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

NCT ID: NCT03730987

Last Updated: 2022-10-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-19

Study Completion Date

2021-07-30

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.

Conditions

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Substance Abuse Domestic Violence HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HoMBRES Intervention Group - Father

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.

Group Type EXPERIMENTAL

HoMBReS intervention

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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 Intervention Group - Father

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.

Group Type ACTIVE_COMPARATOR

Diabetes Prevention Intervention

Intervention Type BEHAVIORAL

Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.

HoMBRES Intervention Group - Adolescent

The adolescent received no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Diabetes Prevention Intervention Group - Adolescent

The adolescent received no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HoMBReS intervention

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.

Intervention Type BEHAVIORAL

Families Talking Together (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.

Intervention Type BEHAVIORAL

Diabetes Prevention Intervention

Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.

Intervention Type BEHAVIORAL

Other Intervention Names

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HoMBReS FTT

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Victoria Mitrani

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victoria Behar-Zusman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Florida International University

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U54MD002266

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20170769

Identifier Type: -

Identifier Source: org_study_id

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