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Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)

Primary Purpose

Alcohol Dependence, Drug Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adapted Enhanced-RESPECT (HIV prevention intervention)
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Dependence focused on measuring HIV, Russia, Prevention, Behavioral intervention, Alcohol dependence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Medical Center

Outcomes

Primary Outcome Measures

HIV risk behaviors:
risky alcohol use
risky drug use
risky sex behavior

Secondary Outcome Measures

RAB score
Addiction Severity Index (ASI)

Full Information

First Posted
September 9, 2005
Last Updated
July 19, 2017
Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00183118
Brief Title
Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)
Official Title
HIV Prevention Partnership in Russian Alcohol Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Drug Dependence
Keywords
HIV, Russia, Prevention, Behavioral intervention, Alcohol dependence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Adapted Enhanced-RESPECT (HIV prevention intervention)
Primary Outcome Measure Information:
Title
HIV risk behaviors:
Title
risky alcohol use
Title
risky drug use
Title
risky sex behavior
Secondary Outcome Measure Information:
Title
RAB score
Title
Addiction Severity Index (ASI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey H. Samet, MD, MA, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Evgeny Krupitsky
Organizational Affiliation
Leningrad Regional Center of Addictions Institution: Pavlov State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18636998
Citation
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. doi: 10.1111/j.1360-0443.2008.02251.x. Epub 2008 Jul 10.
Results Reference
derived

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Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)

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