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

June 25, 2019 updated by: Patrick S Sullivan, Emory University

Understanding Substance Use and Incident HIV/STI Among Young Black Men Having Sex With Men (MSM)

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

469

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30322
        • Rollins School of Public Health
      • Atlanta, Georgia, United States, 30308
        • 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, 30309
        • AID Atlanta
      • Atlanta, Georgia, United States, 30315
        • Southside Medical Center
      • Atlanta, Georgia, United States, 30331
        • SisterLove, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years
Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time Frame: 2 years
2 years
Proportion of recent sex partners who are additionally substance-use partners
Time Frame: 2.5 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time Frame: 2.5 years
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.
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrick S Sullivan, DVM, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 18, 2019

Study Completion (Actual)

March 18, 2019

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00078950
  • 1R01DA038196-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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