Brief Intervention for Rural Women at High Risk for HIV/HCV (WISH)
Acquired Immune Deficiency Syndrome Virus
Other: MI-based HIV Risk Reduction
|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|
- 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
- Risky sexual behavior [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]sex without a condom, number of sex partners, sex exchange, sex while under the influence
- service utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]use of health and behavioral health services
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840722
|Contact: Breonna Douglas, HSemail@example.com|
|Contact: Michele Staton-Tindall, PhDfirstname.lastname@example.org|
|United States, Kentucky|
|Rural Appalachian Research Center||Recruiting|
|Hazard, Kentucky, United States, 41071|
|Sub-Investigator: Jennifer R Havens, PhD|
|Principal Investigator:||Michele Tindall, PhD||University of Kentucky|