Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00183118
First received: September 9, 2005
Last updated: June 1, 2010
Last verified: November 2007

September 9, 2005
June 1, 2010
October 2004
Not Provided
  • HIV risk behaviors:
  • risky alcohol use
  • risky drug use
  • risky sex behavior
Same as current
Complete list of historical versions of study NCT00183118 on ClinicalTrials.gov Archive Site
  • RAB score
  • Addiction Severity Index (ASI)
Same as current
Not Provided
Not Provided
 
Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)
HIV Prevention Partnership in Russian Alcohol Treatment

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Alcohol Dependence
  • Drug Dependence
Behavioral: Adapted Enhanced-RESPECT (HIV prevention intervention)
Not Provided
Samet JH, Krupitsky EM, Cheng DM, Raj A, Egorova VY, Levenson S, Meli S, Bridden C, Verbitskaya EV, Kamb ML, Zvartau EE. Mitigating risky sexual behaviors among Russian narcology hospital patients: the PREVENT (Partnership to Reduce the Epidemic Via Engagement in Narcology Treatment) randomized controlled trial. Addiction. 2008 Sep;103(9):1474-83. Epub 2008 Jul 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2005
Not Provided

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183118
NIAAASAM014821, R21AA014821, NIH AA014821
Not Provided
Jeffrey H. Samet, MD, MA, MPH, Study Director, Boston Medical Center
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Director: Jeffrey H. Samet, MD, MA, MPH Boston Medical Center
Principal Investigator: Evgeny Krupitsky Leningrad Regional Center of Addictions Institution: Pavlov State Medical University
Boston Medical Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP