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HIV and Drug Use in Georgian Women (IMEDI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01331460
First received: February 22, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention
Human Immunodeficiency Virus
Behavioral: RBT
Other: Case-Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: HIV and Drug Use in Georgian Women

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Sexual practices [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment

  • Injection Practices [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]
    Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment

  • Injection practices [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
    Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment

  • Sexual Practices [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]
    Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment


Secondary Outcome Measures:
  • Sexual practices [ Time Frame: 3 months after randomization and 6 months after randomization ] [ Designated as safety issue: No ]
    Unprotected sex at last encounter measured by revised risk behavior assessment

  • Condom Use and Sexual Encounter Negotiation [ Time Frame: 3 months after randomization and 6 months after randomization ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after randomization and 6 months after randomization ] [ Designated as safety issue: No ]
    Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment

  • Drug use [ Time Frame: 3 months after randomization and 6 months after randomization ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after randomization and 6 months after randomization ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 128
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • RBT
  • 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331460

Locations
Georgia
Addiction Research Center, Union Alternative Georgia office
Tbilisi, Georgia, 0177
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Irma Kirtadze, MD Addiction Research Center, Union Alternative Georgia, Tbilisi
Principal Investigator: Hendree Jones, PhD UNC Chapel Hill
  More Information

Additional Information:
Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01331460     History of Changes
Other Study ID Numbers: R01DA029880, R01DA029880
Study First Received: February 22, 2011
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
HIV
HIV risk
Sexually Transmitted Diseases
Drug Use
Women
Drug Treatment
opioids
injection drug use
stimulants
gender-specific treatment

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014