Neurobehavioral Model of HIV in Injection Drug Users
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Neurobehavioral Model of HIV in Injection Drug Users|
- 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.
- 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.
|Study Start Date:||February 2002|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Contact: William W. Latimer, PhD, MPHfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Bloomberg School of Public Health||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: William W. Latimer, PhD, MPH 352-213-0338 email@example.com|
|Principal Investigator: William W. Latimer, Ph.D.,M.P.H.|
|Principal Investigator:||William W. Latimer, PhD, MPH||University of Florida|