HIV and Drug Use in Georgian Women (IMEDI)

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: RBT; Other: Case-Management

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0177
    • Addiction Research Center, Union Alternative Georgia office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual practices	Unprotected sex at last encounter measured by revised risk behavior assessment	3 months after randomization and 6 months after randomization
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	3 months after randomization and 6 months after randomization
Injecting practices	Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment	3 months after randomization and 6 months after randomization
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.	3 months after randomization and 6 months after randomization
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.	3 months after randomization and 6 months after randomization

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 22, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 12, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: HIV; Women; opioids; Sexually Transmitted Diseases; Drug Treatment; Drug Use; stimulants; injection drug use; HIV risk; gender-specific treatment
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01DA029880 (U.S. NIH Grant/Contract)