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- Klinische proef NCT00146445
Behavioral Intervention Trial for HIV-infected Injection Drug Users
Intervention for Seropositive Injection Drug Users - Research and Evaluation (INSPIRE)
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
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California
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San Fransisco, California, Verenigde Staten, 94105
- University of California - San Francisco
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Florida
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Miami, Florida, Verenigde Staten, 33136
- University of Miami
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21231
- Johns Hopkins University
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New York
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Bronx, New York, Verenigde Staten, 10467
- Montefiore Medical Center
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New York, New York, Verenigde Staten, 10029
- New York Academy of Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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- unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months
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- lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months
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-health care visits for HIV primary care in the past 6 months
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-90% or more adherence to HIV medication yesterday and in the past week
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Secundaire uitkomstmaten
Uitkomstmaat |
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-Proportion of HIV status disclosure to sex partners
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: David W Purcell, JD, PhD, Centers for Disease Control and Prevention
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CDC-NCHSTP-2864
- U22/CCU217990
- U22/CCU317999
- U22/CCU417998
- U22/CCU918003
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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