Trial Outcomes & Findings for Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo Respeto, Educacion y Seguridad. (NCT NCT03730987)
NCT ID: NCT03730987
Last Updated: 2022-10-17
Results Overview
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.
COMPLETED
NA
244 participants
At Baseline, at 6 months follow up
2022-10-17
Participant Flow
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.
Participant milestones
| Measure |
HoMBRES Intervention Group - Father
Participants in the intervention study will receive the adapted HoMBRES intervention which consisted of four participatory lectures and discussion session with the facilitator. Only fathers participated in the intervention group.
|
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 participated in the Diabetes Prevention Intervention Group.
|
HoMBRES Intervention Group - Adolescent
The adolescents with the fathers from the HIV/AIDS intervention did not receive any of the adult intervention sessions.
|
Diabetes Prevention Intervention Group - Adolescent
The adolescent from the diabetes prevention intervention with the fathers did not receive the adult intervention.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
61
|
61
|
|
Overall Study
COMPLETED
|
59
|
61
|
59
|
61
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
HoMBRES Intervention Group - Father
Participants in the intervention study will receive the adapted HoMBRES intervention which consisted of four participatory lectures and discussion session with the facilitator. Only fathers participated in the intervention group.
|
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 participated in the Diabetes Prevention Intervention Group.
|
HoMBRES Intervention Group - Adolescent
The adolescents with the fathers from the HIV/AIDS intervention did not receive any of the adult intervention sessions.
|
Diabetes Prevention Intervention Group - Adolescent
The adolescent from the diabetes prevention intervention with the fathers did not receive the adult intervention.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
0
|
Baseline Characteristics
Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo Respeto, Educacion y Seguridad.
Baseline characteristics by cohort
| Measure |
HoMBRES Intervention Group - Father
n=61 Participants
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.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
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.
|
HoMBRES Intervention Group - Adolescent
n=61 Participants
Adolescent from the did not receive any intervention. They only participated in baseline and six months follow up.
|
Diabetes Prevention Intervention Group - Adolescent
n=61 Participants
Adolescent did not receive any intervention. They only participated in baseline and six months follow up.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
n=5 Participants
|
44.4 years
n=7 Participants
|
13.9 years
n=5 Participants
|
13.7 years
n=4 Participants
|
28.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
244 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
61 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
244 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Baseline, at 6 months follow upPopulation: 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.
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.
Outcome measures
| Measure |
HoMBRES Intervention Group - Father
n=58 Participants
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 were included in this group.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers were included in this group.
|
HoMBRES Intervention Group - Adolescent
Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews.
|
HoMBRES Diabetes Control Group - Adolescent
Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews.
|
|---|---|---|---|---|
|
Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors
Baseline
|
42 Participants
|
38 Participants
|
—
|
—
|
|
Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors
6 months follow up
|
38 Participants
|
53 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline, at 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HoMBRES Intervention Group - Father
n=61 Participants
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 were included in this group.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers were included in this group.
|
HoMBRES Intervention Group - Adolescent
Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews.
|
HoMBRES Diabetes Control Group - Adolescent
Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews.
|
|---|---|---|---|---|
|
The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence
Baseline
|
10 Participants
|
9 Participants
|
—
|
—
|
|
The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence
6 months follow up
|
10 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline, at 6 monthsPopulation: 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.
The number of days participant reported drinking in the past 90 days using the Time-Line Followback self-reported questionnaire.
Outcome measures
| Measure |
HoMBRES Intervention Group - Father
n=61 Participants
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 were included in this group.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers were included in this group.
|
HoMBRES Intervention Group - Adolescent
Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews.
|
HoMBRES Diabetes Control Group - Adolescent
Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews.
|
|---|---|---|---|---|
|
The Number of Days Participant Fathers Reported Drinking in the Past 90 Days.
Baseline
|
8.59 days
Standard Deviation 15.26
|
6.72 days
Standard Deviation 11.98
|
—
|
—
|
|
The Number of Days Participant Fathers Reported Drinking in the Past 90 Days.
6 months follow up
|
11.08 days
Standard Deviation 20.20
|
8.48 days
Standard Deviation 14.37
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline, at 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HoMBRES Intervention Group - Father
n=61 Participants
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 were included in this group.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers were included in this group.
|
HoMBRES Intervention Group - Adolescent
Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews.
|
HoMBRES Diabetes Control Group - Adolescent
Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews.
|
|---|---|---|---|---|
|
HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire
Baseline
|
0.65 units on a scale
Standard Deviation 0.18
|
0.65 units on a scale
Standard Deviation 0.21
|
—
|
—
|
|
HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire
6-months follow up
|
0.81 units on a scale
Standard Deviation 0.19
|
0.69 units on a scale
Standard Deviation 0.19
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline, at 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HoMBRES Intervention Group - Father
n=61 Participants
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 were included in this group.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers were included in this group.
|
HoMBRES Intervention Group - Adolescent
Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews.
|
HoMBRES Diabetes Control Group - Adolescent
Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews.
|
|---|---|---|---|---|
|
HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale
Baseline
|
38.30 score on a scale
Standard Deviation 5.10
|
38.80 score on a scale
Standard Deviation 6.10
|
—
|
—
|
|
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 3.70
|
38.50 score on a scale
Standard Deviation 5.40
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline, at 6 monthsPopulation: 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.
The number of drinks per day over the past 90 days using the Timeline Followback.
Outcome measures
| Measure |
HoMBRES Intervention Group - Father
n=61 Participants
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 were included in this group.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers were included in this group.
|
HoMBRES Intervention Group - Adolescent
Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews.
|
HoMBRES Diabetes Control Group - Adolescent
Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews.
|
|---|---|---|---|---|
|
The Number of Drinks Per Day Over the Past 90 Days.
Baseline
|
2.82 drinks per day
Standard Deviation 3.15
|
2.35 drinks per day
Standard Deviation 2.43
|
—
|
—
|
|
The Number of Drinks Per Day Over the Past 90 Days.
6 months follow up
|
2.89 drinks per day
Standard Deviation 3.23
|
3.06 drinks per day
Standard Deviation 3.98
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline, At 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HoMBRES Intervention Group - Father
n=61 Participants
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 were included in this group.
|
Diabetes Prevention Intervention Group - Father
n=61 Participants
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers were included in this group.
|
HoMBRES Intervention Group - Adolescent
n=61 Participants
Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews.
|
HoMBRES Diabetes Control Group - Adolescent
n=61 Participants
Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews.
|
|---|---|---|---|---|
|
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
|
4.3 score on a scale
Standard Deviation 0.6
|
3.41 score on a scale
Standard Deviation 0.92
|
3.36 score on a scale
Standard Deviation 0.96
|
|
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
|
4.4 score on a scale
Standard Deviation 0.6
|
3.27 score on a scale
Standard Deviation 1.09
|
3.47 score on a scale
Standard Deviation 1.07
|
Adverse Events
HoMBRES Intervention Group - Father
Diabetes Prevention Intervention Group - Father
HoMBRES Intervention Group - Adolescent
Diabetes Prevention Intervention Group - Adolescent
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place