Neurobehavioral Model of HIV in Injection Drug Users
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ClinicalTrials.gov Identifier: NCT00198861 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: August 2, 2016
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Condition or disease | Intervention/treatment |
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Drug Abuse HIV Infections | Other: Injection and Non-Injection Drug Users |
Study Type : | Observational |
Actual Enrollment : | 836 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Neurobehavioral Model of HIV in Injection Drug Users |
Study Start Date : | February 2002 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2016 |
Group/Cohort | Intervention/treatment |
---|---|
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
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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.
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- 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.
- 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.

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Ages Eligible for Study: | 15 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Drug users aged 15 to 50 years old.
Exclusion Criteria:
- Acute psychotic, suicidal, homicidal ideation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198861
United States, Maryland | |
University of Florida | |
Baltimore, Maryland, United States, 21202 |
Principal Investigator: | William W. Latimer, PhD, MPH | University of Florida |
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 ( U.S. NIH Grant/Contract ) 5R01DA014498 ( U.S. NIH Grant/Contract ) |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | August 2, 2016 |
Last Verified: | August 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Chemically-Induced Disorders Mental Disorders |