HIV and Drug Use in Georgian Women

Study Overview
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Brief Summary
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The purpose of this study is to determine how drug abuse treatment interventions can be integrated with established Human Immunodeficiency Virus prevention approaches to optimize their combined effectiveness.

Detailed Description
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Eastern Europe is an emerging epicenter of injection drug use and Human Immunodeficiency Virus infection, among women. Within Eastern Europe, the Republic of Georgia is one of the last countries where an Human Immunodeficiency Virus epidemic can still be averted. This proposal responds to RFA-DA-10-008 International Research Collaborations on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome and Drug Use by building on the successful collaboration among United States and Eastern European investigators from the Republic of Georgia and Russia. Recent data from Georgia's neighbor, Russia, reported 59% of Injection Drug Using women Human Immunodeficiency Virus seropositive; this is a threat that looms over Georgia. Understanding the risk factors that operate in Russia that drive this epidemic may help forestall such a catastrophe in Georgia. As such, this proposal directly responds to the Eastern European Region question of How can drug abuse treatment interventions be integrated with established Human Immunodeficiency Virus prevention approaches to optimize their combined effectiveness? Injection drug using Georgian women show prevalence rates of 2% for Human Immunodeficiency Virus and 25% for hepatitis C. The low prevalence of Human Immunodeficiency Virus in Georgian women provides an important window of opportunity to intervene and avoid the possibility of a Human Immunodeficiency Virus epidemic. In Georgia, women's expected subordination to men makes women vulnerable to Human Immunodeficiency Virus/Hepatitis C infection. The public health impact of the proposed project is far-reaching. Taken to scale, our Georgian reinforcement-based treatment model holds the promise not only to lessen the possibility of a Human Immunodeficiency Virus epidemic and slow the increase in the Hepatitis C transmission rate in Georgia, but also to strongly influence the development of women-focused drug abuse intervention models for treatment tailoring and dissemination in other nations.

Official Title
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HIV and Drug Use in Georgian Women

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: RBT
* Other: Case-Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Conversant in Georgian Able to provide informed consent Age 18 years or older Has ever injected illicit drugs Sexually active at least once in the past 30 days. Exclusion Criteria: Male Younger than 18 years Not sexually active at least once in past 30 days Not able to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RBT Experimental<br> | Behavioral: RBT<br>* Intervention for Injection Drug Using Women: Incorporates elements of Reinforcement-Based Treatment and Women's Health CoOp to help prevent drug abuse (and promote drug abstinence) and lower risk of Human Immunodeficiency Virus, violence, and high-risk sexual behaviors.<br>* Other names: Women's Health CoOp;|
| Active Comparator: Case-Management: Treatment as Usual<br> | Other: Case-Management<br>* Standard Intervention: Incorporates standard practice elements like accessing resources, service linkage, monitoring the success of patient-service linkages, and advocating for the patient to help her meet her needs<br>* Other names: Standard Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual practices | Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment | 3 months after randomization | 
| Injection Practices | Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment | 6 months after randomization | 
| Injection practices | Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment | 3 months after randomization | 
| Sexual Practices | Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment | 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual practices | Unprotected sex at last encounter measured by revised risk behavior assessment | 3 months after randomization and 6 months after randomization | 
| Condom Use and Sexual Encounter Negotiation | To use a condom in past 30 days and to negotiate sexual encounters in past 30 days measured by revised risk behavior assessment | 3 months after randomization and 6 months after randomization | 
| Injecting practices | Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment | 3 months after randomization and 6 months after randomization | 
| Drug use | Frequency of opioid use in past 30 days revised risk behavior assessment plus urine test Self-Report verified by biological sample Poisson. Also frequency of stimulant use in past 30 days revised risk behavior assessment and urine test. Addiction Severity Index drug composite score. | 3 months after randomization and 6 months after randomization | 
| Alcohol Use | Frequency of alcohol use in past 30 days Revised Risk Behavior Assessment and breath test. Self-Report verified by biological sample Poisson. Addiction Severity Index alcohol composite score. | 3 months after randomization and 6 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV risk, Sexually Transmitted Diseases, Drug Use, Women, Drug Treatment, opioids, injection drug use, stimulants, gender-specific treatment