- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00289939
Reducing HIV & Domestic Violence Risk in Women Offenders
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
Status
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97292
- SE Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Michael J. Stark, Ph.D., Multnomah County Health Department
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA012572 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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