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
  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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 836
Study Start Date: February 2002
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts 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

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
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
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
University of Florida
Johns Hopkins University
Investigators
Principal Investigator: William W. Latimer, PhD, MPH University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00198861     History of Changes
Other Study ID Numbers: 5R01DA014498-05, 5R01DA014498
Study First Received: September 13, 2005
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
HIV Epidemiology
Neurology
Neuropsychological
HIV Risk Factors
Cognitive Risk Factors
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014