Rapid HIV Testing and Counseling in Drug Abuse Treatment
13 ottobre 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1281
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Arizona
-
Tucson, Arizona, Stati Uniti, 85713
- La Frontera Center, Inc.
-
-
Connecticut
-
Danbury, Connecticut, Stati Uniti, 06818
- Midwestern Connecticut Council on Alcoholism
-
Plainville, Connecticut, Stati Uniti, 06062
- Wheeler Clinic
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21212
- Glenwood Life Counseling Center
-
-
Missouri
-
Cape Girardeau, Missouri, Stati Uniti, 63703
- Gibson Recover Centers
-
-
New Mexico
-
Santa Fe, New Mexico, Stati Uniti, 87505
- The Life Link
-
-
North Carolina
-
Salisbury, North Carolina, Stati Uniti, 28146
- Daymark Recovery Services, Inc.
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97214
- CODA
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Addiction Medicine Services (Western Psychiatric Institute)
-
-
South Carolina
-
Columbia, South Carolina, Stati Uniti, 29203
- Morris Village Alcohol and Drug Treatment Center
-
Columbia, South Carolina, Stati Uniti, 29250
- Lexington / Richland Alcohol and Drug Abuse Council
-
-
Virginia
-
Chesterfield, Virginia, Stati Uniti, 23832
- Chesterfield CSB Substance Abuse Service
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Sperimentale: 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.
|
Participants will be offered an on-site oral fluid HIV rapid test with basic info.
|
|
Comparatore attivo: 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.
|
Participants will be offered a referral list of HIV testing agencies in the community.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Self-Report Receipt of HIV Test Results
Lasso di tempo: One month post-randomization
|
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.
|
One month post-randomization
|
|
Number of Risky Sexual Behaviors
Lasso di tempo: Six months post-randomization
|
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).
|
Six months post-randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sharing of Needles Used in Drug Use
Lasso di tempo: Six months
|
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.
|
Six months
|
|
Self-Report of Ever Having Been Tested
Lasso di tempo: 1 month post-randomization
|
The HIV testing secondary outcomes are all binary (Yes/No).
The below data represents self-reported completion of HIV test by 1 month.
|
1 month post-randomization
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Lisa Metsch, Ph.D., Columbia University
- Investigatore principale: Grant Colfax, M.D., PATH
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2009
Completamento primario (Effettivo)
1 dicembre 2009
Completamento dello studio (Effettivo)
1 febbraio 2010
Date di iscrizione allo studio
Primo inviato
16 dicembre 2008
Primo inviato che soddisfa i criteri di controllo qualità
16 dicembre 2008
Primo Inserito (Stima)
17 dicembre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
14 ottobre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 ottobre 2015
Ultimo verificato
1 settembre 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 20080379
- U10DA013720 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .