Understanding Substance Use and Incident HIV/STI Among Young Black MSM
25 de junio de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
469
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30303
- Grady Health System
-
Atlanta, Georgia, Estados Unidos, 30322
- Rollins School of Public Health
-
Atlanta, Georgia, Estados Unidos, 30308
- Grady Infectious Diseases Clinic (Ponce Clinic)
-
Atlanta, Georgia, Estados Unidos, 30308
- The Ponce de Leon Center of the Grady Health System
-
Atlanta, Georgia, Estados Unidos, 30309
- AID Atlanta
-
Atlanta, Georgia, Estados Unidos, 30315
- Southside Medical Center
-
Atlanta, Georgia, Estados Unidos, 30331
- SisterLove, Inc
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 29 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use
Periodo de tiempo: 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
Periodo de tiempo: 2 years
|
2 years
|
|
|
Proportion of recent sex partners who are additionally substance-use partners
Periodo de tiempo: 2.5 years
|
2.5 years
|
|
|
Incidence rates of HIV
Periodo de tiempo: 2 years
|
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use
Periodo de tiempo: 2.5 years
|
2.5 years
|
|
|
Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)
Periodo de tiempo: 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
Periodo de tiempo: 2 years
|
2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patrick S Sullivan, DVM, PhD, Emory University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2015
Finalización primaria (Actual)
18 de marzo de 2019
Finalización del estudio (Actual)
18 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2015
Publicado por primera vez (Estimar)
21 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00078950
- 1R01DA038196-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre VIH
-
Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
-
Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
-
China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán