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

September 17, 2019 updated by: Michele Staton
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Hazard, Kentucky, United States, 41071
        • Rural Appalachian Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Exchanging Sex
Time Frame: 6 months
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
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michele Staton

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Michele Tindall, PhD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01DA033866-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/A, individual participant data will not be made available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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