NCT00183118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

First QC Date

September 9, 2005

Last Update Submit

July 19, 2017

Conditions

Keywords

HIVRussiaPreventionBehavioral interventionAlcohol dependence

Outcome Measures

Primary Outcomes (4)

  • HIV risk behaviors:

  • risky alcohol use

  • risky drug use

  • risky sex behavior

Secondary Outcomes (2)

  • RAB score

  • Addiction Severity Index (ASI)

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jeffrey H. Samet, MD, MA, MPH

    Boston Medical Center

    STUDY DIRECTOR
  • Evgeny Krupitsky

    Leningrad Regional Center of Addictions Institution: Pavlov State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, General Internal Medicine

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

October 1, 2004

Study Completion

December 1, 2005

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations