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HIVPhase 2/3NCT00146445

Behavioral Intervention Trial for HIV-infected Injection Drug Users

A Phase 2/3 study testing Peer Mentoring Intervention in people with HIV, run by Centers for Disease Control and Prevention at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Peer Mentoring Intervention
How many people
1,000 participants
Where
5 sitesUnited States
Study dates
Aug 2001to Jul 2006
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 10Show fewer
  • 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.

Who cannot join

  • -

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • University of Miami

    Miami, Florida, 33136

  • New York Academy of Medicine

    New York, New York, 10029

  • University of California - San Francisco

    San Francisco, California, 94105

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Intervention for Seropositive Injection Drug Users - Research and Evaluation (INSPIRE)

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.

Conditions
HIV
Being tested
Peer Mentoring Intervention
Keywords
IV drug users

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer Mentoring InterventionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. -Proportion of HIV status disclosure to sex partners

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startAug 2001
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146445
Sponsor's protocol ID
CDC-NCHSTP-2864
Other IDs
U22/CCU217990, U22/CCU317999, U22/CCU417998, U22/CCU918003
Status last verified
Sep 2012
First submitted
2 Sep 2005
Last updated
27 Sep 2012
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Peer Mentoring Intervention in people with HIV, run by Centers for Disease Control and Prevention at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

- unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146445, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.

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