跳至主要内容
临床试验/NCT03730987
NCT03730987已完成不适用

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

University of Miami1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2019年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
244
试验地点
1
主要终点
HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •adults (age 18 or above)
  • •living in semirural and urban areas of Miami Dade
  • •understand and speaks Spanish
  • •has an eligible son ( 11-17 years old)

排除标准

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

研究组 & 干预措施

Diabetes Prevention Intervention Group - Adolescent

No Intervention

The adolescent received no intervention.

HoMBRES Intervention Group - Father

Experimental

Four sessions (2 sessions per week, approximately 1.5 hours each) with the fathers, in which facilitators conduct educational sessions; During the period of social distancing, interventions were 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. Intervention videos were followed up with a telephone call to respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone or videoconferences. Only fathers were included in this group.

干预措施: HoMBReS intervention (Behavioral)

HoMBRES Intervention Group - Father

Experimental

Four sessions (2 sessions per week, approximately 1.5 hours each) with the fathers, in which facilitators conduct educational sessions; During the period of social distancing, interventions were 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. Intervention videos were followed up with a telephone call to respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone or videoconferences. Only fathers were included in this group.

干预措施: Families Talking Together (FTT) (Behavioral)

Diabetes Prevention Intervention Group - Father

Active Comparator

One session of 1.5 hours held once per week. Session content will focus on the importance of physical activity, healthy eating, and maintaining a healthy weight. Only fathers were included in this group.

干预措施: Diabetes Prevention Intervention (Behavioral)

HoMBRES Intervention Group - Adolescent

No Intervention

The adolescent received no intervention.

结局指标

主要结局

HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire

时间窗: 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.

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

时间窗: 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.

The Number of Drinks Per Day Over the Past 90 Days.

时间窗: At Baseline, at 6 months

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

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

时间窗: 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

时间窗: 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.

HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale

时间窗: 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.

次要结局

  • Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale(At Baseline, At 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria Mitrani

Professor

University of Miami

研究点 (1)

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