- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503618
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
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Atlanta, Georgia, United States, 30303
- Grady Health System
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Atlanta, Georgia, United States, 30322
- Rollins School of Public Health
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Atlanta, Georgia, United States, 30308
- Grady Infectious Diseases Clinic (Ponce Clinic)
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Atlanta, Georgia, United States, 30308
- The Ponce de Leon Center of the Grady Health System
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Atlanta, Georgia, United States, 30309
- AID Atlanta
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Atlanta, Georgia, United States, 30315
- Southside Medical Center
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Atlanta, Georgia, United States, 30331
- SisterLove, Inc
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-
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.
Sponsor
Collaborators
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.
General Publications
- Serota DP, Rosenberg ES, Thorne AL, Sullivan PS, Kelley CF. Lack of health insurance is associated with delays in PrEP initiation among young black men who have sex with men in Atlanta, US: a longitudinal cohort study. J Int AIDS Soc. 2019 Oct;22(10):e25399. doi: 10.1002/jia2.25399.
- Serota DP, Rosenberg ES, Sullivan PS, Thorne AL, Rolle CM, Del Rio C, Cutro S, Luisi N, Siegler AJ, Sanchez TH, Kelley CF. Pre-exposure Prophylaxis Uptake and Discontinuation Among Young Black Men Who Have Sex With Men in Atlanta, Georgia: A Prospective Cohort Study. Clin Infect Dis. 2020 Jul 27;71(3):574-582. doi: 10.1093/cid/ciz894.
- Serota DP, Rosenberg ES, Lockard AM, Rolle CM, Luisi N, Cutro S, Del Rio C, Siegler AJ, Sanchez TH, Sullivan PS, Kelley CF. Beyond the Biomedical: Preexposure Prophylaxis Failures in a Cohort of Young Black Men Who Have Sex With Men in Atlanta, Georgia. Clin Infect Dis. 2018 Aug 31;67(6):965-970. doi: 10.1093/cid/ciy297.
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
Additional Relevant MeSH Terms
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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