Brief Intervention for Rural Women at High Risk for HIV/HCV (WISH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01840722|
Recruitment Status : Recruiting
First Posted : April 26, 2013
Last Update Posted : August 7, 2017
|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)|
|Estimated Enrollment :||350 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 2018|
|Estimated Study Completion Date :||June 2018|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840722
|Contact: Breonna Douglas, HSfirstname.lastname@example.org|
|Contact: Michele Staton-Tindall, PhDemail@example.com|
|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|