Neurobehavioral Model of HIV in Injection Drug Users

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00198861
First received: September 13, 2005
Last updated: March 26, 2014
Last verified: March 2014

September 13, 2005
March 26, 2014
February 2002
March 2014   (final data collection date for primary outcome measure)
HIV-Risk Behavior Outcomes [ Time Frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment. ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT00198861 on ClinicalTrials.gov Archive Site
  • Executive Functions [ Time Frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment. ] [ Designated as safety issue: No ]
    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.
  • Serologic Outcomes [ Time Frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment. ] [ Designated as safety issue: No ]
    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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Neurobehavioral Model of HIV in Injection Drug Users
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 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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Drug Abuse
  • HIV Infections
Other: 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.
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
Intervention: Other: Injection and Non-Injection Drug Users
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
836
March 2015
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Drug users aged 15 to 50 years old.

Exclusion Criteria:

  • Acute psychotic, suicidal, homicidal ideation.
Both
15 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00198861
5R01DA014498-05, 5R01DA014498
No
University of Florida
University of Florida
  • National Institute on Drug Abuse (NIDA)
  • Johns Hopkins University
Principal Investigator: William W. Latimer, PhD, MPH University of Florida
University of Florida
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP