Clinical trial NCT00289939: Reducing HIV & Domestic Violence Risk in Women Offenders
Official title: Reducing HIV & Domestic Violence Risk in Women Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Domestic Violence
Sexually Transmitted Diseases
Keywords: women
women's health
HIV
risk factors
risk behaviors
prevention
motivational interviewing
domestic violence
partner violence
behavioral trial
community justice
criminal justice
Lead sponsor: Multnomah County Health Department
Sponsor class: OTHER_GOV
Collaborators: name: Oregon Department of Human Services
First posted: 2006-02-10
Enrollment: 530
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: unprotected sex
measure: injection drug use
measure: intimate partner violence
measure: violence from others
Secondary outcomes:
measure: self-esteem
measure: anxiety
measure: depression
measure: housing stability
measure: employment
measure: education
Other outcomes:
Locations:
city: Portland
country: United States
facility: SE Health Center
state: Oregon
Study officials:
affiliation: Multnomah County Health Department
name: Michael J. Stark, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: