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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:
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.
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 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral - Education | Behavioral | Behavioral - Education 3 educational sessions aimed at reducing risks partner violence, and sexual transmitted infections |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doris W Campbell, PhD, RN | Contact | 813--787-2644 | dcampbe@live.uvi.edu | |
| Theresa B E Berger, MS | Contact | 340-693-1171 | theresa.berger@live.uvi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Doris W Campbell, PhD, RN | University of the Virgin Islands, Caribbean Exploratory Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caribbean Exploratory NIMHD Research Center,University of the Virgin Islands, School of Nursing | Recruiting | Charlotte Amalie | 00802 | Virgin Islands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12020187 | Background | 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. | |
| 12044219 | Background | 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. |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| 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 |
| 19051085 | Background | 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. |
| 17055378 | Background | 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. |
| 18314507 | Background | 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. |
| 18201640 | Background | 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. |
| 12596453 | Background | Krug EG, Mercy JA, Dahlberg LL, Zwi AB. [World report on violence and health]. Biomedica. 2002 Dec;22 Suppl 2:327-36. Spanish. |
| 16502150 | Background | 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. |
| 16292247 | Background | 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. |
| 23295377 | Background | 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. |
| 23006050 | Background | 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. |
| 23066950 | Background | 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. |
| 23929602 | Background | 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. |
| 25248623 | Background | 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. |
| 25226418 | Background | 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. |