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Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Alcohol Dependence Drug Dependence | Behavioral: Adapted Enhanced-RESPECT (HIV prevention intervention) | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | HIV Prevention Partnership in Russian Alcohol Treatment |
- HIV risk behaviors:
- risky alcohol use
- risky drug use
- risky sex behavior
- RAB score
- Addiction Severity Index (ASI)
| Enrollment: | 180 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00183118
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeffrey Samet, Professor, General Internal Medicine, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00183118 History of Changes |
| Other Study ID Numbers: |
H23052 R21AA014821 ( U.S. NIH Grant/Contract ) |
| Study First Received: | September 9, 2005 |
| Last Updated: | July 19, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Jeffrey Samet, Boston Medical Center:
|
HIV Russia Prevention Behavioral intervention Alcohol dependence |
Additional relevant MeSH terms:
|
Alcoholism Substance-Related Disorders Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders |
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 17, 2017