Understanding Substance Use and Incident HIV/STI Among Young Black MSM
2019年6月25日 更新者: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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
469
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Georgia
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Atlanta、Georgia、美国、30303
- Grady Health System
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Atlanta、Georgia、美国、30322
- Rollins School of Public Health
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Atlanta、Georgia、美国、30308
- Grady Infectious Diseases Clinic (Ponce Clinic)
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Atlanta、Georgia、美国、30308
- The Ponce de Leon Center of the Grady Health System
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Atlanta、Georgia、美国、30309
- AID Atlanta
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Atlanta、Georgia、美国、30315
- Southside Medical Center
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Atlanta、Georgia、美国、30331
- SisterLove, Inc
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 29年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
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
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use
大体时间:2 years
|
Prevalence of drug use and association between these factors and HIV seroconversion (hazard ratio)
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2 years
|
Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
大体时间:2 years
|
2 years
|
|
Proportion of recent sex partners who are additionally substance-use partners
大体时间:2.5 years
|
2.5 years
|
|
Incidence rates of HIV
大体时间:2 years
|
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use
大体时间:2.5 years
|
2.5 years
|
|
Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)
大体时间: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
大体时间:2 years
|
2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Patrick S Sullivan, DVM, PhD、Emory University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年7月1日
初级完成 (实际的)
2019年3月18日
研究完成 (实际的)
2019年3月18日
研究注册日期
首次提交
2015年7月17日
首先提交符合 QC 标准的
2015年7月17日
首次发布 (估计)
2015年7月21日
研究记录更新
最后更新发布 (实际的)
2019年6月27日
上次提交的符合 QC 标准的更新
2019年6月25日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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