Brief Intervention for Rural Women at High Risk for HIV/HCV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Number of Participants Having Unprotected Casual Sex
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
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.
Intervention: MI-based HIV Risk Reduction (Other)
Outcomes
Primary Outcomes
Number of Participants Having Unprotected Casual Sex
Time Frame: 6 months
Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months
Secondary Outcomes
- Number of Participants Exchanging Sex(6 months)
- Number of Participants Recently Receiving Physical or Behavioral Health Treatment(6 months)
Investigators
Michele Staton
Associate Professor
University of Kentucky