Sexual Risk BehaviorNCT03009539

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

A study testing eHealth Familias Unidas Primary Care in people with Sexual Risk Behavior and Drug Use, run by University of Miami at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Sexual Risk Behavior, Drug Use, Family Functioning
What is being tested?: eHealth Familias Unidas Primary Care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 921 participants
Where: 12 sitesUnited States
Study dates: 18 Apr 2017to 18 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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 - 17 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.)

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

PrimeCare Pediatrics
Hialeah, Florida, 33016
Ileana Fuentes Clinic
Miami, Florida, 33134
Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital
Miami, Florida, 33136
UM Pediatric Mobile Clinic
Miami, Florida, 33136
UM UHealth Pediatrics at the Professional Arts Center
Miami, Florida, 33136
Borinquean Medical Centers
Miami, Florida, 33137
Borinquen Medical Centers
Miami, Florida, 33137
Kidstown Pediatrics
Miami, Florida, 33137
Belkys Bravo Clinic
Miami, Florida, 33145
Castro Pediatrics
Miami, Florida, 33173
University of Miami UHealth Pediatrics at Kendall
Miami, Florida, 33176
S. Florida Pediatric Partners
Miami, Florida, 33196

Other trials in United States

About this study

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

Conditions: Sexual Risk Behavior, Drug Use, Family Functioning
Being tested: eHealth Familias Unidas Primary Care
Keywords: Prevention with Hispanic youth, eHealth preventive intervention in primary care, Hispanic adolescent, Familias Unidas, eHealth Familias Unidas, effectiveness trial, sexually transmitted disease, parent-centered, Hispanic, sexual risk behavior
Medical subject headings: Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eHealth Familias Unidas Primary CareBehavioural
Also called eHealth Familias Unidas
The experimental condition will consist of "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. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family.

Study groups in NCT03009539
Study group	Role	What they receive
eHealth Familias Unidas Primary Care	Experimental	eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. Receives: Behavioral: eHealth Familias Unidas Primary Care
Treatment as Usual	No intervention	Participants in this condition will not receive an intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Drug Use
Change in drug use will be reported as the episodes of reported drug use for the previous 90 days with questions from Monitoring the Future
Measured: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in Unprotected Sexual Behavior
Change in unprotected sexual behavior was reported as endorsement incidence of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument. Higher values indicate worst outcomes.
Measured: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in Incidence of Sexually Transmitted Infection
Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens
Measured: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months

Secondary outcomes (3)

Change in Family Functioning as Assessed by the Parenting Practices Questionnaire
Change in family functioning will be reported using the Parenting Practices Scale (Tolan et al., 1997). Subscales include positive parenting (9 items, alpha = .78 for adolescents; alpha = .77 for parents) parental involvement( 20 items, alpha = .86 for adolescents; alpha = .85 parents). Responses range from 0 to 4 with higher values indicating better parenting, higher scores indicate more positive outcomes. The mean for each subscale was used to create a sum score.
Measured: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in Family Functioning as Assessed by the Parent Relationship With Peer Group
Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.The mean was used to create a sum score.
Measured: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in Family Functioning as Assessed by the Parent-Adolescent Communication Scale
Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.The mean was used to create a sum score.
Measured: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201718 Dec 2022

First posted4 Jan 2017 (estimated)
Study start18 Apr 2017
Primary completion18 Dec 2022
Study completion18 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sexual Risk BehaviorStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 921 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03009539
Sponsor's protocol ID: 20160035
Other IDs: 1R01DA040756
Status last verified: May 2024
First submitted: 29 Nov 2016
Last updated: 13 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Estrada Y, Lozano A, Graefe B, Lee TK, Mitrani E, Lovan P, Tapia MI, Perrino T, Forster LQ, Gwynn L, Prado G. A Primary Care E-Health Family Intervention for Risk Behaviors in Hispanic Youths: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2637908. doi: 10.1001/jamanetworkopen.2026.37908.
PubMed 42853571

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sexual Risk Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care
ClinicalTrials.gov ID: NCT03009539
Acronym / sponsor ID: 20160035
Conditions: Sexual Risk Behavior, Drug Use, Family Functioning
Keywords: Prevention with Hispanic youth, eHealth preventive intervention in primary care, Hispanic adolescent, Familias Unidas, eHealth Familias Unidas, effectiveness trial, sexually transmitted disease, parent-centered
Study type: Interventional
Recruitment status: Completed
Enrolment: 921 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 18 Apr 2017 (actual)
Primary completion: 18 Dec 2022 (actual)
Study completion: 18 Dec 2022 (actual)
First posted: 4 Jan 2017 (estimated)
Results: Posted 13 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
eHealth Familias Unidas Primary Care	Experimental	Behavioral: eHealth Familias Unidas Primary CareeHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English.
Treatment as Usual	No intervention	–Participants in this condition will not receive an intervention.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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 - 17 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.)

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
eHealth Familias Unidas Primary CareAlso: eHealth Familias UnidasThe experimental condition will consist of "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. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family.	Behavioural	eHealth Familias Unidas Primary Care

Primary outcome

Change in Drug Use
Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in drug use will be reported as the episodes of reported drug use for the previous 90 days with questions from Monitoring the Future
Change in Unprotected Sexual Behavior
Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in unprotected sexual behavior was reported as endorsement incidence of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument. Higher values indicate worst outcomes.
Change in Incidence of Sexually Transmitted Infection
Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens

3 secondary outcomes

Change in Family Functioning as Assessed by the Parenting Practices Questionnaire
Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in Family Functioning as Assessed by the Parent Relationship With Peer Group
Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in Family Functioning as Assessed by the Parent-Adolescent Communication Scale
Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months

Results and safety

Results posted to the registry on 13 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
eHealth Familias Unidas Primary Care-Adolescents	225	93
Treatment as Usual-Adolescents	231	118
eHealth Familias Unidas Primary Care-Parents	225	93
Treatment as Usual-Parents	231	118

Primary outcome: Change in Drug Use

Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months. Mean (Standard Deviation). Unit: Episodes of drug use

Measure	eHealth Familias Unidas Primary Care n = 225	Treatment as Usual n = 231
Baseline	.02 (.22)	.50 (4.33)
6 months post baseline	.09 (.69)	.34 (3.60)
12 months post baseline	.07 (.58)	.59 (4.16)
24 months post baseline	.12 (.73)	1.46 (9.03)
36 months post baseline	.22 (1.78)	1.09 (8.11)

Population analysed: The number of participants represent dyads. However, drug use was not analyzed for parents, only for adolescents. Therefore, these analyses include adolescents only.

Primary outcome: Change in Unprotected Sexual Behavior

Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months. Mean (Standard Deviation). Unit: Episodes of unprotected sexual behavior

Measure	eHealth Familias Unidas Primary Care n = 225	Treatment as Usual n = 231
Baseline	.04 (.39)	.08 (.50)
6 months post baseline	.04 (.33)	.08 (.50)
12 months post baseline	.05 (.43)	.09 (.56)
24 months post baseline	.13 (.66)	.19 (.78)
36 months post baseline	.28 (.89)	.21 (.81)

Population analysed: The number of participants represent dyads. However, unprotected sexual behavior was not analyzed for parents, only for adolescents. Therefore, these analyses include adolescents only.

Primary outcome: Change in Incidence of Sexually Transmitted Infection

Time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months

Population analysed: Analysis for the incidence of sexually transmitted infection was not conducted because the data were not collected. The data were not collected because we discontinued urine collection early on due to the COVID pandemic and associated shutdowns.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
eHealth Familias Unidas Primary Care	0 of 225 (0%)	0 of 225 (0%)	0 of 225
Treatment as Usual	0 of 231 (0%)	0 of 231 (0%)	0 of 231

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42853571Estrada Y, Lozano A, Graefe B, Lee TK, Mitrani E, Lovan P, Tapia MI, Perrino T, Forster LQ, Gwynn L, Prado G. A Primary Care E-Health Family Intervention for Risk Behaviors in Hispanic Youths: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2637908. doi: 10.1001/jamanetworkopen.2026.37908.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guillermo Prado, Ph.D. principal investigator

University of Miami

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing eHealth Familias Unidas Primary Care in people with Sexual Risk Behavior and Drug Use, run by University of Miami at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Drug Use (time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03009539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.