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Family Men (English Title) (HOMBRES)

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ClinicalTrials.gov Identifier: NCT03730987
Recruitment Status : Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Victoria Mitrani, 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 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 Behavioral: Diabetes Prevention Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 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)
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: HoMBRES Intervention
Six sessions (2 sessions per week, approximately 2.5 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
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
Three sessions of 2.5 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.




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.



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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 ( 13-17 years old)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730987


Contacts
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Contact: Patria Rojas, PhD 305 348-7352 proja003@fiu.edu
Contact: Marisabel Canedo, LMSW 305 348-7583 mcanedo@fiu.edu

Locations
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United States, Florida
Florida International University Not yet recruiting
Miami, Florida, United States, 33199
Contact: Patria Rojas, PhD    305-348-7352    proja003@fiu.edu   
Contact: Marisabel Canedo, LMSW    305 348-7583    mcanedo@fiu.edu   
Sponsors and Collaborators
University of Miami
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Patria Rojas, Phd Florida International University

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Responsible Party: Victoria Mitrani, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03730987     History of Changes
Other Study ID Numbers: 20170769
U54MD002266 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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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:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders