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

Not Applicable

Completed

Conditions: Acquired Immune Deficiency Syndrome Virus
Hepatitis C
Drug Abuse

Interventions: Other: MI-based HIV Risk Reduction

Registration Number: NCT01840722

Lead Sponsor: Michele Staton

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 400

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MI-based HIV Risk Reduction	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Having Unprotected Casual Sex	6 months	Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants Exchanging Sex	6 months	Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months
Number of Participants Recently Receiving Physical or Behavioral Health Treatment	6 months	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