RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

NCT00218673 | Completed Phase 3

• 4 other identifiers: DESPR DA0161425R01DA016142R01-16142-1NIDA-16142-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; injection drug use; social networks

Outcome Measures

Primary Outcomes (1)

• Incident number of HIV Infections in social networks

  1 year

Secondary Outcomes (2)

• Self reported risk behaviors: entry into drug treatment, cessation of drug use

  1 year

• Self reported risk behaviors: number of sex partners, freq of condom use

  3 months

Study Arms (2)

experimental

EXPERIMENTAL

social network

Behavioral: Peer mentor intervention

control

NO INTERVENTION

testing and counseling

Interventions

Peer mentor intervention BEHAVIORAL

groups sessions, 8

experimental

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Biomedical Center

Saint Petersburg, 197110, Russia

Location

Related Publications (1)

• Hoffman IF, Latkin CA, Kukhareva PV, Malov SV, Batluk JV, Shaboltas AV, Skochilov RV, Sokolov NV, Verevochkin SV, Hudgens MG, Kozlov AP. A peer-educator network HIV prevention intervention among injection drug users: results of a randomized controlled trial in St. Petersburg, Russia. AIDS Behav. 2013 Sep;17(7):2510-20. doi: 10.1007/s10461-013-0563-4.

  PMID: 23881187 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Carl Latkin, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

RU (1)