Adapted Enhanced-RESPECT (HIV prevention intervention) in Alcohol Dependence and Drug Dependence - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Adapted Enhanced-RESPECT (HIV prevention intervention)

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 Type

Interventional

Enrollment (Actual)

180

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
RAB score
Addiction Severity Index (ASI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria