Viewing Study NCT00183118



Ignite Creation Date: 2024-05-05 @ 11:57 AM
Last Modification Date: 2024-10-26 @ 9:16 AM
Study NCT ID: NCT00183118
Status: COMPLETED
Last Update Posted: 2017-07-21
First Post: 2005-09-09

Brief Title: Russia PREVENT HIV Prevention Partnership in Russian Alcohol Treatment
Sponsor: Boston Medical Center
Organization: Boston Medical Center

Study Overview

Official Title: HIV Prevention Partnership in Russian Alcohol Treatment
Status: COMPLETED
Status Verified Date: 2017-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R21AA014821 NIH None httpsreporternihgovquickSearchR21AA014821