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Reducing HIV & Domestic Violence Risk in Women Offenders

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ClinicalTrials.gov Identifier: NCT00289939
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : February 28, 2006
Sponsor:
Collaborator:
Oregon Department of Human Services
Information provided by:
Multnomah County Health Department

Study Description
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Brief Summary:

The long-term goal of this work is to reduce the prevalence of HIV and domestic violence among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah County Health Department and Oregon Department of Human Services have conducted a randomized trial of an intervention to prevent HIV and domestic violence among women who have recent criminal justice involvement and who are at risk for HIV infection.

Women enrolled in the study were randomly assigned to one of three study conditions:

  • Group 1: these women received information on local resources addressing HIV prevention, domestic violence, and life stability issues; they did not receive any counseling sessions as part of the study itself.
  • Group 2: these women received up to ten supportive counseling sessions based on the techniques of motivational interviewing. These sessions aimed to reduce HIV risk and to improve life stability.
  • Group 3: these women received up to ten supportive counseling sessions based on motivational interviewing. These sessions aimed to reduce risk for HIV and domestic violence and to improve life stability.

The primary hypotheses of this study were:

  • 1. Supportive counseling (motivational interviewing) addressing HIV prevention and increased life stability will lead to reductions of HIV risk behavior among women enrolled in the study.
  • 2. Supportive counseling (motivational interviewing) addressing domestic violence prevention, HIV prevention, and increased life stability, will bring about reductions in experiences of domestic violence and a reduction of HIV risk among these women.
  • 3. The supportive counseling received in this study will enhance these women's self-efficacy, self-esteem, and psychological well-being.

Women in all three experimental groups were interviewed at the beginning of the study and again after 4, 7, and 10 months. These assessment interviews asked questions about: HIV risk; experiences of domestic violence; and life stability issues such as education, employment, and housing; and included biological testing for HIV and sexually transmitted diseases. Women in Group 2 and Group 3 participated in up to 10 sessions of supportive counseling (motivational interviewing) between the time of enrollment and the 4-month interviews.


Condition or disease Intervention/treatment Phase
HIV Infections Domestic Violence Sexually Transmitted Diseases Behavioral: Motivational interviewing to reduce risk for HIV and DV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing HIV & Domestic Violence Risk in Women Offenders
Study Start Date : September 2000
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. unprotected sex
  2. injection drug use
  3. intimate partner violence
  4. violence from others

Secondary Outcome Measures :
  1. self-esteem
  2. anxiety
  3. depression
  4. housing stability
  5. employment
  6. education

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women
  • who were 18 years or older
  • who had been in jail or prison in the past year or who were currently on parole or probation
  • who had engaged in HIV-related risk behaviors (injection drug use, crack use, intercourse with a male injection drug user, exchanging sex, or having had ten or more sexual partners) in the past year

Exclusion Criteria: Women were excluded from the study if:

  • they were unable to give informed consent
  • they were HIV positive at the time of screening for enrollment
  • they reported highly unstable living conditions at screening
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289939


Locations
United States, Oregon
SE Health Center
Portland, Oregon, United States, 97292
Sponsors and Collaborators
Multnomah County Health Department
Oregon Department of Human Services
Investigators
Principal Investigator: Michael J. Stark, Ph.D. Multnomah County Health Department
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00289939     History of Changes
Other Study ID Numbers: R01DA012572 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: February 28, 2006
Last Verified: July 2005

Keywords provided by Multnomah County Health Department:
women
women's health
HIV
risk factors
risk behaviors
prevention
 motivational interviewing
domestic violence
partner violence
behavioral trial
community justice
criminal justice

Additional relevant MeSH terms:
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female