Brief Intervention for Rural Women at High Risk for HIV/HCV (WISH)
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|ClinicalTrials.gov Identifier: NCT01840722|
Recruitment Status : Completed
First Posted : April 26, 2013
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
|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|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 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.
- Number of Participants Having Unprotected Casual Sex [ Time Frame: 6 months ]Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months
- Number of Participants Exchanging Sex [ Time Frame: 6 months ]Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months
- Number of Participants Recently Receiving Physical or Behavioral Health Treatment [ Time Frame: 6 months ]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
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
|United States, Kentucky|
|Rural Appalachian Research Center|
|Hazard, Kentucky, United States, 41071|
|Principal Investigator:||Michele Tindall, PhD||University of Kentucky|