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临床试验/NCT02158962
NCT02158962Unknown不适用

An Integrated Risk Reduction Intervention for Abused African Caribbean Women

University of the Virgin Islands2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Danger Assessment Score

研究概览

简要总结

The purpose of this study is to combine a culturally tailored and integrated Risk Reduction Intervention in the US Virgin Islands (USVI) in a clinical trial randomly assigning abused women to a 1) Healthy Relationships experimental group of three sessions of risk reduction interventions or 2) a Healthy Living comparison control group of three session of health promotion activities to determine if the combined, intervention is safe and effective in a test the following hypotheses:

  1. Women in the integrated risk reduction intervention will score significantly lower on outcome measures of intimate partner abuse (IPA) and STD/HIV risk behaviors end of Session III and at 3 and 6 months than women in the control group
  2. Women in the integrated risk reduction Intervention will score significantly higher on IPA safety behaviors and STI/HIV prevention behaviors at end of Session III and at 3 and 6 months than women in the control group.

Several exploratory and major controlled studies on the mainland US have shown intimate partner violence (IPV) and intimate partner abuse (IPA) to be risk factors for a variety of physical, reproductive and mental health problems, including sexually transmitted infections and HIV/AIDS, many of which are areas of known health disparity for African American and Latina women. A recently completed study of African Caribbean and African American women in the US Virgin Islands revealed that nearly one third of women reported lifetime partner abuse and increased risk for sexually transmitted infections including HIV/AIDS. Abused women in the USVI had significantly more risk factors for HIV/AIDS than did women who were not abused.

The proposed intervention combines an empowerment model designed to help abused women make choices that protect the physical and emotional health of the woman and her family with a sexual safety model designed to help her make choices to reduce her risk of acquiring an STI or contracting HIV/AIDS. The integrated model adapts two interventions that have been tested with African American women on the US mainland and found to be effective as separate interventions for IPV and IPA and reducing the risk of STI/HIV. The adapted interventions will be used with abused African Caribbean women based on an a priori assessment of the cultural attitudes, beliefs and resources available to women living in an island environment with limited resources.

详细描述

I. Background and Significance: Several exploratory and major controlled studies conducted on the mainland US have shown intimate partner violence (IPV) or intimate partner abuse (IPA) to be risk factors for a variety of physical, reproductive and mental health problems, including HIV/AIDS, many of which are areas of known health disparity for African American and Latina women.

The current investigators recently completed the first in-depth prevalence study of violence and abuse of women in the US Virgin islands (USVI) and associated health consequences. This seminal study showed 1) Lifetime prevalence of IPV of 32.8% in the USVI and past two year prevalence of 37.2%%.in a sample of 1059 women aged 18-55 who self-identified as African Caribbean or from African descent and who had an intimate partner during the past two years 2) Past two year physical and/or sexual abuse ranged from 4 % on the island of St Croix to 9% on St Thomas 3) Abused women had significantly more risk factors for Sexually Transmitted Infections (STIs) and HIV/AIDS than did women not abused, and 4) Risk factors for STIs and HIV/AIDS included being forced into vaginal or anal sex, women having concurrent partners or their partners having multiple partners, having a STI, lack of consistent condom use, and exchange sex (trading sex for material goods) This study also found women amenable to being asked about IPV in health care settings where a brief intervention could be feasibly implemented. Preliminary qualitative work illuminated women's perceptions of community and cultural perspectives on IPV in the USVI. The proposed randomized clinical trial (RCT) builds on findings from the prior study.

II. Research Strategy: A RCT will provide a preliminary test of an intervention designed to reduce IPV and IPA and the concurrent risk of STIs and HIV in abused USVI women by empowering their use of safety behaviors and increasing their use of resources... IPV and IPA have been linked to high-risk sexual behaviors, the inability to negotiate safer sex behaviors, and negative sexual health outcomes. The research plan is to deliver a structured intervention to reduce the devastating impact of IPV and IPA for abused women in the USVI.

Time I: Women will respond to baseline data measures using computer assisted self-reports. Data collected include socio-demographic and cultural characteristics of women and their partners, past and recent intimate partner physical, sexual and emotional abuse (SVAWS), Danger Assessment (DA), baseline HIV/STD status and risks for infection, including condom use. To minimize attrition contact information for each participant and for three contact persons (family, friends, and neighbors) will also be collected. Abused women will be randomized by the computer to either the Healthy Relationships Risk Reduction experimental intervention group or the Healthy Lifestyles comparison control group A. Session 1- Risk Reduction Intervention Group. Women in the Experimental Intervention will complete this session following initial assessment and group assignment. The ESP-DOVE IPV Empowerment Intervention is an individualized (60 minute) protocol following the initial enrollment session. Abused women will view a video developed in the US Virgin Islands, using local actors, depicting various experiences of abused Virgin Island. The abused women will participate in a one on one structured, brochure-based intervention with a trained interventionist that addresses information about the cycle of violence, risk factors that may increase a woman's danger of homicide (the Danger Assessment), choices or options (leaving, using local shelter resources, accessing resources in the criminal justice system), safety planning, and specific local and national phone numbers for IPV resources. The intervention provides the woman with information, emphasizing that she has options or The structured ESP- DOVE intervention is interactive and encourages the woman to describe her experiences and choose her options as they proceed. The intervention has been modified to be culturally appropriate for abused women of African Caribbean or African American background living in the US Virgin Islands. Since the context of IPV varies considerably, this approach allows individualization, client input and choice, all thought to enhance intervention success with battered women and other "hard to reach" populations At the same time, the brochure gives the nurse and other interventionists a script to increase uniformity of the intervention across women and interventionists. Four major intervention components: a) IPV information, b) Danger Assessment, c) Safety Planning, and d) Resources are explored. At the end of Session I, the woman in the risk reduction intervention group will provide contact information for Session 2 which will be scheduled one week later.

Time 2: Session 2- Women will assess their needs associated with IPV, safety behaviors and feelings about how their situation is evolving. The need for resources and services will be explored. The session will also focus on helping the women learn how to reduce their risk for HIV/STD infections. This one-on-one behavioral intervention has been found to reduce HIV/STD risk behaviors and STD morbidity among inner-city African American women in primary care settings in a NINR funded randomized controlled trial. The intervention has been modified and culturally tailored for abused women in the US Virgin Islands and involves a skill-building one-on-one session that the facilitator tailors to the specific needs of each participant after conducting an HIV/STD risk assessment interview. It involves STD prevention behavioral skills, video clips, condom demonstration, practice with an anatomical model, and role-playing. Curriculum activities are also designed to help women recognize that faulty reasoning and decision-making can increase their risk of HIV infection. The activities help the women understand the adverse consequences of participating in unsafe sexual activity and the positive consequences of safer sexual practices. Contact information for Session 3 will be validated and a follow up group session scheduled.

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 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman: African American/ African Caribbean/African heritage/Mixed
  • Age 18 - 44 (A.1)
  • Abused (physical, sexual emotional abuse) by an intimate male partner based on responses to screening questions
  • Has had an intimate male partner in the last 2 years
  • Resident of the US Virgin Islands and plans to remain for next two years

排除标准

  • Woman: Not African American/African Caribbean or African Heritage/Mixed
  • Under or over age limit
  • No intimate partner in the last two years
  • No history of physical, sexual or emotional abuse by an intimate partner
  • Non resident of US Virgin Islands

结局指标

主要结局

Danger Assessment Score

时间窗: Change in danger assessment score at three months and six months with significant downward trend

Danger Assessment (DA-2) The DA-2 is a 20-item scale that assesses the danger of intimate partner homicide for battered women. Danger assessment scores will decrease Internal consistency reliability has ranged between 0.60 to 0.86, with test-retest reliability of 0.89 to 0.94). All research samples have included a substantial portion of minority women (primarily African-American) and women from a variety of clinical and community settings.

次要结局

  • Condom Influence Strategies Index(Three months and six month outcome results)

研究者

发起方
University of the Virgin Islands
申办方类型
Other
责任方
Principal Investigator
主要研究者

Doris W Campbell, PhD

Senior Research Professor

University of the Virgin Islands

研究点 (2)

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