Behavioral Intervention Trial for HIV-infected Injection Drug Users
NCT ID: NCT00146445
Last Updated: 2012-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
1000 participants
INTERVENTIONAL
2001-08-31
2006-07-31
Brief Summary
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Detailed Description
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1. decrease sex and injection risk behaviors that put others at risk for HIV infection,
2. increase access to or utilization of HIV primary health care, and
3. increase adherence to HIV medications.
The intervention arm consists of 7 group sessions, 2 individual sessions, and one community experience. The control arm consists of 8 group sessions, aiming at controlling for demand (1st session) and attention (8 group sessions). Behavioral assessments and blood draws (for viral load and CD4 testing) occur at baseline, 6, and 12 month follow-up; a 3 month assessment involves behavioral assessment only. 1161 participants took baseline. Of these, 966 were randomized into the study, and 840, 807, and 821 participants took 3, 6, and 12 month follow-up assessments, respectively.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Peer Mentoring Intervention
Eligibility Criteria
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Inclusion Criteria
* self-identify as a person who has injected drugs in the last 12 months
* self-identify as a person who has had sex with at least one opposite sex partner within the last 3 months
* self-identify as HIV-seropositive
* be confirmed as HIV seropositive through oral fluid (saliva) HIV testing
* live in the geographic region under study,
* agree to have their blood drawn for CD4 count and viral load testing
* be willing to provide basic contact information (for follow-up)
* be able to communicate in English
* not have participated in the full-pilot of this intervention and not have enrolled previously in the present study.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Health Services Resource Adminstration - HIV/AIDS Bureau
UNKNOWN
Centers for Disease Control and Prevention
FED
Responsible Party
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Principal Investigators
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David W Purcell, JD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centers for Disease Control and Prevention
Locations
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University of California - San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
New York Academy of Medicine
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Countries
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References
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Purcell DW, Metsch LR, Latka M, Santibanez S, Gomez CA, Eldred L, Latkin CA; INSPIRE Study Group. Interventions for seropositive injectors-research and evaluation: an integrated behavioral intervention with HIV-positive injection drug users to address medical care, adherence, and risk reduction. J Acquir Immune Defic Syndr. 2004 Oct 1;37 Suppl 2:S110-8. doi: 10.1097/01.qai.0000140609.44016.c4.
Valverde EE, Purcell DW, Waldrop-Valverde D, Malow R, Knowlton AR, Gomez CA, Farrell N, Latka MH; INSPIRE Study Team. Correlates of depression among HIV-positive women and men who inject drugs. J Acquir Immune Defic Syndr. 2007 Nov 1;46 Suppl 2:S96-100. doi: 10.1097/QAI.0b013e318157683b.
Mitchell SG, Edwards LV, Mackenzie S, Knowlton AR, Valverde EE, Arnsten JH, Santibanez S, Latka MH, Mizuno Y; INSPIRE Study Team. Participants' descriptions of social support within a multisite intervention for HIV-seropositive injection drug users (INSPIRE). J Acquir Immune Defic Syndr. 2007 Nov 1;46 Suppl 2:S55-63. doi: 10.1097/QAI.0b013e3181576808.
Purcell DW, Latka MH, Metsch LR, Latkin CA, Gomez CA, Mizuno Y, Arnsten JH, Wilkinson JD, Knight KR, Knowlton AR, Santibanez S, Tobin KE, Rose CD, Valverde EE, Gourevitch MN, Eldred L, Borkowf CB; INSPIRE Study Team. Results from a randomized controlled trial of a peer-mentoring intervention to reduce HIV transmission and increase access to care and adherence to HIV medications among HIV-seropositive injection drug users. J Acquir Immune Defic Syndr. 2007 Nov 1;46 Suppl 2:S35-47. doi: 10.1097/QAI.0b013e31815767c4.
Other Identifiers
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U22/CCU217990
Identifier Type: -
Identifier Source: secondary_id
U22/CCU317999
Identifier Type: -
Identifier Source: secondary_id
U22/CCU417998
Identifier Type: -
Identifier Source: secondary_id
U22/CCU918003
Identifier Type: -
Identifier Source: secondary_id
CDC-NCHSTP-2864
Identifier Type: -
Identifier Source: org_study_id