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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503618
• Other study ID #: IRB00078950
• Secondary ID: 1R01DA038196-01
• Status: Completed
• Start date: July 2015
• Est. completion date: March 18, 2019

Study information

• Verified date: June 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Substance Abuse
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	AID Atlanta	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia
United States	Grady Infectious Diseases Clinic (Ponce Clinic)	Atlanta	Georgia
United States	Rollins School of Public Health	Atlanta	Georgia
United States	SisterLove, Inc	Atlanta	Georgia
United States	Southside Medical Center	Atlanta	Georgia
United States	The Ponce de Leon Center of the Grady Health System	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use	Prevalence of drug use and association between these factors and HIV seroconversion (hazard ratio)	2 years
Primary	Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use		2 years
Primary	Proportion of recent sex partners who are additionally substance-use partners		2.5 years
Primary	Incidence rates of HIV	Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.	2 years
Secondary	Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use		2.5 years
Secondary	Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)	Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.	2 years
Secondary	Rate ratios between sexually transmitted infection (STI) incidence and levels of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use		2 years