HIV and Drug Use in Georgian Women (IMEDI)
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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 |
- 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
- 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: | June 2015 |
| Estimated Primary Completion Date: | May 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:
|
| 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:
|
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 |
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| Contact: Irma Kirtadze, MD | +995 32 304494, 870700106 | irmakirtadze@gmail.com |
| Contact: David Otiashvili, MD | +995 32 304494, 870700106 | datohupo@yahoo.com |
| Georgia | |
| Addiction Research Center, Union Alternative Georgia office | Recruiting |
| Tbilisi, Georgia, 0177 | |
| Contact: Irma Kirtadze, MD +995 32 304494, 870700106 irmakirtadze@gmail.com | |
| Contact: David Otiashvili, MD +995 32 304494, 870700106 datohupo@yahoo.com | |
| Principal Investigator: Irma Kirtadze, MD | |
| Principal Investigator: | Irma Kirtadze, MD | Additcion Research Center, Union Alternative Georgia, Tbilisi |
| Principal Investigator: | Hendree Jones, PhD | RTI International |
More Information
Additional Information:
Publications:
| Responsible Party: | RTI International |
| ClinicalTrials.gov Identifier: | NCT01331460 History of Changes |
| Other Study ID Numbers: | R01DA029880 |
| Study First Received: | February 22, 2011 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by RTI International:
|
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013