Domestic Violence, HIV/AIDS, Substance Abuse
Conditions
Keywords
Family Violence, Hispanic/Latino, Health Disparities, Migrant farmworkers
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.
Detailed 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.
Interventions
BEHAVIORALHoMBReS 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.
BEHAVIORALFamilies 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.
BEHAVIORALDiabetes Prevention Intervention
Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.
Sponsors
University of Miami
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors | 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. |
| The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence | 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. |
| The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. | 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. |
| HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire | 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. |
| HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale | 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. |
| The Number of Drinks Per Day Over the Past 90 Days. | At Baseline, at 6 months | The number of drinks per day over the past 90 days using the Timeline Followback. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVictoria Behar-Zusman, PhD
University of Miami
Participant flow
Recruitment details
Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention.
Participants by arm
| Arm | Count |
|---|---|
| HoMBRES Intervention Group - Father Participants in the intervention study will receive the adapted HoMBRES intervention which consisted of three participatory lectures and discussion session with the facilitator. Only fathers are included in this group. | 61 |
| Diabetes Prevention Intervention Group - Father Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers are included in this group. | 61 |
| HoMBRES Intervention Group - Adolescent Adolescent from the did not receive any intervention. They only participated in baseline and six months follow up. | 61 |
| Diabetes Prevention Intervention Group - Adolescent Adolescent did not receive any intervention. They only participated in baseline and six months follow up. | 61 |
| Total | 244 |
Baseline characteristics
| Characteristic | HoMBRES Intervention Group - Father | Diabetes Prevention Intervention Group - Father | HoMBRES Intervention Group - Adolescent | Diabetes Prevention Intervention Group - Adolescent | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.5 years | 44.4 years | 13.9 years | 13.7 years | 28.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 61 Participants | 61 Participants | 61 Participants | 61 Participants | 244 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 5 Participants | 8 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 10 Participants | 5 Participants | 8 Participants | 41 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 33 Participants | 46 Participants | 51 Participants | 44 Participants | 174 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 61 Participants | 61 Participants | 61 Participants | 61 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 61 | 0 / 61 | 0 / 61 |
| other Total, other adverse events | 0 / 61 | 0 / 61 | 0 / 61 | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 | 0 / 61 | 0 / 61 | 0 / 61 |
Outcome results
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.
Time frame: At Baseline, at 6 months
Population: Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary outcomes and adolescents were only included in the secondary outcomes. The adolescent received no intervention and were not included in the primary outcome dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HoMBRES Intervention Group - Father | HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire | Baseline | 0.65 units on a scale | Standard Deviation 0.18 |
| HoMBRES Intervention Group - Father | HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire | 6-months follow up | 0.81 units on a scale | Standard Deviation 0.19 |
| Diabetes Prevention Intervention Group - Father | HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire | Baseline | 0.65 units on a scale | Standard Deviation 0.21 |
| Diabetes Prevention Intervention Group - Father | HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire | 6-months follow up | 0.69 units on a scale | Standard Deviation 0.19 |
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.
Time frame: At Baseline, at 6 months
Population: Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HoMBRES Intervention Group - Father | HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale | Baseline | 38.30 score on a scale | Standard Deviation 5.1 |
| HoMBRES Intervention Group - Father | HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale | 6 months follow up | 40.20 score on a scale | Standard Deviation 3.7 |
| Diabetes Prevention Intervention Group - Father | HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale | Baseline | 38.80 score on a scale | Standard Deviation 6.1 |
| Diabetes Prevention Intervention Group - Father | HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale | 6 months follow up | 38.50 score on a scale | Standard Deviation 5.4 |
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.
Time frame: At Baseline, at 6 months follow up
Population: Not all participants completed the questions required. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HoMBRES Intervention Group - Father | Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors | Baseline | 42 Participants |
| HoMBRES Intervention Group - Father | Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors | 6 months follow up | 38 Participants |
| Diabetes Prevention Intervention Group - Father | Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors | Baseline | 38 Participants |
| Diabetes Prevention Intervention Group - Father | Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors | 6 months follow up | 53 Participants |
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.
Time frame: At Baseline, at 6 months
Population: Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HoMBRES Intervention Group - Father | The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. | Baseline | 8.59 days | Standard Deviation 15.26 |
| HoMBRES Intervention Group - Father | The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. | 6 months follow up | 11.08 days | Standard Deviation 20.2 |
| Diabetes Prevention Intervention Group - Father | The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. | Baseline | 6.72 days | Standard Deviation 11.98 |
| Diabetes Prevention Intervention Group - Father | The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. | 6 months follow up | 8.48 days | Standard Deviation 14.37 |
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.
Time frame: At Baseline, at 6 months
Population: Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HoMBRES Intervention Group - Father | The Number of Drinks Per Day Over the Past 90 Days. | Baseline | 2.82 drinks per day | Standard Deviation 3.15 |
| HoMBRES Intervention Group - Father | The Number of Drinks Per Day Over the Past 90 Days. | 6 months follow up | 2.89 drinks per day | Standard Deviation 3.23 |
| Diabetes Prevention Intervention Group - Father | The Number of Drinks Per Day Over the Past 90 Days. | Baseline | 2.35 drinks per day | Standard Deviation 2.43 |
| Diabetes Prevention Intervention Group - Father | The Number of Drinks Per Day Over the Past 90 Days. | 6 months follow up | 3.06 drinks per day | Standard Deviation 3.98 |
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.
Time frame: At Baseline, at 6 months
Population: Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HoMBRES Intervention Group - Father | The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence | Baseline | 10 Participants |
| HoMBRES Intervention Group - Father | The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence | 6 months follow up | 10 Participants |
| Diabetes Prevention Intervention Group - Father | The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence | Baseline | 9 Participants |
| Diabetes Prevention Intervention Group - Father | The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence | 6 months follow up | 5 Participants |
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.
Time frame: At Baseline, At 6 months
Population: Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent did not receive any interventions and were not included in the dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HoMBRES Intervention Group - Father | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | Baseline | 4.1 score on a scale | Standard Deviation 0.8 |
| HoMBRES Intervention Group - Father | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | 6 months follow up | 4.2 score on a scale | Standard Deviation 0.6 |
| Diabetes Prevention Intervention Group - Father | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | 6 months follow up | 4.4 score on a scale | Standard Deviation 0.6 |
| Diabetes Prevention Intervention Group - Father | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | Baseline | 4.3 score on a scale | Standard Deviation 0.6 |
| HoMBRES Intervention Group - Adolescent | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | Baseline | 3.41 score on a scale | Standard Deviation 0.92 |
| HoMBRES Intervention Group - Adolescent | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | 6 months follow up | 3.27 score on a scale | Standard Deviation 1.09 |
| HoMBRES Diabetes Control Group - Adolescent | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | Baseline | 3.36 score on a scale | Standard Deviation 0.96 |
| HoMBRES Diabetes Control Group - Adolescent | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | 6 months follow up | 3.47 score on a scale | Standard Deviation 1.07 |