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临床试验/NCT00183118
NCT00183118已完成1 期

HIV Prevention Partnership in Russian Alcohol Treatment

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
180
试验地点
2
主要终点
HIV risk behaviors:

研究概览

简要总结

The purpose of this study is to test an HIV prevention intervention in a Russian substance abuse treatment facility using a randomized trial study design.

详细描述

A randomized controlled trial of an HIV prevention intervention in a narcology hospital using a stratified randomization design (by gender and substance use diagnosis) will be implemented.

We will conduct a trial among 180 inpatient subjects undergoing treatment at the LRCA. This adapted HIV prevention intervention (adapted Enhanced-RESPECT), Project RESPECT, is a 2-session, one-on-one HIV prevention counseling and testing activity with a trained health educator. By random assignment, half of the subjects will receive the Enhanced-RESPECT intervention, which will include 3 additional booster sessions. And half will receive CDC post-test counseling or standard of care depending on the results of their HIV antibody test. The post-test counseling will follow CDC counseling and testing guidelines. Subjects in the Control group who are not HIV-infected will receive the current standard of care in Russia for non-infected patients; receipt of negative test results by a clinician. HIV pre-test counseling occurs within the first 48 hours of patient arrival at LRCA. CDC post-test counseling guidelines represent a higher standard of care than currently exists within this facility for HIV-infected patients and is equivalent to the standard of care recommended for US HIV testing facilities.

All study participants will be evaluated regarding substance abuse and HIV risk behaviors at baseline and follow-up. Follow up interviews will take place at 3 time points (just before discharge from the hospital and at 3 and 6 months post-randomization). All Intervention participants will receive the basic 2-session adapted RESPECT intervention while inpatients; booster sessions for adapted Enhanced-RESPECT HIV Intervention participants will take place after discharge. Booster sessions will be offered once a month for 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-70 years old;
  • In-patient at LRCA (i.e., primary diagnosis of alcohol or drug dependence);
  • Abstinence from alcohol and other substances of abuse for 4 days;
  • Willingness to undergo HIV testing as per standard narcology hospital counseling and testing protocol or known positive HIV serostatus;
  • Provision of contact information (e.g., name, home address, telephone number) of two relatives or close friends who can be contacted to share information that may be used to assist with follow-up;
  • Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg; and
  • Self-reported unprotected anal or vaginal sex in the last 6 months;

排除标准

  • Not fluent in Russian;
  • Severe cognitive impairment (Clinically apparent dementia, active psychosis, or severe paranoid disorder) as judged by a narcology hospital clinician and stated in the records;
  • Inability to provide informed consent;
  • Suspected or diagnosed pulmonary tuberculosis, not receiving treatment;
  • Pending legal charges with potential impending incarceration.

结局指标

主要结局

HIV risk behaviors:

risky alcohol use

risky drug use

risky sex behavior

次要结局

  • RAB score
  • Addiction Severity Index (ASI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Samet

Professor, General Internal Medicine

Boston Medical Center

研究点 (2)

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