Neurobehavioral Model of HIV in Injection Drug Users

HIV Infections Clinical Trial

Official title:

Neurobehavioral Model of HIV in Injection Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198861
• Other study ID #: 5R01DA014498-05
• Secondary ID: 5R01DA014498
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: August 1, 2016
• Start date: February 2002
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: The City College of New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 836
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• Drug users aged 15 to 50 years old.

Exclusion Criteria:

• Acute psychotic, suicidal, homicidal ideation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Abuse
• HIV Infections
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Baltimore	Maryland

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-Risk Behavior Outcomes	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.	Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.	No
Secondary	Executive Functions	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.	Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.	No
Secondary	Serologic Outcomes	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.	Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.	No