Acquired Immune Deficiency Syndrome Virus, Drug Abuse, Hepatitis C
Conditions
Keywords
HIV, HCV, Substance abuse, women
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.
Interventions
OTHERMI-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.
Sponsors
National Institute on Drug Abuse (NIDA)
Michele Staton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Having Unprotected Casual Sex | 6 months | Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Exchanging Sex | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
Adult women were randomly selected from three rural jails in Appalachia, screened, and interviewed face-to-face in a private room in the jail. Study eligibility included: 1) moderate risk of substance abuse based on the NIDA-ASSIST score of 4+ for any drug; 2) residing in Appalachia before incarceration; and 3) willingness to participate.
Pre-assignment details
Of the 688 screened, 248 (36%) did not meet eligibility criteria due to: not being released during time frame (n=203), not engaging in risky sexual practices (n=15), not being from Appalachian (n=21), and not meeting NM-ASSIST criteria (n=9). 440 (64%) met criteria, but 40 were released prior to completing the baseline. The final N=400.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 201 |
| 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.
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. | 199 |
| Total | 400 |
Baseline characteristics
| Characteristic | NIDA Standard HIV Education | MI-based HIV Risk Reduction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 201 Participants | 199 Participants | 400 Participants |
| Age, Continuous | 32.5 years STANDARD_DEVIATION 8.4 | 33.1 years STANDARD_DEVIATION 8.1 | 32.8 years STANDARD_DEVIATION 8.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 200 Participants | 197 Participants | 397 Participants |
| Region of Enrollment United States | 201 participants | 199 participants | 400 participants |
| Risky Sexual Behavior | 84 Participants | 90 Participants | 174 Participants |
| Sex: Female, Male Female | 201 Participants | 199 Participants | 400 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 201 | 1 / 199 |
| other Total, other adverse events | 0 / 201 | 0 / 199 |
| serious Total, serious adverse events | 2 / 201 | 1 / 199 |
Outcome results
Primary
Number of Participants Having Unprotected Casual Sex
Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months
Time frame: 6 months
Population: Participants were lost to study attrition
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIDA Standard HIV Education | Number of Participants Having Unprotected Casual Sex | 27 Participants |
| MI-based HIV Risk Reduction | Number of Participants Having Unprotected Casual Sex | 25 Participants |
Secondary
Number of Participants Exchanging Sex
Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months
Time frame: 6 months
Population: Participants were lost to attrition.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIDA Standard HIV Education | Number of Participants Exchanging Sex | 9 Participants |
| MI-based HIV Risk Reduction | Number of Participants Exchanging Sex | 8 Participants |
Secondary
Number of Participants Recently Receiving Physical or Behavioral Health Treatment
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
Time frame: 6 months
Population: Participants were lost to study attrition.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIDA Standard HIV Education | Number of Participants Recently Receiving Physical or Behavioral Health Treatment | 83 Participants |
| MI-based HIV Risk Reduction | Number of Participants Recently Receiving Physical or Behavioral Health Treatment | 84 Participants |