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NCT00198861 · ClinicalTrials.gov registry record
Neurobehavioral Model of HIV in Injection Drug Users
A clinical trial, sponsored by The City College of New York.
- Completed
- Registry status
- 836
- Enrollment target
NCT00198861: Completed study, sponsored by The City College of New York.
NCT00198861 is a clinical trial that has completed, run by The City College of New York. The registered enrollment target is 836 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00198861 has completed, sponsored by The City College of New York.
- COMPLETED
- Registry status
- 836 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- OTHER Injection and Non-Injection Drug Users
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 836 participants |
| Start Date | 2002-02 |
| Est. Completion | 2016-03 |
What the finished NCT00198861 record still lists
NCT00198861 is an observational study that tracks outcomes without assigning an intervention. The registered 836 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Injection and Non-Injection Drug Users is the first listed.
NCT00198861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00198861 about?
NCT00198861 is a clinical study titled "Neurobehavioral Model of HIV in Injection Drug Users". 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 neuropsychol...
What is the current status of trial NCT00198861?
This trial is currently completed. The enrollment target is 836 participants. The study started on 2002-02. Estimated completion is 2016-03.
What interventions are being tested in trial NCT00198861?
The interventions under investigation include: Injection and Non-Injection Drug Users (OTHER).
Who is sponsoring clinical trial NCT00198861?
This trial is sponsored by The City College of New York, which has 7 total clinical trials registered on ClinicalTrials.gov.
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