Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers
Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers
2 other identifiers
interventional
700
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Oct 2007
Longer than P75 for not_applicable hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2007
CompletedFirst Posted
Study publicly available on registry
June 7, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJuly 21, 2017
July 1, 2017
3.8 years
June 6, 2007
July 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis)
12 months
Secondary Outcomes (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
12 months
Study Arms (2)
1
EXPERIMENTALHealthy Relationships Intervention (HRI)
Attention-control group
ACTIVE COMPARATORhealth education \& support
Interventions
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.
general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
City Drug Addiction Center
Saint Petersburg, Russia
Pavlov State Medical University and Botkin Infectious Disease Hospital
Saint Petersburg, Russia
St. Petersburg AIDS Center
Saint Petersburg, Russia
Related Publications (4)
Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.
PMID: 37158538DERIVEDSamet JH, Blokhina E, Cheng DM, Walley AY, Lioznov D, Gnatienko N, Quinn EK, Bridden C, Chaisson CE, Toussova O, Gifford AL, Raj A, Krupitsky E. A strengths-based case management intervention to link HIV-positive people who inject drugs in Russia to HIV care. AIDS. 2019 Jul 15;33(9):1467-1476. doi: 10.1097/QAD.0000000000002230.
PMID: 30964750DERIVEDLunze K, Lioznov D, Cheng DM, Nikitin RV, Coleman SM, Bridden C, Blokhina E, Krupitsky E, Samet JH. HIV Stigma and Unhealthy Alcohol Use Among People Living with HIV in Russia. AIDS Behav. 2017 Sep;21(9):2609-2617. doi: 10.1007/s10461-017-1820-8.
PMID: 28600603DERIVEDSamet JH, Raj A, Cheng DM, Blokhina E, Bridden C, Chaisson CE, Walley AY, Palfai TP, Quinn EK, Zvartau E, Lioznov D, Krupitsky E. HERMITAGE--a randomized controlled trial to reduce sexually transmitted infections and HIV risk behaviors among HIV-infected Russian drinkers. Addiction. 2015 Jan;110(1):80-90. doi: 10.1111/add.12716. Epub 2014 Oct 16.
PMID: 25170994DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey H. Samet, MD, MA, MPH
Boston Medical Center, Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Section of General Internal Medicine
Study Record Dates
First Submitted
June 6, 2007
First Posted
June 7, 2007
Study Start
October 1, 2007
Primary Completion
July 1, 2011
Study Completion
March 1, 2012
Last Updated
July 21, 2017
Record last verified: 2017-07