Overview

This trial is active, not recruiting.

Conditions drug abuse, hiv infections
Treatment injection and non-injection drug users
Phase phase 1
Sponsor The City College of New York
Collaborator National Institute on Drug Abuse (NIDA)
Start date February 2002
End date March 2015
Trial size 836 participants
Trial identifier NCT00198861, 5R01DA014498, 5R01DA014498-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
(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.

Primary Outcomes

Measure
HIV-Risk Behavior Outcomes
time frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.

Secondary Outcomes

Measure
Executive Functions
time frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
Serologic Outcomes
time frame: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.

Eligibility Criteria

Male or female participants from 15 years up to 50 years old.

Inclusion Criteria: - Drug users aged 15 to 50 years old. Exclusion Criteria: - Acute psychotic, suicidal, homicidal ideation.

Additional Information

Official title Neurobehavioral Model of HIV in Injection Drug Users
Principal investigator William W. Latimer, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by The City College of New York.