Clinical trial NCT01331460: HIV and Drug Use in Georgian Women
Official title: HIV and Drug Use in Georgian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV
HIV risk
Sexually Transmitted Diseases
Drug Use
Women
Drug Treatment
opioids
injection drug use
stimulants
gender-specific treatment
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-08
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Sexual practices
timeFrame: 3 months after randomization
measure: Injection Practices
timeFrame: 6 months after randomization
measure: Injection practices
timeFrame: 3 months after randomization
measure: Sexual Practices
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Sexual practices
timeFrame: 3 months after randomization and 6 months after randomization
measure: Condom Use and Sexual Encounter Negotiation
timeFrame: 3 months after randomization and 6 months after randomization
measure: Injecting practices
timeFrame: 3 months after randomization and 6 months after randomization
measure: Drug use
timeFrame: 3 months after randomization and 6 months after randomization
measure: Alcohol Use
timeFrame: 3 months after randomization and 6 months after randomization
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Addiction Research Center, Union Alternative Georgia office
Study officials:
affiliation: Addiction Research Center, Union Alternative Georgia, Tbilisi
name: Irma Kirtadze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill
name: Hendree Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.drugalcdep.2005.01.006. Epub 2005 Feb 24.
citation: 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.