Behavioral Intervention Trial for HIV-infected Injection Drug Users

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00146445
• Collaborator: Health Services Resource Adminstration - HIV/AIDS Bureau (Other)
• Enrollment: 1,000
• Locations: 5
• Duration (Months): 59
• Patients Per Site: 200
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV	Behavioral: Peer Mentoring Intervention	Phase 2/Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Intervention for Seropositive Injection Drug Users - Research and Evaluation (INSPIRE)
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. - unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months []

2. - lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months []

3. -health care visits for HIV primary care in the past 6 months []

4. -90% or more adherence to HIV medication yesterday and in the past week []

Secondary Outcome Measures

1. -Proportion of HIV status disclosure to sex partners []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - San Francisco	San Fransisco	California	United States	94105
2	University of Miami	Miami	Florida	United States	33136
3	Johns Hopkins University	Baltimore	Maryland	United States	21231
4	Montefiore Medical Center	Bronx	New York	United States	10467
5	New York Academy of Medicine	New York	New York	United States	10029

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• Health Services Resource Adminstration - HIV/AIDS Bureau

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Purcell DW, Metsch LR, Latka M, Santibanez S, Gómez 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.

• Responsible Party: Centers for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT00146445
• Other Study ID Numbers: CDC-NCHSTP-2864; U22/CCU217990; U22/CCU317999; U22/CCU417998; U22/CCU918003
• First Posted: Sep 7, 2005
• Last Update Posted: Sep 27, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Centers for Disease Control and Prevention: IV drug users

Study Results

No Results Posted as of Sep 27, 2012