IMEDI: HIV and Drug Use in Georgian Women

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT01331460

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

128

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Behavioral: RBT Other: Case-Management	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

HIV and Drug Use in Georgian Women

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RBT Experimental	Behavioral: RBT 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
Active Comparator: Case-Management: Treatment as Usual	Other: Case-Management 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

Arm

Intervention/Treatment

Experimental: RBT Experimental

Behavioral: RBT

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

Active Comparator: Case-Management: Treatment as Usual

Other: Case-Management

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

Outcome Measures

Primary Outcome Measures

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

Sexual practices [3 months after randomization and 6 months after randomization]
Unprotected sex at last encounter measured by revised risk behavior assessment
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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Addiction Research Center, Union Alternative Georgia office	Tbilisi		Georgia	0177

Sponsors and Collaborators

University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Irma Kirtadze, MD, Addiction Research Center, Union Alternative Georgia, Tbilisi
Principal Investigator: Hendree Jones, PhD, UNC Chapel Hill