Empowered Sisters Project Making Choices Reducing Risks — ESP  

Domestic Violence Clinical Trial

Official title: An Integrated Risk Reduction Intervention for Abused African Caribbean Women

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.

Time 3: Session 3: The third session will consist of small groups (8-10) of women in a supportive/educational session led by an interventionist and investigator. Sessions held in each district in the USVI and will be scheduled two weeks following Session 2. Women in the experimental intervention group will have another opportunity to integrate issues related to their IPV experiences. . They will interact with other abused women in a setting conducive to sharing attitudes and beliefs about IPV prevention, cultural beliefs about IPV, the need for support, assertiveness training, stress and affect management, safety enhancement strategies and effective behaviors to reduce the risk of HIV and sexually transmitted disease and personal vulnerability. Session three will be offered twice each week in each district until all participants have had an opportunity to complete the intervention. At the end of session 3, the women will be scheduled for a three month follow-up to assess outcomes. Contact information will be reconfirmed.

B. Healthy Living Comparison Control Group Session 1: Women in the Healthy Living comparison control group will complete the baseline assessment using the computer assisted tablets for self-report. Women who report a history of intimate partner abuse will be will be yoked on age (>25 or <below 25) and ethnicity (Hispanic or Non-Hispanic and education (HS grad vs < high school graduation). During Session one, if randomly assigned to the Healthy Living Comparison Control intervention group, they will be focus on Breast Health Education and how to develop a breast health care plan aimed at reducing the risk of breast cancer in women of African heritage. Obesity as a risk factor for breast cancer will be introduced. Booklets on breast health and developing a breast health plan will be provided as well as general resource information on women and child health services. Contact information for the one week follow up will be obtained and the woman given an appointment for Session II.

Session 2: At time two women in the comparison control health promotion group will be involved in a session on Healthy Lifestyles for African Caribbean Women: Reducing Obesity Risks. The one on one interactive session will discuss the association between breast cancer and obesity as well as other major health problems associated with obesity. They learn how to assess their Body Mass Index and measure waist conference to determine whether or not they are at risk for obesity related health problems. The session will last approximately one hour. They will also be briefly reassessed for abuse to determine if abuse is escalating and the need for a referral. Participant contact information will be confirmed and Session 3 scheduled two weeks later.

Session 3: At time three participants in the comparison control health promotion group control will engage in a follow up group session of 6-8 women that will include sharing progress made on developing breast health plans as well as planned choices to reduce obesity and promote healthy lifestyles including diet and exercise. The group discussion will be facilitated by the original facilitator as well as one of the study investigators. Contact information for the final follow up will be will be validated. Participants will complete a post interview on the computer and a 3 month follow-up outcome assessment will be scheduled.

C. Outcome Measures Time 4: Intervention outcomes will be measured at three months to assess effectiveness and safety of the Integrated Risk Reduction Intervention for Women Experiencing IPA. Participants will include women who completed all three sessions of the Risk Reduction intervention or three sessions of the Health Education Comparison Control group. The outcome measures will be completed on computer tablets and will include the same measures that were used at the initial assessment in addition to an assessment of changes in safety and prevention behaviors. Participants will be scheduled for a six month follow-up for final outcome measures.

Time 5: Final post intervention outcome measures will be obtained six months after the participant completes the 3 month outcome measures. The women will again be contacted at least two weeks prior to the scheduled outcomes measures by Caribbean Exploratory NIMHD Research Center Staff to re-confirm the scheduled follow-up and will repeat the same process on computer tablets including outcome measures used at the three month assessment.

D. Data management

1. Preliminary Analyses: Microsoft Access and Excel will be used for record keeping, tracking, and initial data processing. The latest versions of SAS and SPSS computer programs will be used for data management and analysis. Access to the computers and data CDs will be limited both physically and electronically. Computers and data will be stored in an office that is locked when not in use. Access to databases will be restricted with read and write protection. Data analysis will begin with preparatory activities such as the treatment of missing data, identification of outliers and other such data cleaning tasks. A detailed descriptive analysis of all quantitative data will be performed, involving the summarization of data and the use of inferential and graphical exploratory data analytic techniques.

2. Analysis: To conduct a preliminary test of the integrated intervention as described in the brief description, analysis of covariance, frequency and logistic regression will be used to explore potential differences in predictor variables between the two groups. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Domestic Abuse
• Domestic Violence

• NCT number: NCT02158962
• Study type: Interventional
• Source: University of the Virgin Islands
• Contact: Doris W Campbell, PhD, RN
• Phone: 813--787-2644
• Email: dcampbe@live.uvi.edu
• Status: Recruiting
• Phase: N/A
• Start date: August 2014
• Completion date: March 2017