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

Hepatitis C Clinical Trial

— WISH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840722
• Other study ID #: 5R01DA033866-02
• Secondary ID: 5R01DA033866-02
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome Virus
• Acquired Immunodeficiency Syndrome
• Drug Abuse
• Hepatitis C
• HIV Infections
• Immunologic Deficiency Syndromes
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Rural Appalachian Research Center	Hazard	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Michele Staton	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Having Unprotected Casual Sex	Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months	6 months
Secondary	Number of Participants Exchanging Sex	Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months	6 months
Secondary	Number of Participants Recently Receiving Physical or Behavioral Health Treatment	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