NCT02158962

Brief 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2.4 years

First QC Date

June 3, 2014

Last Update Submit

December 29, 2014

Conditions

Domestic ViolenceDomestic Abuse

Keywords

Partner abuseAbuse African Caribbean womenIntimate Partner Violence

Outcome Measures

Primary Outcomes (1)

  • Danger Assessment Score

    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.

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

Secondary Outcomes (1)

  • Condom Influence Strategies Index

    Three months and six month outcome results

Other Outcomes (2)

  • Number of participants with Adverse Events Reports as a measure of safety and efficacy

    Three months and six months

  • Reported sexually transmitted infections and HIV/AIDS

    3 months and six months

Study Arms (2)

Behavioral - Education

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

Behavioral - EducationBEHAVIORAL

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

Also known as: Education, Skill Building
Behavioral - Education

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caribbean Exploratory NIMHD Research Center,University of the Virgin Islands, School of Nursing

Charlotte Amalie, 00802, Virgin Islands

RECRUITING

Related Publications (15)

  • Campbell J, Jones AS, Dienemann J, Kub J, Schollenberger J, O'Campo P, Gielen AC, Wynne C. Intimate partner violence and physical health consequences. Arch Intern Med. 2002 May 27;162(10):1157-63. doi: 10.1001/archinte.162.10.1157.

    PMID: 12020187BACKGROUND

  • Campbell DW, Sharps PW, Gary FA, Campbell JC, Lopez LM. Intimate partner violence in African American women. Online J Issues Nurs. 2002;7(1):5.

    PMID: 12044219BACKGROUND

  • Campbell JC, Baty ML, Ghandour RM, Stockman JK, Francisco L, Wagman J. The intersection of intimate partner violence against women and HIV/AIDS: a review. Int J Inj Contr Saf Promot. 2008 Dec;15(4):221-31. doi: 10.1080/17457300802423224.

    PMID: 19051085BACKGROUND

  • Jones AS, Dienemann J, Schollenberger J, Kub J, O'Campo P, Gielen AC, Campbell JC. Long-term costs of intimate partner violence in a sample of female HMO enrollees. Womens Health Issues. 2006 Sep-Oct;16(5):252-61. doi: 10.1016/j.whi.2006.06.007.

    PMID: 17055378BACKGROUND

  • Brown DS, Finkelstein EA, Mercy JA. Methods for estimating medical expenditures attributable to intimate partner violence. J Interpers Violence. 2008 Dec;23(12):1747-66. doi: 10.1177/0886260508314338. Epub 2008 Feb 26.

    PMID: 18314507BACKGROUND

  • Breiding MJ, Black MC, Ryan GW. Prevalence and risk factors of intimate partner violence in eighteen U.S. states/territories, 2005. Am J Prev Med. 2008 Feb;34(2):112-8. doi: 10.1016/j.amepre.2007.10.001.

    PMID: 18201640BACKGROUND

  • Krug EG, Mercy JA, Dahlberg LL, Zwi AB. [World report on violence and health]. Biomedica. 2002 Dec;22 Suppl 2:327-36. Spanish.

    PMID: 12596453BACKGROUND

  • Gage AJ, Hutchinson PL. Power, control, and intimate partner sexual violence in Haiti. Arch Sex Behav. 2006 Feb;35(1):11-24. doi: 10.1007/s10508-006-8991-0.

    PMID: 16502150BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Trends in HIV/AIDS diagnoses--33 states, 2001-2004. MMWR Morb Mortal Wkly Rep. 2005 Nov 18;54(45):1149-53.

    PMID: 16292247BACKGROUND

  • Lucea MB, Stockman JK, Mana-Ay M, Bertrand D, Callwood GB, Coverston CR, Campbell DW, Campbell JC. Factors influencing resource use by African American and African Caribbean women disclosing intimate partner violence. J Interpers Violence. 2013 May;28(8):1617-41. doi: 10.1177/0886260512468326. Epub 2013 Jan 6.

    PMID: 23295377BACKGROUND

  • Stockman JK, Lucea MB, Draughon JE, Sabri B, Anderson JC, Bertrand D, Campbell DW, Callwood GB, Campbell JC. Intimate partner violence and HIV risk factors among African-American and African-Caribbean women in clinic-based settings. AIDS Care. 2013;25(4):472-80. doi: 10.1080/09540121.2012.722602. Epub 2012 Sep 25.

    PMID: 23006050BACKGROUND

  • Campbell JC, Lucea MB, Stockman JK, Draughon JE. Forced sex and HIV risk in violent relationships. Am J Reprod Immunol. 2013 Feb;69 Suppl 1(0 1):41-4. doi: 10.1111/aji.12026. Epub 2012 Oct 16.

    PMID: 23066950BACKGROUND

  • Sabri B, Stockman JK, Bertrand DR, Campbell DW, Callwood GB, Campbell JC. Victimization experiences, substance misuse, and mental health problems in relation to risk for lethality among African American and African Caribbean women. J Interpers Violence. 2013 Nov;28(16):3223-41. doi: 10.1177/0886260513496902. Epub 2013 Aug 7.

    PMID: 23929602BACKGROUND

  • Draughon JE, Lucea MB, Campbell JC, Paterno MT, Bertrand DR, Sharps PW, Campbell DW, Stockman JK. Impact of Intimate Partner Forced Sex on HIV Risk Factors in Physically Abused African American and African Caribbean Women. J Immigr Minor Health. 2015 Oct;17(5):1313-21. doi: 10.1007/s10903-014-0112-x.

    PMID: 25248623BACKGROUND

  • Stockman JK, Lucea MB, Bolyard R, Bertand D, Callwood GB, Sharps PW, Campbell DW, Campbell JC. Intimate partner violence among African American and African Caribbean women: prevalence, risk factors, and the influence of cultural attitudes. Glob Health Action. 2014 Sep 12;7:24772. doi: 10.3402/gha.v7.24772. eCollection 2014.

    PMID: 25226418BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Doris W Campbell, PhD, RN

    University of the Virgin Islands, Caribbean Exploratory Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris W Campbell, PhD, RN

CONTACT

813--787-2644dcampbe@live.uvi.edu

Theresa B E Berger, MS

CONTACT

340-693-1171theresa.berger@live.uvi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Professor

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 9, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

VI(1)