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Completed

NCT Number: NCT01331460

HIV and Drug Use in Georgian Women

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RBT

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.

Other names: Women's Health CoOp

Case-Management

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

Other names: Treatment-as-Usual, Standard Intervention

Primary outcomes

  1. Sexual practices

    Time frame: 3 months after randomization

    Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment

  2. Injection Practices

    Time frame: 6 months after randomization

    Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment

  3. Injection practices

    Time frame: 3 months after randomization

    Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment

  4. Sexual Practices

    Time frame: 6 months after randomization

    Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment

Secondary outcomes

  1. Sexual practices

    Time frame: 3 months after randomization and 6 months after randomization

    Unprotected sex at last encounter measured by revised risk behavior assessment

  2. Condom Use and Sexual Encounter Negotiation

    Time frame: 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

  3. Injecting practices

    Time frame: 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

  4. Drug use

    Time frame: 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.

  5. Alcohol Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: IMEDI

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Apr 8, 2011
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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