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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acquired Immune Deficiency Syndrome Virus, Hepatitis C, Drug Abuse

Intervention / Treatment
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* Other: MI-based HIV Risk Reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: NIDA Standard HIV Education<br>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 | |
| Experimental: MI-based HIV Risk Reduction<br>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. | Other: MI-based HIV Risk Reduction<br>* 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.<br>* Other names: Portland Women's Health Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Having Unprotected Casual Sex | Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Exchanging Sex | Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months | 6 months | 
| Number of Participants Recently Receiving Physical or Behavioral Health Treatment | Is currently being treated for a physical or mental health problem OR has been in a substance use treatment program in the last 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HCV, Substance abuse, women