Behavioral Intervention Trial for HIV-Infected Injection Drug Users - Article Caverject; Edex Kit
Clinical Trial: Behavioral Intervention Trial for HIV-Infected Injection Drug Users
This study is no longer recruiting patients.
|Peer Mentoring Intervention |
Video & Discussion Intervention (comparison condition)
| Behavior: Peer Mentoring Intervention ||Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: -Proportion of HIV status disclosure to sex partners
Expected Total Enrollment: 1000
Study start: August 2001; Study completion: June 2007
Last follow-up: March 2005; Data entry closure: April 2005
INSPIRE is a four-site (Baltimore, Miami, New York and San Francisco) randomized control trial to develop and evaluate the efficacy of a ten-session intervention for HIV-positive injection drug users. The primary goals of the intervention are to:
- decrease sex and injection risk behaviors that put others at risk for HIV infection,
- increase access to or utilization of HIV primary health care, and
- 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.
- 18 years of age or older
- 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.
University of California - San Francisco, San Fransisco, California, 94105, United States
University of Miami, Miami, Florida, 33136, United States
Johns Hopkins University, Baltimore, Maryland, 21231, United States
New York Academy of Medicine, New York, New York, 10029, United States
Montefiore Medical Center, Bronx, New York, 10467, United States
David W Purcell, JD, PhD, Principal Investigator, Centers for Disease Control and Prevention
Purcell DW, Metsch LR, Latka M, Santibanez S, Gomez CA, Eldred L, Latkin CA; for the 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:S110-S118.
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00146445
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13