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

NCT03730987 | Completed Results DMC

• 2 other identifiers: 20170769U54MD002266
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Abuse; Domestic Violence; HIV/AIDS

Keywords

Family Violence; Hispanic/Latino; Health Disparities; Migrant farmworkers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale

  At Baseline, At 6 months

Study Arms (4)

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.

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.

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.

Interventions

HoMBReS intervention 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.

Also known as: HoMBReS

HoMBRES Intervention Group - Father

Families Talking Together (FTT) 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.

Also known as: FTT

HoMBRES Intervention Group - Father

Diabetes Prevention Intervention BEHAVIORAL

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

Diabetes Prevention Intervention Group - Father

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender identity is self-reported.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Victoria Behar-Zusman
• Organization: University of Miami

vbehar-zusman@miami.edu

305-2849139

Study Officials

• Victoria Behar-Zusman, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 5, 2018
• Study Start: April 19, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: October 17, 2022
• Results First Posted: October 17, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)