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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02503618
First Posted: July 21, 2015
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Eli Rosenberg, Emory University
  Purpose
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.

Condition
HIV Substance Abuse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding Substance Use and Incident HIV/STI Among Young Black Men Having Sex With Men (MSM)

Resource links provided by NLM:


Further study details as provided by Eli Rosenberg, Emory University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Dried blood spot testing, whole blood

Estimated Enrollment: 476
Study Start Date: July 2015
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
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

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02503618


Locations
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Grady Infectious Diseases Clinic (Ponce Clinic)
Atlanta, Georgia, United States, 30308
The Ponce de Leon Center of the Grady Health System
Atlanta, Georgia, United States, 30308
AID Atlanta
Atlanta, Georgia, United States, 30309
Southside Medical Center
Atlanta, Georgia, United States, 30315
Rollins School of Public Health
Atlanta, Georgia, United States, 30322
SisterLove, Inc
Atlanta, Georgia, United States, 30331
Sponsors and Collaborators
Emory University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Patrick S Sullivan, DVM, PhD Emory University
  More Information

Responsible Party: Eli Rosenberg, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02503618     History of Changes
Other Study ID Numbers: IRB00078950
1R01DA038196-01 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2015
First Posted: July 21, 2015
Last Update Posted: October 27, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders