Family Men (English Title) (HOMBRES)

• ClinicalTrials.gov Identifier: NCT03730987
• Recruitment Status: Completed
• First Posted: November 5, 2018
• Last Update Posted: October 25, 2021
• Sponsor: University of Miami
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Victoria Mitrani, University of Miami

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.

Condition or disease	Intervention/treatment	Phase
Substance Abuse; Domestic Violence; HIV/AIDS	Behavioral: HoMBReS intervention; Behavioral: Families Talking Together (FTT); Behavioral: Diabetes Prevention Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 305 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)
• Actual Study Start Date: April 19, 2019
• Actual Primary Completion Date: July 30, 2021
• Actual Study Completion Date: July 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: HoMBRES Intervention; Four sessions (2 sessions per week, approximately 1.5 hours each) with the fathers, in which facilitators conduct educational sessions with groups of 6-8 men per group. One of the sessions includes an intervention of families talking together.	Behavioral: HoMBReS intervention; The experimental group (group A) will receive an intervention based on social cognitive theory and empowerment education that aims to reduce risky sexual behaviors among recently migrated rural men.; Other Name: HoMBReS; 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, and prepare them to teach adolescents assertiveness and substance abuse refusal skills.; Other Name: FTT
Active Comparator: 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.	Behavioral: Diabetes Prevention Intervention; Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.

Outcome Measures

Primary Outcome Measures :

1. Change in quantity of substance use [ Time Frame: Baseline, 6 months ]
   As measured by the Time-Line Followback questionnaire with participants self-reporting number of drinks per day
2. Change in self-reported engagement in risky sexual behaviors [ Time Frame: Baseline, 6 months ]
   As measured using the PhenX Toolkit Sexual Risk Behavior self-reported instrument utilizing the number of unprotected sexual encounters as well as number of sexual partners
3. Change in self-reported experiences of violence [ Time Frame: Baseline, 6 months ]
   As measured using the PhenX Toolkit Exposures to Violence self-reported instrument
4. Change in frequency of substance use [ Time Frame: Baseline, 6 months ]
   As measured by the Time-Line Followback self-reported questionnaire with participants self-reporting number days drinking

Secondary Outcome Measures :

1. Change in Level of self-reported communication with son [ Time Frame: Baseline, 6 months ]
   As measured using the self-reported Parenting Practices Instrument, 12 item Parental Monitoring subscale rated on a 7-item Likert scale. Scores range from 0-72, with higher scores indicating higher levels of parental monitoring.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Gender identity is self-reported.
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• male
• adults (age 18 or above)
• farmworker
• 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

Contacts and Locations

Locations

United States, Florida

Florida International University

Miami, Florida, United States, 33199

Sponsors and Collaborators

University of Miami

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Victoria Behar-Zusman, PhD; University of Miami

  Study Documents (Full-Text)

Documents provided by Victoria Mitrani, University of Miami:

Informed Consent Form  [PDF] April 12, 2020

More Information

• Responsible Party: Victoria Mitrani, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03730987
• Other Study ID Numbers: 20170769; U54MD002266 ( U.S. NIH Grant/Contract )
• First Posted: November 5, 2018
• Last Update Posted: October 25, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Victoria Mitrani, University of Miami:

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

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders