Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00483483

Purpose

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 patients with risky drinking in the Russian inpatient setting.

Condition	Intervention	Phase
HIV Infections	Behavioral: Individual and group HIV risk behavior counseling sessions Behavioral: health education and support group	Phase III

MedlinePlus related topics: AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Official Title:	Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	700
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
Attention-control group: Active Comparator health education & support	Behavioral: health education and support group general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.

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 five 2-hour structured group sessions in addition to two 1-hour individualized sessions over the course of 10 days. Subjects in the attention-control group will participate in general health information sessions in the same format (i.e., 2 individualized and 5 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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;
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483483

Contacts

Contact: Evgeny M. Krupitsky, MD, PhD

9-011-7812-296-9905

kru@ek3506.spb.edu

Locations

Russian Federation
Pavlov State Medical University and Botkin Infectious Disease Hospital	Recruiting
St. Petersburg, Russian Federation
Contact: Evgeny M. Krupitsky, MD, PhD 9-011-7812-296-9905 kru@ek3506.spb.edu
Principal Investigator: Edwin E. Zvartau, MD, PhD

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Jeffrey H. Samet, MD, MA, MPH

Boston Medical Center, Boston University

More Information

Responsible Party:	Boston Medical Center ( Jeffrey H. Samet, MD, MA, MPH )
Study ID Numbers:	NIAAASAM-016059, NIH Grant 1R01AA016059-01
Study First Received:	June 6, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00483483
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

HIV
Unsafe sex
High-risk sex
Needle sharing
STDs

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009