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Clinical Trials

MainTitle

Neurobehavioral Model of HIV in Injection Drug Users

This study has been completed
Sponsor
The City College of New York

Collaborator
National Institute on Drug Abuse (NIDA)
Johns Hopkins University

Information provided by (Responsible Party)
Dr. William Latimer, The City College of New York

ClinicalTrials.gov Identifier
NCT00198861

First received: September 13, 2005
Last updated: August 1, 2016
Last Verified: August 2016
History of Changes
Purpose

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 Intervention Phase
Drug Abuse
HIV Infections

Other : Injection and Non-Injection Drug Users
Phase 1

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

Further study details as provided by Dr. William Latimer, The City College of New York:

Primary Outcome Measures

  • HIV-Risk Behavior Outcomes [ Time Frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment. ]
    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.
Secondary Outcome Measures:
  • Executive Functions [ Time Frame: 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.
  • Serologic Outcomes [ Time Frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment. ]
    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.

Enrollment: 836
Study Start Date: February 2002
Study Completion Date: March 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
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.

Eligibility

Eligibility

Ages Eligible for Study: 15 Years to 50 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Probability Sample  

Study Population

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.

Criteria

Inclusion Criteria:

  • Drug users aged 15 to 50 years old.


Exclusion Criteria:
  • Acute psychotic, suicidal, homicidal ideation.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

Locations

United States, Maryland
University of Florida
Baltimore, Maryland, United States, 21202

Sponsors and Collaborators

The City College of New York
National Institute on Drug Abuse (NIDA)
Johns Hopkins University

Investigators

Principal Investigator: William W. Latimer, PhD, MPH University of Florida
More Information

More Information


Responsible Party: Dr. William Latimer, Professor and Dean, The City College of New York  
ClinicalTrials.gov Identifier: NCT00198861   History of Changes  
Other Study ID Numbers: 5R01DA014498-05  
  5R01DA014498  
Study First Received: September 13, 2005  
Last Updated: August 1, 2016  

Keywords provided by Dr. William Latimer, The City College of New York:

HIV Epidemiology
Neurology
Neuropsychological
HIV Risk Factors
Cognitive Risk Factors
HIV

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.