- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00198861
Neurobehavioral Model of HIV in Injection Drug Users
1 augusti 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
836
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Maryland
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Baltimore, Maryland, Förenta staterna, 21202
- University of Florida
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år till 50 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- Drug users aged 15 to 50 years old.
Exclusion Criteria:
- Acute psychotic, suicidal, homicidal ideation.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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
|
(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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
HIV-Risk Behavior Outcomes
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Executive Functions
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: William W. Latimer, PhD, MPH, University of Florida
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2002
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 mars 2016
Studieregistreringsdatum
Först inskickad
13 september 2005
Först inskickad som uppfyllde QC-kriterierna
13 september 2005
Första postat (Uppskatta)
20 september 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5R01DA014498-05 (U.S.S. NIH-anslag/kontrakt)
- 5R01DA014498 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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