The purpose of this study is to test whether a ten-session behavioral intervention for HIV-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for HIV infection, increasing access to or utilization of HIV primary health care, and increasing adherence to HIV medications.

Condition	Intervention	Phase
Peer Mentoring Intervention Video & Discussion Intervention (comparison condition)	Behavior: Peer Mentoring Intervention	Phase II Phase III

Further Study Details: 

Primary Outcomes: - unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months; - lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months; -health care visits for HIV primary care in the past 6 months; -90% or more adherence to HIV medication yesterday and in the past week
Secondary Outcomes: -Proportion of HIV status disclosure to sex partners
Expected Total Enrollment:  1000

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:

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

-

California
      University of California - San Francisco, San Fransisco,  California,  94105,  United States
Florida
      University of Miami, Miami,  Florida,  33136,  United States
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21231,  United States
New York
      New York Academy of Medicine, New York,  New York,  10029,  United States
      Montefiore Medical Center, Bronx,  New York,  10467,  United States

Study chairs or principal investigators

David W Purcell, JD, PhD,  Principal Investigator,  Centers for Disease Control and Prevention   

Study ID Numbers:  CDC-NCHSTP-2864; U22/CCU217990; U22/CCU317999; U22/CCU417998; U22/CCU918003
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