Behavioral Intervention Trial for HIV-infected Injection Drug Users

Centers for Disease Control and Prevention (CDC) logo

Centers for Disease Control and Prevention (CDC)

Status and phase

Completed
Phase 3
Phase 2

Conditions

HIV

Treatments

Behavioral: Peer Mentoring Intervention

Study type

Interventional

Funder types

Other U.S. Federal agency
Other

Identifiers

NCT00146445
U22/CCU417998
U22/CCU217990
U22/CCU918003
CDC-NCHSTP-2864
U22/CCU317999

Details and patient eligibility

About

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.

Full 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: 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

-

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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