Empowered Sisters Project Making Choices Reducing Risks (ESP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of the Virgin Islands
Sponsor:
Information provided by (Responsible Party):
Doris W Campbell, PhD, University of the Virgin Islands
ClinicalTrials.gov Identifier:
NCT02158962
First received: June 3, 2014
Last updated: December 29, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Domestic Violence
Domestic Abuse
Behavioral: Behavioral - Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Integrated Risk Reduction Intervention for Abused African Caribbean Women

Further study details as provided by University of the Virgin Islands:

Primary Outcome Measures:
  • Danger Assessment Score [ Time Frame: Change in danger assessment score at three months and six months with significant downward trend ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Condom Influence Strategies Index [ Time Frame: Three months and six month outcome results ] [ Designated as safety issue: Yes ]
    Abused women report increased use of safe sexual behaviors including increased scores on the condom use negotiation scale and increased self-reported practice of sexual safety behaviors..


Other Outcome Measures:
  • Number of participants with Adverse Events Reports as a measure of safety and efficacy [ Time Frame: Three months and six months ] [ Designated as safety issue: Yes ]
    Change (decrease) in number of participants reporting incidents physical, sexual and/ or emotional problems related to IPV or IPV and increased use of safety plans and community resources by abused women

  • Reported sexually transmitted infections and HIV/AIDS [ Time Frame: 3 months and six months ] [ Designated as safety issue: Yes ]
    Change (decrease ) in number of abused women reporting an STI's and increased reports of behaviors that reduce risk for HIV among abused women in the integrated risk reduction intervention.


Estimated Enrollment: 200
Study Start Date: August 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral - Education

3 Educational Sessions

Session 1 - Reducing Risk for Intimate Partner Violence (IPV); Session 2 - Reducing risk for Sexually Transmitted Infections including HIV (STI/HIV) Session 3 - A group session which reinforces skills for reducing IPV and STI/ HIV risk reduction.

Behavioral: Behavioral - Education

Behavioral - Education

3 educational sessions aimed at reducing risks partner violence, and sexual transmitted infections

Other Names:
  • Education
  • Skill Building
Active Comparator: Behavioral - Education

3 Educational Sessions

Session 1 - Breast Health Education and Developing A Breast Cancer Risk Reduction Plan Session 2 - Reducing risk for overweight and obesity and Developing a Healthy Eating and Activity Plan Session 3 - A group session which integrates and reinforces skills from Sessions 1 and 2.

Behavioral: Behavioral - Education

Behavioral - Education

3 educational sessions aimed at reducing risks partner violence, and sexual transmitted infections

Other Names:
  • Education
  • Skill Building

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02158962

Contacts
Contact: Doris W Campbell, PhD, RN 813--787-2644 dcampbe@live.uvi.edu
Contact: Theresa B E Berger, MS 340-693-1171 theresa.berger@live.uvi.edu

Locations
Virgin Islands (U.S.)
Caribbean Exploratory NIMHD Research Center,University of the Virgin Islands, School of Nursing Recruiting
St Thomas, Virgin Islands (U.S.), 00802
Contact: Doris W Campbell, PhD, ARNP    340-693-1171    dcampbe@live.uvi.edu   
Contact: Theresa E Berger, MS    340 693 1171    theresa.berger@live.uvi.edu   
Principal Investigator: Doris W Campbell, PhD         
Sub-Investigator: Gloria B Callwood, PhD         
Sub-Investigator: Marilyn B Hall, PhD         
Sub-Investigator: Desiree Bertrand, MS         
Sub-Investigator: Aletha Baumann, PhD         
Sponsors and Collaborators
University of the Virgin Islands
Investigators
Principal Investigator: Doris W Campbell, PhD, RN University of the Virgin Islands, Caribbean Exploratory Research Center
  More Information

Publications:

Responsible Party: Doris W Campbell, PhD, Senior Research Professor, University of the Virgin Islands
ClinicalTrials.gov Identifier: NCT02158962     History of Changes
Other Study ID Numbers: [460913-1]
Study First Received: June 3, 2014
Last Updated: December 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of the Virgin Islands:
Partner abuse
Abuse African Caribbean women
Intimate Partner Violence

ClinicalTrials.gov processed this record on May 27, 2015