NCT00146445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_2 hiv

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

4.9 years

First QC Date

September 2, 2005

Last Update Submit

September 26, 2012

Conditions

HIV

Keywords

IV drug users

Outcome Measures

Primary Outcomes (4)

  • - 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 (1)

  • -Proportion of HIV status disclosure to sex partners

Interventions

Peer Mentoring InterventionBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California - San Francisco

San Francisco, California, 94105, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

New York Academy of Medicine

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (4)

  • 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.

    PMID: 15385907BACKGROUND

  • 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.

    PMID: 18089990DERIVED

  • 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.

    PMID: 18089985DERIVED

  • 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.

    PMID: 18089983DERIVED

Study Officials

  • David W Purcell, JD, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

August 1, 2001

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

US(5)