Brief Intervention for Rural Women at High Risk for HIV/HCV (WISH)
|ClinicalTrials.gov Identifier: NCT01840722|
Recruitment Status : Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immune Deficiency Syndrome Virus Hepatitis C Drug Abuse||Other: MI-based HIV Risk Reduction||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Brief Intervention for Rural Women at High Risk for HIV/HCV|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
- Sex risk behavior [ Time Frame: 6 months ]sex without protection, sex with risky partners, sex under the influence of drugs/alcohol
- Risky sexual behavior [ Time Frame: 6 months ]sex without a condom, number of sex partners, sex exchange, sex while under the influence
- service utilization [ Time Frame: 6 months ]use of health and behavioral health services
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840722
|United States, Kentucky|
|Rural Appalachian Research Center|
|Hazard, Kentucky, United States, 41071|
|Principal Investigator:||Michele Tindall, PhD||University of Kentucky|