Study to Reduce Intravenous Exposures (STRIVE)
Status: | Completed |
---|---|
Conditions: | HIV / AIDS, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 35 |
Updated: | 1/12/2017 |
Start Date: | June 2002 |
End Date: | February 2005 |
Behavioral Intervention Trial to Reduce Transmission Risks and Improve HCV Treatment Access Among HCV-infected Injection Drug Users
The purpose of this study is to determine whether a six-session, small group behavioral
intervention based on "peer-volunteer activism" is effective in (1) decreasing distributive
sharing of syringes and other injection paraphernalia and (2) increasing utilization of
HCV-related healthcare services among HCV-infected injection drug users
intervention based on "peer-volunteer activism" is effective in (1) decreasing distributive
sharing of syringes and other injection paraphernalia and (2) increasing utilization of
HCV-related healthcare services among HCV-infected injection drug users
The purpose of this study is to determine the efficacy of a peer-volunteer intervention to
reduce high-risk transmission behaviors among hepatitis C virus (HCV)-infected young adult
injection drug users (IDUs), and to identify the proportion of these individuals who would
be eligible and willing to undergo treatment to eradicate HCV infection. HCV is one of the
most frequently occurring human viral infections, having an estimated worldwide prevalence
of 3%. In many regions of the United States, between 65% and 95% of IDUs are
HCV-seropositive and capable of transmitting the infection. To date, research studies
targeting infected individuals to prevent secondary transmission of chronic blood-borne
viral infection have generally been limited to post-test counseling and case management. In
addition, recent data suggest that medical treatment of HCV infection may be most effective
when offered soon after HCV seroconversion. However, the proportion of HCV-infected IDUs who
meet strict national guidelines for HCV treatment is likely to be small because treatment is
usually postponed while drug use continues. Determining the proportion of infected
individuals who may be both eligible and willing to undergo HCV therapy is highly important
for guiding national standards and objectives to achieve greater numbers of IDUs in HCV
therapy. We have previously reported that fewer than 1% of HCV-infected IDUs in Baltimore
are currently receiving such therapy. Early initiation of HCV treatment among young IDUs in
conjunction with a reduction in HCV transmission risk behaviors may ultimately lead to a
reduction in incident HCV infection at the individual and the community levels.
This study is a randomized controlled trial to determine the efficacy of a "peer-volunteer
activism" intervention to reduce distributive syringe and injection paraphernalia sharing
behaviors among HCV positive IDUs and promote the uptake of HCV care and treatment. If
proven effective, this intervention would substantially decrease the risk of HCV infection
in the community. To address these aims, we plan to recruit, screen, and randomly assign 750
IDUs age 18-35 years who are HCV-seropositive but HIV-seronegative in Baltimore, New York
and Seattle to a behavioral intervention (250 per site), and prospectively monitor
participants behavior at 3- and 6-month follow-up visits.
reduce high-risk transmission behaviors among hepatitis C virus (HCV)-infected young adult
injection drug users (IDUs), and to identify the proportion of these individuals who would
be eligible and willing to undergo treatment to eradicate HCV infection. HCV is one of the
most frequently occurring human viral infections, having an estimated worldwide prevalence
of 3%. In many regions of the United States, between 65% and 95% of IDUs are
HCV-seropositive and capable of transmitting the infection. To date, research studies
targeting infected individuals to prevent secondary transmission of chronic blood-borne
viral infection have generally been limited to post-test counseling and case management. In
addition, recent data suggest that medical treatment of HCV infection may be most effective
when offered soon after HCV seroconversion. However, the proportion of HCV-infected IDUs who
meet strict national guidelines for HCV treatment is likely to be small because treatment is
usually postponed while drug use continues. Determining the proportion of infected
individuals who may be both eligible and willing to undergo HCV therapy is highly important
for guiding national standards and objectives to achieve greater numbers of IDUs in HCV
therapy. We have previously reported that fewer than 1% of HCV-infected IDUs in Baltimore
are currently receiving such therapy. Early initiation of HCV treatment among young IDUs in
conjunction with a reduction in HCV transmission risk behaviors may ultimately lead to a
reduction in incident HCV infection at the individual and the community levels.
This study is a randomized controlled trial to determine the efficacy of a "peer-volunteer
activism" intervention to reduce distributive syringe and injection paraphernalia sharing
behaviors among HCV positive IDUs and promote the uptake of HCV care and treatment. If
proven effective, this intervention would substantially decrease the risk of HCV infection
in the community. To address these aims, we plan to recruit, screen, and randomly assign 750
IDUs age 18-35 years who are HCV-seropositive but HIV-seronegative in Baltimore, New York
and Seattle to a behavioral intervention (250 per site), and prospectively monitor
participants behavior at 3- and 6-month follow-up visits.
Inclusion Criteria:
- HCV antibody positive
- age between 18 and 35 years old;
- reported injection drug use in the past 6 months
- willing to provide a blood sample for liver function testing
Exclusion Criteria:
- HIV antibody positive
- planned on moving from city within the next 12 months;
- unable to comprehend English well enough to complete English-only assessments and
group sessions
We found this trial at
3
sites
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1216 5th Avenue
New York, New York 10029
New York, New York 10029
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