NCT00289939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Timeline
Completed

Started Sep 2000

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

February 28, 2006

Status Verified

July 1, 2005

First QC Date

February 9, 2006

Last Update Submit

February 27, 2006

Conditions

Keywords

womenwomen's healthHIVrisk factorsrisk behaviorspreventionmotivational interviewingdomestic violencepartner violencebehavioral trialcommunity justicecriminal justice

Outcome Measures

Primary Outcomes (4)

  • unprotected sex

  • injection drug use

  • intimate partner violence

  • violence from others

Secondary Outcomes (6)

  • self-esteem

  • anxiety

  • depression

  • housing stability

  • employment

  • +1 more secondary outcomes

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SE Health Center

Portland, Oregon, 97292, United States

Location

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesRisk-Taking

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Michael J. Stark, Ph.D.

    Multnomah County Health Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

September 1, 2000

Study Completion

January 1, 2005

Last Updated

February 28, 2006

Record last verified: 2005-07

Locations