Tracking Information
Start Date ICMJE | October 2007 |
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Estimated Primary Completion Date | February 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 History | Complete 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 ICMJE | Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers |
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Official Title ICMJE | Maximizing 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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study |
Condition ICMJE | HIV Infections |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 700 | ||||
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Estimated Completion Date | December 2011 | ||||
Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00483483 | ||||
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Responsible Party | Jeffrey H. Samet, MD, MA, MPH, Boston Medical Center | ||||
Study ID Numbers ICMJE | NIAAASAM-016059, NIH Grant 1R01AA016059-01 | ||||
Study Sponsor ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||
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Investigators ICMJE |
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Information Provided By | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |