Empowered Sisters Project Making Choices Reducing Risks

NCT02158962 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-12-30

No results posted yet for this study

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.

Conditions

  • Domestic Violence
  • Domestic Abuse

Interventions

BEHAVIORAL

Behavioral - Education

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

Sponsors & Collaborators

  • University of the Virgin Islands

    lead OTHER

Principal Investigators

  • Doris W Campbell, PhD, RN · University of the Virgin Islands, Caribbean Exploratory Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-01-31
Completion
2017-03-31

Countries

  • Virgin Islands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158962 on ClinicalTrials.gov