Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)

Sponsor

Boston Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00183118

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

180

Enrollment

Location

Duration (Months)

12.9

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

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 :

Oct 1, 2004

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

RAB score []
Addiction Severity Index (ASI) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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