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- Klinische proef NCT00809445
Rapid HIV Testing and Counseling in Drug Abuse Treatment
13 oktober 2015 bijgewerkt door: Daniel J Feaster, University of Miami
HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study.
The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing.
The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
This is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study.
The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of HIV test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing.
The study will also assess the effectiveness of the three testing strategies in reducing HIV sexual risk behaviors.
Injection drug risk behavior will be a secondary outcome.
Participants will complete a baseline assessment to report their demographics, HIV testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups.
At one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV test results.
At six months post-randomization, participants will complete a follow-up assessment to assess any changes in their HIV sexual risk behaviors.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1281
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Tucson, Arizona, Verenigde Staten, 85713
- La Frontera Center, Inc.
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Connecticut
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Danbury, Connecticut, Verenigde Staten, 06818
- Midwestern Connecticut Council on Alcoholism
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Plainville, Connecticut, Verenigde Staten, 06062
- Wheeler Clinic
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21212
- Glenwood Life Counseling Center
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Missouri
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Cape Girardeau, Missouri, Verenigde Staten, 63703
- Gibson Recover Centers
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New Mexico
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Santa Fe, New Mexico, Verenigde Staten, 87505
- The Life Link
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North Carolina
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Salisbury, North Carolina, Verenigde Staten, 28146
- Daymark Recovery Services, Inc.
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Oregon
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Portland, Oregon, Verenigde Staten, 97214
- CODA
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Addiction Medicine Services (Western Psychiatric Institute)
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South Carolina
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Columbia, South Carolina, Verenigde Staten, 29203
- Morris Village Alcohol and Drug Treatment Center
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Columbia, South Carolina, Verenigde Staten, 29250
- Lexington / Richland Alcohol and Drug Abuse Council
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Virginia
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Chesterfield, Virginia, Verenigde Staten, 23832
- Chesterfield CSB Substance Abuse Service
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- At least 18 years of age
- HIV-negative or HIV status unknown
- No receipt of results from HIV test initiated within last 12 months
- Be able to communicate in English
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: HIV rapid test & counseling
Participants will be offered an oral fluid HIV rapid test (via oral swab) and brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach (Project RESPECT-2 counseling).
Prior to receiving testing, study participants must first provide consent for HIV testing.
Consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test.
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Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
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Experimenteel: HIV rapid test and info
Participants will be offered an oral fluid HIV rapid test (via oral swab).
Prior to receiving testing, study participants must first provide consent for HIV testing.
Again, consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test.
Participants will receive rapid HIV testing and test results after signing the consent to be tested.
In both Groups 1 and 2, participants who test reactive (preliminary positive) will be counseled on the sexual risk behaviors associated with transmission of HIV and the acquisition of STDs, as is current clinical practice with those testing HIV positive.
Confirmed positives will be linked to HIV primary care.
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Participants will be offered an on-site oral fluid HIV rapid test with basic info.
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Actieve vergelijker: HIV testing referral
Participants randomized to group 3 will receive a referral list for HIV community-testing agencies.
Each CTP site will have previously prepared an extensive referral list of testing sites in the surrounding geographic area.
By virtue of their status as patients in the CTPs, they will receive whatever HIV testing and HIV education referrals the CTPs normally provide to their patients.
This is the standard of care at CTPs that do not provide on-site testing.
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Participants will be offered a referral list of HIV testing agencies in the community.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Self-Report Receipt of HIV Test Results
Tijdsspanne: One month post-randomization
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The HIV testing primary outcome is self-reported receipt of HIV test results.
This will be measured at one month post-randomization for all participants.
We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results.
Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test.
Completion of testing refers to whether or not a participant completes the HIV test.
Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.
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One month post-randomization
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Number of Risky Sexual Behaviors
Tijdsspanne: Six months post-randomization
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The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).
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Six months post-randomization
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sharing of Needles Used in Drug Use
Tijdsspanne: Six months
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Change in sharing of needles.
The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.
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Six months
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Self-Report of Ever Having Been Tested
Tijdsspanne: 1 month post-randomization
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The HIV testing secondary outcomes are all binary (Yes/No).
The below data represents self-reported completion of HIV test by 1 month.
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1 month post-randomization
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Lisa Metsch, Ph.D., Columbia University
- Hoofdonderzoeker: Grant Colfax, M.D., PATH
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Metsch LR, Feaster DJ, Gooden L, Matheson T, Mandler RN, Haynes L, Tross S, Kyle T, Gallup D, Kosinski AS, Douaihy A, Schackman BR, Das M, Lindblad R, Erickson S, Korthuis PT, Martino S, Sorensen JL, Szapocznik J, Walensky R, Branson B, Colfax GN. Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. Am J Public Health. 2012 Jun;102(6):1160-7. doi: 10.2105/AJPH.2011.300460. Epub 2012 Apr 19.
- Schackman BR, Metsch LR, Colfax GN, Leff JA, Wong A, Scott CA, Feaster DJ, Gooden L, Matheson T, Haynes LF, Paltiel AD, Walensky RP. The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial. Drug Alcohol Depend. 2013 Feb 1;128(1-2):90-7. doi: 10.1016/j.drugalcdep.2012.08.009. Epub 2012 Sep 9.
- Schackman BR, Leff JA, Barter DM, DiLorenzo MA, Feaster DJ, Metsch LR, Freedberg KA, Linas BP. Cost-effectiveness of rapid hepatitis C virus (HCV) testing and simultaneous rapid HCV and HIV testing in substance abuse treatment programs. Addiction. 2015 Jan;110(1):129-43. doi: 10.1111/add.12754.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2009
Primaire voltooiing (Werkelijk)
1 december 2009
Studie voltooiing (Werkelijk)
1 februari 2010
Studieregistratiedata
Eerst ingediend
16 december 2008
Eerst ingediend dat voldeed aan de QC-criteria
16 december 2008
Eerst geplaatst (Schatting)
17 december 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
14 oktober 2015
Laatste update ingediend die voldeed aan QC-criteria
13 oktober 2015
Laatst geverifieerd
1 september 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20080379
- U10DA013720 (Subsidie/contract van de Amerikaanse NIH)
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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