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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00289939
Other study ID # R01DA012572
Secondary ID
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
Est. primary completion date
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


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
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