Brief Intervention for Rural Women at High Risk for HIV/HCV (WISH)

Michele Staton

Status: Completed

Conditions: Acquired Immune Deficiency Syndrome Virus; Hepatitis C; Drug Abuse

Treatments: Other: MI-based HIV Risk Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01840722

5R01DA033866-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

NIDA Standard HIV Education

No Intervention group

Description:

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

MI-based HIV Risk Reduction

Experimental group

Description:

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.

Treatment:

Other: MI-based HIV Risk Reduction