HIV Clinical Trial - HIV Prevention for Injecting Drug Users in Kazakhstan

Status Completed

Clinical Trial Summary

The proposed study addresses a significant public health threat of HIV, HCV and other STIs among a very high risk population of active IDUs and their sexual partners in Kazakhstan a region that is experiencing one of the fastest rising HIV epidemics in the world. There is a race to develop and implement effective HIV preventive interventions for IDUs and their sexual partners to stem the spread of HIV, HCV and other STIs in Almaty, Shu and other Central Asian towns along drug trafficking routes. The proposed study will test the effectiveness of a couplesbased HIV/STI risk reduction intervention to decrease new cases of HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well as to reduce unsafe injection practices and increase condom use among injecting drug users (IDUs) and their heterosexual, intimate partners in Kazakhstan.

Clinical Trial Description

The proposed study will rigorously test the efficacy of an innovative, couplesbased HIV/STI risk reduction intervention to decrease new cases of HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well as to reduce unsafe injection practices and increase condom use among injecting drug users (IDUs) and their heterosexual intimate partners in Kazakhstan. Central Asia has experienced one of the fastest growing HIV/AIDS epidemics due to a sharp increase in injection drug use. For the proposed study, the participants will be 400 IDUs and their heterosexual intimate partners. These 400 couples will be randomized to one of two interventions: a 5session couplesbased HIV/STI risk reduction intervention or a 5session couplesbased wellness promotion intervention, which will serve as a control condition. Participants will be assessed with repeated measures at baseline, 3, 6, and 12months postintervention. The primary behavioral outcomes are selfreported proportion of injection acts in which needles or syringes are shared in the past 90 days and proportion of condom protected acts of sexual intercourse in the past 90 days. The primary biological outcomes are the rate of new HIV and HCV cases, and the cumulative incidence of Chlamydia, gonorrhea, and syphilis over the 12month postintervention period. The proposed study will advance the understanding of HIV/HCV/STI risk reduction among IDUs and thereby may help to stem the rising epidemic of HIV, HCV, and STIs in Kazakhstan and Central Asia. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

AIDS
HIV

Clinical Trial Details

NCT number	NCT01690442
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	Phase 2
Start date	May 2008
Completion date	November 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.