Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)

Alcohol Dependence Clinical Trial

Official title:

HIV Prevention Partnership in Russian Alcohol Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183118
• Other study ID #: H23052
• Secondary ID: R21AA014821
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: July 19, 2017
• Start date: October 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Drug Dependence
• Substance-Related Disorders

Intervention

Behavioral:
• Adapted Enhanced-RESPECT (HIV prevention intervention)

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV risk behaviors:
Primary	risky alcohol use
Primary	risky drug use
Primary	risky sex behavior
Secondary	RAB score
Secondary	Addiction Severity Index (ASI)