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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Kentucky
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michele Tindall, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01840722
First received: April 19, 2013
Last updated: April 17, 2014
Last verified: April 2014

April 19, 2013
April 17, 2014
April 2013
April 2017   (final data collection date for primary outcome measure)
  • Injection drug use [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    any injection drug use by needle
  • Sex risk behavior [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    sex without protection, sex with risky partners, sex under the influence of drugs/alcohol
Same as current
Complete list of historical versions of study NCT01840722 on ClinicalTrials.gov Archive Site
service utilization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
utilization of health and behavioral health services including health, mental health, and substance abuse treatment, as well as HIV/HCV services.
Same as current
Not Provided
Not Provided
 
Brief Intervention for Rural Women at High Risk for HIV/HCV
Brief Intervention for Rural Women at High Risk for HIV/HCV

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Acquired Immune Deficiency Syndrome Virus
  • Hepatitis C
  • Drug Abuse
Other: 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.
Other Names:
  • Motivational Interviewing for HIV Risk Reduction
  • Portland Women's Health Program
  • No Intervention: 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
  • Experimental: 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: Other: MI-based HIV Risk Reduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
April 2018
April 2017   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Breonna Douglas, HS 606-487-0189 breonna.douglas@uky.edu
Contact: Michele Staton-Tindall, PhD 859-257-2483 mstindall@uky.edu
United States
 
NCT01840722
5 R01 DA033866-02
No
Michele Tindall, University of Kentucky
Michele Tindall
National Institute on Drug Abuse (NIDA)
Principal Investigator: Michele Tindall, PhD University of Kentucky
University of Kentucky
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP