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Neurobehavioral Model of HIV in Injection Drug Users

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), April 2006

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
John Hopkins University
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00198861
  Purpose

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.


Condition Phase
Drug Abuse
HIV Infections
Phase I

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Neurobehavioral Model of HIV in Injection Drug Users

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment:   700
Study Start Date:   February 2002
Estimated Study Completion Date:   June 2006

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Drug users aged 15 to 50 years old.

Exclusion Criteria:

  • Acute psychotic, suicidal, homicidal ideation.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198861

Contacts
Contact: William W. Latimer, Ph.D., M.P.H.     410-206-5805     wlatimer@jhsph.edu    

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health     Recruiting
      Baltimore, Maryland, United States, 21205
      Contact: William W. Latimer, Ph.D., M.P.H.     410-206-5805     wlatimer@jhsph.edu    
      Principal Investigator: William W. Latimer, Ph.D.,M.P.H.            

Sponsors and Collaborators

Investigators
Principal Investigator:     William W. Latimer, Ph.D., M.P.H.     Johns Hopkins Bloomberg School of Public Health    
Principal Investigator:     William W. Latimer, Ph.D., M.P.H.     Johns Hopkins Bloomberg School of Public Health    
  More Information


Study ID Numbers:   5R01DA014498-05, 5R01DA014498-05
First Received:   September 13, 2005
Last Updated:   April 28, 2008
ClinicalTrials.gov Identifier:   NCT00198861
Health Authority:   United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV Epidemiology  
Neurology  
Neuropsychological  
HIV Risk Factors
Cognitive Risk Factors
HIV

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 21, 2008




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