Substance AbuseHoMBRESNCT03730987
Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo Respeto, Educacion y Seguridad.
A study testing HoMBReS intervention, Families Talking Together (FTT) and Diabetes Prevention Intervention in people with Substance Abuse and Domestic Violence, run by University of Miami at 1 site in United States.
Trial summary
The overall objective of this project is to adapt and enhance HoMBReS (Hispanic Men Building Respect, Education, and Safety within Families /Hombres Manteniendo Respeto, Educacion y Seguridad de Familia), a Center for Disease Control (CDC)-identified best-evidence HIV behavioral intervention designed to reduce… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Domestic Violence, HIV/AIDS
- What is being tested?
- HoMBReS intervention, Families Talking Together (FTT) and Diabetes Prevention Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 30 Jul 2021
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- adults (age 18 or above)
- living in semirural and urban areas of Miami Dade
- Latino
- understand and speaks Spanish
- has an eligible son ( 11-17 years old)
Who cannot join
- father does not provide consent and permission for his son
- son does not provide assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)
The overall objective of this project is to adapt and enhance HoMBReS (Hispanic Men Building Respect, Education, and Safety within Families /Hombres Manteniendo Respeto, Educacion y Seguridad de Familia), a Center for Disease Control (CDC)-identified best-evidence HIV behavioral intervention designed to reduce substance abuse, family violence, and HIV/AIDS (SAVA) among sexually active heterosexual Latino seasonal farmworkers (LSFWs) in rural areas.
Read the detailed description
The HoMBRES de Familia project study (HoMBRES) examined the efficacy of a culturally adapted group intervention program with fathers from a seasonal farm working community and an Urban community in South Florida. The HoMBRES intervention study adapted and tested the efficacy of an intervention that can be adopted, implemented, and sustained with Latino fathers who live or work in the farm industry, construction, services, self employed or any other work industry in the semi-rural areas and urban areas of Miami Dade County. The HoMBRES intervention seeked to reduce risk for the SAVA (Substance Abuse, Violence, and HIV/AIDS infection) syndemic among this group of men and their adolescent sons.
The intervention HoMBRES consisted of four sessions remotely facilitated via a well-tested video platform accessible by a link sent to the participants' telephone, computer, tablet or IPad (approximately 1.5 hours each session). Staff scheduled the times when participants will watch the videotaped sessions in order to be available for their questions. Intervention videos were followed up with a telephone call to discuss presentation and respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone. Video sessions were completed within two weeks time period. Participants in the control group received one single video on diabetes prevention. Both groups were followed up six months post baseline interview.
- Conditions
- Substance Abuse, Domestic Violence, HIV/AIDS
- Being tested
- HoMBReS intervention, Families Talking Together (FTT), Diabetes Prevention Intervention
- Keywords
- Family Violence, Hispanic/Latino, Health Disparities, Migrant farmworkers
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoMBReS interventionBehavioural
Also called HoMBReS
Adapted intervention based on social cognitive theory and empowerment education that aims to reduce risky sexual behaviors, substance abuse and HIV among recently immigrated rural and urban men.
Families Talking Together (FTT)Behavioural
Also called FTT
The brief intervention, is a parent-based intervention to teach parents effective strategies proven to reduce adolescent sexual risk behavior. The intervention specifically targets the parent (not the adolescent) to: promote communication skills, build parent-adolescent relationships, develop effective monitoring strategies, reduce alcohol use, risky sexual behaviors and prepare them to teach adolescents assertiveness and substance abuse refusal skills.
Diabetes Prevention InterventionBehavioural
Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.
| Study group | Role | What they receive |
|---|---|---|
| HoMBRES Intervention Group - Father | Experimental | Four sessions (2 sessions per week, approximately 1.5 hours each) with the fathers, in which facilitators conduct educational sessions; During the period of social distancing, interventions were remotely facilitated via a well-tested video platform accessible by a link sent to the participants' telephone, computer, tablet or IPad (approximately 1.5 hours each session. Intervention videos were followed up with a telephone call to respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone or videoconferences. Only fathers were included in this group. Receives: Behavioral: HoMBReS intervention; Behavioral: Families Talking Together (FTT) |
| Diabetes Prevention Intervention Group - Father | Active comparator | One session of 1.5 hours held once per week. Session content will focus on the importance of physical activity, healthy eating, and maintaining a healthy weight. Only fathers were included in this group. Receives: Behavioral: Diabetes Prevention Intervention |
| HoMBRES Intervention Group - Adolescent | No intervention | The adolescent received no intervention. |
| Diabetes Prevention Intervention Group - Adolescent | No intervention | The adolescent received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors
The number of participants that responded 'yes' to any of the following questions on the PhenX Toolkit Sexual Risk Behavior will be reported as self-reporting engagement in risky sexual behaviors; a) engaging in unprotected sexual encounters, b) more than one partner, c) anal sex with man in the last 6 months.
Measured: At Baseline, at 6 months follow up
The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence
As measured using the PhenX Toolkit Exposures to Violence self-reported instrument. The variable was recoded using four categories: (1) "Your partner physically hurt you; (2) Insult or talk down to you; (3) Threaten you with harm; (4) Scream or curse at you. The responses are scored on a Likert-type scale 1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, and 5=Always. The number of participants reporting 3 or higher on the Likert scale to any of the four categories, will be recorded as experiencing intra-partner violence.
Measured: At Baseline, at 6 months
The Number of Days Participant Fathers Reported Drinking in the Past 90 Days.
The number of days participant reported drinking in the past 90 days using the Time-Line Followback self-reported questionnaire.
Measured: At Baseline, at 6 months
HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire
As measured by the Brief HIV Knowledge Questionnaire. The proportion of correct answers will be reported (ranging from 0 to 1), with a score closer to 1 indicating higher HIV knowledge.
Measured: At Baseline, at 6 months
HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale
Self-Efficacy for Sexually Transmitted Infection (STI) and HIV Scale is a 9-item scale measuring the level of confidence in the ability to prevent STI and HIV infection. The measure uses a 5-point Likert scale (1=not sure at all to 5= completely sure). Total score ranges 9 to 45, with a higher score indicating a higher level of HIV self-efficacy.
Measured: At Baseline, at 6 months
The Number of Drinks Per Day Over the Past 90 Days.
The number of drinks per day over the past 90 days using the Timeline Followback.
Measured: At Baseline, at 6 months
Secondary outcomes (1)
Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale
The self-reported Parenting Practices Scale has a total score ranging from 1-5, with higher scores indicating higher levels of parental monitoring among the fathers. The adolescents responded to the son's version of the scale.
Measured: At Baseline, At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start19 Apr 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
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.
- Other trials for Substance AbuseStudies 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
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Victoria Mitrani, University of Miami
- Investigators
- Victoria Behar-Zusman, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730987
- Sponsor's protocol ID
- 20170769
- Other IDs
- U54MD002266
- Acronym
- HoMBRES
- Status last verified
- Sep 2022
- First submitted
- 16 Oct 2018
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)
- ClinicalTrials.gov ID
- NCT03730987
- Acronym / sponsor ID
- HoMBRES / 20170769
- Conditions
- Substance Abuse, Domestic Violence, HIV/AIDS
- Keywords
- Family Violence, Hispanic/Latino, Health Disparities, Migrant farmworkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Posted 17 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this project is to adapt and enhance HoMBReS (Hispanic Men Building Respect, Education, and Safety within Families /Hombres Manteniendo Respeto, Educacion y Seguridad de Familia), a Center for Disease Control (CDC)-identified best-evidence HIV behavioral intervention designed to reduce substance abuse, family violence, and HIV/AIDS (SAVA) among sexually active heterosexual Latino seasonal farmworkers (LSFWs) in rural areas.
Detailed description
The HoMBRES de Familia project study (HoMBRES) examined the efficacy of a culturally adapted group intervention program with fathers from a seasonal farm working community and an Urban community in South Florida. The HoMBRES intervention study adapted and tested the efficacy of an intervention that can be adopted, implemented, and sustained with Latino fathers who live or work in the farm industry, construction, services, self employed or any other work industry in the semi-rural areas and urban areas of Miami Dade County. The HoMBRES intervention seeked to reduce risk for the SAVA (Substance Abuse, Violence, and HIV/AIDS infection) syndemic among this group of men and their adolescent sons.
The intervention HoMBRES consisted of four sessions remotely facilitated via a well-tested video platform accessible by a link sent to the participants' telephone, computer, tablet or IPad (approximately 1.5 hours each session). Staff scheduled the times when participants will watch the videotaped sessions in order to be available for their questions. Intervention videos were followed up with a telephone call to discuss presentation and respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone. Video sessions were completed within two weeks time period. Participants in the control group received one single video on diabetes prevention. Both groups were followed up six months post baseline interview.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HoMBRES Intervention Group - Father | Experimental | Behavioral: HoMBReS intervention, Behavioral: Families Talking Together (FTT)Four sessions (2 sessions per week, approximately 1.5 hours each) with the fathers, in which facilitators conduct educational sessions; During the period of social distancing, interventions were remotely facilitated via a well-tested video platform accessible by a link sent to the participants' telephone, computer, tablet or IPad (approximately 1.5 hours each session. Intervention videos were followed up with a telephone call to respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone or videoconferences. Only fathers were included in this group. |
| Diabetes Prevention Intervention Group - Father | Active comparator | Behavioral: Diabetes Prevention InterventionOne session of 1.5 hours held once per week. Session content will focus on the importance of physical activity, healthy eating, and maintaining a healthy weight. Only fathers were included in this group. |
| HoMBRES Intervention Group - Adolescent | No intervention | –The adolescent received no intervention. |
| Diabetes Prevention Intervention Group - Adolescent | No intervention | –The adolescent received no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male
- adults (age 18 or above)
- living in semirural and urban areas of Miami Dade
- Latino
- understand and speaks Spanish
Key exclusion criteria (2 listed)
- father does not provide consent and permission for his son
- son does not provide assent
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 |
|---|---|---|
| HoMBReS interventionAlso: HoMBReSAdapted intervention based on social cognitive theory and empowerment education that aims to reduce risky sexual behaviors, substance abuse and HIV among recently immigrated rural and urban men. | Behavioural | HoMBRES Intervention Group - Father |
| Families Talking Together (FTT)Also: FTTThe brief intervention, is a parent-based intervention to teach parents effective strategies proven to reduce adolescent sexual risk behavior. The intervention specifically targets the parent (not the adolescent) to: promote communication skills, build parent-adolescent relationships, develop effective monitoring strategies, reduce alcohol use, risky sexual behaviors and prepare them to teach adolescents assertiveness and substance abuse refusal skills. | Behavioural | HoMBRES Intervention Group - Father |
| Diabetes Prevention InterventionSession content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight. | Behavioural | Diabetes Prevention Intervention Group - Father |
Primary outcome
Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors
Time frame: At Baseline, at 6 months follow up
The number of participants that responded 'yes' to any of the following questions on the PhenX Toolkit Sexual Risk Behavior will be reported as self-reporting engagement in risky sexual behaviors; a) engaging in unprotected sexual encounters, b) more than one partner, c) anal sex with man in the last 6 months.
The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence
Time frame: At Baseline, at 6 months
As measured using the PhenX Toolkit Exposures to Violence self-reported instrument. The variable was recoded using four categories: (1) "Your partner physically hurt you; (2) Insult or talk down to you; (3) Threaten you with harm; (4) Scream or curse at you. The responses are scored on a Likert-type scale 1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, and 5=Always. The number of participants reporting 3 or higher on the Likert scale to any of the four categories, will be recorded as experiencing intra-partner violence.
The Number of Days Participant Fathers Reported Drinking in the Past 90 Days.
Time frame: At Baseline, at 6 months
The number of days participant reported drinking in the past 90 days using the Time-Line Followback self-reported questionnaire.
HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire
Time frame: At Baseline, at 6 months
As measured by the Brief HIV Knowledge Questionnaire. The proportion of correct answers will be reported (ranging from 0 to 1), with a score closer to 1 indicating higher HIV knowledge.
HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale
Time frame: At Baseline, at 6 months
Self-Efficacy for Sexually Transmitted Infection (STI) and HIV Scale is a 9-item scale measuring the level of confidence in the ability to prevent STI and HIV infection. The measure uses a 5-point Likert scale (1=not sure at all to 5= completely sure). Total score ranges 9 to 45, with a higher score indicating a higher level of HIV self-efficacy.
The Number of Drinks Per Day Over the Past 90 Days.
Time frame: At Baseline, at 6 months
The number of drinks per day over the past 90 days using the Timeline Followback.
1 secondary outcome
Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale
Time frame: At Baseline, At 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Victoria Behar-Zusman, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoMBReS intervention, Families Talking Together (FTT) and Diabetes Prevention Intervention in people with Substance Abuse and Domestic Violence, run by University of Miami at 1 site 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 6 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 17 Oct 2022). 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?
Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors (time frame: At Baseline, at 6 months follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.