ClinicalTrials.gg
CompletedNCT00146445Updated Sep 27, 2012

Behavioral Intervention Trial for HIV-infected Injection Drug Users

A Phase 2/3 interventional study of Peer Mentoring Intervention in HIV, sponsored by Centers for Disease Control and Prevention. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-27.

Sponsored by Centers for Disease Control and Prevention · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV

Keywords

  • IV drug users
03

In context

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants

Interventions

  • BehavioralPeer Mentoring Intervention
06

What researchers measure

Primary outcomes

  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 outcomes

  1. -Proportion of HIV status disclosure to sex partners

07

Study locations

5 sites
  • University of California - San Francisco
    San Francisco, 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
    The Bronx, New York 10467, United States
08

References and documents

Publications

  • 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. PubMed 15385907 ↗
  • 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. PubMed 18089990 ↗
  • 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. PubMed 18089985 ↗
  • 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. PubMed 18089983 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2001, a primary completion of Jul 2006 and a completion of Jul 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2005
First posted
Sep 7, 2005
Start
Aug 2001
Primary completionActual
Jul 2006
CompletionActual
Jul 2006
Last update
Sep 27, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00146445
Collaborators
Health Services Resource Adminstration - HIV/AIDS Bureau
Responsible party
Sponsor
First posted
Sep 7, 2005
Start date
Aug 2001
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Sep 27, 2012

Study contacts

David W Purcell, JD, PhD
principal investigator · Centers for Disease Control and Prevention

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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