Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00483483
First received: June 6, 2007
Last updated: June 18, 2012
Last verified: June 2012

June 6, 2007
June 18, 2012
October 2007
July 2011   (final data collection date for primary outcome measure)
Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Number of unprotected sex acts # of unclean drug injections # of sexually transmitted infections (by urinalysis) [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00483483 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers
Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • 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.
  • Experimental: 1
    Healthy Relationships Intervention (HRI)
    Intervention: Behavioral: Individual and group HIV risk behavior counseling sessions
  • Active Comparator: Attention-control group
    health education & support
    Intervention: Behavioral: health education and support group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
March 2012
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00483483
NIAAASAM-016059, R01AA016059, NIH Grant 1R01AA016059-01
No
Jeffrey Samet, Boston Medical Center
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Jeffrey H. Samet, MD, MA, MPH Boston Medical Center, Boston University
Boston Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP