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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
  Purpose

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.


Condition Intervention
Acquired Immune Deficiency Syndrome Virus
Hepatitis C
Drug Abuse
Other: MI-based HIV Risk Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Brief Intervention for Rural Women at High Risk for HIV/HCV

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 350
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840722

Contacts
Contact: Breonna Douglas, HS 606-487-0189 breonna.douglas@uky.edu
Contact: Michele Staton-Tindall, PhD 859-257-2483 mstindall@uky.edu

Locations
United States, Kentucky
Rural Appalachian Research Center Recruiting
Hazard, Kentucky, United States, 41071
Sub-Investigator: Jennifer R Havens, PhD         
Sponsors and Collaborators
Michele Tindall
Investigators
Principal Investigator: Michele Tindall, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: Michele Tindall, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01840722     History of Changes
Other Study ID Numbers: 5 R01 DA033866-02
Study First Received: April 19, 2013
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
HIV
HCV
Substance abuse
women

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Immune System Diseases
Lentivirus Infections
Liver Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014