An observational study in HIV and Substance Abuse, sponsored by Emory University. Completed at 7 sites in United States. Open to male participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by Emory University · Observational
The scientific purpose of this study is to look at how substance use may relate to human immunodeficiency virus (HIV) infection among young black men who have sex with men in Atlanta.
Young black men who have sex with men (YBMSM) are a critically at-risk population in the United States and Atlanta that faces extremely high incidence rates of HIV and other sexually transmitted infections (STIs). The understanding of what places this group of men at high risk is incomplete, and the role of substances in amplifying that risk is unclear. This study will fill a number of gaps about how substances and partnerships place YBMSM at increased HIV risk. The study includes several innovative aspects. First, the investigators are using a theoretical framework to understand multilevel associations between substance use and HIV risk behavior in YBMSM in the southeastern United States, a critically at-risk but understudied population. Second, the investigators are using a variety of enhanced measurement methods to understand these associations. The investigators are supplementing self-reported substance use with objective measures to enhance the sensitivity of classifying recent use. The investigators will analyze incident HIV/STI endpoints in addition to self-reported sexual behaviors. The investigators will use detailed, event-based and dyadic measures of substance use and its covariates, which will capture both sexual and non-sexual contexts of use. Although previous cohort studies have explored alcohol and drug use during sexual events among men who have sex with men (MSM), few studies have described both sexual and non-sexual patterns of, and motivations for, substance use among YBMSM, and none have incorporated longitudinal biomarkers of substance use and related these to incident infection outcomes. Finally, the investigators are using a mixed-methods approach to provide context to the quantitative findings. By recruiting subjects to a nested qualitative study within the larger cohort based on their interval-specific risks, the investigators will gain in-depth information regarding the emergence, persistence, and resolution of these complex relationships between substances and sexual risk behaviors among YBMSM and how these relationships emerge and are resolved over time.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 469 is above the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Young black men who have sex with men in Atlanta, Georgia will be recruited in a variety of venues in Atlanta. If needed, there will be targeted recruitment via Facebook.
Exclusion Criteria:
Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-negative
Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-positive
Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use
Prevalence of drug use and association between these factors and HIV seroconversion (hazard ratio)
Time frame: 2 years
Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time frame: 2 years
Proportion of recent sex partners who are additionally substance-use partners
Time frame: 2.5 years
Incidence rates of HIV
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
Time frame: 2 years
Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time frame: 2.5 years
Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
Time frame: 2 years
Rate ratios between sexually transmitted infection (STI) incidence and levels of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time frame: 2 years
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Emory University