc.) 

 
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(c) Exclusion Criteria 
 
i) Families reporting plans to move out of the South Florida area during the 
study.     
ii) Families reporting that adolescent has been diagnosed with a developmental 
delay.  
 
(d) Screening for Eligibility  
 
Clinic staff will let the research team know between a day and two weeks before 
whether they have Hispanic youth ages 12 - 16 scheduled to come into the clinic and 
if so at what time. When the potentially eligible family checks in, the family will be 
moved to a small office space where the assessor and/or facilitator will be. The 
assessor and/or facilitator will screen parent and youth (separately) by asking 
parents pre-defined screening questions (i.e. the inclusion criteria). If the participant 
declines at any moment, verbal consent or assent will be asked for the participant to 
complete a brief questionnaire.  
 
Additionally, we will do the following: 
a) UM/Jackson patients (parents only) will receive a letter (hand delivered, e-mail 
and/or mail) from their physicians informing them about the study. This letter will 
inform participants that they will be receiving a call from research study personnel 
to see if they are interested in participating. Additionally, a phone number will be 
provided for the potential parent participant to contact research personnel. 
  
b) Research study staff will request permission from each clinic to have access to 
their scheduling system. On a daily basis, research study personnel will access data 
on which individuals have a scheduled appointment. No health information will be 
available to research study staff, only whether there is an appointment scheduled. 
Study staff will screen these individuals, at the clinic, to see which meet criteria. 
Study staff will then go to waiting room to recruit those that meet criteria.   
 
 
6) Number of Subjects 
 
456 adolescents, 456 caregivers 
 
7) Study-Wide Recruitment Methods 
(a) Methods 
 
There will be a pilot of the study’s procedures prior to the start of this main trial. 
This pilot study will take place in January of 2017. There will be approximately a total 
of 12 families asked to participate from four different sites: UHealth Pediatrics at the 

 
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Professional Arts Center, University of Miami Pediatric Mobile Clinic, Ambulatory 
Care Center West Pediatrics at Jackson Memorial Hospital, S. Florida Pediatrics, 
Kidstown Pediatrics, LLC, UHealth at Kendall, Nicklaus Children’s Hospital, Borinquen 
Medical Centers, and Primecare Family Centers. Participants will be asked to test out 
different components of the intervention such as the electronic consent/assent 
forms, surveys, and the website. They will be asked to attend one online meeting 
with their family and a facilitator as well as watch the first group session online. 
Finally, adolescents will be asked to pilot test the procedures for the STI test sample. 
Parents will be compensated $30 cash for their time, and adolescents will be 
compensated $20 cash for the completion of both the survey and urine sample. 
 
All recruitment, assessment, and intervention activities will be conducted exclusively 
by approved study staff.  
 
To recruit participants, our research staff will interface with the clinic staff from each 
of the pediatric clinics. Prior to recruitment (e.g. a week or day before), clinic staff 
will let the research team know whether they have Hispanic youth ages 12 - 16 
scheduled for a clinic appointment and, if so, at what time. If so, the assessor or 
facilitator will arrive to the clinic preceding the potential participant’s appointment 
(in case the target youth and his/her primary caregiver arrive early).   
 
Additionally, we will do the following: 
a) UM/Jackson patients (parents only) will receive a letter (e-mail and/or mail) from 
their physicians informing them about the study. This letter will inform participants 
that they will be receiving a call from research study personnel to see if they are 
interested in participating. Additionally, a phone number will be provided for the 
potential parent participant to contact research personnel. 
  
b) Research study staff will request permission from each clinic to have access to 
their scheduling system. On a daily basis, research study personnel will access data 
on which individuals have a scheduled appointment. No health information will be 
available to research study staff, only whether there is an appointment scheduled. 
Study staff will screen these individuals, at the clinic, to see which meet criteria. 
Study staff will then go to waiting room to recruit those that meet criteria.   
 
When the potential participating family checks in, clinic staff will briefly introduce 
the study and ask if the family would like more information. If so, the family will be 
moved to a small office space or clinical exam room where the assessor and/or 
facilitator will be at. In the office space or exam room, participants will be asked 
whether they are interested in learning more about a study to prevent HIV and 
substance use among Hispanic youth. Parents and adolescents will be screened for 
eligibility, and if the individual states that he/she meets the criteria and would like to 
learn more information, the recruitment process will continue. If the family declines, 
they will be asked to complete a brief questionnaire (detailed below). If the family 

 
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would like more information, Familias Unidas facilitators will explain the study in 
detail to parents and youth and have interested participants sign the informed 
consent (parents) and informed assent (adolescents). To avoid coercion of the youth 
by the parent, adolescent and parents will each be in different rooms when they sign 
consent and assent to ensure that the adolescent has total privacy. In case the 
adolescent does not want to sign, the family will be told they did not meet one or 
more of the inclusion/exclusion criteria but the facilitator will not reveal to the 
parent that the child did not sign (to avoid any consequences to the 
child). Participants who are not interested in participating in the study will still be 
asked to provide the following information: 
Adolescents: age, gender, lifetime drug use, lifetime sexual activity, grade, 
nationality and time in the US 
 
Parents: age, gender, income, level of education, nationality and time in the US 
 
This collected information from non-participants will not contain any names, 
therefore, it will be de-identified. We will attempt to collect this information from 
participants who say no at initial contact and from participants who go through the 
screening and then refuse to participate. To collect this information, we will request 
verbal consent and assent. We are requesting permission to only utilize a verbal 
consent and assent because it is unlikely that participants who do not wish to 
participate in the study will answer these questions if they have to identify 
themselves by signing a consent form. 
 
For participating families, once the family completes the consent/assent, they 
complete the baseline assessment. Once the baseline assessment is complete, 
adolescent will take an STI test, and the family is blindly randomized to one of the 
two study conditions, they, the primary caregiver and adolescent, will be 
compensated for their time.  
 
Families that are interested in participating in the study, but do not have time to 
complete consent/assent and baseline assessment in the clinic will be offered the 
option to be visited at home. If the family agrees, a research team member will visit 
the family during an arranged time to complete the consent/assent, baseline 
assessment and urine test with the adolescent.  
 
Total time to recruit, including baseline assessment, randomization and 
compensation, will be approximately 45 minutes, but it may vary from family to 
family depending on whether or not the family needs more or less time to 
comprehend the study procedures. At each of the five assessment time points, 
baseline, 6, 12, 24, 36 months, the parent will be compensated, $40, $45, $50, $55 
and $60, respectively. At each of the assessment time points, baseline, 6, 12, 24, 36 

 
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months, the adolescent will be compensated with $20 cash for completing both the 
survey and the STI test. 
 
(b) Materials 
Posters will be hung at each of the primary care offices. The poster will be an 
enlarged version of the flyer.  
 
 
8) Study Timelines 
(a) The duration of an individual subject’s participation in the study 
4 years 
 
(b) The duration anticipated to enroll all study subjects 
2 years 
 
(c) The estimated date for the investigators to complete this study 
February 2022 
 
9) Study Endpoints 
 
(a) Study endpoints 
i) Primary: 
- 
Frequency of (past 90-day) drug use in Hispanic adolescents over time. 
- 
Frequency of (past 90-day) unprotected sex in Hispanic adolescents over 
time. 
- 
STI incidence (specifically, the incidence of gonorrhea and chlamydia). 
 
ii) Secondary: 
- 
Improvements in family functioning over time (e.g. parent-adolescent 
communication, parental monitoring of peers). 
- 
Frequency of unprotected sex will be partially mediated by improvements in 
family functioning over time. 
- 
Reduction of STI incidence will be partially mediated by improvements in 
family functioning and decreases in unprotected sex over time. 
 
(b) Safety endpoints 
Not applicable. 
 
10) Procedures Involved 
(a) Study Design 
 

 
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This study tests the effectiveness of eHealth Familias Unidas Primary Care in 
preventing drug use, unprotected sexual behavior, and STIs in a universal 
sample of Hispanic youth, this study will use a randomized trial design with 
two levels of intervention (eHealth Familias Unidas Primary Care and 
prevention 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.  
 
Once both primary care giver and adolescent have completed the 
consent/assent, they will complete the baseline assessment electronically. 
Once the baseline assessment is complete, they will be randomized to one of 
the two conditions: eHealth Familias Unidas Primary Care (experimental 
prevention as usual (control) Condition. Please see attached for 
consent/assent forms (in English and Spanish). All consent forms will be 
completed electronically. All confidential study participant information will 
be stored electronically in secure University of Miami systems.   
 
i) eHealth Familias Unidas Primary Care 
eHealth Familias Unidas Primary Care is an adaptation of the face-to-face 
version of Familias Unidas. As with face-to-face Familias Unidas, eHealth 
Familias Unidas Primary Care aims to prevent drug use, sexual risk 
behaviors, and STIs by improving family functioning (including 
communication between parents and youth). eHealth Familias Unidas 
Primary Care consists of 12 sessions total (8 mock group sessions and 4 
virtual family sessions). The mock group sessions are approximately 30 
minutes in duration and were designed to recreate the content and 
process of the eight parent groups of the evidence-based face-to-face 
Familias Unidas intervention. The content was recreated under the 
context of a daytime talk show, a culturally centric device, in which real-
life Hispanic parents were cast as the guests on the talk show and led 
discussions about the same topics that would be seen by a parent in the 
face-to-face intervention. As in the face-to-face intervention, the parent 
actors processed situations commonly experienced by parents of 
adolescent children by sharing personal anecdotes and role-playing new 
skills. A telenovela series was also incorporated into the mock group 
sessions to facilitate processing around the common topics, e.g. parent-
adolescent communication, adolescent risk behavior, and behavior 
management. Each mock group session features one 10-15 minute 
telenovela, whose theme corresponds with the session topic. The 
sessions also include interactive exercises which are used to reinforce 
session content and to adapt the participatory learning strategy used in 
the face-to-face intervention. The type of interactive exercise varies from 
session to session and includes true/false questions, multiple-choice 
questions, and point-and-click responses. Parents are provided with 

 
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instant feedback regarding their responses and all on-screen text (e.g. 
instructions, response choices, answer summaries) is paired with audio to 
reduce literacy-related barriers. The intervention facilitators are able to 
review parents' responses and use this information to facilitate 
discussion between parents and adolescents during the online family 
sessions. 
 
The four virtual family sessions will be conducted by a trained study team 
member or pediatric staff member (elsewhere, "Facilitator") according to 
the same protocol used in the face-to-face Familias Unidas intervention. 
However, eHealth Familias Unidas will use online video conferencing 
technologies to virtually recreate the therapeutic environment of the 
family session. The sessions are delivered via the Internet utilizing 
webcams and a videoconferencing software called VSee. eHealth Familias 
Unidas Primary Care facilitators will be responsible for scheduling and 
delivering the four online family sessions with each of their families. The 
online family sessions will provide parents the opportunity to practice 
with their adolescent the skills that they learned in the mock parent 
group sessions. The content of each of these four family sessions is 
identical to that of face-to-face Familias Unidas. Virtual family sessions 
will be conducted in Spanish and/or English so to accommodate the 
language preferences of the parent and adolescent participants of each 
family session. Pending parent and adolescent consent and assent, all 
virtual family sessions will be video-recorded via VSee. All recorded 
sessions will be stored in secure University of Miami servers and will be 
labeled with the family’s case ID.  The recordings will only be used for 
purposes of clinical supervision, research and training—provided 
participant consent/assent. 
 
A log-in procedure accessed through the Familias Unidas website will 
serve as the mechanism by which to ensure secure access and 
confidentiality for participants. Each participant will be assigned a unique 
log-in name and password, which will provide them access to the eHealth 
Familias Unidas Primary Care session. The log-in procedure will also 
facilitate the close monitoring of participants, particularly as it relates to 
session participation rates. Specifically, the log-in procedure will be 
utilized to record who (i.e., which participant), when (i.e., day/time), how 
long (e.g., time of session attendance), and for what purpose (e.g., which 
session) the intervention website was accessed.  
 
Our information technology team employs the latest technology to 
ensure security and confidentiality of participants, including but not 
limited to data error checking through forms, filtering output, and the 
use of encryption. Server Port Hardening will be implemented to keep 

 
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the web server safe from intrusion. Additionally, a Secure Socket Layer 
Encryption certificate will be issued to help prevent Internet fraud. The 
implementation of SSLs (i.e., cryptographic protocols) aims to enhance 
security over the Internet. IT will conduct stringent testing of web 
applications prior to the implementation of eHealth Familias Unidas 
Primary Care to prevent any exploits from occurring and to ensure the 
confidentiality of participants. 
 
ii) Control Condition 
Participants randomized to the control condition continue prevention as 
usual. These participants will not be receiving any services from our staff. 
These participants will only be asked to complete a survey at each of the 
5 time points: when they first enroll, and at 6, 12, 24, and 36 months. The 
adolescent will also be asked to provide a sample for an STI test during 
each of these time points.  
 
(b) Assessments 
 
After the intervention is complete, assessors will call the families to return to 
complete follow up assessments. The follow up assessments will occur on the 
University of Miami Miller School of Medicine Campus, at the clinic sites or at 
the homes of the participants. The follow up assessments collect the same 
data as the baseline assessment. All measures will be self-report and 
completed using survey software provided by the study team 
 
(c) Data Collection 
 
Demographics. A demographics form developed by the creators of Familias 
Unidas will be administered to caregivers and youth in order to collect 
information on contact information, age, date/place of birth, number of 
years residing in the U.S., parents' marital status, and family income. 
 
Family functioning (reported by both youth and parents) consists of parental 
investment in the adolescent and parent-adolescent communication. 
Parental investment in the adolescent will be assessed using 1) the Parenting 
Practices (Loeber et al., 1999), and 2) the Family Relations Scale (Tolan et al., 
1997). Two subscales of the Parenting Practices: (a) extent of parental 
involvement (20 items) and (b) positive parenting (9 items) will be used to 
assess parental investment. Cronbach’s alpha for the two (parent reported) 
subscales were .83 and .78, respectively. Cronbach’s alpha for the two 
(adolescent reported) subscales were .86 and .85, respectively. The Family 
Relations Scale assesses the amount of social support the adolescent receives 
from the parent (6 items) (Tolan et al., 1997). Cronbach’s alpha for this 
subscale is .73 (parents) and .70 (youth).  

 
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Communication will be assessed via the Parent-Adolescent Communication 
Scale (Barnes & Olson, 1985), which assesses the quality and content of 
communication between parents and youth. Youth report on the quality and 
content of communication they perceive with their parent. In the parent 
version, parents report on their perception of the quality and content of their 
communication with their youth. Cronbach’s alpha coefficients for this 
measure was .85 (parents) and .93 (youth).  
 
 
Youth’s own sexual risk behaviors will be assessed using a 22-item 
instrument from Jemmott, Jemmott, and Fong (1998). This self-report 
measure will be used to document the number of times youth report having 
sex (oral, vaginal, and anal) in their lifetime and in the past 3 months. This 
instrument is also used to document the number of times youth has been 
exposed to situations of high risk during sexual intercourse (e.g. having 
unprotected sex and/or being under the influence of alcohol or drugs while 
having sex). This measure also asks participants whether they have sex with 
males and/or females.  
 
Youth’s and parents’ own drug use will be measured using items used as part 
of the Monitoring the Future survey (Johnston et al., 2010). This 47-item self-
report instrument assesses lifetime drug use and the frequency of drug use 
(by type of drug) in the 3 months prior to assessment. Additionally, questions 
regarding the use of e-cigarettes and hookahs for lifetime use, the previous 
90 days and previous 30 days will be asked. CRAFFT (10 items) will assess the 
consequences of alcohol and drug use. Finally, three questions regarding 
second hand smoking will be asked:   
How much do you think you are exposed to tobacco smoke at home?” 
(select one: not at all, somewhat, moderately, a lot, extremely 
How much do you think you are exposed to tobacco smoke outside of 
home?” (select one: not at all, somewhat, moderately, a lot, extremely 
How many years in total did you live in the same household with someone 
else who smoked tobacco products?" 
The Klein Sexual Orientation measure (adolescents only, 8 items) will be used to 
assess adolescent sexual orientation and preferences. 
Vancouver Index of Acculturation (VIA; parents and adolescents, 20 items) will 
be used to assesses acculturation and practices. 
The CES-D (parents and adolescents, 20 items) will be used to assess symptoms 
of depression.  
ACES (for parents only, 17 questions) will assess adverse events before the age 
of 18 for parents  

 
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The CASA (for parent and adolescent, 8 items) will assess use of community 
services.  
Four items (adolescent only) have been incorporated to evaluate experiences 
with bullying.  
The Revised Behavior Problem Checklist (RBPC; parent only, 55 items): the 
externalizing subscales of the RBPC will be used to assess adolescent problem 
behaviors from the parent perspective.  
The externalizing subscales of the Youth Self Report (YSR; adolescent only, 32 
items) will be used to evaluate adolescent problem behaviors from the 
adolescent perspective.  
Health related quality of life (QOL; parent and adolescent, six items) will be used 
to examine physical, mental and emotional health.  
CRAFFT (adolescent, 10 items): assesses the consequences of alcohol and drug 
use. 
 
Five questions have been created to assess participant understanding of the 
consent form.  
 
In addition to the self-report measures described above, we will measure 
gonorrhea and chlamydia by a real-time PCR assay for the direct, qualitative 
detection of the plasmid DNA of Chlamydia trachomatis and the genomic 
DNA of Neisseria gonorrhea which is currently being used in clinical practice 
and clinical trials at our institution. This assay has shown high sensitivity and 
specificity for the detection of both organisms in asymptomatic and 
symptomatic patients. Youth who test positive for an STI will be referred to 
treatment.  Youth will also be encouraged to refer sex partners for 
treatment. The county health department will be notified of reportable STIs. 
For analyses, sexually transmitted infection incidence will be defined as a 
positive laboratory test result for a new chlamydia or gonorrhea infection at 
any of the five assessment time points. Previous studies with ethnic minority 
youth have demonstrated feasibility and a high acceptance rate with respect 
to the collection of biological markers for determining STI incidence.  
 
We would also like to collect data from clinic facilitators, clinic leaders, and 
physicians to assess organizational level factors and attitudes towards 
evidence-based interventions. To do this, we will use the below measures: 
 
Attitudes Towards Evidence-Based Practice Scale (EBP; facilitator; 15 
items): this measure will be administered to facilitators to assess their 
views on evidence-based practices.   

 
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Multifactor Leadership Questionnaire (clinic leaders/physician, 21 items):  
this measure will be administered to clinic leaders/physicians to assess 
transformational and transactional leadership behavior.   
Implementation Leadership Scale (ILS; Clinic leaders/physicians, 11 items): 
this measure assesses the degree to which organizational leaders support 
their staff in the implementation of evidence-based interventions 
Implementation Climate Scale (clinic leaders/physician, 18 items): 
assesses the level of a strategic organizational climate within an 
organization. 
 
 
11) Data and Specimen Banking* 
For STI measurement, a urine sample will be collected from the adolescent at 
each time point. Both the adolescent and the research assessor shall be 
present (at the same time) during the procedures outlined in this section. 
The procedures for the data to be stored or associated with each specimen 
are described below: 
 
(a) Both the adolescent and the research assessor shall keep the 
adolescent’s urine specimen in view at all times before the specimen is 
sealed and labeled. If any of the specimen is transferred to another 
container, the research assessor shall ask the adolescent to observe the 
transfer and sealing of the container with a tamper-evident seal. 
(b) The research assessor shall place an identification label securely on each 
container. The label must contain the date, the adolescent’s specimen 
number, and the adolescent’s code number as the identifying 
information. The research assessor shall apply a tamper-evident seal on 
each container if it is separate from the label. The specimen bottle must 
be securely sealed to prevent undetected tampering. 
(c) The adolescent shall initial the identification label(s) on the specimen 
bottle(s) with his or her case ID in order to certify that the specimen was 
collected from him or her.  
 
(d) The specimen and chain-of-custody forms must be packaged for transfer 
to Quest laboratories. If the specimens are not immediately prepared for 
transfer, they must be appropriately safeguarded during temporary 
storage. The collected urine will be picked up by Quest laboratories a 
minimum of once per week.  
(e) While any part of the chain-of-custody procedures is being performed, 
the specimens and custody documents must be under the control of the 
involved research assessor. The assessor may not leave the collection site 
during the interval between presentation of the specimen by the 
adolescent and securing of the specimens with identifying labels bearing 

 
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the adolescent's specimen identification numbers and Case ID. If the 
involved assessor momentarily leaves his or her workstation, the sealed 
specimens must be secured or taken with him or her. If the assessor is 
leaving for an extended period of time, the specimens must be packaged 
for transfer to Quest laboratories and secured before the assessor leaves 
the collection site. 
(f) The specimen(s) sealed in a shipping container must be immediately 
transferred, appropriately safeguarded during temporary storage, or kept 
under the personal control of an authorized individual until transferred.   
(g) The research assessor shall ensure that a custody-and-control form is 
packaged with its associated urine specimen bottle.  
(h)  
 
12) Data Management* 
 
(a) Data Analysis Plan and Power Analysis 
 
H1a: eHealth Familias Unidas Primary Care will be effective, relative to Care as 
Usual, in reducing the frequency of (past 90-day) drug use in Hispanic adolescents 
over time.  
 
This hypothesis will be analyzed using Latent Growth Modeling (LGM). Growth 
models can be expressed in terms that are identical to models using random 
coefficients regression, mixed models or multi-level models, where the first level fits 
each response in time to an individual-level growth model. The second level 
represents the condition effect on the slope of drug use.  LGM analyses will test for 
differences in trajectories of drug use over the 5 assessment time points among the 
2 conditions. As recommended by Raudenbush and Bryk, we will use 2-level analysis 
to determine whether the mean trajectories of drug use for eHealth Familias Unidas 
Primary Care and prevention as usual differ significantly over time. Data analysis for 
this hypothesis and all others will be conducted using Mplus (v 7.2). 
 
Power. Mplus Monte Carlo simulation with 10000 replications was used to 
calculate the power for this hypothesis using a latent growth curve model 
framework with one covariate (i.e., condition assignment) and missing data. 
With 5 time points (0, 6, 12, 24 and 36 months) and assuming a 5% attrition 
rate at each assessment (also assuming equal sample size across both 
conditions), with 228 cases in each condition at baseline (or 185 at the final 
assessment timepoint in each condition), we have 80% power to detect a 
regression coefficient equal to 0.09 (effect size = 0.3) in the regression of the 
slope growth factor on intervention condition. This is considered slightly over 
a small (0.2) effect size. 
 

 
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H1b: eHealth Familias Unidas Primary Care will be effective, relative to 
prevention as usual, in reducing the frequency of (past 90-day) unprotected 
sex in Hispanic adolescents over time. 
 
The analytic plan and power analysis for this hypothesis are similar to that of 
H1a. 
 
H1c: eHealth Familias Unidas Primary Care will be effective, relative to  
prevention as usual, in reducing STI incidence (specifically, the incidence of 
gonorrhea and chlamydia). 
 
This hypothesis will be analyzed using a univariate logistic regression for the 
binary outcome, new diagnoses of STIs (Yes/No). STI incidence will be 
defined as a positive laboratory test result for a new chlamydia or gonorrhea 
infection at any of the four follow up assessment timepoints. In the analysis 
for this hypothesis, condition will predict STI diagnosis. The test of the 
hypothesis will be based on a Wald test comparing the intervention 
regression coefficient to its standard error. Additionally, the time of STI 
diagnosis will be included as a covariate in the logistic regression to test the 
robustness of the intervention’s effect. 
 
Power.  According to CDC national statistics, the annual STI incidence rate is 
3.16% for Hispanic adolescents aged 15 to 19. Thus, we expect the 3-year STI 
incidence rate in the control group to be approximately 9.2%. Using a one-
sided Z test with pooled variance to test the difference between two 
independent proportions (assuming the same 5% attrition rate at each 
assessment timepoint), the study has over 80% power to detect a difference 
of 6.1% in STI incidence between the two conditions. This difference in 
proportions translates to an effect size of Cohen’s h = 0.26, considered a 
small (h = 0.2) to medium (h = 0.5) effect size, according to Cohen (1988). 
 
H2a: Intervention effects on frequency of drug use will be partially mediated 
by improvements in family functioning over time. 
 
To test for mediation, we will use the "product of coefficients" test described 
by MacKinnon and colleagues, which is based on the distribution of the 
indirect effect of the intervention through the mediator (Cohen, 1988). This 
procedure tests whether the product of the coefficients from the 
intervention to the mediator (a) and from the mediator to the outcome (b) is 
significantly different from zero. Specifically, we will estimate paths between 
intervention and family functioning (a), and between family functioning and 
drug use (b). Because we have five time points, our first mediation analyses 
will fit bivariate growth curves for both family functioning and drug use and 
examine the role of the (latent) slope of family functioning on the slope of 

 
Page 18 of 30 
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drug use. The product of the two pathways (a)*(b) is the indirect effect of 
eHealth Familias Unidas Primary Care to drug use through the family 
functioning trajectory. As noted above, we will be testing whether the 
product (a)*(b) is statistically significantly different from zero, by comparing 
the observed value of (a)*(b) to the empirical distribution calculated using 
the bias-corrected bootstrap. In addition to this long-term developmental 
mediation model, we will also test if the initial changes in family functioning 
from baseline to the 6 month follow-up mediate the effect of intervention on 
drug use trajectory. Our team has expertise in conducting mediational 
analyses in multilevel models. 
 
Power. Mplus Monte Carlo simulation with 10000 replications was used to 
calculate the power for this hypothesis using a mediation model framework. 
With a final sample size of 370 (assuming 5% attrition rate at each 
assessment timepoint), we have 80% power to uncover a significant 
mediating effect when the regression coefficient of pathways ‘a’ is 
approximately -0.36 and ‘b’ is approximately -0.18 (i.e., R2 effect size were 
0.033 for the relationship between X and M (i.e., path ‘a;) and M and Y (i.e., 
path ‘b’), which is considered a small effect (Cohen, 1988). 
 
H2b: Intervention effects on frequency of unprotected sex will be partially 
mediated by improvements in family functioning over time. 
 
The analytic plan and power analysis for this hypothesis are similar to that of 
H1b. 
 
H2c: Intervention effects on STI incidence will be partially mediated by 
improvements in family functioning and decreases in unprotected sex over 
time. 
 
We will use MacKinnon’s method103 described in H1b with the exception 
that the outcome for this hypothesis is binary. The Weighted Least Squares 
Means and Variance adjusted (WLSMV) estimator in Mplus will be used to 
estimate the indirect effect. With WLSMV, a continuous latent response 
variable (y*) underlying the observed dichotomous variable is used to test for 
the mediated or indirect effect. 
 
Power. We aimed to identify the minimal detectable regression coefficient 
for the mediator based on Vittinghoff and colleagues’ methodology. The 
results show that we have 80% power to detect a mediating effect if the 
logistic regression coefficient for the mediator is 0.63, which is equal to an 
OR of 1.88, corresponding to an effect size of d = 0.35. According to Cohen, 
this is considered a small (d = 0.2) to medium (d = 0.5) effect size.  
 

 
Page 19 of 30 
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(b) Secure Data and Quality Control 
 
All adolescent and parent self-report measures will be administered 
electronically through a tablet. 
 
Data will be uploaded weekly in a database housed on a server maintained 
and secured by the University of Miami Department of Public Health 
Sciences. The server is password protected as well as protected by a firewall. 
The Principal Investigator will have access to the data electronically on his 
password protected laptop. His designees (i.e. Project Coordinator and 
Statistician) will also have access to electronically stored data. Principal 
Investigator and his team are on the tenth floor of the Clinical Research 
Center at 1120 N.W. 14th Street, Miami, FL 33136. 
 
We will also collect identifying data (e.g. participant name and contact 
information). This data will be collected electronically and stored in secure 
University of Miami systems. We will use a record system in which all 
participant records are filed numerically by case number, with no identifying 
information attached to the outcome data. A master sheet, with individual 
names and their respective code numbers will be kept electronically and 
accessed only under the supervision of the Principal Investigator. No one 
other than the Principal Investigator, the Project Coordinator, and approved 
study staff will have access to records identifying subjects’ names at any 
time. Only the Principal Investigator and the Project Coordinator (under the 
supervision of the Principal Investigator) will have access to both the 
participants’ identifying information and their assessment data. 
 
(c) Data and Specimen 
 
If both the parent and adolescent have agreed to these tests, urine will be collected 
from adolescent participants to test for gonorrhea and chlamydia. The research 
assessor will be responsible for properly implementing urine collection procedures, 
storing and labeling (without identifiers) the collected urine. Urine will be collected 
from the adolescent in a completely private manner; at no moment will the assessor 
watch the adolescent collect the urine specimen. The urine will be analyzed by 
Quest Diagnostics. Detailed procedures are outlined in section 11) Data and 
Specimen Banking. 
 
13) Provisions to Monitor the Data to Ensure the Safety of Subjects* 
We do not expect for this study to create more than minimal risk for the 
participating families. Yet, the study will be monitored by the study 
investigators and/or sponsors. In addition, a formally constituted Scientific 
Advisory Board will help monitor the study if additional advice is needed. 
 

 
Page 20 of 30 
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14) Withdrawal of Subjects* 
Participants will be told that this study is completely voluntary and that they 
have the right not to participate in any intervention procedure. They also can 
completely withdraw from the study at any time without any negative 
consequences. 
In past studies, we have not had to withdraw subjects. There is potential for 
withdrawal of subjects if the adolescent is arrested, reports suicidal ideation, 
or some other extreme adverse event. If a subject is arrested, reports suicidal 
ideation, or some other extreme adverse event, a qualified study personnel, 
i.e., the clinical supervisor, may ask them to please withdraw from the study, 
and if appropriate, refer them to the correct treatment. 
According to IRB, if a subject becomes incarcerated while enrolled in a study, 
all research interactions and interventions with that subject, and the 
obtaining of identifiable private information about the subject must cease.  
 
15) Risks to Subjects* 
We do not expect that there will be any negative consequences from 
participating in this study. However, the sensitive nature of some 
intervention topics (e.g. sexual behaviors and drug use) may be embarrassing 
and/or distressing to some participants. It is also possible that they may feel 
tired or fatigued after answering the questionnaires, or made uncomfortable 
by the questions that are asked. In addition, STI testing may involve minimal 
physical discomfort for the adolescent. Being tested for STIs may also cause 
anxiety for the adolescent and/or parent regardless of the adolescent’s test 
results. Receiving positive results may make the adolescent and/or parent 
very upset. If the test is negative, there is still the possibility that the 
adolescent could be infected with an STI and test positive at some time in the 
future. Also, it is always possible that the test results could be invalid. Should 
an adolescent test positive for gonorrhea and/or chlamydia, the facilitator, 
with guidance from the clinical supervisor, a licensed clinical social worker, 
and principal investigator, will work with the adolescent on how to process 
disclosure of the positive test result to the parent or legal guardian. If after 
discussions with the facilitator and clinical supervisor, the adolescent still 
refuses to disclose (the law in FL does not require parents to be notified of 
STI infection) because s/he fears negative consequences such as being 
thrown out of the house or severe family discord, the facilitator and clinical 
supervisor will work with the adolescent to connect her/him to proper 
treatment. If an adolescent tests positive for an STI, we are required, by 
Florida law, to report the result to the Florida Department of Health.  
If a parent or adolescent reports elevated levels of depression, or if an 
adolescent reports incidence of bullying, he or she will be directed to speak 
with a facilitator for further assessment. If necessary, a referral will be made 
for additional services.  

 
Page 21 of 30 
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16) Potential Benefits to Subjects* 
There may be direct benefits to participating in this study. Depending on 
which intervention participants are assigned to, adolescents may be less 
likely to use drugs and engage in risky behaviors such as having sex without a 
condom. Additionally, depending on the intervention, families may 
communicate more effectively.  
 
17) Vulnerable Populations* 
The research involves children under the age of 18. To avoid coercion or 
undue influence, the adolescents will assent and complete assessments 
separate from their primary care giver. In case the adolescent does not want 
to assent, the family will be told they did not meet one or more of the 
inclusion/exclusion criteria but the facilitator will not reveal to the parent 
that the child did not assent (to avoid any consequences to the child).  
 
18) Multi-Site Research* 
Participants will be recruited from South Florida Pediatric Partners, Nicklaus 
Children’s Hospital, Borinquen Medical Centers, Primecare Family Centers, and from 
Kidstown, which are both located outside the University of Miami.  
 
19) Community-Based Participatory Research* 
Not applicable.  
 
20) Sharing of Results with Subjects* 
  Youth will be encouraged to refer sex partners for treatment. The county 
health department will be notified of reportable STIs. The subjects, county 
health department will be notified via phone call or in-person by a study 
personnel team member.  
 
21) Setting 
The research team will identify and recruit potential subjects in nine pediatric 
clinics. 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 clinic we have partnered with is a mobile clinic that provides 
medical care at no charge to uninsured youth. Both of these clinics 
participated in our pilot feasibility and acceptability study. The third and 
fourth sites are private pediatric care clinic. These sites serve mostly insured 
youth. The fifth clinic is Jackson Memorial Medical Center, a general 
community clinic in Miami. The sixth clinic is UHealth Kendall which is a part 
of the UM system. The seventh clinic is Nicklaus Children’s Hospital, a private 

 
Page 22 of 30 
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hospital located in Miami-Dade. The eighth and ninth clinics are pediatric 
centers serving the S. Florida community, Borinquen Medical Centers and 
Prime Care Family Centers. All recruitment, consent/assent, baseline 
assessment, and randomization will occur in one of the clinics. The 
intervention will be delivered via the Internet, thus subjects will most likely 
be in their homes or a place with Internet capabilities (e.g. school, library) to 
receive the intervention. The follow up assessments and STI testing will take 
place on the University of Miami Miller School of Medicine Campus, one of 
the clinic sites, or the participant’s homes.  
 
22) Resources Available 
(a) Investigative team Qualifications  
Dr. Prado, a first-generation Mexican researcher, is Miller Professor of Public 
Health Sciences, Director of the Division of Prevention Science and 
Community Health, and Dean of the Graduate School at the University of 
Miami. Prado has been conducting research with Hispanic youth for 15 years 
and has published extensively in this area with over 100 peer-reviewed 
publications. Prado’s research on drug use and sexual risk behavior 
prevention has been recognized by numerous organizations, including the 
Society for Prevention Research, the National Hispanic Science Network, and 
the Society for Research on Adolescence. Throughout his career, Prado has 
received over $75 million dollars of extramural funding as either PI, Co-I, or 
mentor. Prado has presented on his program of research at the National 
Institutes of Health, the Centers for Disease Control and Prevention, and the 
Institute of Medicine. Prado has substantial experience coordinating and 
managing the research activities of major longitudinal randomized clinical 
trials including recruitment, data collection, quality control, data analysis, 
and dissemination of study findings. He will be dedicating 30% of his effort to 
the proposed study. 
 
Other study personnel includes pediatricians. Three of the pediatricians (Drs. 
Gwyn, Forster, and Ofir) have an academic faculty appointment at the 
University of Miami and have collaborated on extramurally funded studies 
and have published. All of the pediatricians have experience working with 
Hispanic families in their practice.   
 
Other study personnel includes, Dr. Yannine Estrada who has a doctoral 
degree in Counseling Psychology. She is currently the principal investigator of 
a mentored cooperative agreement funded by the Centers for Disease 
Control and Prevention. Estrada has led, in conjunction with senior mentors 
Prado and Pantin, the Internet adaptation of Familias Unidas. Estrada will be 
responsible for coordinating the research and research-clinical interface 

 
Page 23 of 30 
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aspects of the study. She will be responsible for developing the procedures 
manual for the study; establishing and maintaining project files; maintaining 
collaborative relationships with the IRB (along with Prado); and developing 
and implementing quality control assurance procedures. In addition, Estrada 
will be responsible for making all necessary preparations for the 
assessments, as well as overseeing the assessors with the data collection 
across all five years. These tasks include but are not limited to, preparing all 
equipment, re-training of the assessors, and overseeing the assessments of 
both youth and parent study participants. Estrada will be responsible for 
overseeing the assessors in the recruitment and retention of study 
participants and overseeing the screening of potential study participants. Of 
important note, is that Estrada is the Research Coordinator/Project Director 
for a study which has achieved over 95% retention (over 18 months). Estrada 
will also collaborate with the senior investigative team in planning the 
outcome analyses and in preparing manuscripts for publication. 
 
Ms. Maria Tapia, Clinical Trainer and Supervisor is a Licensed Clinical Social 
Worker with over 20 years of experience working with Hispanic families. She 
is trained in delivering family-based interventions, including Familias Unidas, 
to Hispanic parents and their youth. Tapia has engaged over 85% of Hispanic 
parents into the Familias Unidas intervention over the past 10 years. She also 
has extensive experience training and supervising on the Familias Unidas 
model. In fact, Tapia has trained over 50 individuals in the Familias Unidas 
intervention over the past three years. For the proposed study, Tapia will be 
responsible for training and supervising the pediatric care facilitators in the 
delivery of the intervention. She will conduct the supervision meetings with 
the pediatric care facilitators and will help them problem solve potential 
barriers of intervention engagement and retention. Additionally, Tapia will 
handle any adverse or serious adverse events that may come up during the 
assessments.  
 
Assessors will be assigned to each of the pediatric care clinics.  Each of the 
pediatric care clinics will have one pediatric care facilitator (nurse assistant, 
licensed clinical social worker, mental health counselor). Assessor and/or 
facilitators will be responsible for screening potential study participants. 
Assessors are responsible for conducing the parent and youth assessments 
over the five years. The assessor will also be responsible for scheduling these 
assessments. Finally, the assessor will also be responsible for maintaining 
cordial contact in between assessment time points, in order to maximize 
retention rates at assessments. They will also be responsible for tracking 
family completion of online sessions and progression through the 
intervention.  
 

 
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Other study personnel, such as student and research assistants will be 
trained in study operating procedures, including consent/assent. All study 
personnel members are CITI trained and are adequately informed about the 
protocol, research procedures, and their duties and functions. Trainings will 
be held for study personnel members before the beginning of the study in: 
protocol, research procedures, and assessments. Study personnel will be 
asked to role play procedures at the training. If more training is needed, they 
will be trained again throughout the study. All of the study personnel have 
been involved in NIH funded studies and are all familiar with the 
recruitment/study procedures as those being proposed. Regardless of 
experience, trainings will still be held by the lead clinical supervisor and 
principal investigator to assure all study personnel members are adherent to 
the study procedures. Weekly meetings will also be held to discuss study 
updates, issues or concerns.  
 
(b) Resources Available 
 
The physicians and trained mental health professionals from the clinics are 
the medical and/or psychological resources for the subjects. We only 
anticipate that the subjects are in need of these resources, outside of their 
usual use, if they test positive for an STI.  The clinic sites are: UHealth 
Pediatrics at the Professional Arts Center, University of Miami Pediatric 
Mobile Clinic, UHealth at Kendal, Ambulatory Care Center West Pediatrics at 
Jackson Memorial Hospital, Kidstown Pediatrics, LLC, Nicklaus Children’s 
Hospital, South Florida Pediatric Partners, Borinquen Medical Centers, and 
Primecare Family Centers.  
 
UHealth Pediatrics at the Professional Arts Center. The Department of 
Pediatrics at UHealth is nationally and internationally acclaimed for 
education, research, patient care, and biomedical innovation. Offering a 
variety of services from routine healthcare and immunizations to the 
treatment of severe and chronic illnesses, UHealth Pediatrics is integrated 
into a dynamic research environment where innovative and effective 
preventive and treatments services are delivered and under development. 
UHealth Pediatrics is affiliated with Holtz Children’s Hospital, one of the 
largest children’s hospitals in the southeast United States. With over 150 
child health specialists honored as Best Doctors®, UHealth Pediatrics has 
more Best Doctors than any institution in South Florida. UHealth Pediatrics at 
the Professional Arts Center is one of 9 UHealth sites. The pediatrics offices 
at UHealth have 10 exam rooms, a small conference/meeting area, and a 
reception/waiting area.  UHealth Pediatrics at the Professional Arts Center is 
directed by Dr. Lourdes Forster, a co-investigator on the proposed 
application.  
 

 
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University of Miami Pediatric Mobile Clinic. The University of Miami 
Pediatric Mobile Clinic (UMPMC) has provided medical care to uninsured 
children since 1992. Services provided include well-visits, sports physicals, 
immunizations, management of chronic conditions, urgent care, mental 
health, and social work. UMPMC provides direct primary medical care for 
nearly 3,000 children a year who are without health insurance, access to 
medical providers and linking to specialists. UMPMC is a bus with medical 
supplies and three medical exam rooms. UMPMC’s staff members travel with 
the bus across a 50 mile radius to serve communities with the highest 
percentage of children living in poverty and/or likely to be uninsured. Specific 
communities that will continue to be served through this program include: 
Little Havana, Homestead, Florida City, Little Haiti/North Miami, 
Westchester, and North Dade. Most of the visited areas have a community 
center or school rooms that can be utilized for extra medical exam room 
space. Typically, each site can offer three rooms. Dr. Lisa Gwynn, a co-
investigator on the proposed study, is the Medical Director for the University 
of Miami Pediatric Mobile Clinic.  
 
UHealth at Kendall. We will recruit participants from UHealth at Kendall 
which is a part of the University of Miami health system. UHealth at Kendall 
has more than 60 physicians and serves children in the S. Florida area, 
including general pediatrics.  
 
Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital. 
Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital is 
located within the Jackson Memorial Health System. The Jackson Memorial 
Health System is governed by the Public Health Trust, a dedicated team of 
citizen volunteers acting on behalf of the Miami-Dade Board of County 
Commissioners. Jackson Health System consists of Jackson Memorial 
Hospital; multiple primary care and specialty care centers; a variety of 
school-based clinics serving elementary, middle and high schools; two long-
term care nursing facilities; six Corrections Health Services clinics; a network 
of mental health facilities; Holtz Children’s Hospital; Jackson Rehabilitation 
Hospital; Jackson Behavioral Health Hospital; Jackson North Medical Center, 
and; Jackson South Community Hospital. Jackson Memorial Hospital is an 
accredited, non-profit, tertiary care hospital and the major teaching facility 
for the University of Miami Leonard M. Miller School of Medicine. With more 
than 1,550 licensed beds, Jackson Memorial Hospital is a referral center, a 
magnet for medical research, and home to Ryder Trauma Center - the only 
adult and pediatric Level 1 trauma center in Miami-Dade County. Ambulatory 
Care Center West Pediatrics at Jackson Memorial Hospital provides patients 
with comprehensive care in a variety of services including pediatric primary 
care, gynecology and obstetrics. The pediatric practice serves over 7,000 
children and youth a year.  The Ambulatory Care Center West has more than 

 
Page 26 of 30 
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a dozen exam rooms for the pediatricians. Dr. Audrey Ofir, co-investigator on 
the proposed application, is the Director of Ambulatory Pediatrics. 
 
Kidstown Pediatrics, LLC. Kidstown Pediatrics, LLC, is located in a residential 
area 10 minutes outside of downtown Miami. It is housed in a multistory 
office building and has 2,000 square feet available for office space. Kidstown 
is a private practice that provides comprehensive primary care services for 
children of all ages. Specific treatments offered include HPV vaccination, 
medical care for asthma, treatment for ADD/ADHD, and other vaccinations. 
Emergency services are available 24 hours a day, 7 days a week, but it is 
generally open from 8:30am to evening, Monday through Friday.  Dr. 
Margaret Okonkwo, a practicing and board certified pediatrician, is President 
of KidTown, LLC. Dr. Okonkwo has been in practice for more than 10 years 
and serves approximately 6,000 children and adolescents per year. 
 
South Florida Pediatric Partners. South Florida Pediatric Partners is a private 
pediatric practice located in Kendall, Florida. It is directed by Dr. Carol Da 
Costa, a solo practitioner who has been part of the community for the last 15 
years. She provides comprehensive pediatric primary care services for 
children of all ages. Dr. Da Costa serves over 100 Hispanic families per week 
and provides routine well-child care (e.g., vaccinations) as well as treatment 
for a range of childhood illnesses and symptoms. The clinic is open Monday-
Friday 9am-5:30pm and two Saturdays per month. Patients also have access 
to an after-hours emergency line. 
 
Nicklaus Children’s Hospital. Nicklaus Children’s hospital is a pediatric 
healthcare center that serves children from birth through adolescence. This 
hospital has over 740 physicians and more than 3,500 employees.  
 
Borinquen Medical Centers was established in 1972 as a grass-roots effort to 
provide medical care in Miami-Dade County. It offers comprehensive Primary 
Health Care, dental and behavioral health care.  
 
       Primecare Family Care provides pediatric to children and adolescents in the  
       Hialeah area.  
 
 
 
23) Prior Approvals 
N/A 
 

 
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24) Local Number of Subjects 
Approximately 2500 subjects will be screened, and 912 will be enrolled. 
Additionally approximately 12 parents and 12 adolescents will participate in 
the pilot study.  
 
25) Confidentiality 
The issues surrounding confidentiality are of supreme importance and 
sensitivity because personal information will be obtained from the 
adolescent and their family members. Participants sign a statement attesting 
to their understanding that the information they provide will be held as 
personal and confidential. Consent forms clearly state the right to refuse 
participation at any time. In addition, because this project involves the 
collection of drug use and sexual behavior information, to strengthen the 
security of our records in relation to local and state courts, a Confidentiality 
Certificate under section 502C of Part E, Title II of the Comprehensive Drug 
Abuse Prevention and Control Act of 1970, Public Law 91-513, has been 
obtained. This Certificate has been utilized in previous prevention studies 
and has been instrumental in maintaining the privacy/confidentiality of 
sensitive client information. 
 
To assure confidentiality at STI testing during each time point, only the 
adolescent and the research assessor will be present (at the same time) 
during the procedure. Urine will be collected from the adolescent in a 
completely private manner; at no moment will the assessor watch the 
adolescent collect the urine specimen. Both the adolescent and the research 
assessor shall keep the adolescent’s urine specimen in view at all times 
before the specimen is sealed and labeled. The research assessor will place 
an identification label securely on each container. The label will contain the 
adolescent’s code number as the only source of identifying information. The 
assessor will drop off to study research offices the collected urine sample on 
the same day that it is collected.  
  
In addition, we will do everything we can to keep others from learning about the 
participants in this study. As mentioned above, to help further protect their privacy, 
the study researchers have been granted a Federal Certificate of Confidentiality 
from the National Institutes of Health. With this Certificate, the researchers cannot 
be forced, even by a court order, to share research information that may identify the 
participants in any civil, criminal, administrative, legislative, or other proceedings in 
any court. The researchers will use the Certificate to resist any demands for 
information that would identify the participants, except to prevent serious harm to 
them or others, and as explained below. 
 
The participants should understand that a Certificate of Confidentiality does not 
prevent them, or a member of their family, from voluntarily releasing information 

 
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about themselves, or their involvement in this study. If an insurer or employer learns 
about their participation, and obtains participant’s consent to receive research 
information, then we may not use the Certificate of Confidentiality to withhold this 
information. This means that the participants and their family must also actively 
protect their own privacy. Disclosure will be necessary, however, upon request for 
the purpose of audit or evaluation, and is limited only to Department of Health and 
Human Services employees involved in the review. The participant should 
understand that we will in all cases, take the necessary action, which may include 
reporting to authorities, to prevent serious harm to themselves or others. 
 
26) Provisions to Protect the Privacy Interests of Subjects 
During the recruitment and electronic consent/assent process, and prior to 
the assessments, the subjects are told that information is private, 
confidential and only accessed by specific study personnel. The subject is 
given a case ID to further protect their identity. The subject is free to ask any 
questions, and the consent form has the contact information of the Principal 
Investigator should they have further questions and the phone number to 
the University of Miami’s Human Subjects office.  
 
Please refer to Section 12(b) Secure Data and Quality Control. 
 
As described before, each follow-up visit will include screening for Neisseria 
gonorrheae (GC) and Chlamydia trachomatis (CT) as indicated by reported 
sexual risk behaviors and per local site clinical and public health standards. 
Adolescents will be encouraged to refer sexual partners for treatment.  
 
27) Compensation for Research-Related Injury 
Not applicable. 
 
28) Economic Burden to Subjects 
Not applicable. 
 
29) Consent Process 
(a) Obtaining Consent 
 
University of Miami research study personnel will screen families in the 
clinics that are interested in participating. They will present and read the 
electronic consent forms to the caregivers who are eligible to participate 
based on the inclusion and exclusion criteria. The consent form will be an 
electronic document, and each page will bear the HSRO approval 
stamp/watermark. If a participant prefers the consent or assent process to 
be non-electronic, a paper consent or assent form will be provided. After the 
caregivers understand the study and after all questions have been answered 

 
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Revised: November 2017 
to their satisfaction, individuals who elect to participate in the study will be 
asked to sign the consent form. The consent process will last approximately 
30 minutes, but it may take caregivers a little less or a little more depending 
on how clearly they comprehend the study procedures.  
 
If a parent is not available to complete consent, a legal guardian is allowed to 
provide permission for the adolescent to assent. A legal guardian is a step 
mother or step father, or another person who has obtained legal rights to 
the child. During the recruitment screening process, study personnel will 
determine if the primary caregiver is a legal guardian if they demonstrate the 
correct paperwork. 
 
Since recruitment will take place at different clinics, it is a possibility that 
potentially eligible families will visit the clinic when the research team is not 
present. If the clinic personnel identifies such a family, they will be able to 
provide them with a flyer about the study and information on how to contact 
the research team. If the family is interested and contacts the research team, 
they will be provided with the next date that the research team will be at the 
clinic so that the family can be informed about the study and conduct the 
consent, assent and baseline assessment, if the family is interested in being 
in the study.  
 
(b) Non-English Speaking Subjects 
 
The consent forms will also be available in Spanish. The consent forms have 
been translated, back-translated and pilot tested for understanding in past 
pilot studies.  
 
(c) Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
We would like to request  information from parents and adolescents that decide 
not to participate in the study. We are collecting this information because in at 
least two manuscripts where we report main outcomes for Familias Unidas, 
reviewers have requested information regarding participants who decide not to 
engage in the trial. This information will be completely de-dentified. We would 
like to collect this information through the use of a verbal consent and verbal 
assent. We are requesting permission to only utilize a verbal consent and assent 
(not signed) because it is unlikely that participants who do not want to 
participate in the study will answer these questions if they have to identify 
themselves by signing a consent or assent form.  
 
(d) Subjects who are not yet adults (infants, children, teenagers) 
 

 
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Adolescents, ages 12-16, will go through a similar process as their parents. 
Their age is confirmed with the pediatric clinic administrator, nurses, and/or 
physician. After the parent has consented, the facilitators will present the 
assent forms to the adolescent. This will occur in a different room without 
the caregivers present to prevent the adolescents from being coerced to 
participate. Only the adolescent present for the clinic appointment will 
complete the assent form. The assent process will last approximately 30 
minutes, but it may take the adolescent a little more or a little less 
depending on how clear they comprehend study procedures. 
 
(e) Cognitively Impaired Adults 
Not applicable. 
 
(f) Adults Unable to Consent 
Not applicable. 
 
30) Process to Document Consent in Writing 
Consents will be stored electronically in secure University of Miami servers. 
Information for de-identified participants who do not wish to participate in 
the study and provided verbal consent/assent to answer the questions for 
non-participating families will be kept in secure University of Miami servers. 
 
31) Drugs or Devices 
Not applicable.