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Understanding Substance Use and Incident HIV/STI Among Young Black MSM

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ClinicalTrials.gov Identifier: NCT02503618
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University

Tracking Information
First Submitted Date July 17, 2015
First Posted Date July 21, 2015
Last Update Posted Date June 27, 2019
Study Start Date July 2015
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2015)
  • Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use [ Time Frame: 2 years ]
    Prevalence of drug use and association between these factors and HIV seroconversion (hazard ratio)
  • 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 [ Time Frame: 2 years ]
    Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2015)
  • 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) [ Time Frame: 2 years ]
    Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding Substance Use and Incident HIV/STI Among Young Black MSM
Official Title Understanding Substance Use and Incident HIV/STI Among Young Black Men Having Sex With Men (MSM)
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Dried blood spot testing, whole blood
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • HIV
  • Substance Abuse
Intervention Not Provided
Study Groups/Cohorts
  • HIV-negative YBMSM
    Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-negative
  • HIV-positive YBMSM
    Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-positive
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 25, 2019)
469
Original Estimated Enrollment
 (submitted: July 17, 2015)
476
Actual Study Completion Date March 18, 2019
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • male at birth
  • currently identifies as male
  • age ≥18 years and < 30 years at enrollment
  • had anal sex with a man in lifetime
  • has had any sex with a man in the past 3 months
  • self-reported race is black/African American
  • lives in Atlanta area and plans to remain for 2 years
  • is able to complete the survey instruments in English
  • is willing to provide at least 2 means of contact
  • is willing to be re-contacted for the return of HIV/STI testing results, and for other study reasons as necessary
  • is not enrolled in an HIV prevention trial

Exclusion Criteria:

  • self-reported multiple or non-Black/African American race(s)
  • self-reported Hispanic ethnicity
  • (for prospective follow-up) participant screens HIV-positive
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02503618
Other Study ID Numbers IRB00078950
1R01DA038196-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Patrick S Sullivan, Emory University
Study Sponsor Emory University
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Patrick S Sullivan, DVM, PhD Emory University
PRS Account Emory University
Verification Date June 2019