Addiction Research Center, Union Alternative Georgia office
Tbilisi, 0177, Georgia
NCT Number: NCT01331460
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Tbilisi, 0177, Georgia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Women's Health CoOp
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
Other names: Treatment-as-Usual, Standard Intervention
Time frame: 3 months after randomization
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Time frame: 6 months after randomization
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Time frame: 3 months after randomization
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Time frame: 6 months after randomization
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Time frame: 3 months after randomization and 6 months after randomization
Unprotected sex at last encounter measured by revised risk behavior assessment
Time frame: 3 months after randomization and 6 months after randomization
To use a condom in past 30 days and to negotiate sexual encounters in past 30 days measured by revised risk behavior assessment
Time frame: 3 months after randomization and 6 months after randomization
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Time frame: 3 months after randomization and 6 months after randomization
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.
Time frame: 3 months after randomization and 6 months after randomization
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.
University of North Carolina, Chapel Hill
Other
Acronym: IMEDI
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