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

HIV/AIDS Clinical Trial

— HoMBRES  

Official title:

Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730987
• Other study ID #: 20170769
• Secondary ID: U54MD002266
• Status: Completed
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: September 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Domestic Violence
• HIV/AIDS
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• HoMBReS intervention
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.
• 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, reduce alcohol use, risky sexual behaviors and prepare them to teach adolescents assertiveness and substance abuse refusal skills.
• Diabetes Prevention Intervention
Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	At Baseline, At 6 months