RCT of Russian IDU Peer Network HIV Prevention Intervention - 1
| Tracking Information | |||||
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| First Received Date ICMJE | September 16, 2005 | ||||
| Last Updated Date | May 19, 2011 | ||||
| Start Date ICMJE | October 2003 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incident number of HIV Infections in social networks [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Incident number of HIV Infections in social networks | ||||
| Change History | Complete list of historical versions of study NCT00218673 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | RCT of Russian IDU Peer Network HIV Prevention Intervention - 1 | ||||
| Official Title ICMJE | Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention | ||||
| Brief Summary | The purpose of this study is to conduct a randomized controlled trial to assess the efficacy of a peer-educator intervention focused on injection drug users and their drug and sexual networks. We expect that participants who receive the intervention will demonstrate a reduction in the rate of HIV infection and HIV risk behaviors and members of their risk network will also demonstrate reductions in risk behaviors compared to those in the control group. |
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| Detailed Description | Intravenous drug use (IDU) is driving the HIV epidemic in Russia; over 90% of all HIV-1 infections have occurred within communities of IDUs. In St. Petersburg (population 5 million), the prevalence of HIV infection in IDUs (estimated population 100,000) leapt from 4% in 1999 to 12% in 2000. At present there are an estimated 5-7 million IDUs, a four-fold increase since the end of the Soviet Union. In St. Petersburg, there has been a three-fold increase in regular IDUs and a nine-fold increase in teenage IDUs during the past five years. The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Providing peer educator training to IDUs may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the IDU educators' social networks. Prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of HIV transmission among the peer educators and the members of their social networks. Comparison condition: Informed by the Centers for Disease Control model of best practice" standard of care of HIV testing and counseling, participants in the comparison condition will receive risk reduction education and motivational counseling to reduce their risk behaviors. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Behavioral: Peer mentor intervention
groups sessions, 8 |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Russian Federation | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00218673 | ||||
| Other Study ID Numbers ICMJE | DESPR DA016142, 5R01DA016142-05, 5R01DA016142-04, 5R01DA016142-03, 5R01DA016142-02, 1R01DA016142-01, R01-16142-1, NIDA-16142-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Carl Latkin, JHU | ||||
| Study Sponsor ICMJE | Johns Hopkins Bloomberg School of Public Health | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Johns Hopkins Bloomberg School of Public Health | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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