HIV and Drug Use in Georgian Women

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Other: Case-Management; Behavioral: RBT

• Registration Number: NCT01331460
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-02-22
• Study Start: 2011-04
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-08
• Primary Completion: 2015-06
• Study Completion: 2016-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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.

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Exclusion Criteria

• Male
• Younger than 18 years
• Not sexually active at least once in past 30 days
• Not able to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case-Management: Treatment as Usual	Case-Management	-
RBT Experimental	RBT	-

Primary Outcome Measures

Name	Time	Method
Injection Practices	6 months after randomization	Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Sexual practices	3 months after randomization	Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Injection practices	3 months after randomization	Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Sexual Practices	6 months after randomization	Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment

Secondary Outcome Measures

Name	Time	Method
Injecting practices	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
Drug use	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.
Condom Use and Sexual Encounter Negotiation	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
Sexual practices	3 months after randomization and 6 months after randomization	Unprotected sex at last encounter measured by revised risk behavior assessment
Alcohol Use	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.

Trial Locations

Locations (1)

Addiction Research Center, Union Alternative Georgia office; 🇬🇪 Tbilisi, Georgia