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HIV and Drug Use in Georgian Women (IMEDI)

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
RBT
Case-Management
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring HIV, HIV risk, Sexually Transmitted Diseases, Drug Use, Women, Drug Treatment, opioids, injection drug use, stimulants, gender-specific treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Addiction Research Center, Union Alternative Georgia office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RBT Experimental

Case-Management: Treatment as Usual

Arm Description

Outcomes

Primary Outcome Measures

Sexual practices
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Injection Practices
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Injection practices
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Sexual Practices
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment

Secondary Outcome Measures

Sexual practices
Unprotected sex at last encounter measured by revised risk behavior assessment
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
Injecting practices
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
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.
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.

Full Information

First Posted
February 22, 2011
Last Updated
August 12, 2016
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01331460
Brief Title
HIV and Drug Use in Georgian Women
Acronym
IMEDI
Official Title
HIV and Drug Use in Georgian Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, HIV risk, Sexually Transmitted Diseases, Drug Use, Women, Drug Treatment, opioids, injection drug use, stimulants, gender-specific treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RBT Experimental
Arm Type
Experimental
Arm Title
Case-Management: Treatment as Usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
RBT
Other Intervention Name(s)
Women's Health CoOp
Intervention Description
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
Other
Intervention Name(s)
Case-Management
Other Intervention Name(s)
Treatment-as-Usual, Standard Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Sexual practices
Description
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Time Frame
3 months after randomization
Title
Injection Practices
Description
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Time Frame
6 months after randomization
Title
Injection practices
Description
Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment
Time Frame
3 months after randomization
Title
Sexual Practices
Description
Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Sexual practices
Description
Unprotected sex at last encounter measured by revised risk behavior assessment
Time Frame
3 months after randomization and 6 months after randomization
Title
Condom Use and Sexual Encounter Negotiation
Description
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
Title
Injecting practices
Description
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
Title
Drug use
Description
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
Title
Alcohol Use
Description
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.
Time Frame
3 months after randomization and 6 months after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irma Kirtadze, MD
Organizational Affiliation
Addiction Research Center, Union Alternative Georgia, Tbilisi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hendree Jones, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Research Center, Union Alternative Georgia office
City
Tbilisi
ZIP/Postal Code
0177
Country
Georgia

12. IPD Sharing Statement

Citations:
PubMed Identifier
19444667
Citation
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.
Results Reference
background
PubMed Identifier
16002021
Citation
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.
Results Reference
background
PubMed Identifier
26644132
Citation
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.
Results Reference
derived
Links:
URL
http://www.informaworld.com/smpp/title~content=t713403300
Description
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HIV and Drug Use in Georgian Women

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