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临床试验/NCT01331460
NCT01331460已完成不适用

HIV and Drug Use in Georgian Women

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Injection Practices

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Younger than 18 years
  • Not sexually active at least once in past 30 days
  • Not able to provide informed consent

结局指标

主要结局

Injection Practices

时间窗: 6 months after randomization

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

Sexual practices

时间窗: 3 months after randomization

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

Injection practices

时间窗: 3 months after randomization

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

Sexual Practices

时间窗: 6 months after randomization

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

次要结局

  • Injecting practices(3 months after randomization and 6 months after randomization)
  • Drug use(3 months after randomization and 6 months after randomization)
  • Condom Use and Sexual Encounter Negotiation(3 months after randomization and 6 months after randomization)
  • Sexual practices(3 months after randomization and 6 months after randomization)
  • Alcohol Use(3 months after randomization and 6 months after randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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HIV and Drug Use in Georgian Women | 临床试验