Reducing HIV & Domestic Violence Risk in Women Offenders

February 27, 2006 updated by: Multnomah County Health Department

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.

Study Overview

Study Type

Interventional

Enrollment

530

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97292
        • SE Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
unprotected sex
injection drug use
intimate partner violence
violence from others

Secondary Outcome Measures

Outcome Measure
self-esteem
anxiety
depression
housing stability
employment
education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael J. Stark, Ph.D., Multnomah County Health Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion

December 7, 2022

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2006

Last Update Submitted That Met QC Criteria

February 27, 2006

Last Verified

July 1, 2005

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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