Brief Intervention for Rural Women at High Risk for HIV/HCV

NCT ID: NCT01840722

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2019-05-31

Brief Summary

The overall aim of this study is to reduce risk behaviors and increase health and behavioral health service utilization among disadvantaged, drug-using rural women at high risk for HIV and HCV. This project has potential to make a significant contribution to science by providing knowledge about the health, risk behaviors, and service utilization of a vulnerable and understudied group of women during a time of emerging and significant public health risk in a rural Appalachian setting. Successful completion of the aims of this project will advance the delivery of a low-cost, potentially high impact intervention with implications for a number of other real world settings (such as criminal justice venues) where other disadvantaged high-risk drug users can be identified and targeted for intervention.

Detailed Description

Specific Aim 1: Compare the effectiveness of an evidence-based HIV risk reduction intervention (MI-HIV) to HIV Education (NIDA Standard) in reducing sex risk behaviors, injection practices, and drug use among a culturally unique sample of disadvantaged, drug-using rural women at high-risk for HIV and HCV. This aim will be accomplished through the random selection of high-risk rural women drug users from rural jails, screening and assessment for high-risk behavior, and random assignment to the HIV-Ed or MI-HIV intervention conditions. Follow-up interviews at 3, 6, and 12 months in the community post-release will examine changes in high-risk behavior. It is expected that MI-HIV participants will report significantly greater reductions in risky injection drug use practices, other drug use, and sex risk behaviors than women who participate in the HIV-Ed condition.

Specific Aim 2: Examine MI-HIV Intervention engagement as a predictor of community health and behavioral health service utilization (including drug treatment and mental health) at follow-up among disadvantaged, drug-using rural women at high risk for HIV and HCV. This aim will focus on community service utilization during the follow-up period by the intervention and education comparison group, and how health and behavioral health service utilization relates to patterns of HIV/HCV risk behavior. It is expected that MI-HIV participants will utilize more services due to increased motivation for treatment and treatment planning following the brief intervention.

Conditions

Acquired Immune Deficiency Syndrome Virus; Hepatitis C; Drug Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

NIDA Standard HIV Education

NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources

Group Type: NO_INTERVENTION

No interventions assigned to this group

MI-based HIV Risk Reduction

MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.

Group Type: EXPERIMENTAL

MI-based HIV Risk Reduction

Intervention Type: OTHER

As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.

Interventions

MI-based HIV Risk Reduction

As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.

Intervention Type: OTHER

Other Intervention Names

Motivational Interviewing for HIV Risk Reduction; Portland Women's Health Program

Eligibility Criteria

Inclusion Criteria

• ASSIST score of 4+
• engagement in at least one sex risk behavior in the past 3 months
• willingness to participate in brief intervention sessions
• no evidence of cognitive impairment
• no evidence of active psychosis (currently experiencing hallucinations)
• no self-reported current symptoms of physical withdrawal from a recent episode of drug use
• incarceration period of 1 week - 3 months in order to complete intervention sessions

Exclusion Criteria

• ASSIST score of <4
• no engagement in at least one sex risk behavior in the past 3 months
• not willing to participate in brief intervention sessions
• evidence of cognitive impairment
• evidence of active psychosis (currently experiencing hallucinations)
• self-reported current symptoms of physical withdrawal from a recent episode of drug use
• incarceration period of less than 1 week or greater than 3 months in order to complete intervention sessions

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Michele Staton

OTHER

Sponsor Role: lead

Responsible Party

Michele Staton

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michele Tindall, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Rural Appalachian Research Center

Hazard, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

5R01DA033866-02

Identifier Type: NIH

Identifier Source: secondary_id

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5R01DA033866-02

Identifier Type: NIH

Identifier Source: org_study_id

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