HIV and Drug Use in Georgian Women

Human Immunodeficiency Virus Clinical Trial

— IMEDI  

Official title:

HIV and Drug Use in Georgian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331460
• Other study ID #: R01DA029880
• Secondary ID: R01DA029880
• Status: Completed
• Phase: N/A
• First received: February 22, 2011
• Last updated: August 12, 2016
• Start date: April 2011
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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:
• 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

Locations

Country	Name	City	State
Georgia	Addiction Research Center, Union Alternative Georgia office	Tbilisi

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Georgia, 

References & Publications (2)

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. — View 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. Epub 2005 Feb 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual practices	Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment	3 months after randomization	No
Primary	Injection Practices	Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment	6 months after randomization	No
Primary	Injection practices	Frequency of sharing other injection equipment in the past 30 days measured by revised risk behavior assessment	3 months after randomization	No
Primary	Sexual Practices	Frequency of unprotected sexual acts in the past 30 days measured by revised risk behavior assessment	6 months after randomization	No
Secondary	Sexual practices	Unprotected sex at last encounter measured by revised risk behavior assessment	3 months after randomization and 6 months after randomization	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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