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Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00483483
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to test in a randomized controlled trial the effectiveness of a US secondary HIV prevention program to reduce HIV risk behaviors, STD acquisition, and alcohol consumption among HIV-infected Russians with risky drinking.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Individual and group HIV risk behavior counseling sessions Behavioral: health education and support group

Detailed Description:

Russia has one of the fastest growing AIDS epidemics in the world, with an estimated 1 million HIV-infected persons. Initially the Russian HIV epidemic was almost exclusively among injection drug users (IDUs); however, concern exists that HIV is expanding into the general population via sexual transmission. Alcohol use, highly prevalent in Russia, may increase high-risk sexual behaviors among IDUs and alcohol dependent persons. Furthermore, animal models suggest that alcohol consumption plays a permissive role for HIV replication as the resultant higher viral loads may increase risk of transmission. Thus alcohol use may accelerate HIV transmission to the general population in Russia.

The study will randomize 700 HIV-infected patients with risky alcohol consumption to an adapted Healthy Relationships Intervention (HRI) or attention-control support groups. The intervention will be culturally adapted and modified to address substance use and associated risk behaviors. Subjects participating in the HRI will attend three 90-120 min structured group sessions in addition to two 30-60 min individualized sessions over the course of 5-10 days. Subjects in the attention-control group will participate in general health information sessions in the same format (i.e., 2 individualized and 3 group sessions) during the same timeframe.

All patients will be assessed at baseline (pre-randomization) and 6-months and 12-months post-randomization at the recruitment site. Primary outcomes are HIV sex and drug risk behaviors and sexually transmitted diseases. Additionally, subjects will be assessed regarding secondary outcomes including alcohol consumption, quality of life and social support, victimization, suicide, overdose, and disclosure of HIV serostatus.

We hypothesize that relative to the comparison group, participants receiving the adapted Healthy Relationships Intervention will have reduced HIV sex and drug risk behaviors and STD acquisition. If the intervention is effective among HIV-infected hospitalized patients, it could be used to address other HIV infected persons in a variety of Russian settings potentially reducing the transmission of HIV by decreasing risky sex and drug use behaviors among Russians.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers
Study Start Date : October 2007
Primary Completion Date : July 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Healthy Relationships Intervention (HRI)
Behavioral: Individual and group HIV risk behavior counseling sessions
Healthy Relationships Intervention (HRI) culturally adapted and modified to address substance use and associated risk behaviors; subjects will attend three 2-hour structured group sessions in addition to two 1-hour individualized sessions over the course of 10 days.
Other Name: HRI
Active Comparator: Attention-control group
health education & support
Behavioral: health education and support group
general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.

Outcome Measures

Primary Outcome Measures :
  1. Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Percentage of protected sex episodes, percentage of unprotected sex episodes Multiple drug partners, Number of sexually transmitted infections (by self report), Alcohol consumption, Disclosure of HIV serostatus [ Time Frame: 12 months ]

Eligibility Criteria

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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;
  • HIV positive;
  • Alcohol consumption at NIAAA at-risk drinking levels (greater than 14 drinks per week [or more than 4 drinks per day] for men, and greater than 7 drinks per week [or more than 3 drinks per day] for women) during the 30 days prior to hospital admission, For subjects whose drinking was not risky 30 days prior to hospital admission, we will ask if their drinking was equivalent to binge amounts on any day in the prior 6 months;
  • Self-reported unprotected anal or vaginal sex in the last 6 months;
  • 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 150 kilometers of St. Petersburg; and
  • Possession of a home telephone;
  • Fluent in Russian;
  • Ability to provide informed consent.

Exclusion Criteria:

  • Severe cognitive impairment (i.e., clinically apparent dementia, active psychosis, or severe paranoid disorder) as judged by a hospital clinician and stated in the records;
  • Acute illness precluding ability to participate in assessment for eligibility (however these patients may be assessed again on a subsequent day);
  • Trying to get (partner) pregnant.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483483

Russian Federation
City Drug Addiction Center
St. Petersburg, Russian Federation
Pavlov State Medical University and Botkin Infectious Disease Hospital
St. Petersburg, Russian Federation
St. Petersburg AIDS Center
St. Petersburg, Russian Federation
Sponsors and Collaborators
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Jeffrey H. Samet, MD, MA, MPH Boston Medical Center, Boston University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Samet, Chief, Section of General Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00483483     History of Changes
Other Study ID Numbers: H-25082
R01AA016059 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 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:
Unsafe sex
High-risk sex
Needle sharing

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases