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

NCT01840722 | Completed Results

• 1 other identifier: 5R01DA033866-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Immune Deficiency Syndrome Virus; Hepatitis C; Drug Abuse

Keywords

HIV; HCV; Substance abuse; women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Exchanging Sex

  6 months

• Number of Participants Recently Receiving Physical or Behavioral Health Treatment

  6 months

Study Arms (2)

NIDA Standard HIV Education

NO INTERVENTION

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

MI-based HIV Risk Reduction

EXPERIMENTAL

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

Interventions

MI-based HIV Risk Reduction OTHER

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.

Also known as: Motivational Interviewing for HIV Risk Reduction, Portland Women's Health Program

MI-based HIV Risk Reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michele Staton: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rural Appalachian Research Center

Hazard, Kentucky, 41071, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C; Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Michele Staton, Associate Professor
• Organization: University of Kentucky

mstaton@uky.edu

859-257-2483

Study Officials

• Michele Tindall, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: April 26, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)