Clinical trial NCT01840722: Brief Intervention for Rural Women at High Risk for HIV/HCV
Official title: Brief Intervention for Rural Women at High Risk for HIV/HCV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Immune Deficiency Syndrome Virus
Hepatitis C
Drug Abuse
Keywords: HIV
HCV
Substance abuse
women
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-04-26
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Having Unprotected Casual Sex
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Exchanging Sex
timeFrame: 6 months
measure: Number of Participants Recently Receiving Physical or Behavioral Health Treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Hazard
country: United States
facility: Rural Appalachian Research Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Michele Tindall, PhD
role: PRINCIPAL_INVESTIGATOR
References: