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

Not Applicable

Completed

• Conditions: Substance Abuse; Domestic Violence; HIV/AIDS
• Interventions: Behavioral: Diabetes Prevention Intervention; Behavioral: HoMBReS intervention; Behavioral: Families Talking Together (FTT)

• Registration Number: NCT03730987
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-05
• Study Start: 2019-04-19
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Results First Submitted: 2022-07-30
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Results First Posted: 2022-10-17
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 244

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)

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Exclusion Criteria

• father does not provide consent and permission for his son
• son does not provide assent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Prevention Intervention Group - Father	Diabetes Prevention Intervention	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.
HoMBRES Intervention Group - Father	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.
HoMBRES Intervention Group - Father	HoMBReS intervention	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.

Primary Outcome Measures

Name	Time	Method
The Number of Drinks Per Day Over the Past 90 Days.	At Baseline, at 6 months	The number of drinks per day over the past 90 days using the Timeline Followback.
Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors	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	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.
HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale	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 Days Participant Fathers Reported Drinking in the Past 90 Days.	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	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.

Secondary Outcome Measures

Name	Time	Method
Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale	At Baseline, At 6 months	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.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States