- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00198861
Neurobehavioral Model of HIV in Injection Drug Users
1. august 2016 oppdatert av: Dr. William Latimer, The City College of New York
The purpose of this R01 study is to evaluate the association between neuropsychological executive dysfunction and HIV infection among young injection and non-injection drug users.
A longitudinal study will be conducted in which the cohort of seronegative drug users completing a baseline neuropsychological battery are re-assessed on three subsequent occasions, roughly six months apart.
The primary aim of the longitudinal study is to estimate the magnitude of the suspected causal relationship between executive dysfunction and HIV-risk behaviors while adjusting for time-invariant (e.g.
sex, ethnicity) and time-varying (e.g.
degree of drug abuse) covariates.
We also seek to evaluate: (1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors.
If successful, this project will shed new light on significant and potentially malleable HIV-risk factors in injection and non-injection drug users.
This will be important evidence because injection drug abuse continues to account for a large proportion of HIV seroconversions particularly among young women and minorities.
As such, this RO1 research project serves as an important initial step in a line of innovative investigations about suspected causal associations between neuropsychological deficits and HIV-risk behaviors in drug users.
Ultimately, this line of investigation should lead to changes in public and clinical practices designed to prevent HIV infection.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
836
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21202
- University of Florida
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
15 år til 50 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
In total, we seek to recruit 150 HIV positive and 800 HIV negative drug users who are between the ages of 15 and 50 years and who have used illicit drugs within the previous five years of enrollment.
Beskrivelse
Inclusion Criteria:
- Drug users aged 15 to 50 years old.
Exclusion Criteria:
- Acute psychotic, suicidal, homicidal ideation.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Injection and Non-Injection Drug Users
(1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors
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(1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HIV-Risk Behavior Outcomes
Tidsramme: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
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Among the drug-related HIV-risk behaviors are drug use cessation and relapse, risky injection practices, including direct and indirect syringe sharing, disinfection practices, and injection in high risk contexts (e.g.
shooting galleries).
Sexual practices include number and types of partners (gender), type(s) of sexual acts (oral, vaginal and anal intercourse), condom use, survival sex (sex for money, drugs, shelter, food and protection), and incident sexually transmitted diseases.
|
Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Executive Functions
Tidsramme: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
|
Executive function measures will be derived for working memory, response inhibition, planning, decision making, and conceptual reasoning/cognitive flexibility.
A measure of working memory may be derived from the Digits Backward portion of the WAIS-III Digit Span subtest.
Components of response inhibition will be assessed by a Go No-Go task that measures impulse control and the Stroop Color-Word Test that measures interference control.
A measure of impulse control may be derived from the errors of commission score from the Go No-Go task.
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Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
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Serologic Outcomes
Tidsramme: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
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HIV antibody testing is performed at the baseline and semi-annual follow-up visits using standard ELISA screening and confirmatory Western Blots.
In addition, Hepatitis B and C antibody testing is performed at baseline and follow-up visits.
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Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: William W. Latimer, PhD, MPH, University of Florida
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2002
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. mars 2016
Datoer for studieregistrering
Først innsendt
13. september 2005
Først innsendt som oppfylte QC-kriteriene
13. september 2005
Først lagt ut (Anslag)
20. september 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5R01DA014498-05 (U.S. NIH-stipend/kontrakt)
- 5R01DA014498 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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