Domestic Violence Clinical Trial
— ESPOfficial title:
An Integrated Risk Reduction Intervention for Abused African Caribbean Women
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Virgin Islands (U.S.) | Caribbean Exploratory NIMHD Research Center,University of the Virgin Islands, School of Nursing | St Thomas |
Lead Sponsor | Collaborator |
---|---|
University of the Virgin Islands |
Virgin Islands (U.S.),
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Campbell JC, Lucea MB, Stockman JK, Draughon JE. Forced sex and HIV risk in violent relationships. Am J Reprod Immunol. 2013 Feb;69 Suppl 1:41-4. doi: 10.1111/aji.12026. Epub 2012 Oct 16. Review. — View Citation
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. — View Citation
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. — View Citation
Gage AJ, Hutchinson PL. Power, control, and intimate partner sexual violence in Haiti. Arch Sex Behav. 2006 Feb;35(1):11-24. — View Citation
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. — View Citation
Krug EG, Mercy JA, Dahlberg LL, Zwi AB. [World report on violence and health]. Biomedica. 2002 Dec;22 Suppl 2:327-36. Spanish. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants with Adverse Events Reports as a measure of safety and efficacy | 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 | Three months and six months | Yes |
Other | Reported sexually transmitted infections and HIV/AIDS | 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. | 3 months and six months | Yes |
Primary | 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 | Yes |
Secondary | Condom Influence Strategies Index | 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.. | Three months and six month outcome results | Yes |
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