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Completed

NCT Number: NCT02503618

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

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Key information

Age range

18 year–29 year

Sex eligibility

Male

Study type

Observational

Primary location

AID Atlanta, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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. Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use

    Time frame: 2 years

  3. Proportion of recent sex partners who are additionally substance-use partners

    Time frame: 2.5 years

  4. 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 outcomes

  1. Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use

    Time frame: 2.5 years

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2015
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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