RCT of Russian IDU Peer Network HIV Prevention Intervention - 1
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ClinicalTrials.gov Identifier: NCT00218673 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: May 13, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Peer mentor intervention | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: experimental
social network
|
Behavioral: Peer mentor intervention
groups sessions, 8
|
No Intervention: control
testing and counseling
|
- Incident number of HIV Infections in social networks [ Time Frame: 1 year ]
- Self reported risk behaviors: entry into drug treatment, cessation of drug use [ Time Frame: 1 year ]
- Self reported risk behaviors: number of sex partners, freq of condom use [ Time Frame: 3 months ]

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Ages Eligible for Study: | 16 Years to 100 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Of legal age to independently provide written informed consent for research
- Report having injected drugs at least 12 times in the last three months
- HIV seronegative (ELISA confirmed)
- Willing and able to recruit at least three HIV risk network members who are eligible for study participation
Exclusion Criteria:
- Prior or concurrent enrollment in the last 6 months in another HIV behavioral or biomedical prevention study
- Psychological disturbance or cognitive impairment that appears to limit the ability to understand study procedures, as determined by clinic staff
- Any other condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere with the study objectives

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218673
Russian Federation | |
Biomedical Center | |
St. Petersburg, Russian Federation, 197110 |
Principal Investigator: | Carl Latkin, Ph.D. | Johns Hopkins University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Carl Latkin, Professor, Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00218673 History of Changes |
Other Study ID Numbers: |
DESPR DA016142 5R01DA016142 ( U.S. NIH Grant/Contract ) R01-16142-1 NIDA-16142-1 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | May 13, 2016 |
Last Verified: | May 2016 |
Keywords provided by Carl Latkin, Johns Hopkins Bloomberg School of Public Health:
HIV injection drug use social networks |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |