Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Drug Dependence
Behavioral: Adapted Enhanced-RESPECT (HIV prevention intervention)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: HIV Prevention Partnership in Russian Alcohol Treatment

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • HIV risk behaviors:
  • risky alcohol use
  • risky drug use
  • risky sex behavior

Secondary Outcome Measures:
  • RAB score
  • Addiction Severity Index (ASI)

Estimated Enrollment: 180
Study Start Date: October 2004
Study Completion Date: December 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183118

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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
  More Information

No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey H. Samet, MD, MA, MPH, Study Director, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00183118     History of Changes
Other Study ID Numbers: NIAAASAM014821, R21AA014821, NIH AA014821
Study First Received: September 9, 2005
Last Updated: June 1, 2010
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
HIV
Russia
Prevention
Behavioral intervention
Alcohol dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 27, 2014