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Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)

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ClinicalTrials.gov Identifier: NCT00183118
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alcohol Dependence Drug Dependence Behavioral: Adapted Enhanced-RESPECT (HIV prevention intervention) Phase 1 Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HIV Prevention Partnership in Russian Alcohol Treatment
Study Start Date : October 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HIV risk behaviors:
  2. risky alcohol use
  3. risky drug use
  4. risky sex behavior

Secondary Outcome Measures :
  1. RAB score
  2. Addiction Severity Index (ASI)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183118


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeffrey Samet, Professor, General Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00183118     History of Changes
Other Study ID Numbers: H23052
R21AA014821 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
 Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs