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

Primary Purpose

Substance Abuse, Domestic Violence, HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HoMBReS intervention
Families Talking Together (FTT)
Diabetes Prevention Intervention
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse focused on measuring Family Violence, Hispanic/Latino, Health Disparities, Migrant farmworkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

Arm Label

HoMBRES Intervention Group - Father

Diabetes Prevention Intervention Group - Father

HoMBRES Intervention Group - Adolescent

Diabetes Prevention Intervention Group - Adolescent

Arm Description

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.

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.

The adolescent received no intervention.

The adolescent received no intervention.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 16, 2018
Last Updated
September 20, 2022
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03730987
Brief Title
Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo Respeto, Educacion y Seguridad.
Acronym
HoMBRES
Official Title
Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Domestic Violence, HIV/AIDS
Keywords
Family Violence, Hispanic/Latino, Health Disparities, Migrant farmworkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HoMBRES Intervention Group - Father
Arm Type
Experimental
Arm Description
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.
Arm Title
Diabetes Prevention Intervention Group - Father
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HoMBRES Intervention Group - Adolescent
Arm Type
No Intervention
Arm Description
The adolescent received no intervention.
Arm Title
Diabetes Prevention Intervention Group - Adolescent
Arm Type
No Intervention
Arm Description
The adolescent received no intervention.
Intervention Type
Behavioral
Intervention Name(s)
HoMBReS intervention
Other Intervention Name(s)
HoMBReS
Intervention Description
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
Intervention Name(s)
Families Talking Together (FTT)
Other Intervention Name(s)
FTT
Intervention Description
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
Intervention Name(s)
Diabetes Prevention Intervention
Intervention Description
Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.
Primary Outcome Measure Information:
Title
Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors
Description
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.
Time Frame
At Baseline, at 6 months follow up
Title
The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence
Description
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.
Time Frame
At Baseline, at 6 months
Title
The Number of Days Participant Fathers Reported Drinking in the Past 90 Days.
Description
The number of days participant reported drinking in the past 90 days using the Time-Line Followback self-reported questionnaire.
Time Frame
At Baseline, at 6 months
Title
HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire
Description
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.
Time Frame
At Baseline, at 6 months
Title
HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale
Description
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.
Time Frame
At Baseline, at 6 months
Title
The Number of Drinks Per Day Over the Past 90 Days.
Description
The number of drinks per day over the past 90 days using the Timeline Followback.
Time Frame
At Baseline, at 6 months
Secondary Outcome Measure Information:
Title
Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale
Description
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.
Time Frame
At Baseline, At 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gender identity is self-reported.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Behar-Zusman, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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