NCT03730987: HoMBRES

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

Completed NA Results posted Last updated 17 October 2022

What this trial tests

NA trial testing HoMBReS intervention in Substance Abuse in 244 participants. Completed in 30 July 2021.

Timeline

19 April 2019

Primary endpoint
30 July 2021

30 July 2021

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	244
Start date	19 April 2019
Primary completion	30 July 2021
Estimated completion	30 July 2021
Sites	1 location across United States

Drugs / interventions tested

• HoMBReS intervention
• Families Talking Together (FTT)
• Diabetes Prevention Intervention

Conditions studied

• Substance Abuse — all drugs for Substance Abuse →
• Domestic Violence — all drugs for Domestic Violence →
• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

University of Miami

Who can join

18 and older, male only, with Substance Abuse or Domestic Violence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors Primary · 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.

Baseline

Group	Value	95% CI
HoMBRES Intervention Group - Father	42
Diabetes Prevention Intervention Group - Father	38

6 months follow up

Group	Value	95% CI
HoMBRES Intervention Group - Father	38
Diabetes Prevention Intervention Group - Father	53

The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence Primary · 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.

Baseline

Group	Value	95% CI
HoMBRES Intervention Group - Father	10
Diabetes Prevention Intervention Group - Father	9

6 months follow up

Group	Value	95% CI
HoMBRES Intervention Group - Father	10
Diabetes Prevention Intervention Group - Father	5

The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. Primary · 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.

Baseline

Group	Value	95% CI
HoMBRES Intervention Group - Father	8.59	± 15.26
Diabetes Prevention Intervention Group - Father	6.72	± 11.98

6 months follow up

Group	Value	95% CI
HoMBRES Intervention Group - Father	11.08	± 20.20
Diabetes Prevention Intervention Group - Father	8.48	± 14.37

HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire Primary · 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.

Baseline

Group	Value	95% CI
HoMBRES Intervention Group - Father	0.65	± 0.18
Diabetes Prevention Intervention Group - Father	0.65	± 0.21

6-months follow up

Group	Value	95% CI
HoMBRES Intervention Group - Father	0.81	± 0.19
Diabetes Prevention Intervention Group - Father	0.69	± 0.19

HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale Primary · 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.

Baseline

Group	Value	95% CI
HoMBRES Intervention Group - Father	38.30	± 5.10
Diabetes Prevention Intervention Group - Father	38.80	± 6.10

6 months follow up

Group	Value	95% CI
HoMBRES Intervention Group - Father	40.20	± 3.70
Diabetes Prevention Intervention Group - Father	38.50	± 5.40

The Number of Drinks Per Day Over the Past 90 Days. Primary · At Baseline, at 6 months

The number of drinks per day over the past 90 days using the Timeline Followback.

Baseline

Group	Value	95% CI
HoMBRES Intervention Group - Father	2.82	± 3.15
Diabetes Prevention Intervention Group - Father	2.35	± 2.43

6 months follow up

Group	Value	95% CI
HoMBRES Intervention Group - Father	2.89	± 3.23
Diabetes Prevention Intervention Group - Father	3.06	± 3.98

Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale Secondary · 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.

Baseline

Group	Value	95% CI
HoMBRES Intervention Group - Father	4.1	± 0.8
Diabetes Prevention Intervention Group - Father	4.3	± 0.6
HoMBRES Intervention Group - Adolescent	3.41	± 0.92
HoMBRES Diabetes Control Group - Adolescent	3.36	± 0.96

6 months follow up

Group	Value	95% CI
HoMBRES Intervention Group - Father	4.2	± 0.6
Diabetes Prevention Intervention Group - Father	4.4	± 0.6
HoMBRES Intervention Group - Adolescent	3.27	± 1.09
HoMBRES Diabetes Control Group - Adolescent	3.47	± 1.07

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized clinical trial testing the effectiveness of an adapted online HIV/AIDS prevention intervention among Latino men.
   Rojas P, Wang W, Colon-Burgos JF, Tineo YAC, et al · · 2025 · cited 1× · PMID 40775256 · DOI 10.1038/s41598-025-14006-y