Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo Respeto, Educacion y Seguridad.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)

Conditions
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Substance Abuse, HIV/AIDS, Domestic Violence

Intervention / Treatment
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* Behavioral: HoMBReS intervention
* Behavioral: Families Talking Together (FTT)
* Behavioral: Diabetes Prevention Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: father does not provide consent and permission for his son son does not provide assent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HoMBRES Intervention Group - Father<br>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. | Behavioral: HoMBReS intervention<br>* 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.<br>* Other names: HoMBReS;Behavioral: Families Talking Together (FTT)<br>* 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.<br>* Other names: FTT;|
| Active Comparator: Diabetes Prevention Intervention Group - Father<br>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. | Behavioral: Diabetes Prevention Intervention<br>* Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.<br>|
| No Intervention: HoMBRES Intervention Group - Adolescent<br>The adolescent received no intervention. | |
| No Intervention: Diabetes Prevention Intervention Group - Adolescent<br>The adolescent received no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | At Baseline, at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Baseline, At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Violence, Hispanic/Latino, Health Disparities, Migrant farmworkers