Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers


Tracking Information

Start Date  ICMJEOctober 2007
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 21, 2007)
Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: June 6, 2007)
Number of unprotected sex acts # of unclean drug injections # of sexually transmitted infections (by urinalysis) [ Time Frame: 12 months ]
Change HistoryComplete list of historical versions of study NCT00483483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 21, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: June 6, 2007)
Percentage of protected sex episodes Percentage of unprotected sex episodes Multiple drug partners # of sexually transmitted infections (by self report) Alcohol consumption Disclosure of HIV serostatus [ Time Frame: 12 months ]

Descriptive Information

Brief Title  ICMJEProject HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers
Official Title  ICMJEMaximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers
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 patients with risky drinking in the Russian inpatient setting.

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.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Condition  ICMJEHIV Infections
Intervention  ICMJE
  • 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
  • Behavioral: health education and support group
    general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.
Study Arms / Comparison Groups
  • 1: Experimental
    Healthy Relationships Intervention (HRI)
    Intervention: Behavioral: Individual and group HIV risk behavior counseling sessions
  • Attention-control group: Active Comparator
    health education & support
    Intervention: Behavioral: health education and support group

Recruitment Information

Estimated Enrollment  ICMJE700
Estimated Completion DateDecember 2011
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years to 70 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Evgeny M. Krupitsky, MD, PhD9-011-7812-296-9905kru@ek3506.spb.edu
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00483483
Responsible PartyJeffrey H. Samet, MD, MA, MPH, Boston Medical Center
Study ID Numbers  ICMJENIAAASAM-016059, NIH Grant 1R01AA016059-01
Study Sponsor  ICMJENational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Jeffrey H. Samet, MD, MA, MPHBoston Medical Center, Boston University
Information Provided ByNational Institute on Alcohol Abuse and Alcoholism (NIAAA)