HIV and Drug Use in Georgian Women

NCT ID: NCT01331460

Last Updated: 2016-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-01-31

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.

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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RBT Experimental

Group Type EXPERIMENTAL

RBT

Intervention Type BEHAVIORAL

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.

Case-Management: Treatment as Usual

Group Type ACTIVE_COMPARATOR

Case-Management

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Other Intervention Names

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Women's Health CoOp Treatment-as-Usual Standard Intervention

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irma Kirtadze, MD

Role: PRINCIPAL_INVESTIGATOR

Addiction Research Center, Union Alternative Georgia, Tbilisi

Hendree Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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Addiction Research Center, Union Alternative Georgia office

Tbilisi, , Georgia

Site Status

Countries

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Georgia

References

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Costenbader EC, Otiashvili D, Meyer W, Zule WA, Orr A, Kirtadze I. Secrecy and risk among MSM in Tbilisi, Georgia. AIDS Care. 2009 May;21(5):591-7. doi: 10.1080/09540120802385587.

Reference Type BACKGROUND
PMID: 19444667 (View on PubMed)

Jones HE, Wong CJ, Tuten M, Stitzer ML. Reinforcement-based therapy: 12-month evaluation of an outpatient drug-free treatment for heroin abusers. Drug Alcohol Depend. 2005 Aug 1;79(2):119-28. doi: 10.1016/j.drugalcdep.2005.01.006. Epub 2005 Feb 24.

Reference Type BACKGROUND
PMID: 16002021 (View on PubMed)

Jones HE, Kirtadze I, Otiashvili D, Murphy K, O'Grady KE, Zule W, Krupitsky E, Wechsberg WM. Feasibility and initial efficacy of a culturally sensitive women-centered substance use intervention in Georgia: Sex risk outcomes. Subst Abuse Treat Prev Policy. 2015 Dec 8;10:47. doi: 10.1186/s13011-015-0043-0.

Reference Type DERIVED
PMID: 26644132 (View on PubMed)

Related Links

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Other Identifiers

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R01DA029880

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA029880

Identifier Type: NIH

Identifier Source: org_study_id

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