Reducing HIV & Domestic Violence Risk in Women Offenders

HIV Infections Clinical Trial

Official title:

Reducing HIV & Domestic Violence Risk in Women Offenders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289939
• Other study ID #: R01DA012572
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2006
• Last updated: February 27, 2006
• Start date: September 2000
• Est. completion date: January 2005

Study information

• Verified date: July 2005
• Source: Multnomah County Health Department
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Domestic Violence
• HIV Infections
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Motivational interviewing to reduce risk for HIV and DV

Locations

Country	Name	City	State
United States	SE Health Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Multnomah County Health Department	Oregon Department of Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unprotected sex
Primary	injection drug use
Primary	intimate partner violence
Primary	violence from others
Secondary	self-esteem
Secondary	anxiety
Secondary	depression
Secondary	housing stability
Secondary	employment
Secondary	education